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In Case You Missed It: COVID
The potential problem(s) with a once-a-year COVID vaccine
Comments from the White House this week suggesting a once-a-year COVID-19 shot for most Americans, “just like your annual flu shot,” were met with backlash from many who say COVID and influenza come from different viruses and need different schedules.
Remarks, from “capitulation” to too few data, hit the airwaves and social media.
Some, however, agree with the White House vision and say that asking people to get one shot in the fall instead of periodic pushes for boosters will raise public confidence and buy-in and reduce consumer confusion.
Health leaders, including Bob Wachter, MD, chair of the department of medicine at the University of California, San Francisco, say they like the framing of the concept – that people who are not high-risk should plan each year for a COVID shot and a flu shot.
& we need strategy to bump uptake,” Dr. Wachter tweeted this week.
But the numbers of Americans seeking boosters remain low. Only one-third of all eligible people 50 years and older have gotten a second COVID booster, according to the Centers for Disease Control and Prevention. About half of those who got the original two shots got a first booster.
Meanwhile, the United States is still averaging about 70,000 new COVID cases and more than 300 deaths every day.
The suggested change in approach comes as Pfizer/BioNTech and Moderna roll out their new boosters that target Omicron subvariants BA.4 and BA.5 after the CDC recommended their use and the U.S. Food and Drug Administration approved emergency use authorization.
“As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant,” President Joe Biden said in a statement promoting the yearly approach.
Some say annual shot premature
Other experts say it’s too soon to tell whether an annual approach will work.
“We have no data to support that current vaccines, including the new BA.5 booster, will provide durable protection beyond 4-6 months. It would be good to aspire to this objective, and much longer duration or protection, but that will likely require next generation and nasal vaccines,” said Eric Topol, MD, Medscape’s editor-in-chief and founder and director of the Scripps Research Translational Institute.
A report in Nature Reviews Immunology states, “Mucosal vaccines offer the potential to trigger robust protective immune responses at the predominant sites of pathogen infection” and potentially “can prevent an infection from becoming established in the first place, rather than only curtailing infection and protecting against the development of disease symptoms.”
Dr. Topol tweeted after the White House statements, “[An annual vaccine] has the ring of Covid capitulation.”
William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., told this news organization that he cautions against interpreting the White House comments as official policy.
“This is the difficulty of having public health announcements come out of Washington,” he said. “They ought to come out of the CDC.”
He says there is a reasonable analogy between COVID and influenza, but warns, “don’t push the analogy.”
They are both serious respiratory viruses that can cause much illness and death in essentially the same populations, he notes. These are the older, frail people, people who have underlying illnesses or are immunocompromised.
Both viruses also mutate. But there the paths diverge.
“We’ve gotten into a pattern of annually updating the influenza vaccine because it is such a singularly seasonal virus,” Dr. Schaffner said. “Basically it disappears during the summer. We’ve had plenty of COVID during the summers.”
For COVID, he said, “We will need a periodic booster. Could this be annually? That would certainly make it easier.” But it’s too soon to tell, he said.
Dr. Schaffner noted that several manufacturers are working on a combined flu/COVID vaccine.
Just a ‘first step’ toward annual shot
The currently updated COVID vaccine may be the first step toward an annual vaccine, but it’s only the first step, Dr. Schaffner said. “We haven’t committed to further steps yet because we’re watching this virus.”
Syra Madad, DHSc, MSc, an infectious disease epidemiologist at Harvard University’s Belfer Center for Science and International Affairs, Cambridge, Mass., and the New York City hospital system, told this news organization that arguments on both sides make sense.
Having a single message once a year can help eliminate the considerable confusion involving people on individual timelines with different levels of immunity and separate campaigns for COVID and flu shots coming at different times of the year.
“Communication around vaccines is very muddled and that shows in our overall vaccination rates, particularly booster rates,” she says. “The overall strategy is hopeful and makes sense if we’re going to progress that way based on data.”
However, she said that the data are just not there yet to show it’s time for an annual vaccine. First, scientists will need to see how long protection lasts with the Omicron-specific vaccine and how well and how long it protects against severe disease and death as well as infection.
COVID is less predictable than influenza and the influenza vaccine has been around for decades, Dr. Madad noted. With influenza, the patterns are more easily anticipated with their “ladder-like pattern,” she said. “COVID-19 is not like that.”
What is hopeful, she said, “is that we’ve been in the Omicron dynasty since November of 2021. I’m hopeful that we’ll stick with that particular variant.”
Dr. Topol, Dr. Schaffner, and Dr. Madad declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Comments from the White House this week suggesting a once-a-year COVID-19 shot for most Americans, “just like your annual flu shot,” were met with backlash from many who say COVID and influenza come from different viruses and need different schedules.
Remarks, from “capitulation” to too few data, hit the airwaves and social media.
Some, however, agree with the White House vision and say that asking people to get one shot in the fall instead of periodic pushes for boosters will raise public confidence and buy-in and reduce consumer confusion.
Health leaders, including Bob Wachter, MD, chair of the department of medicine at the University of California, San Francisco, say they like the framing of the concept – that people who are not high-risk should plan each year for a COVID shot and a flu shot.
& we need strategy to bump uptake,” Dr. Wachter tweeted this week.
But the numbers of Americans seeking boosters remain low. Only one-third of all eligible people 50 years and older have gotten a second COVID booster, according to the Centers for Disease Control and Prevention. About half of those who got the original two shots got a first booster.
Meanwhile, the United States is still averaging about 70,000 new COVID cases and more than 300 deaths every day.
The suggested change in approach comes as Pfizer/BioNTech and Moderna roll out their new boosters that target Omicron subvariants BA.4 and BA.5 after the CDC recommended their use and the U.S. Food and Drug Administration approved emergency use authorization.
“As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant,” President Joe Biden said in a statement promoting the yearly approach.
Some say annual shot premature
Other experts say it’s too soon to tell whether an annual approach will work.
“We have no data to support that current vaccines, including the new BA.5 booster, will provide durable protection beyond 4-6 months. It would be good to aspire to this objective, and much longer duration or protection, but that will likely require next generation and nasal vaccines,” said Eric Topol, MD, Medscape’s editor-in-chief and founder and director of the Scripps Research Translational Institute.
A report in Nature Reviews Immunology states, “Mucosal vaccines offer the potential to trigger robust protective immune responses at the predominant sites of pathogen infection” and potentially “can prevent an infection from becoming established in the first place, rather than only curtailing infection and protecting against the development of disease symptoms.”
Dr. Topol tweeted after the White House statements, “[An annual vaccine] has the ring of Covid capitulation.”
William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., told this news organization that he cautions against interpreting the White House comments as official policy.
“This is the difficulty of having public health announcements come out of Washington,” he said. “They ought to come out of the CDC.”
He says there is a reasonable analogy between COVID and influenza, but warns, “don’t push the analogy.”
They are both serious respiratory viruses that can cause much illness and death in essentially the same populations, he notes. These are the older, frail people, people who have underlying illnesses or are immunocompromised.
Both viruses also mutate. But there the paths diverge.
“We’ve gotten into a pattern of annually updating the influenza vaccine because it is such a singularly seasonal virus,” Dr. Schaffner said. “Basically it disappears during the summer. We’ve had plenty of COVID during the summers.”
For COVID, he said, “We will need a periodic booster. Could this be annually? That would certainly make it easier.” But it’s too soon to tell, he said.
Dr. Schaffner noted that several manufacturers are working on a combined flu/COVID vaccine.
Just a ‘first step’ toward annual shot
The currently updated COVID vaccine may be the first step toward an annual vaccine, but it’s only the first step, Dr. Schaffner said. “We haven’t committed to further steps yet because we’re watching this virus.”
Syra Madad, DHSc, MSc, an infectious disease epidemiologist at Harvard University’s Belfer Center for Science and International Affairs, Cambridge, Mass., and the New York City hospital system, told this news organization that arguments on both sides make sense.
Having a single message once a year can help eliminate the considerable confusion involving people on individual timelines with different levels of immunity and separate campaigns for COVID and flu shots coming at different times of the year.
“Communication around vaccines is very muddled and that shows in our overall vaccination rates, particularly booster rates,” she says. “The overall strategy is hopeful and makes sense if we’re going to progress that way based on data.”
However, she said that the data are just not there yet to show it’s time for an annual vaccine. First, scientists will need to see how long protection lasts with the Omicron-specific vaccine and how well and how long it protects against severe disease and death as well as infection.
COVID is less predictable than influenza and the influenza vaccine has been around for decades, Dr. Madad noted. With influenza, the patterns are more easily anticipated with their “ladder-like pattern,” she said. “COVID-19 is not like that.”
What is hopeful, she said, “is that we’ve been in the Omicron dynasty since November of 2021. I’m hopeful that we’ll stick with that particular variant.”
Dr. Topol, Dr. Schaffner, and Dr. Madad declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Comments from the White House this week suggesting a once-a-year COVID-19 shot for most Americans, “just like your annual flu shot,” were met with backlash from many who say COVID and influenza come from different viruses and need different schedules.
Remarks, from “capitulation” to too few data, hit the airwaves and social media.
Some, however, agree with the White House vision and say that asking people to get one shot in the fall instead of periodic pushes for boosters will raise public confidence and buy-in and reduce consumer confusion.
Health leaders, including Bob Wachter, MD, chair of the department of medicine at the University of California, San Francisco, say they like the framing of the concept – that people who are not high-risk should plan each year for a COVID shot and a flu shot.
& we need strategy to bump uptake,” Dr. Wachter tweeted this week.
But the numbers of Americans seeking boosters remain low. Only one-third of all eligible people 50 years and older have gotten a second COVID booster, according to the Centers for Disease Control and Prevention. About half of those who got the original two shots got a first booster.
Meanwhile, the United States is still averaging about 70,000 new COVID cases and more than 300 deaths every day.
The suggested change in approach comes as Pfizer/BioNTech and Moderna roll out their new boosters that target Omicron subvariants BA.4 and BA.5 after the CDC recommended their use and the U.S. Food and Drug Administration approved emergency use authorization.
“As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant,” President Joe Biden said in a statement promoting the yearly approach.
Some say annual shot premature
Other experts say it’s too soon to tell whether an annual approach will work.
“We have no data to support that current vaccines, including the new BA.5 booster, will provide durable protection beyond 4-6 months. It would be good to aspire to this objective, and much longer duration or protection, but that will likely require next generation and nasal vaccines,” said Eric Topol, MD, Medscape’s editor-in-chief and founder and director of the Scripps Research Translational Institute.
A report in Nature Reviews Immunology states, “Mucosal vaccines offer the potential to trigger robust protective immune responses at the predominant sites of pathogen infection” and potentially “can prevent an infection from becoming established in the first place, rather than only curtailing infection and protecting against the development of disease symptoms.”
Dr. Topol tweeted after the White House statements, “[An annual vaccine] has the ring of Covid capitulation.”
William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., told this news organization that he cautions against interpreting the White House comments as official policy.
“This is the difficulty of having public health announcements come out of Washington,” he said. “They ought to come out of the CDC.”
He says there is a reasonable analogy between COVID and influenza, but warns, “don’t push the analogy.”
They are both serious respiratory viruses that can cause much illness and death in essentially the same populations, he notes. These are the older, frail people, people who have underlying illnesses or are immunocompromised.
Both viruses also mutate. But there the paths diverge.
“We’ve gotten into a pattern of annually updating the influenza vaccine because it is such a singularly seasonal virus,” Dr. Schaffner said. “Basically it disappears during the summer. We’ve had plenty of COVID during the summers.”
For COVID, he said, “We will need a periodic booster. Could this be annually? That would certainly make it easier.” But it’s too soon to tell, he said.
Dr. Schaffner noted that several manufacturers are working on a combined flu/COVID vaccine.
Just a ‘first step’ toward annual shot
The currently updated COVID vaccine may be the first step toward an annual vaccine, but it’s only the first step, Dr. Schaffner said. “We haven’t committed to further steps yet because we’re watching this virus.”
Syra Madad, DHSc, MSc, an infectious disease epidemiologist at Harvard University’s Belfer Center for Science and International Affairs, Cambridge, Mass., and the New York City hospital system, told this news organization that arguments on both sides make sense.
Having a single message once a year can help eliminate the considerable confusion involving people on individual timelines with different levels of immunity and separate campaigns for COVID and flu shots coming at different times of the year.
“Communication around vaccines is very muddled and that shows in our overall vaccination rates, particularly booster rates,” she says. “The overall strategy is hopeful and makes sense if we’re going to progress that way based on data.”
However, she said that the data are just not there yet to show it’s time for an annual vaccine. First, scientists will need to see how long protection lasts with the Omicron-specific vaccine and how well and how long it protects against severe disease and death as well as infection.
COVID is less predictable than influenza and the influenza vaccine has been around for decades, Dr. Madad noted. With influenza, the patterns are more easily anticipated with their “ladder-like pattern,” she said. “COVID-19 is not like that.”
What is hopeful, she said, “is that we’ve been in the Omicron dynasty since November of 2021. I’m hopeful that we’ll stick with that particular variant.”
Dr. Topol, Dr. Schaffner, and Dr. Madad declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Full-dose antithrombotic aids selected COVID-19 ICU patients
BARCELONA – Hospitalized patients in the ICU because of an acute COVID-19 infection had significantly fewer thrombotic events and complications when treated with full-dose anticoagulation, compared with patients who received standard-dose anticoagulation prophylaxis, but full-dose anticoagulation also triggered an excess of moderate and severe bleeding events, randomized trial results show.
The new findings from the COVID-PACT trial in an exclusively U.S.-based cohort of 382 on-treatment patients in the ICU with COVID-19 infection may lead to a change in existing guidelines, which currently recommend standard-dose prophylaxis based on results from prior head-to-head comparisons, such as guidelines posted March 2022 from the American Society of Hematology.
” after weighing an individual patient’s risk for both thrombotic events and bleeding, David D. Berg, MD, said at the annual congress of the European Society of Cardiology. Simultaneous with his report at the congress, the results also appeared online in the journal Circulation.
“What the results tell us is that full-dose anticoagulation in critically ill patients with COVID-19 is highly effective for reducing thrombotic complications,” said Dr. Berg, a cardiologist and critical care physician at Brigham and Women’s Hospital, Boston.
The report’s designated discussant agreed with Dr. Berg’s conclusions.
‘Need to replace the guidelines’
“We probably need to replace the guidelines,” said Eduardo Ramacciotti, MD, PhD, MPH, a professor of vascular surgery at Santa Casa School of Medicine, São Paulo. Dr. Ramacciotti praised the study’s design, the endpoints, and the fact that the design excluded patients at high risk for bleeding complications, particularly those with a fibrinogen level below 200 mg/dL (2 g/L).
But other experts questioned the significance of the COVID-PACT results given that the outcomes did not show that full-dose anticoagulation produced incremental improvement in patient survival.
“We should abandon the thought that intensified anticoagulation should be routine, because it did not overall increase the number of patients discharged from the hospital alive,” commented John W. Eikelboom, MBBS, a professor of hematology and thromboembolism at McMaster University, Hamilton, Ont.
“Preventing venous thrombosis is a good thing, but the money is in saving lives and stopping need for ventilation, and we haven’t been successful doing that with an antithrombotic strategy,” said Dr. Eikelboom. “It is useful to prevent venous thrombosis, but we need to look elsewhere to improve the outcomes of [critically ill] patients with COVID-19.”
Reducing thromboembolism is a ‘valid goal’
Dr. Berg took a different view. “It’s a valid goal to try to reduce venous thromboembolism complications,” the major benefit seen in his study, he said. “There is clinical significance to reducing thrombotic events in terms of how people feel, their functional status, and their complications. There are a lot of clinically relevant consequences of thrombosis beyond mortality.”
COVID-PACT ran at 34 U.S. centers from August 2020 to March 2022 but stopped short of its enrollment goal of 750 patients because of waning numbers of patients with COVID-19 admitted to ICUs. In addition to randomly assigning patients within 96 hours of their ICU admission to full-dose anticoagulation or to standard-dose antithrombotic prophylaxis, the study included a second, concurrent randomization to the antiplatelet agent clopidogrel (Plavix) or to no antiplatelet drug. Both randomizations used an open-label design.
The results failed to show a discernable effect from adding clopidogrel on both the primary efficacy and primary safety endpoints, adding to accumulated evidence that treatment with an antiplatelet agent, including aspirin, confers no antithrombotic benefit in patients with COVID-19.
The trial’s participants averaged 61 years old, 68% were obese, 59% had hypertension, and 32% had diabetes. The median time after ICU admission when randomized treatment began was 2.1 days, and researchers followed patients for a median of 13 days, including a median time on anticoagulation of 10.6 days.
The trial design allowed clinicians to use either low molecular weight heparin or unfractionated heparin for anticoagulation, and 82% of patients received low molecular weight heparin as their initial treatment. The prespecified design called for an on-treatment analysis because of an anticipated high crossover rate. During the trial, 34% of patients who started on the prophylactic dose switched to full dose, and 17% had the reverse crossover.
95% increased win ratio with full dose
The study’s primary efficacy endpoint used a win-ratio analysis that included seven different adverse outcomes that ranged from death from venous or arterial thrombosis to clinically silent deep vein thrombosis. Treatment with full-dose anticoagulation led to a significant 95% increase in win ratio.
Researchers also applied a more conventional time-to-first-event secondary efficacy analysis, which showed that full-dose anticoagulation cut the incidence of an adverse outcome by a significant 44% relative to prophylactic dosing.
The two study groups showed no difference in all-cause death rates. The efficacy advantage of the full-dose regimen was driven by reduced rates of venous thrombotic events, especially a reduction in clinically evident deep vein thrombotic events.
The primary safety endpoint was the rate of fatal or life-threatening bleeding episodes, and while life-threatening bleeds were numerically more common among the full-dose recipients (four events, compared with one event on prophylaxis dosing) the difference was not significant, and no patients died from a bleeding event.
More secondary safety bleeds
The safety difference showed up in a secondary measure of bleeding severity, the rate of GUSTO moderate or severe bleeds. These occurred in 15 of the full-dose recipients, compared with 1 patient on the prophylactic dose.
Dr. Berg highlighted that several prior studies have assessed various anticoagulation regimens in critically ill (ICU-admitted and on respiratory or cardiovascular support) patients with COVID-19. For example, two influential reports published in 2021 by the same team of investigators in the New England Journal of Medicine had sharply divergent results.
One multicenter study, which tested full-dose heparin against prophylactic treatment in more than 1,000 critically ill patients, was stopped prematurely because it had not shown a significant difference between the treatment arms. The second study, in more than 2,000 multicenter patients with COVID-19 who did not require critical-level organ support, showed clear superiority of the full-dose heparin regimen.
Notably, both previous studies used a different primary efficacy endpoint than the COVID-PACT study. The earlier reports both measured efficacy in terms of patients being alive and off organ support by 21 days from randomization.
Patients to exclude
Although Dr. Berg stressed the clear positive result, he also cautioned that they should not apply to patients excluded from the study: those with severe coagulopathies, those with severe thrombocytopenia, and patients already maintained on dual antiplatelet therapy. He also cautioned against using the full-dose strategy in elderly patients, because in COVID-PACT, those who developed bleeding complications tended to be older.
Dr. Berg also noted that heparin prophylaxis is a well-established intervention for ICU-admitted patients without COVID-19 for the purpose of preventing venous thromboembolisms without evidence that this approach reduces deaths or organ failure.
But he conceded that “the priority of treatment depends on whether it saves lives, so anticoagulation is probably not as high a priority as other effective treatments” that reduce mortality. “Preventing venous thromboembolism has rarely been shown to have a mortality benefit,” Dr. Berg noted.
COVID-PACT received no direct commercial funding. Dr. Berg has been a consultant to AstraZeneca, Mobility Bio, and Youngene Therapeutics, and he participated in a trial sponsored by Kowa. Dr. Ramacciotti has been a consultant to or speaker on behalf of Aspen, Bayer, Daiichi Sankyo, Mylan, Pfizer, and Sanofi, and he has received research support from Bayer, Esperon, Novartis, and Pfizer. Dr. Eikelboom has received honoraria and research support from Bayer.
A version of this article first appeared on Medscape.com.
BARCELONA – Hospitalized patients in the ICU because of an acute COVID-19 infection had significantly fewer thrombotic events and complications when treated with full-dose anticoagulation, compared with patients who received standard-dose anticoagulation prophylaxis, but full-dose anticoagulation also triggered an excess of moderate and severe bleeding events, randomized trial results show.
The new findings from the COVID-PACT trial in an exclusively U.S.-based cohort of 382 on-treatment patients in the ICU with COVID-19 infection may lead to a change in existing guidelines, which currently recommend standard-dose prophylaxis based on results from prior head-to-head comparisons, such as guidelines posted March 2022 from the American Society of Hematology.
” after weighing an individual patient’s risk for both thrombotic events and bleeding, David D. Berg, MD, said at the annual congress of the European Society of Cardiology. Simultaneous with his report at the congress, the results also appeared online in the journal Circulation.
“What the results tell us is that full-dose anticoagulation in critically ill patients with COVID-19 is highly effective for reducing thrombotic complications,” said Dr. Berg, a cardiologist and critical care physician at Brigham and Women’s Hospital, Boston.
The report’s designated discussant agreed with Dr. Berg’s conclusions.
‘Need to replace the guidelines’
“We probably need to replace the guidelines,” said Eduardo Ramacciotti, MD, PhD, MPH, a professor of vascular surgery at Santa Casa School of Medicine, São Paulo. Dr. Ramacciotti praised the study’s design, the endpoints, and the fact that the design excluded patients at high risk for bleeding complications, particularly those with a fibrinogen level below 200 mg/dL (2 g/L).
But other experts questioned the significance of the COVID-PACT results given that the outcomes did not show that full-dose anticoagulation produced incremental improvement in patient survival.
“We should abandon the thought that intensified anticoagulation should be routine, because it did not overall increase the number of patients discharged from the hospital alive,” commented John W. Eikelboom, MBBS, a professor of hematology and thromboembolism at McMaster University, Hamilton, Ont.
“Preventing venous thrombosis is a good thing, but the money is in saving lives and stopping need for ventilation, and we haven’t been successful doing that with an antithrombotic strategy,” said Dr. Eikelboom. “It is useful to prevent venous thrombosis, but we need to look elsewhere to improve the outcomes of [critically ill] patients with COVID-19.”
Reducing thromboembolism is a ‘valid goal’
Dr. Berg took a different view. “It’s a valid goal to try to reduce venous thromboembolism complications,” the major benefit seen in his study, he said. “There is clinical significance to reducing thrombotic events in terms of how people feel, their functional status, and their complications. There are a lot of clinically relevant consequences of thrombosis beyond mortality.”
COVID-PACT ran at 34 U.S. centers from August 2020 to March 2022 but stopped short of its enrollment goal of 750 patients because of waning numbers of patients with COVID-19 admitted to ICUs. In addition to randomly assigning patients within 96 hours of their ICU admission to full-dose anticoagulation or to standard-dose antithrombotic prophylaxis, the study included a second, concurrent randomization to the antiplatelet agent clopidogrel (Plavix) or to no antiplatelet drug. Both randomizations used an open-label design.
The results failed to show a discernable effect from adding clopidogrel on both the primary efficacy and primary safety endpoints, adding to accumulated evidence that treatment with an antiplatelet agent, including aspirin, confers no antithrombotic benefit in patients with COVID-19.
The trial’s participants averaged 61 years old, 68% were obese, 59% had hypertension, and 32% had diabetes. The median time after ICU admission when randomized treatment began was 2.1 days, and researchers followed patients for a median of 13 days, including a median time on anticoagulation of 10.6 days.
The trial design allowed clinicians to use either low molecular weight heparin or unfractionated heparin for anticoagulation, and 82% of patients received low molecular weight heparin as their initial treatment. The prespecified design called for an on-treatment analysis because of an anticipated high crossover rate. During the trial, 34% of patients who started on the prophylactic dose switched to full dose, and 17% had the reverse crossover.
95% increased win ratio with full dose
The study’s primary efficacy endpoint used a win-ratio analysis that included seven different adverse outcomes that ranged from death from venous or arterial thrombosis to clinically silent deep vein thrombosis. Treatment with full-dose anticoagulation led to a significant 95% increase in win ratio.
Researchers also applied a more conventional time-to-first-event secondary efficacy analysis, which showed that full-dose anticoagulation cut the incidence of an adverse outcome by a significant 44% relative to prophylactic dosing.
The two study groups showed no difference in all-cause death rates. The efficacy advantage of the full-dose regimen was driven by reduced rates of venous thrombotic events, especially a reduction in clinically evident deep vein thrombotic events.
The primary safety endpoint was the rate of fatal or life-threatening bleeding episodes, and while life-threatening bleeds were numerically more common among the full-dose recipients (four events, compared with one event on prophylaxis dosing) the difference was not significant, and no patients died from a bleeding event.
More secondary safety bleeds
The safety difference showed up in a secondary measure of bleeding severity, the rate of GUSTO moderate or severe bleeds. These occurred in 15 of the full-dose recipients, compared with 1 patient on the prophylactic dose.
Dr. Berg highlighted that several prior studies have assessed various anticoagulation regimens in critically ill (ICU-admitted and on respiratory or cardiovascular support) patients with COVID-19. For example, two influential reports published in 2021 by the same team of investigators in the New England Journal of Medicine had sharply divergent results.
One multicenter study, which tested full-dose heparin against prophylactic treatment in more than 1,000 critically ill patients, was stopped prematurely because it had not shown a significant difference between the treatment arms. The second study, in more than 2,000 multicenter patients with COVID-19 who did not require critical-level organ support, showed clear superiority of the full-dose heparin regimen.
Notably, both previous studies used a different primary efficacy endpoint than the COVID-PACT study. The earlier reports both measured efficacy in terms of patients being alive and off organ support by 21 days from randomization.
Patients to exclude
Although Dr. Berg stressed the clear positive result, he also cautioned that they should not apply to patients excluded from the study: those with severe coagulopathies, those with severe thrombocytopenia, and patients already maintained on dual antiplatelet therapy. He also cautioned against using the full-dose strategy in elderly patients, because in COVID-PACT, those who developed bleeding complications tended to be older.
Dr. Berg also noted that heparin prophylaxis is a well-established intervention for ICU-admitted patients without COVID-19 for the purpose of preventing venous thromboembolisms without evidence that this approach reduces deaths or organ failure.
But he conceded that “the priority of treatment depends on whether it saves lives, so anticoagulation is probably not as high a priority as other effective treatments” that reduce mortality. “Preventing venous thromboembolism has rarely been shown to have a mortality benefit,” Dr. Berg noted.
COVID-PACT received no direct commercial funding. Dr. Berg has been a consultant to AstraZeneca, Mobility Bio, and Youngene Therapeutics, and he participated in a trial sponsored by Kowa. Dr. Ramacciotti has been a consultant to or speaker on behalf of Aspen, Bayer, Daiichi Sankyo, Mylan, Pfizer, and Sanofi, and he has received research support from Bayer, Esperon, Novartis, and Pfizer. Dr. Eikelboom has received honoraria and research support from Bayer.
A version of this article first appeared on Medscape.com.
BARCELONA – Hospitalized patients in the ICU because of an acute COVID-19 infection had significantly fewer thrombotic events and complications when treated with full-dose anticoagulation, compared with patients who received standard-dose anticoagulation prophylaxis, but full-dose anticoagulation also triggered an excess of moderate and severe bleeding events, randomized trial results show.
The new findings from the COVID-PACT trial in an exclusively U.S.-based cohort of 382 on-treatment patients in the ICU with COVID-19 infection may lead to a change in existing guidelines, which currently recommend standard-dose prophylaxis based on results from prior head-to-head comparisons, such as guidelines posted March 2022 from the American Society of Hematology.
” after weighing an individual patient’s risk for both thrombotic events and bleeding, David D. Berg, MD, said at the annual congress of the European Society of Cardiology. Simultaneous with his report at the congress, the results also appeared online in the journal Circulation.
“What the results tell us is that full-dose anticoagulation in critically ill patients with COVID-19 is highly effective for reducing thrombotic complications,” said Dr. Berg, a cardiologist and critical care physician at Brigham and Women’s Hospital, Boston.
The report’s designated discussant agreed with Dr. Berg’s conclusions.
‘Need to replace the guidelines’
“We probably need to replace the guidelines,” said Eduardo Ramacciotti, MD, PhD, MPH, a professor of vascular surgery at Santa Casa School of Medicine, São Paulo. Dr. Ramacciotti praised the study’s design, the endpoints, and the fact that the design excluded patients at high risk for bleeding complications, particularly those with a fibrinogen level below 200 mg/dL (2 g/L).
But other experts questioned the significance of the COVID-PACT results given that the outcomes did not show that full-dose anticoagulation produced incremental improvement in patient survival.
“We should abandon the thought that intensified anticoagulation should be routine, because it did not overall increase the number of patients discharged from the hospital alive,” commented John W. Eikelboom, MBBS, a professor of hematology and thromboembolism at McMaster University, Hamilton, Ont.
“Preventing venous thrombosis is a good thing, but the money is in saving lives and stopping need for ventilation, and we haven’t been successful doing that with an antithrombotic strategy,” said Dr. Eikelboom. “It is useful to prevent venous thrombosis, but we need to look elsewhere to improve the outcomes of [critically ill] patients with COVID-19.”
Reducing thromboembolism is a ‘valid goal’
Dr. Berg took a different view. “It’s a valid goal to try to reduce venous thromboembolism complications,” the major benefit seen in his study, he said. “There is clinical significance to reducing thrombotic events in terms of how people feel, their functional status, and their complications. There are a lot of clinically relevant consequences of thrombosis beyond mortality.”
COVID-PACT ran at 34 U.S. centers from August 2020 to March 2022 but stopped short of its enrollment goal of 750 patients because of waning numbers of patients with COVID-19 admitted to ICUs. In addition to randomly assigning patients within 96 hours of their ICU admission to full-dose anticoagulation or to standard-dose antithrombotic prophylaxis, the study included a second, concurrent randomization to the antiplatelet agent clopidogrel (Plavix) or to no antiplatelet drug. Both randomizations used an open-label design.
The results failed to show a discernable effect from adding clopidogrel on both the primary efficacy and primary safety endpoints, adding to accumulated evidence that treatment with an antiplatelet agent, including aspirin, confers no antithrombotic benefit in patients with COVID-19.
The trial’s participants averaged 61 years old, 68% were obese, 59% had hypertension, and 32% had diabetes. The median time after ICU admission when randomized treatment began was 2.1 days, and researchers followed patients for a median of 13 days, including a median time on anticoagulation of 10.6 days.
The trial design allowed clinicians to use either low molecular weight heparin or unfractionated heparin for anticoagulation, and 82% of patients received low molecular weight heparin as their initial treatment. The prespecified design called for an on-treatment analysis because of an anticipated high crossover rate. During the trial, 34% of patients who started on the prophylactic dose switched to full dose, and 17% had the reverse crossover.
95% increased win ratio with full dose
The study’s primary efficacy endpoint used a win-ratio analysis that included seven different adverse outcomes that ranged from death from venous or arterial thrombosis to clinically silent deep vein thrombosis. Treatment with full-dose anticoagulation led to a significant 95% increase in win ratio.
Researchers also applied a more conventional time-to-first-event secondary efficacy analysis, which showed that full-dose anticoagulation cut the incidence of an adverse outcome by a significant 44% relative to prophylactic dosing.
The two study groups showed no difference in all-cause death rates. The efficacy advantage of the full-dose regimen was driven by reduced rates of venous thrombotic events, especially a reduction in clinically evident deep vein thrombotic events.
The primary safety endpoint was the rate of fatal or life-threatening bleeding episodes, and while life-threatening bleeds were numerically more common among the full-dose recipients (four events, compared with one event on prophylaxis dosing) the difference was not significant, and no patients died from a bleeding event.
More secondary safety bleeds
The safety difference showed up in a secondary measure of bleeding severity, the rate of GUSTO moderate or severe bleeds. These occurred in 15 of the full-dose recipients, compared with 1 patient on the prophylactic dose.
Dr. Berg highlighted that several prior studies have assessed various anticoagulation regimens in critically ill (ICU-admitted and on respiratory or cardiovascular support) patients with COVID-19. For example, two influential reports published in 2021 by the same team of investigators in the New England Journal of Medicine had sharply divergent results.
One multicenter study, which tested full-dose heparin against prophylactic treatment in more than 1,000 critically ill patients, was stopped prematurely because it had not shown a significant difference between the treatment arms. The second study, in more than 2,000 multicenter patients with COVID-19 who did not require critical-level organ support, showed clear superiority of the full-dose heparin regimen.
Notably, both previous studies used a different primary efficacy endpoint than the COVID-PACT study. The earlier reports both measured efficacy in terms of patients being alive and off organ support by 21 days from randomization.
Patients to exclude
Although Dr. Berg stressed the clear positive result, he also cautioned that they should not apply to patients excluded from the study: those with severe coagulopathies, those with severe thrombocytopenia, and patients already maintained on dual antiplatelet therapy. He also cautioned against using the full-dose strategy in elderly patients, because in COVID-PACT, those who developed bleeding complications tended to be older.
Dr. Berg also noted that heparin prophylaxis is a well-established intervention for ICU-admitted patients without COVID-19 for the purpose of preventing venous thromboembolisms without evidence that this approach reduces deaths or organ failure.
But he conceded that “the priority of treatment depends on whether it saves lives, so anticoagulation is probably not as high a priority as other effective treatments” that reduce mortality. “Preventing venous thromboembolism has rarely been shown to have a mortality benefit,” Dr. Berg noted.
COVID-PACT received no direct commercial funding. Dr. Berg has been a consultant to AstraZeneca, Mobility Bio, and Youngene Therapeutics, and he participated in a trial sponsored by Kowa. Dr. Ramacciotti has been a consultant to or speaker on behalf of Aspen, Bayer, Daiichi Sankyo, Mylan, Pfizer, and Sanofi, and he has received research support from Bayer, Esperon, Novartis, and Pfizer. Dr. Eikelboom has received honoraria and research support from Bayer.
A version of this article first appeared on Medscape.com.
Why some infectious disease docs are ‘encouraged’ by new bivalent COVID vaccines
A panel of infectious disease experts shared their take recently on the importance of the newly approved bivalent COVID-19 vaccines, why authorization without human data is not for them a cause for alarm, and what they are most optimistic about at this stage of the pandemic.
“I’m very encouraged by this new development,” Kathryn M. Edwards, MD, said during a media briefing sponsored by the Infectious Diseases Society of America (IDSA).
, she said. “It does seem that if you have a circulating strain BA.4 and BA.5, hitting it with the appropriate vaccine targeted for that is most immunogenic, certainly. We will hopefully see that in terms of effectiveness.”
Changing the vaccines at this point is appropriate, Walter A. Orenstein, MD, said. “One of our challenges is that this virus mutates. Our immune response is focused on an area of the virus that can change and be evaded,” said Dr. Orenstein, professor and associate director of the Emory Vaccine Center at Emory University, Atlanta.
“This is different than measles or polio,” he said. “But for influenza and now with SARS-CoV-2 ... we have to update our vaccines, because the virus changes.”
Man versus mouse
Dr. Edwards addressed the controversy over a lack of human data specific to these next-generation Pfizer/BioNTech and Moderna vaccines. “I do not want people to be unhappy or worried that the bivalent vaccine will act in a different way than the ones that we have been administering for the past 2 years.”
The Food and Drug Administration emergency use authorization may have relied primarily on animal studies, she said, but mice given a vaccine specific to BA.4 and BA.5 “have a much more robust immune response,” compared with those given a BA.1 vaccine.
Also, “over and over and over again we have seen with these SARS-CoV-2 vaccines that the mouse responses mirror the human responses,” said Dr. Edwards, scientific director of the Vanderbilt Vaccine Research Program at Vanderbilt University, Nashville, Tenn., and an IDSA fellow.
“Human data will be coming very soon to look at the immunogenicity,” she said.
A ‘glass half full’ perspective
When asked what they are most optimistic about at this point in the COVID-19 pandemic, Dr. Orenstein said, “I’m really positive in the sense that the vaccines we have are already very effective against severe disease, death, and hospitalization. I feel really good about that. And we have great tools.
“The bottom line for me is, I want to get it myself,” he said regarding the bivalent vaccine.
“There are a lot of things to be happy with,” Dr. Edwards said. “I’m kind of a glass-half-full kind of person.”
Dr. Edwards is confident that the surveillance systems now in place can accurately detect major changes in the virus, including new variants. She is also optimistic about the mRNA technology that allows rapid updates to COVID-19 vaccines.
Furthermore, “I’m happy that we’re beginning to open up – that we can go do different things that we have done in the past and feel much more comfortable,” she said.
More motivational messaging needed
Now is also a good time to renew efforts to get people vaccinated.
“We invested a lot into developing these vaccines, but I think we also need to invest in what I call ‘implementation science research,’ ” Dr. Orenstein said, the goal being to convince people to get vaccinated.
He pointed out that it’s vaccinations, not vaccines, that saves lives. “Vaccine doses that remain in the vial are 0% effective.
“When I was director of the United States’ immunization program at the CDC,” Dr. Orenstein said, “my director of communications used to say that you need the right message delivered by the right messenger through the right communications channel.”
Dr. Edwards agreed that listening to people’s concerns and respecting their questions are important. “We also need to make sure that we use the proper messenger, just as Walt said. Maybe the proper messenger isn’t an old gray-haired lady,” she said, referring to herself, “but it’s someone that lives in your community or is your primary care doctor who has taken care of you or your children for many years.”
Research on how to better motivate people to get vaccinated is warranted, Dr. Edwards said, as well as on “how to make sure that this is really a medical issue and not a political issue. That’s been a really big problem.”
A version of this article first appeared on Medscape.com.
A panel of infectious disease experts shared their take recently on the importance of the newly approved bivalent COVID-19 vaccines, why authorization without human data is not for them a cause for alarm, and what they are most optimistic about at this stage of the pandemic.
“I’m very encouraged by this new development,” Kathryn M. Edwards, MD, said during a media briefing sponsored by the Infectious Diseases Society of America (IDSA).
, she said. “It does seem that if you have a circulating strain BA.4 and BA.5, hitting it with the appropriate vaccine targeted for that is most immunogenic, certainly. We will hopefully see that in terms of effectiveness.”
Changing the vaccines at this point is appropriate, Walter A. Orenstein, MD, said. “One of our challenges is that this virus mutates. Our immune response is focused on an area of the virus that can change and be evaded,” said Dr. Orenstein, professor and associate director of the Emory Vaccine Center at Emory University, Atlanta.
“This is different than measles or polio,” he said. “But for influenza and now with SARS-CoV-2 ... we have to update our vaccines, because the virus changes.”
Man versus mouse
Dr. Edwards addressed the controversy over a lack of human data specific to these next-generation Pfizer/BioNTech and Moderna vaccines. “I do not want people to be unhappy or worried that the bivalent vaccine will act in a different way than the ones that we have been administering for the past 2 years.”
The Food and Drug Administration emergency use authorization may have relied primarily on animal studies, she said, but mice given a vaccine specific to BA.4 and BA.5 “have a much more robust immune response,” compared with those given a BA.1 vaccine.
Also, “over and over and over again we have seen with these SARS-CoV-2 vaccines that the mouse responses mirror the human responses,” said Dr. Edwards, scientific director of the Vanderbilt Vaccine Research Program at Vanderbilt University, Nashville, Tenn., and an IDSA fellow.
“Human data will be coming very soon to look at the immunogenicity,” she said.
A ‘glass half full’ perspective
When asked what they are most optimistic about at this point in the COVID-19 pandemic, Dr. Orenstein said, “I’m really positive in the sense that the vaccines we have are already very effective against severe disease, death, and hospitalization. I feel really good about that. And we have great tools.
“The bottom line for me is, I want to get it myself,” he said regarding the bivalent vaccine.
“There are a lot of things to be happy with,” Dr. Edwards said. “I’m kind of a glass-half-full kind of person.”
Dr. Edwards is confident that the surveillance systems now in place can accurately detect major changes in the virus, including new variants. She is also optimistic about the mRNA technology that allows rapid updates to COVID-19 vaccines.
Furthermore, “I’m happy that we’re beginning to open up – that we can go do different things that we have done in the past and feel much more comfortable,” she said.
More motivational messaging needed
Now is also a good time to renew efforts to get people vaccinated.
“We invested a lot into developing these vaccines, but I think we also need to invest in what I call ‘implementation science research,’ ” Dr. Orenstein said, the goal being to convince people to get vaccinated.
He pointed out that it’s vaccinations, not vaccines, that saves lives. “Vaccine doses that remain in the vial are 0% effective.
“When I was director of the United States’ immunization program at the CDC,” Dr. Orenstein said, “my director of communications used to say that you need the right message delivered by the right messenger through the right communications channel.”
Dr. Edwards agreed that listening to people’s concerns and respecting their questions are important. “We also need to make sure that we use the proper messenger, just as Walt said. Maybe the proper messenger isn’t an old gray-haired lady,” she said, referring to herself, “but it’s someone that lives in your community or is your primary care doctor who has taken care of you or your children for many years.”
Research on how to better motivate people to get vaccinated is warranted, Dr. Edwards said, as well as on “how to make sure that this is really a medical issue and not a political issue. That’s been a really big problem.”
A version of this article first appeared on Medscape.com.
A panel of infectious disease experts shared their take recently on the importance of the newly approved bivalent COVID-19 vaccines, why authorization without human data is not for them a cause for alarm, and what they are most optimistic about at this stage of the pandemic.
“I’m very encouraged by this new development,” Kathryn M. Edwards, MD, said during a media briefing sponsored by the Infectious Diseases Society of America (IDSA).
, she said. “It does seem that if you have a circulating strain BA.4 and BA.5, hitting it with the appropriate vaccine targeted for that is most immunogenic, certainly. We will hopefully see that in terms of effectiveness.”
Changing the vaccines at this point is appropriate, Walter A. Orenstein, MD, said. “One of our challenges is that this virus mutates. Our immune response is focused on an area of the virus that can change and be evaded,” said Dr. Orenstein, professor and associate director of the Emory Vaccine Center at Emory University, Atlanta.
“This is different than measles or polio,” he said. “But for influenza and now with SARS-CoV-2 ... we have to update our vaccines, because the virus changes.”
Man versus mouse
Dr. Edwards addressed the controversy over a lack of human data specific to these next-generation Pfizer/BioNTech and Moderna vaccines. “I do not want people to be unhappy or worried that the bivalent vaccine will act in a different way than the ones that we have been administering for the past 2 years.”
The Food and Drug Administration emergency use authorization may have relied primarily on animal studies, she said, but mice given a vaccine specific to BA.4 and BA.5 “have a much more robust immune response,” compared with those given a BA.1 vaccine.
Also, “over and over and over again we have seen with these SARS-CoV-2 vaccines that the mouse responses mirror the human responses,” said Dr. Edwards, scientific director of the Vanderbilt Vaccine Research Program at Vanderbilt University, Nashville, Tenn., and an IDSA fellow.
“Human data will be coming very soon to look at the immunogenicity,” she said.
A ‘glass half full’ perspective
When asked what they are most optimistic about at this point in the COVID-19 pandemic, Dr. Orenstein said, “I’m really positive in the sense that the vaccines we have are already very effective against severe disease, death, and hospitalization. I feel really good about that. And we have great tools.
“The bottom line for me is, I want to get it myself,” he said regarding the bivalent vaccine.
“There are a lot of things to be happy with,” Dr. Edwards said. “I’m kind of a glass-half-full kind of person.”
Dr. Edwards is confident that the surveillance systems now in place can accurately detect major changes in the virus, including new variants. She is also optimistic about the mRNA technology that allows rapid updates to COVID-19 vaccines.
Furthermore, “I’m happy that we’re beginning to open up – that we can go do different things that we have done in the past and feel much more comfortable,” she said.
More motivational messaging needed
Now is also a good time to renew efforts to get people vaccinated.
“We invested a lot into developing these vaccines, but I think we also need to invest in what I call ‘implementation science research,’ ” Dr. Orenstein said, the goal being to convince people to get vaccinated.
He pointed out that it’s vaccinations, not vaccines, that saves lives. “Vaccine doses that remain in the vial are 0% effective.
“When I was director of the United States’ immunization program at the CDC,” Dr. Orenstein said, “my director of communications used to say that you need the right message delivered by the right messenger through the right communications channel.”
Dr. Edwards agreed that listening to people’s concerns and respecting their questions are important. “We also need to make sure that we use the proper messenger, just as Walt said. Maybe the proper messenger isn’t an old gray-haired lady,” she said, referring to herself, “but it’s someone that lives in your community or is your primary care doctor who has taken care of you or your children for many years.”
Research on how to better motivate people to get vaccinated is warranted, Dr. Edwards said, as well as on “how to make sure that this is really a medical issue and not a political issue. That’s been a really big problem.”
A version of this article first appeared on Medscape.com.
Vitamin D supplementation shows no COVID-19 prevention
Two large studies out of the United Kingdom and Norway show vitamin D supplementation has no benefit – as low dose, high dose, or in the form of cod liver oil supplementation – in preventing COVID-19 or acute respiratory tract infections, regardless of whether individuals are deficient or not.
The studies, published in the BMJ, underscore that “vaccination is still the most effective way to protect people from COVID-19, and vitamin D and cod liver oil supplementation should not be offered to healthy people with normal vitamin D levels,” writes Peter Bergman, MD, of the Karolinska Institute, Stockholm, in an editorial published alongside the studies.
Suboptimal levels of vitamin D are known to be associated with an increased risk of acute respiratory infections, and some observational studies have linked low 25-hydroxyvitamin D (25[OH]D) with more severe COVID-19; however, data on a possible protective effect of vitamin D supplementation in preventing infection have been inconsistent.
U.K. study compares doses
To further investigate the relationship with infections, including COVID-19, in a large cohort, the authors of the first of the two BMJ studies, a phase 3 open-label trial, enrolled 6,200 people in the United Kingdom aged 16 and older between December 2020 and June 2021 who were not taking vitamin D supplements at baseline.
Half of participants were offered a finger-prick blood test, and of the 2,674 who accepted, 86.3% were found to have low concentrations of 25(OH)D (< 75 nmol/L). These participants were provided with vitamin D supplementation at a lower (800 IU/day; n = 1328) or higher dose (3,200 IU/day; n = 1,346) for 6 months. The other half of the group received no tests or supplements.
The results showed minimal differences between groups in terms of rates of developing at least one acute respiratory infection, which occurred in 5% of those in the lower-dose group, 5.7% in the higher-dose group, and 4.6% of participants not offered supplementation.
Similarly, there were no significant differences in the development of real-time PCR-confirmed COVID-19, with rates of 3.6% in the lower-dose group, 3.0% in the higher-dose group, and 2.6% in the group not offered supplementation.
The study is “the first phase 3 randomized controlled trial to evaluate the effectiveness of a test-and-treat approach for correction of suboptimal vitamin D status to prevent acute respiratory tract infections,” report the authors, led by Adrian R. Martineau, MD, PhD, of Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
While uptake and supplementation in the study were favorable, “no statistically significant effect of either dose was seen on the primary outcome of swab test, doctor-confirmed acute respiratory tract infection, or on the major secondary outcome of swab test-confirmed COVID-19,” they conclude.
Traditional use of cod liver oil of benefit?
In the second study, researchers in Norway, led by Arne Soraas, MD, PhD, of the department of microbiology, Oslo University Hospital, evaluated whether that country’s long-held tradition of consuming cod liver oil during the winter to prevent vitamin D deficiency could affect the development of COVID-19 or outcomes.
For the Cod Liver Oil for COVID-19 Prevention Study (CLOC), a large cohort of 34,601 adults with a mean age of 44.9 years who were not taking daily vitamin D supplements were randomized to receive 5 mL/day of cod liver oil, representing a surrogate dose of 400 IU/day of vitamin D (n = 17,278), or placebo (n = 17,323) for up to 6 months.
In contrast with the first study, the vast majority of patients in the CLOC study (86%) had adequate vitamin D levels, defined as greater than 50 nmol/L, at baseline.
Again, however, the results showed no association between increased vitamin D supplementation with cod liver oil and PCR-confirmed COVID-19 or acute respiratory infections, with approximately 1.3% in each group testing positive for COVID-19 over a median of 164 days.
Supplementation with cod liver oil was also not associated with a reduced risk of any of the coprimary endpoints, including other acute respiratory infections.
“Daily supplementation with cod liver oil, a low-dose vitamin D, eicosapentaenoic acid, and docosahexaenoic acid supplement, for 6 months during the SARS-CoV-2pandemic among Norwegian adults did not reduce the incidence of SARS-CoV-2 infection, serious COVID-19, or other acute respiratory infections,” the authors report.
Key study limitations
In his editorial, Dr. Bergman underscores the limitations of two studies – also acknowledged by the authors – including the key confounding role of vaccines that emerged during the studies.
“The null findings of the studies should be interpreted in the context of a highly effective vaccine rolled out during both studies,” Dr. Bergman writes.
In the U.K. study, for instance, whereas only 1.2% of participants were vaccinated at baseline, the rate soared to 89.1% having received at least one dose by study end, potentially masking any effect of vitamin D, he says.
Additionally, for the Norway study, Dr. Bergman notes that cod liver oil also contains a substantial amount of vitamin A, which can be a potent immunomodulator.
“Excessive intake of vitamin A can cause adverse effects and may also interfere with vitamin D-mediated effects on the immune system,” he writes.
With two recent large meta-analyses showing benefits of vitamin D supplementation to be specifically among people who are vitamin D deficient, “a pragmatic approach for the clinician could be to focus on risk groups” for supplementation, Dr. Bergman writes.
“[These include] those who could be tested before supplementation, including people with dark skin, or skin that is rarely exposed to the sun, pregnant women, and elderly people with chronic diseases.”
The U.K. trial was supported by Barts Charity, Pharma Nord, the Fischer Family Foundation, DSM Nutritional Products, the Exilarch’s Foundation, the Karl R. Pfleger Foundation, the AIM Foundation, Synergy Biologics, Cytoplan, the Clinical Research Network of the U.K. National Institute for Health and Care Research, the HDR UK BREATHE Hub, the U.K. Research and Innovation Industrial Strategy Challenge Fund, Thornton & Ross, Warburtons, Hyphens Pharma, and philanthropist Matthew Isaacs.
The CLOC trial was funded by Orkla Health, the manufacturer of the cod liver oil used in the trial. Dr. Bergman has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Two large studies out of the United Kingdom and Norway show vitamin D supplementation has no benefit – as low dose, high dose, or in the form of cod liver oil supplementation – in preventing COVID-19 or acute respiratory tract infections, regardless of whether individuals are deficient or not.
The studies, published in the BMJ, underscore that “vaccination is still the most effective way to protect people from COVID-19, and vitamin D and cod liver oil supplementation should not be offered to healthy people with normal vitamin D levels,” writes Peter Bergman, MD, of the Karolinska Institute, Stockholm, in an editorial published alongside the studies.
Suboptimal levels of vitamin D are known to be associated with an increased risk of acute respiratory infections, and some observational studies have linked low 25-hydroxyvitamin D (25[OH]D) with more severe COVID-19; however, data on a possible protective effect of vitamin D supplementation in preventing infection have been inconsistent.
U.K. study compares doses
To further investigate the relationship with infections, including COVID-19, in a large cohort, the authors of the first of the two BMJ studies, a phase 3 open-label trial, enrolled 6,200 people in the United Kingdom aged 16 and older between December 2020 and June 2021 who were not taking vitamin D supplements at baseline.
Half of participants were offered a finger-prick blood test, and of the 2,674 who accepted, 86.3% were found to have low concentrations of 25(OH)D (< 75 nmol/L). These participants were provided with vitamin D supplementation at a lower (800 IU/day; n = 1328) or higher dose (3,200 IU/day; n = 1,346) for 6 months. The other half of the group received no tests or supplements.
The results showed minimal differences between groups in terms of rates of developing at least one acute respiratory infection, which occurred in 5% of those in the lower-dose group, 5.7% in the higher-dose group, and 4.6% of participants not offered supplementation.
Similarly, there were no significant differences in the development of real-time PCR-confirmed COVID-19, with rates of 3.6% in the lower-dose group, 3.0% in the higher-dose group, and 2.6% in the group not offered supplementation.
The study is “the first phase 3 randomized controlled trial to evaluate the effectiveness of a test-and-treat approach for correction of suboptimal vitamin D status to prevent acute respiratory tract infections,” report the authors, led by Adrian R. Martineau, MD, PhD, of Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
While uptake and supplementation in the study were favorable, “no statistically significant effect of either dose was seen on the primary outcome of swab test, doctor-confirmed acute respiratory tract infection, or on the major secondary outcome of swab test-confirmed COVID-19,” they conclude.
Traditional use of cod liver oil of benefit?
In the second study, researchers in Norway, led by Arne Soraas, MD, PhD, of the department of microbiology, Oslo University Hospital, evaluated whether that country’s long-held tradition of consuming cod liver oil during the winter to prevent vitamin D deficiency could affect the development of COVID-19 or outcomes.
For the Cod Liver Oil for COVID-19 Prevention Study (CLOC), a large cohort of 34,601 adults with a mean age of 44.9 years who were not taking daily vitamin D supplements were randomized to receive 5 mL/day of cod liver oil, representing a surrogate dose of 400 IU/day of vitamin D (n = 17,278), or placebo (n = 17,323) for up to 6 months.
In contrast with the first study, the vast majority of patients in the CLOC study (86%) had adequate vitamin D levels, defined as greater than 50 nmol/L, at baseline.
Again, however, the results showed no association between increased vitamin D supplementation with cod liver oil and PCR-confirmed COVID-19 or acute respiratory infections, with approximately 1.3% in each group testing positive for COVID-19 over a median of 164 days.
Supplementation with cod liver oil was also not associated with a reduced risk of any of the coprimary endpoints, including other acute respiratory infections.
“Daily supplementation with cod liver oil, a low-dose vitamin D, eicosapentaenoic acid, and docosahexaenoic acid supplement, for 6 months during the SARS-CoV-2pandemic among Norwegian adults did not reduce the incidence of SARS-CoV-2 infection, serious COVID-19, or other acute respiratory infections,” the authors report.
Key study limitations
In his editorial, Dr. Bergman underscores the limitations of two studies – also acknowledged by the authors – including the key confounding role of vaccines that emerged during the studies.
“The null findings of the studies should be interpreted in the context of a highly effective vaccine rolled out during both studies,” Dr. Bergman writes.
In the U.K. study, for instance, whereas only 1.2% of participants were vaccinated at baseline, the rate soared to 89.1% having received at least one dose by study end, potentially masking any effect of vitamin D, he says.
Additionally, for the Norway study, Dr. Bergman notes that cod liver oil also contains a substantial amount of vitamin A, which can be a potent immunomodulator.
“Excessive intake of vitamin A can cause adverse effects and may also interfere with vitamin D-mediated effects on the immune system,” he writes.
With two recent large meta-analyses showing benefits of vitamin D supplementation to be specifically among people who are vitamin D deficient, “a pragmatic approach for the clinician could be to focus on risk groups” for supplementation, Dr. Bergman writes.
“[These include] those who could be tested before supplementation, including people with dark skin, or skin that is rarely exposed to the sun, pregnant women, and elderly people with chronic diseases.”
The U.K. trial was supported by Barts Charity, Pharma Nord, the Fischer Family Foundation, DSM Nutritional Products, the Exilarch’s Foundation, the Karl R. Pfleger Foundation, the AIM Foundation, Synergy Biologics, Cytoplan, the Clinical Research Network of the U.K. National Institute for Health and Care Research, the HDR UK BREATHE Hub, the U.K. Research and Innovation Industrial Strategy Challenge Fund, Thornton & Ross, Warburtons, Hyphens Pharma, and philanthropist Matthew Isaacs.
The CLOC trial was funded by Orkla Health, the manufacturer of the cod liver oil used in the trial. Dr. Bergman has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Two large studies out of the United Kingdom and Norway show vitamin D supplementation has no benefit – as low dose, high dose, or in the form of cod liver oil supplementation – in preventing COVID-19 or acute respiratory tract infections, regardless of whether individuals are deficient or not.
The studies, published in the BMJ, underscore that “vaccination is still the most effective way to protect people from COVID-19, and vitamin D and cod liver oil supplementation should not be offered to healthy people with normal vitamin D levels,” writes Peter Bergman, MD, of the Karolinska Institute, Stockholm, in an editorial published alongside the studies.
Suboptimal levels of vitamin D are known to be associated with an increased risk of acute respiratory infections, and some observational studies have linked low 25-hydroxyvitamin D (25[OH]D) with more severe COVID-19; however, data on a possible protective effect of vitamin D supplementation in preventing infection have been inconsistent.
U.K. study compares doses
To further investigate the relationship with infections, including COVID-19, in a large cohort, the authors of the first of the two BMJ studies, a phase 3 open-label trial, enrolled 6,200 people in the United Kingdom aged 16 and older between December 2020 and June 2021 who were not taking vitamin D supplements at baseline.
Half of participants were offered a finger-prick blood test, and of the 2,674 who accepted, 86.3% were found to have low concentrations of 25(OH)D (< 75 nmol/L). These participants were provided with vitamin D supplementation at a lower (800 IU/day; n = 1328) or higher dose (3,200 IU/day; n = 1,346) for 6 months. The other half of the group received no tests or supplements.
The results showed minimal differences between groups in terms of rates of developing at least one acute respiratory infection, which occurred in 5% of those in the lower-dose group, 5.7% in the higher-dose group, and 4.6% of participants not offered supplementation.
Similarly, there were no significant differences in the development of real-time PCR-confirmed COVID-19, with rates of 3.6% in the lower-dose group, 3.0% in the higher-dose group, and 2.6% in the group not offered supplementation.
The study is “the first phase 3 randomized controlled trial to evaluate the effectiveness of a test-and-treat approach for correction of suboptimal vitamin D status to prevent acute respiratory tract infections,” report the authors, led by Adrian R. Martineau, MD, PhD, of Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
While uptake and supplementation in the study were favorable, “no statistically significant effect of either dose was seen on the primary outcome of swab test, doctor-confirmed acute respiratory tract infection, or on the major secondary outcome of swab test-confirmed COVID-19,” they conclude.
Traditional use of cod liver oil of benefit?
In the second study, researchers in Norway, led by Arne Soraas, MD, PhD, of the department of microbiology, Oslo University Hospital, evaluated whether that country’s long-held tradition of consuming cod liver oil during the winter to prevent vitamin D deficiency could affect the development of COVID-19 or outcomes.
For the Cod Liver Oil for COVID-19 Prevention Study (CLOC), a large cohort of 34,601 adults with a mean age of 44.9 years who were not taking daily vitamin D supplements were randomized to receive 5 mL/day of cod liver oil, representing a surrogate dose of 400 IU/day of vitamin D (n = 17,278), or placebo (n = 17,323) for up to 6 months.
In contrast with the first study, the vast majority of patients in the CLOC study (86%) had adequate vitamin D levels, defined as greater than 50 nmol/L, at baseline.
Again, however, the results showed no association between increased vitamin D supplementation with cod liver oil and PCR-confirmed COVID-19 or acute respiratory infections, with approximately 1.3% in each group testing positive for COVID-19 over a median of 164 days.
Supplementation with cod liver oil was also not associated with a reduced risk of any of the coprimary endpoints, including other acute respiratory infections.
“Daily supplementation with cod liver oil, a low-dose vitamin D, eicosapentaenoic acid, and docosahexaenoic acid supplement, for 6 months during the SARS-CoV-2pandemic among Norwegian adults did not reduce the incidence of SARS-CoV-2 infection, serious COVID-19, or other acute respiratory infections,” the authors report.
Key study limitations
In his editorial, Dr. Bergman underscores the limitations of two studies – also acknowledged by the authors – including the key confounding role of vaccines that emerged during the studies.
“The null findings of the studies should be interpreted in the context of a highly effective vaccine rolled out during both studies,” Dr. Bergman writes.
In the U.K. study, for instance, whereas only 1.2% of participants were vaccinated at baseline, the rate soared to 89.1% having received at least one dose by study end, potentially masking any effect of vitamin D, he says.
Additionally, for the Norway study, Dr. Bergman notes that cod liver oil also contains a substantial amount of vitamin A, which can be a potent immunomodulator.
“Excessive intake of vitamin A can cause adverse effects and may also interfere with vitamin D-mediated effects on the immune system,” he writes.
With two recent large meta-analyses showing benefits of vitamin D supplementation to be specifically among people who are vitamin D deficient, “a pragmatic approach for the clinician could be to focus on risk groups” for supplementation, Dr. Bergman writes.
“[These include] those who could be tested before supplementation, including people with dark skin, or skin that is rarely exposed to the sun, pregnant women, and elderly people with chronic diseases.”
The U.K. trial was supported by Barts Charity, Pharma Nord, the Fischer Family Foundation, DSM Nutritional Products, the Exilarch’s Foundation, the Karl R. Pfleger Foundation, the AIM Foundation, Synergy Biologics, Cytoplan, the Clinical Research Network of the U.K. National Institute for Health and Care Research, the HDR UK BREATHE Hub, the U.K. Research and Innovation Industrial Strategy Challenge Fund, Thornton & Ross, Warburtons, Hyphens Pharma, and philanthropist Matthew Isaacs.
The CLOC trial was funded by Orkla Health, the manufacturer of the cod liver oil used in the trial. Dr. Bergman has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BMJ
Low testosterone may raise risk of COVID hospitalization
researchers have found.
Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.
Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.
The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.
Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”
“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.
Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.
“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.
Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.
“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”
According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.
“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.
However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.
“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”
Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.
“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.
Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”
Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers have found.
Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.
Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.
The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.
Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”
“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.
Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.
“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.
Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.
“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”
According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.
“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.
However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.
“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”
Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.
“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.
Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”
Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers have found.
Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.
Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.
The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.
Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”
“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.
Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.
“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.
Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.
“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”
According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.
“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.
However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.
“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”
Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.
“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.
Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”
Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
CDC says 44% of people hospitalized with COVID had third dose or booster
, the Centers for Disease Control and Prevention says.
Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
FROM MMWR
New study supports safety of COVID-19 boosters during pregnancy
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Unvaccinated 10 times more likely to be hospitalized for Omicron
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
FROM JAMA INTERNAL MEDICINE
Asymptomatic infections drive many epidemics, including monkeypox, polio, and COVID
Monkeypox, COVID, and polio: These three very different diseases have been dominating news cycles recently, but they share at least one common characteristic: some people can become infected – and in turn infect others – while showing no symptoms.
In 1883, the famous bacteriologist Friedrich Loeffler (1852-1915) recognized that an individual’s asymptomatic carriage of bacteria could lead to diphtheria in others.
“Typhoid Mary” is perhaps the quintessential example of asymptomatic transmission of infections leading to illness and death. At the turn of the 20th century, young Mary Mallon emigrated from Ireland to New York, where she soon became a cook for wealthy Manhattan families.
George Soper, a sanitary engineer, was hired by a stricken family to investigate. After epidemiologic study, he suspected that Mary was a carrier of Salmonella typhi, the bacterial cause of typhoid fever. He persuaded the New York Department of Health to test her – against her will – for infection. After her stool was found to test positive for Salmonella, Mary was forcibly moved to North Brother Island, where she remained largely isolated from others for the next 2 years. In 1910, she was released by a new commissioner after promising not to work as a cook.
However, working under an assumed name, Mary resumed cooking at the Sloane Hospital for Women in Manhattan. Over the next 3 months, at least 25 staff members became ill. Having been found out, Mary was again exiled to the island, where she spent the rest of her life. She died in 1938 after having infected at least 122 people, five of whom died.
COVID
Asymptomatic infections are primary drivers of COVID. Earlier in the pandemic, a meta-analysis suggested a 40% rate of asymptomatic infections, although some early reports arrived at lower estimates. A 2021 JAMA Network Open modeling study indicated a 60% rate.
Those rates are changing with the Omicron variants, of which even more cases are asymptomatic. Is this from a mutation in the virus? Some suggest that it is most likely attributable to prior vaccination resulting in boosted immunity and infections being milder. Of concern is that, although people may be asymptomatic, they still have the same viral load in their nose and can readily transmit infection.
Vincent Racaniello, PhD, a professor of virology at Columbia University in New York, told this news organization that “SARS-CoV-2 COVID is so effective at transmitting because it does this asymptomatic transmission. And so you’re out and about; you have no idea that you’re infected. You’re effectively doing what we call community transmission.”
This distinguishes SARS-CoV-2 from SARS-CoV-1. SARS-CoV-1 – which caused the SARS epidemic in 2002–2004 – had very little asymptomatic shedding. With COVID, on the other hand, “A lot of people are infected but never transmit,” Dr. Racaniello added. “I think 80% of transmissions are done by 20% of infected people because those are the ones who are shedding the most virus.”
Polio
The August case of paralytic polio in Rockland County, N.Y., is “the first case of polio reported in the United States in nearly 10 years, and only the second instance of community transmission identified in the U.S. since 1979,” a spokesperson for the Centers for Disease Control and Prevention said in an email. “Although no additional cases of polio have been reported at this time, recent wastewater findings elevate concerns that poliovirus is present in these communities, posing a risk to those who are unvaccinated.”
Poliovirus has now been found in the wastewater of New York City and three surrounding counties: Rockland, Orange, and Sullivan.
Unlike COVID, which is spread through air and respiratory secretions, polio has primarily fecal-oral transmission, meaning it is spread by people ingesting food or water contaminated with stool.
According to the World Health Organization, up to 90% of infections are unrecognized because the person has no to minimal symptoms. Symptoms are nonspecific in the remainder. Only a small proportion of those infected go on to develop paralysis.
Paul Offit, MD, a virologist and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told this news organization that before widespread immunization, polio “caused 25,000 – 30,000 children every year to be paralyzed and 1,500 to die. Roughly 1 of every 200 children who was infected was paralyzed. We had the inactivated vaccine followed by the oral polio vaccine (OPV). The price that we paid for the OPV was that rarely it could revert to the so-called neurovirulent type, a paralytic type.”
Use of the OPV was discontinued in 2000 in the United States but is still widely used worldwide because it is inexpensive and easier to administer than injections. It appeared that we were close to completely eradicating polio, as we had smallpox, but then vaccine-derived polio virus (VDPV) started cropping up in Africa, the Middle East, and Asia. They are mainly from the type 2 virus, as is the New York case. There have been three other cases of VDPV in the United States since 2000.
Now, Dr. Offit estimates that only 1 in 2,000 of those infected become paralyzed. This is why the CDC and epidemiologists are so concerned about the Rockland patient – that one case of paralysis could represent a large pool of people who are infected with polio and are asymptomatic, continuing to shed infectious virus into the sewage.
The CDC confirmed that it began conducting wastewater testing for polio in August 2022. In their interviews for this article, Dr. Offit and Dr. Racaniello were both critical of this, stressing that it is essential to do wastewater testing nationally, since asymptomatic polio can be expected to crop up from international travelers who have received OPV.
Many countries conduct that kind of wastewater surveillance. Dr. Racaniello was particularly critical of the CDC. “We’ve been telling CDC for years, at least a decade, Why don’t you check the wastewater?,” Dr. Racaniello said, “It’s been known for many years that we should be looking to monitor the circulation of these viruses. So we are using paralysis as a sentinel to say that this virus is in the wastewater, which is just not acceptable!”
Apparently there was some concern that the public would not understand. Dr. Offit viewed it as one more piece of necessary education: “You shouldn’t be alarmed about this as long as you’re vaccinated. If you’re not vaccinated, realize that this is a risk you’re taking.”
Monkeypox
Monkeypox cases have been skyrocketing in the United States in recent weeks. More than 18,000 cases have been reported since the first case in Boston on May 19, 2022.
“Monkeypox was such a rare zoonotic disease, and the disease always historically was introduced through animal contact,” Stuart Isaacs, MD, a pox virologist at the University of Pennsylvania, said in an interview. “And then the infected person would have potential spread within the household as the most common human-to-human spread, The sexual transmission is driving a lot of this infection and potentially allowing this to efficiently spread from person to person.”
A recent study from Belgium, available only as a preprint, created concerns about potential asymptomatic transmission of monkeypox Three men had undergone testing for anogenital chlamydia and gonorrhea but showed no clinical signs of monkeypox. The same samples were later tested by polymerase chain reaction (PCR), and their viral load in anorectal swabs was similar to or slightly lower than that of symptomatic patients. While no cultures were done, the patients seroconverted by later antibody testing, confirming infection.
Via email, a CDC spokesperson noted, “At this time, CDC does not have enough data to support transmission from aerosolized virus for the ongoing monkeypox outbreak, or to assess the risks for transmission from asymptomatic people. The data supports the main source of transmission currently as close contact with someone who is infected with monkeypox.”
Dr. Isaacs agreed, saying studies of smallpox, a related orthopox virus, also suggested this.
In the United Kingdom, the Institute of Tropical Medicine is offering PCR testing for monkeypox to all patients who come for gonorrhea/chlamydia screening. Dr. Racaniello said, “I think that would be great to get a sense of who is infected. Then you could look at the results and say what fraction of people go on to develop lesions, and they give you a sense of the asymptomatic rate, which we don’t know at this point.”
Unfortunately, to be tested for monkeypox in the United States requires that the patient have a lesion. “This is part of the dropped ball of public health in the U.S.,” Dr. Racaniello said. “We’re not thinking about this. .... We need to be doing [infectivity] experiments. So then the question is, how much infectious virus do you need to transmit?”
Conclusion
We’ve seen that asymptomatic carriage of bacteria and viruses occurs readily with typhoid, COVID, diphtheria, and polio (among many other organisms, such as methicillin-resistant Staphylococcus aureus or group A strep) and is far less likely with monkeypox.
Two common denominators emerged from these interviews. The first and biggest hurdle is identifying asymptomatic carriers, which is hampered by the politicization of the CDC and funding cuts to public health. “It used to be the CDC was all about public health, and now it’s administrators, unfortunately,” said Dr. Racaniello, citing science writer Laurie Garrett, author of the influential 1994 book, “The Coming Plague”.
We don’t conduct proper surveillance, he pointed out. Wastewater surveillance has been neglected for more than a decade. It has been used for SARS-CoV-2 but is only now being initiated for polio and monkeypox. Norovirus testing would also be especially helpful in reducing foodborne outbreaks, Dr. Racaniello suggested.
The second common denominator is the need to increase the availability and uptake of vaccines. As Dr. Racaniello said about COVID, “The virus is here to stay. It’s never going to go away. It’s in humans. It’s in a lot of animals. So we’re stuck with it. We’re going to have outbreaks every year. So what do you do? Get vaccinated.” And he added, “Vaccination is the most important strategy to go on with our lives.”
Dr. Isaacs was a bit more tempered, not wanting to oversell the vaccine. He said, “The vaccine is just part of the toolkit,” which includes education, testing, isolation, and reducing risk, all of which decrease the transmission cycles.
Speaking of how antivaccine advocates had specifically targeted the Hasidic community in New York State’s Rockland County, Dr. Offit noted, “I don’t think it’s a knowledge deficit as much as a trust deficit.” He said officials should identify people in communities such as these who are trusted and have them become the influencers.
The final major hurdle to controlling these outbreaks remains global disparities in care. Monkeypox has been endemic in Nigeria for decades. It was only when it spread to Europe and America that it received attention. Polio has been actively circulating in Africa and the Middle East but is only getting attention because of the New York case.
Africa was unable to afford COVID vaccines until recently. While many in the United States are on their fourth booster, as of December 2021, more than 80% of people in Africa had not yet received a single dose, according to an article by Munyaradzi Makoni in The Lancet Respiratory Medicine.
Echoing Dr. Peter Hotez’s long-standing plea for “vaccine diplomacy,” Dr. Racaniello concluded, “My philosophy has always been we should give [vaccines] to them. I mean, we spend trillions on guns. Can’t we spend a few hundred million on vaccines? We should give away everything in terms of medicine to countries that need it, and people would like us a lot better than they do now. I think it would be such a great way of getting countries to like us. … So what if it costs a billion dollars a year? It’s a drop in the bucket for us.”
Given globalization, an infectious outbreak anywhere is a risk to all.
Dr. Racaniello and Dr. Offit report no relevant financial relationships. Dr. Isaacs receives royalties from UpToDate.
A version of this article first appeared on Medscape.com.
Monkeypox, COVID, and polio: These three very different diseases have been dominating news cycles recently, but they share at least one common characteristic: some people can become infected – and in turn infect others – while showing no symptoms.
In 1883, the famous bacteriologist Friedrich Loeffler (1852-1915) recognized that an individual’s asymptomatic carriage of bacteria could lead to diphtheria in others.
“Typhoid Mary” is perhaps the quintessential example of asymptomatic transmission of infections leading to illness and death. At the turn of the 20th century, young Mary Mallon emigrated from Ireland to New York, where she soon became a cook for wealthy Manhattan families.
George Soper, a sanitary engineer, was hired by a stricken family to investigate. After epidemiologic study, he suspected that Mary was a carrier of Salmonella typhi, the bacterial cause of typhoid fever. He persuaded the New York Department of Health to test her – against her will – for infection. After her stool was found to test positive for Salmonella, Mary was forcibly moved to North Brother Island, where she remained largely isolated from others for the next 2 years. In 1910, she was released by a new commissioner after promising not to work as a cook.
However, working under an assumed name, Mary resumed cooking at the Sloane Hospital for Women in Manhattan. Over the next 3 months, at least 25 staff members became ill. Having been found out, Mary was again exiled to the island, where she spent the rest of her life. She died in 1938 after having infected at least 122 people, five of whom died.
COVID
Asymptomatic infections are primary drivers of COVID. Earlier in the pandemic, a meta-analysis suggested a 40% rate of asymptomatic infections, although some early reports arrived at lower estimates. A 2021 JAMA Network Open modeling study indicated a 60% rate.
Those rates are changing with the Omicron variants, of which even more cases are asymptomatic. Is this from a mutation in the virus? Some suggest that it is most likely attributable to prior vaccination resulting in boosted immunity and infections being milder. Of concern is that, although people may be asymptomatic, they still have the same viral load in their nose and can readily transmit infection.
Vincent Racaniello, PhD, a professor of virology at Columbia University in New York, told this news organization that “SARS-CoV-2 COVID is so effective at transmitting because it does this asymptomatic transmission. And so you’re out and about; you have no idea that you’re infected. You’re effectively doing what we call community transmission.”
This distinguishes SARS-CoV-2 from SARS-CoV-1. SARS-CoV-1 – which caused the SARS epidemic in 2002–2004 – had very little asymptomatic shedding. With COVID, on the other hand, “A lot of people are infected but never transmit,” Dr. Racaniello added. “I think 80% of transmissions are done by 20% of infected people because those are the ones who are shedding the most virus.”
Polio
The August case of paralytic polio in Rockland County, N.Y., is “the first case of polio reported in the United States in nearly 10 years, and only the second instance of community transmission identified in the U.S. since 1979,” a spokesperson for the Centers for Disease Control and Prevention said in an email. “Although no additional cases of polio have been reported at this time, recent wastewater findings elevate concerns that poliovirus is present in these communities, posing a risk to those who are unvaccinated.”
Poliovirus has now been found in the wastewater of New York City and three surrounding counties: Rockland, Orange, and Sullivan.
Unlike COVID, which is spread through air and respiratory secretions, polio has primarily fecal-oral transmission, meaning it is spread by people ingesting food or water contaminated with stool.
According to the World Health Organization, up to 90% of infections are unrecognized because the person has no to minimal symptoms. Symptoms are nonspecific in the remainder. Only a small proportion of those infected go on to develop paralysis.
Paul Offit, MD, a virologist and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told this news organization that before widespread immunization, polio “caused 25,000 – 30,000 children every year to be paralyzed and 1,500 to die. Roughly 1 of every 200 children who was infected was paralyzed. We had the inactivated vaccine followed by the oral polio vaccine (OPV). The price that we paid for the OPV was that rarely it could revert to the so-called neurovirulent type, a paralytic type.”
Use of the OPV was discontinued in 2000 in the United States but is still widely used worldwide because it is inexpensive and easier to administer than injections. It appeared that we were close to completely eradicating polio, as we had smallpox, but then vaccine-derived polio virus (VDPV) started cropping up in Africa, the Middle East, and Asia. They are mainly from the type 2 virus, as is the New York case. There have been three other cases of VDPV in the United States since 2000.
Now, Dr. Offit estimates that only 1 in 2,000 of those infected become paralyzed. This is why the CDC and epidemiologists are so concerned about the Rockland patient – that one case of paralysis could represent a large pool of people who are infected with polio and are asymptomatic, continuing to shed infectious virus into the sewage.
The CDC confirmed that it began conducting wastewater testing for polio in August 2022. In their interviews for this article, Dr. Offit and Dr. Racaniello were both critical of this, stressing that it is essential to do wastewater testing nationally, since asymptomatic polio can be expected to crop up from international travelers who have received OPV.
Many countries conduct that kind of wastewater surveillance. Dr. Racaniello was particularly critical of the CDC. “We’ve been telling CDC for years, at least a decade, Why don’t you check the wastewater?,” Dr. Racaniello said, “It’s been known for many years that we should be looking to monitor the circulation of these viruses. So we are using paralysis as a sentinel to say that this virus is in the wastewater, which is just not acceptable!”
Apparently there was some concern that the public would not understand. Dr. Offit viewed it as one more piece of necessary education: “You shouldn’t be alarmed about this as long as you’re vaccinated. If you’re not vaccinated, realize that this is a risk you’re taking.”
Monkeypox
Monkeypox cases have been skyrocketing in the United States in recent weeks. More than 18,000 cases have been reported since the first case in Boston on May 19, 2022.
“Monkeypox was such a rare zoonotic disease, and the disease always historically was introduced through animal contact,” Stuart Isaacs, MD, a pox virologist at the University of Pennsylvania, said in an interview. “And then the infected person would have potential spread within the household as the most common human-to-human spread, The sexual transmission is driving a lot of this infection and potentially allowing this to efficiently spread from person to person.”
A recent study from Belgium, available only as a preprint, created concerns about potential asymptomatic transmission of monkeypox Three men had undergone testing for anogenital chlamydia and gonorrhea but showed no clinical signs of monkeypox. The same samples were later tested by polymerase chain reaction (PCR), and their viral load in anorectal swabs was similar to or slightly lower than that of symptomatic patients. While no cultures were done, the patients seroconverted by later antibody testing, confirming infection.
Via email, a CDC spokesperson noted, “At this time, CDC does not have enough data to support transmission from aerosolized virus for the ongoing monkeypox outbreak, or to assess the risks for transmission from asymptomatic people. The data supports the main source of transmission currently as close contact with someone who is infected with monkeypox.”
Dr. Isaacs agreed, saying studies of smallpox, a related orthopox virus, also suggested this.
In the United Kingdom, the Institute of Tropical Medicine is offering PCR testing for monkeypox to all patients who come for gonorrhea/chlamydia screening. Dr. Racaniello said, “I think that would be great to get a sense of who is infected. Then you could look at the results and say what fraction of people go on to develop lesions, and they give you a sense of the asymptomatic rate, which we don’t know at this point.”
Unfortunately, to be tested for monkeypox in the United States requires that the patient have a lesion. “This is part of the dropped ball of public health in the U.S.,” Dr. Racaniello said. “We’re not thinking about this. .... We need to be doing [infectivity] experiments. So then the question is, how much infectious virus do you need to transmit?”
Conclusion
We’ve seen that asymptomatic carriage of bacteria and viruses occurs readily with typhoid, COVID, diphtheria, and polio (among many other organisms, such as methicillin-resistant Staphylococcus aureus or group A strep) and is far less likely with monkeypox.
Two common denominators emerged from these interviews. The first and biggest hurdle is identifying asymptomatic carriers, which is hampered by the politicization of the CDC and funding cuts to public health. “It used to be the CDC was all about public health, and now it’s administrators, unfortunately,” said Dr. Racaniello, citing science writer Laurie Garrett, author of the influential 1994 book, “The Coming Plague”.
We don’t conduct proper surveillance, he pointed out. Wastewater surveillance has been neglected for more than a decade. It has been used for SARS-CoV-2 but is only now being initiated for polio and monkeypox. Norovirus testing would also be especially helpful in reducing foodborne outbreaks, Dr. Racaniello suggested.
The second common denominator is the need to increase the availability and uptake of vaccines. As Dr. Racaniello said about COVID, “The virus is here to stay. It’s never going to go away. It’s in humans. It’s in a lot of animals. So we’re stuck with it. We’re going to have outbreaks every year. So what do you do? Get vaccinated.” And he added, “Vaccination is the most important strategy to go on with our lives.”
Dr. Isaacs was a bit more tempered, not wanting to oversell the vaccine. He said, “The vaccine is just part of the toolkit,” which includes education, testing, isolation, and reducing risk, all of which decrease the transmission cycles.
Speaking of how antivaccine advocates had specifically targeted the Hasidic community in New York State’s Rockland County, Dr. Offit noted, “I don’t think it’s a knowledge deficit as much as a trust deficit.” He said officials should identify people in communities such as these who are trusted and have them become the influencers.
The final major hurdle to controlling these outbreaks remains global disparities in care. Monkeypox has been endemic in Nigeria for decades. It was only when it spread to Europe and America that it received attention. Polio has been actively circulating in Africa and the Middle East but is only getting attention because of the New York case.
Africa was unable to afford COVID vaccines until recently. While many in the United States are on their fourth booster, as of December 2021, more than 80% of people in Africa had not yet received a single dose, according to an article by Munyaradzi Makoni in The Lancet Respiratory Medicine.
Echoing Dr. Peter Hotez’s long-standing plea for “vaccine diplomacy,” Dr. Racaniello concluded, “My philosophy has always been we should give [vaccines] to them. I mean, we spend trillions on guns. Can’t we spend a few hundred million on vaccines? We should give away everything in terms of medicine to countries that need it, and people would like us a lot better than they do now. I think it would be such a great way of getting countries to like us. … So what if it costs a billion dollars a year? It’s a drop in the bucket for us.”
Given globalization, an infectious outbreak anywhere is a risk to all.
Dr. Racaniello and Dr. Offit report no relevant financial relationships. Dr. Isaacs receives royalties from UpToDate.
A version of this article first appeared on Medscape.com.
Monkeypox, COVID, and polio: These three very different diseases have been dominating news cycles recently, but they share at least one common characteristic: some people can become infected – and in turn infect others – while showing no symptoms.
In 1883, the famous bacteriologist Friedrich Loeffler (1852-1915) recognized that an individual’s asymptomatic carriage of bacteria could lead to diphtheria in others.
“Typhoid Mary” is perhaps the quintessential example of asymptomatic transmission of infections leading to illness and death. At the turn of the 20th century, young Mary Mallon emigrated from Ireland to New York, where she soon became a cook for wealthy Manhattan families.
George Soper, a sanitary engineer, was hired by a stricken family to investigate. After epidemiologic study, he suspected that Mary was a carrier of Salmonella typhi, the bacterial cause of typhoid fever. He persuaded the New York Department of Health to test her – against her will – for infection. After her stool was found to test positive for Salmonella, Mary was forcibly moved to North Brother Island, where she remained largely isolated from others for the next 2 years. In 1910, she was released by a new commissioner after promising not to work as a cook.
However, working under an assumed name, Mary resumed cooking at the Sloane Hospital for Women in Manhattan. Over the next 3 months, at least 25 staff members became ill. Having been found out, Mary was again exiled to the island, where she spent the rest of her life. She died in 1938 after having infected at least 122 people, five of whom died.
COVID
Asymptomatic infections are primary drivers of COVID. Earlier in the pandemic, a meta-analysis suggested a 40% rate of asymptomatic infections, although some early reports arrived at lower estimates. A 2021 JAMA Network Open modeling study indicated a 60% rate.
Those rates are changing with the Omicron variants, of which even more cases are asymptomatic. Is this from a mutation in the virus? Some suggest that it is most likely attributable to prior vaccination resulting in boosted immunity and infections being milder. Of concern is that, although people may be asymptomatic, they still have the same viral load in their nose and can readily transmit infection.
Vincent Racaniello, PhD, a professor of virology at Columbia University in New York, told this news organization that “SARS-CoV-2 COVID is so effective at transmitting because it does this asymptomatic transmission. And so you’re out and about; you have no idea that you’re infected. You’re effectively doing what we call community transmission.”
This distinguishes SARS-CoV-2 from SARS-CoV-1. SARS-CoV-1 – which caused the SARS epidemic in 2002–2004 – had very little asymptomatic shedding. With COVID, on the other hand, “A lot of people are infected but never transmit,” Dr. Racaniello added. “I think 80% of transmissions are done by 20% of infected people because those are the ones who are shedding the most virus.”
Polio
The August case of paralytic polio in Rockland County, N.Y., is “the first case of polio reported in the United States in nearly 10 years, and only the second instance of community transmission identified in the U.S. since 1979,” a spokesperson for the Centers for Disease Control and Prevention said in an email. “Although no additional cases of polio have been reported at this time, recent wastewater findings elevate concerns that poliovirus is present in these communities, posing a risk to those who are unvaccinated.”
Poliovirus has now been found in the wastewater of New York City and three surrounding counties: Rockland, Orange, and Sullivan.
Unlike COVID, which is spread through air and respiratory secretions, polio has primarily fecal-oral transmission, meaning it is spread by people ingesting food or water contaminated with stool.
According to the World Health Organization, up to 90% of infections are unrecognized because the person has no to minimal symptoms. Symptoms are nonspecific in the remainder. Only a small proportion of those infected go on to develop paralysis.
Paul Offit, MD, a virologist and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told this news organization that before widespread immunization, polio “caused 25,000 – 30,000 children every year to be paralyzed and 1,500 to die. Roughly 1 of every 200 children who was infected was paralyzed. We had the inactivated vaccine followed by the oral polio vaccine (OPV). The price that we paid for the OPV was that rarely it could revert to the so-called neurovirulent type, a paralytic type.”
Use of the OPV was discontinued in 2000 in the United States but is still widely used worldwide because it is inexpensive and easier to administer than injections. It appeared that we were close to completely eradicating polio, as we had smallpox, but then vaccine-derived polio virus (VDPV) started cropping up in Africa, the Middle East, and Asia. They are mainly from the type 2 virus, as is the New York case. There have been three other cases of VDPV in the United States since 2000.
Now, Dr. Offit estimates that only 1 in 2,000 of those infected become paralyzed. This is why the CDC and epidemiologists are so concerned about the Rockland patient – that one case of paralysis could represent a large pool of people who are infected with polio and are asymptomatic, continuing to shed infectious virus into the sewage.
The CDC confirmed that it began conducting wastewater testing for polio in August 2022. In their interviews for this article, Dr. Offit and Dr. Racaniello were both critical of this, stressing that it is essential to do wastewater testing nationally, since asymptomatic polio can be expected to crop up from international travelers who have received OPV.
Many countries conduct that kind of wastewater surveillance. Dr. Racaniello was particularly critical of the CDC. “We’ve been telling CDC for years, at least a decade, Why don’t you check the wastewater?,” Dr. Racaniello said, “It’s been known for many years that we should be looking to monitor the circulation of these viruses. So we are using paralysis as a sentinel to say that this virus is in the wastewater, which is just not acceptable!”
Apparently there was some concern that the public would not understand. Dr. Offit viewed it as one more piece of necessary education: “You shouldn’t be alarmed about this as long as you’re vaccinated. If you’re not vaccinated, realize that this is a risk you’re taking.”
Monkeypox
Monkeypox cases have been skyrocketing in the United States in recent weeks. More than 18,000 cases have been reported since the first case in Boston on May 19, 2022.
“Monkeypox was such a rare zoonotic disease, and the disease always historically was introduced through animal contact,” Stuart Isaacs, MD, a pox virologist at the University of Pennsylvania, said in an interview. “And then the infected person would have potential spread within the household as the most common human-to-human spread, The sexual transmission is driving a lot of this infection and potentially allowing this to efficiently spread from person to person.”
A recent study from Belgium, available only as a preprint, created concerns about potential asymptomatic transmission of monkeypox Three men had undergone testing for anogenital chlamydia and gonorrhea but showed no clinical signs of monkeypox. The same samples were later tested by polymerase chain reaction (PCR), and their viral load in anorectal swabs was similar to or slightly lower than that of symptomatic patients. While no cultures were done, the patients seroconverted by later antibody testing, confirming infection.
Via email, a CDC spokesperson noted, “At this time, CDC does not have enough data to support transmission from aerosolized virus for the ongoing monkeypox outbreak, or to assess the risks for transmission from asymptomatic people. The data supports the main source of transmission currently as close contact with someone who is infected with monkeypox.”
Dr. Isaacs agreed, saying studies of smallpox, a related orthopox virus, also suggested this.
In the United Kingdom, the Institute of Tropical Medicine is offering PCR testing for monkeypox to all patients who come for gonorrhea/chlamydia screening. Dr. Racaniello said, “I think that would be great to get a sense of who is infected. Then you could look at the results and say what fraction of people go on to develop lesions, and they give you a sense of the asymptomatic rate, which we don’t know at this point.”
Unfortunately, to be tested for monkeypox in the United States requires that the patient have a lesion. “This is part of the dropped ball of public health in the U.S.,” Dr. Racaniello said. “We’re not thinking about this. .... We need to be doing [infectivity] experiments. So then the question is, how much infectious virus do you need to transmit?”
Conclusion
We’ve seen that asymptomatic carriage of bacteria and viruses occurs readily with typhoid, COVID, diphtheria, and polio (among many other organisms, such as methicillin-resistant Staphylococcus aureus or group A strep) and is far less likely with monkeypox.
Two common denominators emerged from these interviews. The first and biggest hurdle is identifying asymptomatic carriers, which is hampered by the politicization of the CDC and funding cuts to public health. “It used to be the CDC was all about public health, and now it’s administrators, unfortunately,” said Dr. Racaniello, citing science writer Laurie Garrett, author of the influential 1994 book, “The Coming Plague”.
We don’t conduct proper surveillance, he pointed out. Wastewater surveillance has been neglected for more than a decade. It has been used for SARS-CoV-2 but is only now being initiated for polio and monkeypox. Norovirus testing would also be especially helpful in reducing foodborne outbreaks, Dr. Racaniello suggested.
The second common denominator is the need to increase the availability and uptake of vaccines. As Dr. Racaniello said about COVID, “The virus is here to stay. It’s never going to go away. It’s in humans. It’s in a lot of animals. So we’re stuck with it. We’re going to have outbreaks every year. So what do you do? Get vaccinated.” And he added, “Vaccination is the most important strategy to go on with our lives.”
Dr. Isaacs was a bit more tempered, not wanting to oversell the vaccine. He said, “The vaccine is just part of the toolkit,” which includes education, testing, isolation, and reducing risk, all of which decrease the transmission cycles.
Speaking of how antivaccine advocates had specifically targeted the Hasidic community in New York State’s Rockland County, Dr. Offit noted, “I don’t think it’s a knowledge deficit as much as a trust deficit.” He said officials should identify people in communities such as these who are trusted and have them become the influencers.
The final major hurdle to controlling these outbreaks remains global disparities in care. Monkeypox has been endemic in Nigeria for decades. It was only when it spread to Europe and America that it received attention. Polio has been actively circulating in Africa and the Middle East but is only getting attention because of the New York case.
Africa was unable to afford COVID vaccines until recently. While many in the United States are on their fourth booster, as of December 2021, more than 80% of people in Africa had not yet received a single dose, according to an article by Munyaradzi Makoni in The Lancet Respiratory Medicine.
Echoing Dr. Peter Hotez’s long-standing plea for “vaccine diplomacy,” Dr. Racaniello concluded, “My philosophy has always been we should give [vaccines] to them. I mean, we spend trillions on guns. Can’t we spend a few hundred million on vaccines? We should give away everything in terms of medicine to countries that need it, and people would like us a lot better than they do now. I think it would be such a great way of getting countries to like us. … So what if it costs a billion dollars a year? It’s a drop in the bucket for us.”
Given globalization, an infectious outbreak anywhere is a risk to all.
Dr. Racaniello and Dr. Offit report no relevant financial relationships. Dr. Isaacs receives royalties from UpToDate.
A version of this article first appeared on Medscape.com.
CDC gives final approval to Omicron COVID-19 vaccine boosters
The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.
The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.
The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.
What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.
ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Dr. Sanchez said.
Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.
“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”
Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.
Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.
“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.
Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.
“So after thinking about it, I am comfortable even though we don’t have human data,” he said.
There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.
The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.
But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.
“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.
The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.
“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.
The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.
The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.
What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.
ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Dr. Sanchez said.
Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.
“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”
Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.
Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.
“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.
Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.
“So after thinking about it, I am comfortable even though we don’t have human data,” he said.
There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.
The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.
But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.
“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.
The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.
“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.
The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.
The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.
What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.
ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Dr. Sanchez said.
Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.
“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”
Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.
Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.
“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.
Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.
“So after thinking about it, I am comfortable even though we don’t have human data,” he said.
There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.
The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.
But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.
“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.
The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.
“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.
A version of this article first appeared on WebMD.com.