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CVST after COVID-19 vaccine: New data confirm high mortality rate
, confirming the severity of the reaction and the associated high mortality rate.
The new series comes from an international registry of consecutive patients who experienced CVST within 28 days of COVID-19 vaccination between March 29 and June 18, 2021, from 81 hospitals in 19 countries.
The cases are described in an article published online on Sept. 28. in JAMA Neurology.
“This is a reliable description on the clinical condition of these patients with CVST associated with COVID-19 vaccination. It is striking that this a much worse condition than CVST not associated with COVID-19 vaccination, with a much higher rate of intracerebral hemorrhage and coma and a much higher mortality rate,” senior author Jonathan M. Coutinho, MD, Amsterdam University Medical Centers, told this news organization.
These data confirm the observations from an earlier U.K. cohort in which cases of cerebral venous thrombosis linked to COVID-19 vaccination occurred.
“This is the biggest series, and as an international series, it gives a broader perspective from a larger range of countries,” Dr. Coutinho said. “All the data together show that, although this side effect is rare, the consequences are very severe,” he added.
In the current study, the researchers regarded CVST as being linked to the vaccine if it was accompanied by thrombosis with thrombocytopenia syndrome (TTS), as evidenced by thrombosis and new-onset thrombocytopenia.
In the cohort of 116 patients with CVST after COVID-19 vaccination, 78 (67.2%) had thrombosis with TTS and were thus classified as having had a vaccine-related adverse event. These patients were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%); 47% died during hospitalization.
These patients were compared with the 38 patients in the same cohort who had CVST but in whom there was no indication of concomitant thrombosis and thrombocytopenia. The case patients were also compared with a control group of 207 patients with CVST who were included in a separate international registry before the COVID-19 pandemic.
Mortality rates were much higher among the patients deemed to have had a vaccine-related CVST. The in-hospital mortality rate was 47%, compared with 5% among the patients in the same cohort who did not have TTS and 3.9% among the prepandemic control group.
The mortality rate was even higher (61%) among patients in the TTS group for whom the diagnosis was made before the condition garnered attention in the scientific community. The mortality rate was 42% among patients diagnosed later.
Of the 78 patients in whom CVST and TTS occurred after COVID-19 vaccination in this cohort, 76 had received the AstraZeneca vaccine (in 75 patients, CVST and TTS occurred after the first vaccination; in one patient, they occurred after the second vaccination). One patient had received the Johnson & Johnson vaccine, and one had received the Pfizer vaccine.
“After more analysis, the case after the Pfizer vaccination is not believed to be caused by the vaccine,” Dr. Coutinho said. “In that case, the patient had a platelet count just below the lower limit and was taking an immunomodulator drug that is known to be associated with thrombocytopenia.”
For two patients who received the AstraZeneca vaccine, there was also an alternative explanation for the thrombocytopenia.
Dr. Coutinho also pointed out that the Johnson & Johnson vaccine has been used mainly in the United States, and these data were largely from other countries.
The median time from vaccination to CVST symptom onset was 9 days in the TTS group. The median platelet count at hospital admission among patients with postvaccination CVST-TTS was 45. Three patients presented with a normal platelet count and developed thrombocytopenia during admission; two patients presented with mild thrombocytopenia, 30 presented with moderate thrombocytopenia, and 43 presented with severe thrombocytopenia.
Antibodies against platelet factor 4 (PF4) were measured in 69 patients with TTS, of whom 63 (91%) tested positive (the one patient in whom TTS occurred after the patient received the Pfizer vaccine did not test positive). However, the researchers note that sensitivity varies among different PF4 ELISA tests. Findings of platelet activation assays were positive in all 36 tested patients.
In the TTS group, 52 patients (67%) received immunomodulation therapy, most often intravenous immunoglobulins (IVIG). Among patients treated with IVIG, the mortality rate was lower (28%).
Different from CVST linked to natural COVID-19 infection
Dr. Coutinho noted that CVST can occur in natural SARS-CoV-2 infection but that vaccine-associated CVST is very different.
“In natural COVID-19 infection, there is an increased risk of thrombosis, and some patients can get CVST as a part of this, but in these cases, this is not accompanied by thrombocytopenia. While the CVST in natural COVID-19 infection is also associated with a bad prognosis, this is more to do with the underlying disease. It is normally the very sick COVID patients who develop CVST, and these patients usually die from the underlying disease rather than the CVST itself,” he explained.
“Clinicians need to be aware of vaccine-related CVST, as it requires very specific and rapid treatment,” Dr. Coutinho stressed.
“Patients presenting with an extremely severe headache (unlike any headache they’ve had before) or with seizures or a focal deficit (weakness in arm or problems with speaking or vision) within 4 weeks of an adenovirus COVID-19 vaccination should ring alarm bells. It is important to do diagnostics quickly, with a platelet count the most important first step, and a rapid CT/MRI scan,” he said.
Other tests that should be conducted are D-dimer for thrombosis and the PF4 antibody test. But results for the PF4 antibody test can take days to come back, and clinicians shouldn’t wait for that, Dr. Coutinho notes.
“Specific treatment needs to be given immediately – with anticoagulation (preferably nonheparin) and immunomodulation with IVIG to stop the immune reaction. Platelets should not be given – that may seem counterintuitive in patients with a low platelet count, but giving platelets makes it worse,” he said.
Is there a geographic difference?
Dr. Coutinho pointed out that fewer cases of this vaccine-related CVST are being reported at the current time.
“We are not sure why this is the case. These adenovirus vaccines are not being used much now in Western countries, but our collaboration covers many less developed countries in South America and Asia, which are relying heavily on these vaccines. We are now shifting focus to these countries, but so far we have only seen a handful of cases from these areas,” he said.
He suggested that this may be because these countries started their vaccination programs later and are vaccinating their elderly (who are not so susceptible to this side effect) first, or it may be because of some environmental or genetic factor that has not yet been discovered.
“This is now an important research question – is the risk of vaccine-induced CVST the same in different countries or ethnicities? This could influence decisions on future vaccine strategies,” Dr. Coutinho said.
“So far, female sex is the strongest risk factor for vaccine-induced CVST. In our cohort, 81% of cases were in women. In addition, 95% were White, but that doesn’t allow us to conclude that this is a risk factor, as the majority of people who have been vaccinated are White. So, we have no clear insight into that yet,” he said.
In a comment for this news organization, the lead author of the previous U.K. report of a series of 70 cases of cerebral venous thrombosis linked to COVID-19 vaccination, Richard Perry, PhD, University College Hospital, London, described this new report as “an excellent study, with many of the same strengths and weaknesses as our study and has very similar results.”
Dr. Perry noted that the two studies used slightly different definitions of vaccine-induced thrombotic thrombocytopenia, but the cases reported appear to be very similar overall. “It is reassuring and gratifying to see that they have made such similar observations,” he said.
“And as they have drawn their cases from a broad range of countries whereas ours were all from the U.K., this provides evidence that the observations from both studies are reasonably generalizable,” he added.
Dr. Perry pointed out that this new report states that TTS occurred in one patient after the patient had received a second dose of the AstraZeneca vaccine. “I would like to know more about this case, because we didn’t see any cases after a second dose in our cohort,” he said.
Dr. Coutinho responded that he didn’t believe this was the first reported case after the second dose.
The study did not receive any specific funding. Dr. Coutinho has received grants paid to his institution from Boehringer Ingelheim and Bayer and payments paid to his institution for data safety monitoring board participation by Bayer.
A version of this article first appeared on Medscape.com.
, confirming the severity of the reaction and the associated high mortality rate.
The new series comes from an international registry of consecutive patients who experienced CVST within 28 days of COVID-19 vaccination between March 29 and June 18, 2021, from 81 hospitals in 19 countries.
The cases are described in an article published online on Sept. 28. in JAMA Neurology.
“This is a reliable description on the clinical condition of these patients with CVST associated with COVID-19 vaccination. It is striking that this a much worse condition than CVST not associated with COVID-19 vaccination, with a much higher rate of intracerebral hemorrhage and coma and a much higher mortality rate,” senior author Jonathan M. Coutinho, MD, Amsterdam University Medical Centers, told this news organization.
These data confirm the observations from an earlier U.K. cohort in which cases of cerebral venous thrombosis linked to COVID-19 vaccination occurred.
“This is the biggest series, and as an international series, it gives a broader perspective from a larger range of countries,” Dr. Coutinho said. “All the data together show that, although this side effect is rare, the consequences are very severe,” he added.
In the current study, the researchers regarded CVST as being linked to the vaccine if it was accompanied by thrombosis with thrombocytopenia syndrome (TTS), as evidenced by thrombosis and new-onset thrombocytopenia.
In the cohort of 116 patients with CVST after COVID-19 vaccination, 78 (67.2%) had thrombosis with TTS and were thus classified as having had a vaccine-related adverse event. These patients were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%); 47% died during hospitalization.
These patients were compared with the 38 patients in the same cohort who had CVST but in whom there was no indication of concomitant thrombosis and thrombocytopenia. The case patients were also compared with a control group of 207 patients with CVST who were included in a separate international registry before the COVID-19 pandemic.
Mortality rates were much higher among the patients deemed to have had a vaccine-related CVST. The in-hospital mortality rate was 47%, compared with 5% among the patients in the same cohort who did not have TTS and 3.9% among the prepandemic control group.
The mortality rate was even higher (61%) among patients in the TTS group for whom the diagnosis was made before the condition garnered attention in the scientific community. The mortality rate was 42% among patients diagnosed later.
Of the 78 patients in whom CVST and TTS occurred after COVID-19 vaccination in this cohort, 76 had received the AstraZeneca vaccine (in 75 patients, CVST and TTS occurred after the first vaccination; in one patient, they occurred after the second vaccination). One patient had received the Johnson & Johnson vaccine, and one had received the Pfizer vaccine.
“After more analysis, the case after the Pfizer vaccination is not believed to be caused by the vaccine,” Dr. Coutinho said. “In that case, the patient had a platelet count just below the lower limit and was taking an immunomodulator drug that is known to be associated with thrombocytopenia.”
For two patients who received the AstraZeneca vaccine, there was also an alternative explanation for the thrombocytopenia.
Dr. Coutinho also pointed out that the Johnson & Johnson vaccine has been used mainly in the United States, and these data were largely from other countries.
The median time from vaccination to CVST symptom onset was 9 days in the TTS group. The median platelet count at hospital admission among patients with postvaccination CVST-TTS was 45. Three patients presented with a normal platelet count and developed thrombocytopenia during admission; two patients presented with mild thrombocytopenia, 30 presented with moderate thrombocytopenia, and 43 presented with severe thrombocytopenia.
Antibodies against platelet factor 4 (PF4) were measured in 69 patients with TTS, of whom 63 (91%) tested positive (the one patient in whom TTS occurred after the patient received the Pfizer vaccine did not test positive). However, the researchers note that sensitivity varies among different PF4 ELISA tests. Findings of platelet activation assays were positive in all 36 tested patients.
In the TTS group, 52 patients (67%) received immunomodulation therapy, most often intravenous immunoglobulins (IVIG). Among patients treated with IVIG, the mortality rate was lower (28%).
Different from CVST linked to natural COVID-19 infection
Dr. Coutinho noted that CVST can occur in natural SARS-CoV-2 infection but that vaccine-associated CVST is very different.
“In natural COVID-19 infection, there is an increased risk of thrombosis, and some patients can get CVST as a part of this, but in these cases, this is not accompanied by thrombocytopenia. While the CVST in natural COVID-19 infection is also associated with a bad prognosis, this is more to do with the underlying disease. It is normally the very sick COVID patients who develop CVST, and these patients usually die from the underlying disease rather than the CVST itself,” he explained.
“Clinicians need to be aware of vaccine-related CVST, as it requires very specific and rapid treatment,” Dr. Coutinho stressed.
“Patients presenting with an extremely severe headache (unlike any headache they’ve had before) or with seizures or a focal deficit (weakness in arm or problems with speaking or vision) within 4 weeks of an adenovirus COVID-19 vaccination should ring alarm bells. It is important to do diagnostics quickly, with a platelet count the most important first step, and a rapid CT/MRI scan,” he said.
Other tests that should be conducted are D-dimer for thrombosis and the PF4 antibody test. But results for the PF4 antibody test can take days to come back, and clinicians shouldn’t wait for that, Dr. Coutinho notes.
“Specific treatment needs to be given immediately – with anticoagulation (preferably nonheparin) and immunomodulation with IVIG to stop the immune reaction. Platelets should not be given – that may seem counterintuitive in patients with a low platelet count, but giving platelets makes it worse,” he said.
Is there a geographic difference?
Dr. Coutinho pointed out that fewer cases of this vaccine-related CVST are being reported at the current time.
“We are not sure why this is the case. These adenovirus vaccines are not being used much now in Western countries, but our collaboration covers many less developed countries in South America and Asia, which are relying heavily on these vaccines. We are now shifting focus to these countries, but so far we have only seen a handful of cases from these areas,” he said.
He suggested that this may be because these countries started their vaccination programs later and are vaccinating their elderly (who are not so susceptible to this side effect) first, or it may be because of some environmental or genetic factor that has not yet been discovered.
“This is now an important research question – is the risk of vaccine-induced CVST the same in different countries or ethnicities? This could influence decisions on future vaccine strategies,” Dr. Coutinho said.
“So far, female sex is the strongest risk factor for vaccine-induced CVST. In our cohort, 81% of cases were in women. In addition, 95% were White, but that doesn’t allow us to conclude that this is a risk factor, as the majority of people who have been vaccinated are White. So, we have no clear insight into that yet,” he said.
In a comment for this news organization, the lead author of the previous U.K. report of a series of 70 cases of cerebral venous thrombosis linked to COVID-19 vaccination, Richard Perry, PhD, University College Hospital, London, described this new report as “an excellent study, with many of the same strengths and weaknesses as our study and has very similar results.”
Dr. Perry noted that the two studies used slightly different definitions of vaccine-induced thrombotic thrombocytopenia, but the cases reported appear to be very similar overall. “It is reassuring and gratifying to see that they have made such similar observations,” he said.
“And as they have drawn their cases from a broad range of countries whereas ours were all from the U.K., this provides evidence that the observations from both studies are reasonably generalizable,” he added.
Dr. Perry pointed out that this new report states that TTS occurred in one patient after the patient had received a second dose of the AstraZeneca vaccine. “I would like to know more about this case, because we didn’t see any cases after a second dose in our cohort,” he said.
Dr. Coutinho responded that he didn’t believe this was the first reported case after the second dose.
The study did not receive any specific funding. Dr. Coutinho has received grants paid to his institution from Boehringer Ingelheim and Bayer and payments paid to his institution for data safety monitoring board participation by Bayer.
A version of this article first appeared on Medscape.com.
, confirming the severity of the reaction and the associated high mortality rate.
The new series comes from an international registry of consecutive patients who experienced CVST within 28 days of COVID-19 vaccination between March 29 and June 18, 2021, from 81 hospitals in 19 countries.
The cases are described in an article published online on Sept. 28. in JAMA Neurology.
“This is a reliable description on the clinical condition of these patients with CVST associated with COVID-19 vaccination. It is striking that this a much worse condition than CVST not associated with COVID-19 vaccination, with a much higher rate of intracerebral hemorrhage and coma and a much higher mortality rate,” senior author Jonathan M. Coutinho, MD, Amsterdam University Medical Centers, told this news organization.
These data confirm the observations from an earlier U.K. cohort in which cases of cerebral venous thrombosis linked to COVID-19 vaccination occurred.
“This is the biggest series, and as an international series, it gives a broader perspective from a larger range of countries,” Dr. Coutinho said. “All the data together show that, although this side effect is rare, the consequences are very severe,” he added.
In the current study, the researchers regarded CVST as being linked to the vaccine if it was accompanied by thrombosis with thrombocytopenia syndrome (TTS), as evidenced by thrombosis and new-onset thrombocytopenia.
In the cohort of 116 patients with CVST after COVID-19 vaccination, 78 (67.2%) had thrombosis with TTS and were thus classified as having had a vaccine-related adverse event. These patients were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%); 47% died during hospitalization.
These patients were compared with the 38 patients in the same cohort who had CVST but in whom there was no indication of concomitant thrombosis and thrombocytopenia. The case patients were also compared with a control group of 207 patients with CVST who were included in a separate international registry before the COVID-19 pandemic.
Mortality rates were much higher among the patients deemed to have had a vaccine-related CVST. The in-hospital mortality rate was 47%, compared with 5% among the patients in the same cohort who did not have TTS and 3.9% among the prepandemic control group.
The mortality rate was even higher (61%) among patients in the TTS group for whom the diagnosis was made before the condition garnered attention in the scientific community. The mortality rate was 42% among patients diagnosed later.
Of the 78 patients in whom CVST and TTS occurred after COVID-19 vaccination in this cohort, 76 had received the AstraZeneca vaccine (in 75 patients, CVST and TTS occurred after the first vaccination; in one patient, they occurred after the second vaccination). One patient had received the Johnson & Johnson vaccine, and one had received the Pfizer vaccine.
“After more analysis, the case after the Pfizer vaccination is not believed to be caused by the vaccine,” Dr. Coutinho said. “In that case, the patient had a platelet count just below the lower limit and was taking an immunomodulator drug that is known to be associated with thrombocytopenia.”
For two patients who received the AstraZeneca vaccine, there was also an alternative explanation for the thrombocytopenia.
Dr. Coutinho also pointed out that the Johnson & Johnson vaccine has been used mainly in the United States, and these data were largely from other countries.
The median time from vaccination to CVST symptom onset was 9 days in the TTS group. The median platelet count at hospital admission among patients with postvaccination CVST-TTS was 45. Three patients presented with a normal platelet count and developed thrombocytopenia during admission; two patients presented with mild thrombocytopenia, 30 presented with moderate thrombocytopenia, and 43 presented with severe thrombocytopenia.
Antibodies against platelet factor 4 (PF4) were measured in 69 patients with TTS, of whom 63 (91%) tested positive (the one patient in whom TTS occurred after the patient received the Pfizer vaccine did not test positive). However, the researchers note that sensitivity varies among different PF4 ELISA tests. Findings of platelet activation assays were positive in all 36 tested patients.
In the TTS group, 52 patients (67%) received immunomodulation therapy, most often intravenous immunoglobulins (IVIG). Among patients treated with IVIG, the mortality rate was lower (28%).
Different from CVST linked to natural COVID-19 infection
Dr. Coutinho noted that CVST can occur in natural SARS-CoV-2 infection but that vaccine-associated CVST is very different.
“In natural COVID-19 infection, there is an increased risk of thrombosis, and some patients can get CVST as a part of this, but in these cases, this is not accompanied by thrombocytopenia. While the CVST in natural COVID-19 infection is also associated with a bad prognosis, this is more to do with the underlying disease. It is normally the very sick COVID patients who develop CVST, and these patients usually die from the underlying disease rather than the CVST itself,” he explained.
“Clinicians need to be aware of vaccine-related CVST, as it requires very specific and rapid treatment,” Dr. Coutinho stressed.
“Patients presenting with an extremely severe headache (unlike any headache they’ve had before) or with seizures or a focal deficit (weakness in arm or problems with speaking or vision) within 4 weeks of an adenovirus COVID-19 vaccination should ring alarm bells. It is important to do diagnostics quickly, with a platelet count the most important first step, and a rapid CT/MRI scan,” he said.
Other tests that should be conducted are D-dimer for thrombosis and the PF4 antibody test. But results for the PF4 antibody test can take days to come back, and clinicians shouldn’t wait for that, Dr. Coutinho notes.
“Specific treatment needs to be given immediately – with anticoagulation (preferably nonheparin) and immunomodulation with IVIG to stop the immune reaction. Platelets should not be given – that may seem counterintuitive in patients with a low platelet count, but giving platelets makes it worse,” he said.
Is there a geographic difference?
Dr. Coutinho pointed out that fewer cases of this vaccine-related CVST are being reported at the current time.
“We are not sure why this is the case. These adenovirus vaccines are not being used much now in Western countries, but our collaboration covers many less developed countries in South America and Asia, which are relying heavily on these vaccines. We are now shifting focus to these countries, but so far we have only seen a handful of cases from these areas,” he said.
He suggested that this may be because these countries started their vaccination programs later and are vaccinating their elderly (who are not so susceptible to this side effect) first, or it may be because of some environmental or genetic factor that has not yet been discovered.
“This is now an important research question – is the risk of vaccine-induced CVST the same in different countries or ethnicities? This could influence decisions on future vaccine strategies,” Dr. Coutinho said.
“So far, female sex is the strongest risk factor for vaccine-induced CVST. In our cohort, 81% of cases were in women. In addition, 95% were White, but that doesn’t allow us to conclude that this is a risk factor, as the majority of people who have been vaccinated are White. So, we have no clear insight into that yet,” he said.
In a comment for this news organization, the lead author of the previous U.K. report of a series of 70 cases of cerebral venous thrombosis linked to COVID-19 vaccination, Richard Perry, PhD, University College Hospital, London, described this new report as “an excellent study, with many of the same strengths and weaknesses as our study and has very similar results.”
Dr. Perry noted that the two studies used slightly different definitions of vaccine-induced thrombotic thrombocytopenia, but the cases reported appear to be very similar overall. “It is reassuring and gratifying to see that they have made such similar observations,” he said.
“And as they have drawn their cases from a broad range of countries whereas ours were all from the U.K., this provides evidence that the observations from both studies are reasonably generalizable,” he added.
Dr. Perry pointed out that this new report states that TTS occurred in one patient after the patient had received a second dose of the AstraZeneca vaccine. “I would like to know more about this case, because we didn’t see any cases after a second dose in our cohort,” he said.
Dr. Coutinho responded that he didn’t believe this was the first reported case after the second dose.
The study did not receive any specific funding. Dr. Coutinho has received grants paid to his institution from Boehringer Ingelheim and Bayer and payments paid to his institution for data safety monitoring board participation by Bayer.
A version of this article first appeared on Medscape.com.
Booster shot back-and-forth creates uncertainty, confusion
Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.
, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.
The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.
“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.
This kind of mixed messaging is generating more questions than answers.
“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.
When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”
“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association.
Boosting misinformation?
“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.
Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”
These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.
“That’s unfortunate because it’s a complete fallacy.”
Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”
“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.
More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
‘Gaming the system’
Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”
“Some people are gaming the system to get their booster or second shot of J&J,” he said.
For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”
“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”
Dr. Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a liability line?
Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.
“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”
Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.
But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.
“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
Despite confusion, demand is up
Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.
“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”
“There is quite a bit of excitement out there,” he said.
Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”
Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
‘Walk, don’t run’
To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.
“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.
CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.
“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.
“We will come and look at the data for Moderna and J&J in very short order.”
Dr. Edje and Mr. Caswell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.
, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.
The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.
“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.
This kind of mixed messaging is generating more questions than answers.
“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.
When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”
“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association.
Boosting misinformation?
“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.
Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”
These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.
“That’s unfortunate because it’s a complete fallacy.”
Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”
“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.
More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
‘Gaming the system’
Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”
“Some people are gaming the system to get their booster or second shot of J&J,” he said.
For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”
“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”
Dr. Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a liability line?
Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.
“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”
Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.
But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.
“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
Despite confusion, demand is up
Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.
“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”
“There is quite a bit of excitement out there,” he said.
Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”
Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
‘Walk, don’t run’
To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.
“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.
CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.
“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.
“We will come and look at the data for Moderna and J&J in very short order.”
Dr. Edje and Mr. Caswell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.
, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.
The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.
“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.
This kind of mixed messaging is generating more questions than answers.
“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.
When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”
“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association.
Boosting misinformation?
“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.
Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”
These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.
“That’s unfortunate because it’s a complete fallacy.”
Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”
“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.
More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
‘Gaming the system’
Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”
“Some people are gaming the system to get their booster or second shot of J&J,” he said.
For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”
“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”
Dr. Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a liability line?
Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.
“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”
Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.
But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.
“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
Despite confusion, demand is up
Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.
“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”
“There is quite a bit of excitement out there,” he said.
Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”
Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
‘Walk, don’t run’
To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.
“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.
CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.
“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.
“We will come and look at the data for Moderna and J&J in very short order.”
Dr. Edje and Mr. Caswell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Worsening motor function tied to post COVID syndrome in Parkinson’s disease
, new research suggests.
Results from a small, international retrospective case study show that about half of participants with Parkinson’s disease who developed post–COVID-19 syndrome experienced a worsening of motor symptoms and that their need for anti-Parkinson’s medication increased.
“In our series of 27 patients with Parkinson’s disease, 85% developed post–COVID-19 symptoms,” said lead investigator Valentina Leta, MD, Parkinson’s Foundation Center of Excellence, Kings College Hospital, London.
The most common long-term effects were worsening of motor function and an increase in the need for daily levodopa. Other adverse effects included fatigue; cognitive disturbances, including brain fog, loss of concentration, and memory deficits; and sleep disturbances, such as insomnia, Dr. Leta said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Long-term sequelae
Previous studies have documented worsening of motor and nonmotor symptoms among patients with Parkinson’s disease in the acute phase of COVID-19. Results of these studies suggest that mortality may be higher among patients with more advanced Parkinson’s disease, comorbidities, and frailty.
Dr. Leta noted that long-term sequelae with so-called long COVID have not been adequately explored, prompting the current study.
The case series included 27 patients with Parkinson’s disease in the United Kingdom, Italy, Romania, and Mexico who were also affected by COVID-19. The investigators defined post–COVID-19 syndrome as “signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks, and are not explained by an alternative diagnosis.”
Because some of the symptoms are also associated with Parkinson’s disease, symptoms were attributed to post–COVID-19 only if they occurred after a confirmed severe acute respiratory infection with SARS-CoV-2 or if patients experienced an acute or subacute worsening of a pre-existing symptom that had previously been stable.
Among the participants, 59.3% were men. The mean age at the time of Parkinson’s disease diagnosis was 59.0 ± 12.7 years, and the mean Parkinson’s disease duration was 9.2 ± 7.8 years. The patients were in Hoehn and Yahr stage 2.0 ± 1.0 at the time of their COVID-19 diagnosis.
Charlson Comorbidity Index score at COVID-19 diagnosis was 2.0 ± 1.5, and the levodopa equivalent daily dose (LEDD) was 1053.5 ± 842.4 mg.
Symptom worsening
“Cognitive disturbances” were defined as brain fog, concentration difficulty, or memory problems. “Peripheral neuropathy symptoms” were defined as having feelings of pins and needles or numbness.
By far, the most prevalent sequelae were worsening motor symptoms and increased need for anti-Parkinson’s medications. Each affected about half of the study cohort, the investigators noted.
Dr. Leta added the non-Parkinson’s disease-specific findings are in line with the existing literature on long COVID in the general population. The severity of COVID-19, as indicated by a history of hospitalization, did not seem to correlate with development of post–COVID-19 syndrome in patients with Parkinson’s disease.
In this series, few patients had respiratory, cardiovascular, gastrointestinal, musculoskeletal, or dermatologic symptoms. Interestingly, only four patients reported a loss of taste or smell.
The investigators noted that in addition to viral illness, the stress of prolonged lockdown during the pandemic and reduced access to health care and rehabilitation programs may contribute to the burden of post–COVID-19 syndrome in patients with Parkinson’s disease.
Study limitations cited include the relatively small sample size and the lack of a control group. The researchers noted the need for larger studies to elucidate the natural history of COVID-19 among patients with Parkinson’s disease in order to raise awareness of their needs and to help develop personalized management strategies.
Meaningful addition
Commenting on the findings, Kyle Mitchell, MD, movement disorders neurologist, Duke University, Durham, N.C., said he found the study to be a meaningful addition in light of the fact that data on the challenges that patients with Parkinson’s disease may face after having COVID-19 are limited.
“What I liked about this study was there’s data from multiple countries, what looks like a diverse population of study participants, and really just addressing a question that we get asked a lot in clinic and we see a fair amount, but we don’t really know a lot about: how people with Parkinson’s disease will do during and post COVID-19 infection,” said Dr. Mitchell, who was not involved with the research.
He said the worsening of motor symptoms and the need for increased dopaminergic medication brought some questions to mind.
“Is this increase in medications permanent, or is it temporary until post-COVID resolves? Or is it truly something where they stay on a higher dose?” he asked.
Dr. Mitchell said he does not believe the worsening of symptoms is specific to COVID-19 and that he sees individuals with Parkinson’s disease who experience setbacks “from any number of infections.” These include urinary tract infections and influenza, which are associated with worsening mobility, rigidity, tremor, fatigue, and cognition.
“People with Parkinson’s disease seem to get hit harder by infections in general,” he said.
The study had no outside funding. Dr. Leta and Dr. Mitchell have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Results from a small, international retrospective case study show that about half of participants with Parkinson’s disease who developed post–COVID-19 syndrome experienced a worsening of motor symptoms and that their need for anti-Parkinson’s medication increased.
“In our series of 27 patients with Parkinson’s disease, 85% developed post–COVID-19 symptoms,” said lead investigator Valentina Leta, MD, Parkinson’s Foundation Center of Excellence, Kings College Hospital, London.
The most common long-term effects were worsening of motor function and an increase in the need for daily levodopa. Other adverse effects included fatigue; cognitive disturbances, including brain fog, loss of concentration, and memory deficits; and sleep disturbances, such as insomnia, Dr. Leta said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Long-term sequelae
Previous studies have documented worsening of motor and nonmotor symptoms among patients with Parkinson’s disease in the acute phase of COVID-19. Results of these studies suggest that mortality may be higher among patients with more advanced Parkinson’s disease, comorbidities, and frailty.
Dr. Leta noted that long-term sequelae with so-called long COVID have not been adequately explored, prompting the current study.
The case series included 27 patients with Parkinson’s disease in the United Kingdom, Italy, Romania, and Mexico who were also affected by COVID-19. The investigators defined post–COVID-19 syndrome as “signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks, and are not explained by an alternative diagnosis.”
Because some of the symptoms are also associated with Parkinson’s disease, symptoms were attributed to post–COVID-19 only if they occurred after a confirmed severe acute respiratory infection with SARS-CoV-2 or if patients experienced an acute or subacute worsening of a pre-existing symptom that had previously been stable.
Among the participants, 59.3% were men. The mean age at the time of Parkinson’s disease diagnosis was 59.0 ± 12.7 years, and the mean Parkinson’s disease duration was 9.2 ± 7.8 years. The patients were in Hoehn and Yahr stage 2.0 ± 1.0 at the time of their COVID-19 diagnosis.
Charlson Comorbidity Index score at COVID-19 diagnosis was 2.0 ± 1.5, and the levodopa equivalent daily dose (LEDD) was 1053.5 ± 842.4 mg.
Symptom worsening
“Cognitive disturbances” were defined as brain fog, concentration difficulty, or memory problems. “Peripheral neuropathy symptoms” were defined as having feelings of pins and needles or numbness.
By far, the most prevalent sequelae were worsening motor symptoms and increased need for anti-Parkinson’s medications. Each affected about half of the study cohort, the investigators noted.
Dr. Leta added the non-Parkinson’s disease-specific findings are in line with the existing literature on long COVID in the general population. The severity of COVID-19, as indicated by a history of hospitalization, did not seem to correlate with development of post–COVID-19 syndrome in patients with Parkinson’s disease.
In this series, few patients had respiratory, cardiovascular, gastrointestinal, musculoskeletal, or dermatologic symptoms. Interestingly, only four patients reported a loss of taste or smell.
The investigators noted that in addition to viral illness, the stress of prolonged lockdown during the pandemic and reduced access to health care and rehabilitation programs may contribute to the burden of post–COVID-19 syndrome in patients with Parkinson’s disease.
Study limitations cited include the relatively small sample size and the lack of a control group. The researchers noted the need for larger studies to elucidate the natural history of COVID-19 among patients with Parkinson’s disease in order to raise awareness of their needs and to help develop personalized management strategies.
Meaningful addition
Commenting on the findings, Kyle Mitchell, MD, movement disorders neurologist, Duke University, Durham, N.C., said he found the study to be a meaningful addition in light of the fact that data on the challenges that patients with Parkinson’s disease may face after having COVID-19 are limited.
“What I liked about this study was there’s data from multiple countries, what looks like a diverse population of study participants, and really just addressing a question that we get asked a lot in clinic and we see a fair amount, but we don’t really know a lot about: how people with Parkinson’s disease will do during and post COVID-19 infection,” said Dr. Mitchell, who was not involved with the research.
He said the worsening of motor symptoms and the need for increased dopaminergic medication brought some questions to mind.
“Is this increase in medications permanent, or is it temporary until post-COVID resolves? Or is it truly something where they stay on a higher dose?” he asked.
Dr. Mitchell said he does not believe the worsening of symptoms is specific to COVID-19 and that he sees individuals with Parkinson’s disease who experience setbacks “from any number of infections.” These include urinary tract infections and influenza, which are associated with worsening mobility, rigidity, tremor, fatigue, and cognition.
“People with Parkinson’s disease seem to get hit harder by infections in general,” he said.
The study had no outside funding. Dr. Leta and Dr. Mitchell have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
Results from a small, international retrospective case study show that about half of participants with Parkinson’s disease who developed post–COVID-19 syndrome experienced a worsening of motor symptoms and that their need for anti-Parkinson’s medication increased.
“In our series of 27 patients with Parkinson’s disease, 85% developed post–COVID-19 symptoms,” said lead investigator Valentina Leta, MD, Parkinson’s Foundation Center of Excellence, Kings College Hospital, London.
The most common long-term effects were worsening of motor function and an increase in the need for daily levodopa. Other adverse effects included fatigue; cognitive disturbances, including brain fog, loss of concentration, and memory deficits; and sleep disturbances, such as insomnia, Dr. Leta said.
The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
Long-term sequelae
Previous studies have documented worsening of motor and nonmotor symptoms among patients with Parkinson’s disease in the acute phase of COVID-19. Results of these studies suggest that mortality may be higher among patients with more advanced Parkinson’s disease, comorbidities, and frailty.
Dr. Leta noted that long-term sequelae with so-called long COVID have not been adequately explored, prompting the current study.
The case series included 27 patients with Parkinson’s disease in the United Kingdom, Italy, Romania, and Mexico who were also affected by COVID-19. The investigators defined post–COVID-19 syndrome as “signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks, and are not explained by an alternative diagnosis.”
Because some of the symptoms are also associated with Parkinson’s disease, symptoms were attributed to post–COVID-19 only if they occurred after a confirmed severe acute respiratory infection with SARS-CoV-2 or if patients experienced an acute or subacute worsening of a pre-existing symptom that had previously been stable.
Among the participants, 59.3% were men. The mean age at the time of Parkinson’s disease diagnosis was 59.0 ± 12.7 years, and the mean Parkinson’s disease duration was 9.2 ± 7.8 years. The patients were in Hoehn and Yahr stage 2.0 ± 1.0 at the time of their COVID-19 diagnosis.
Charlson Comorbidity Index score at COVID-19 diagnosis was 2.0 ± 1.5, and the levodopa equivalent daily dose (LEDD) was 1053.5 ± 842.4 mg.
Symptom worsening
“Cognitive disturbances” were defined as brain fog, concentration difficulty, or memory problems. “Peripheral neuropathy symptoms” were defined as having feelings of pins and needles or numbness.
By far, the most prevalent sequelae were worsening motor symptoms and increased need for anti-Parkinson’s medications. Each affected about half of the study cohort, the investigators noted.
Dr. Leta added the non-Parkinson’s disease-specific findings are in line with the existing literature on long COVID in the general population. The severity of COVID-19, as indicated by a history of hospitalization, did not seem to correlate with development of post–COVID-19 syndrome in patients with Parkinson’s disease.
In this series, few patients had respiratory, cardiovascular, gastrointestinal, musculoskeletal, or dermatologic symptoms. Interestingly, only four patients reported a loss of taste or smell.
The investigators noted that in addition to viral illness, the stress of prolonged lockdown during the pandemic and reduced access to health care and rehabilitation programs may contribute to the burden of post–COVID-19 syndrome in patients with Parkinson’s disease.
Study limitations cited include the relatively small sample size and the lack of a control group. The researchers noted the need for larger studies to elucidate the natural history of COVID-19 among patients with Parkinson’s disease in order to raise awareness of their needs and to help develop personalized management strategies.
Meaningful addition
Commenting on the findings, Kyle Mitchell, MD, movement disorders neurologist, Duke University, Durham, N.C., said he found the study to be a meaningful addition in light of the fact that data on the challenges that patients with Parkinson’s disease may face after having COVID-19 are limited.
“What I liked about this study was there’s data from multiple countries, what looks like a diverse population of study participants, and really just addressing a question that we get asked a lot in clinic and we see a fair amount, but we don’t really know a lot about: how people with Parkinson’s disease will do during and post COVID-19 infection,” said Dr. Mitchell, who was not involved with the research.
He said the worsening of motor symptoms and the need for increased dopaminergic medication brought some questions to mind.
“Is this increase in medications permanent, or is it temporary until post-COVID resolves? Or is it truly something where they stay on a higher dose?” he asked.
Dr. Mitchell said he does not believe the worsening of symptoms is specific to COVID-19 and that he sees individuals with Parkinson’s disease who experience setbacks “from any number of infections.” These include urinary tract infections and influenza, which are associated with worsening mobility, rigidity, tremor, fatigue, and cognition.
“People with Parkinson’s disease seem to get hit harder by infections in general,” he said.
The study had no outside funding. Dr. Leta and Dr. Mitchell have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MDS VIRTUAL CONGRESS 2021
COVID-19: Greater mortality among psych patients remains a mystery
Antipsychotics are not responsible for the increased COVID-related death rate among patients with serious mental illness (SMI), new research shows.
The significant increase in COVID-19 mortality that continues to be reported among those with schizophrenia and schizoaffective disorder “underscores the importance of protective interventions for this group, including priority vaccination,” study investigator Katlyn Nemani, MD, research assistant professor, department of psychiatry, New York University, told this news organization.
The study was published online September 22 in JAMA Psychiatry.
Threefold increase in death
Previous research has linked a diagnosis of a schizophrenia spectrum disorder, which includes schizophrenia and schizoaffective disorder, to an almost threefold increase in mortality among patients with COVID-19.
Some population-based research has also reported a link between antipsychotic medication use and increased risk for COVID-related mortality, but these studies did not take psychiatric diagnoses into account.
“This raised the question of whether the increased risk observed in this population is related to underlying psychiatric illness or its treatment,” said Dr. Nemani.
The retrospective cohort study included 464 adults (mean age, 53 years) who were diagnosed with COVID-19 between March 3, 2020, and Feb. 17, 2021, and who had previously been diagnosed with schizophrenia spectrum disorder or bipolar disorder. Of these, 42.2% were treated with an antipsychotic medication.
The primary endpoint was death within 60 days of COVID-19 diagnosis. Covariates included sociodemographic characteristics, such as patient-reported race and ethnicity, age, and insurance type, a psychiatric diagnosis, medical comorbidities, and smoking status.
Of the total, 41 patients (8.8%) died. The 60-day fatality rate was 13.7% among patients with a schizophrenia spectrum disorder (n = 182) and 5.7% among patients with bipolar disorder (n = 282).
Antipsychotic treatment was not significantly associated with mortality (odds ratio, 1.00; 95% confidence interval, 0.48-2.08; P = .99).
“This suggests that antipsychotic medication is unlikely to be responsible for the increased risk we’ve observed in this population, although this finding needs to be replicated,” said Dr. Nemani.
Surprise finding
A diagnosis of a schizophrenia spectrum disorder was associated with an almost threefold increased risk for mortality compared with bipolar disorder (OR, 2.88; 95% CI, 1.36-6.11; P = .006).
“This was a surprising finding,” said Dr. Nemani.
She noted that there is evidence suggesting the immune system may play a role in the pathogenesis of schizophrenia, and research has shown that pneumonia and infection are among the leading causes of premature mortality in this population.
As well, several potential risk factors disproportionately affect people with serious mental illness, including an increase in the prevalence of medical comorbidities such as cardiovascular disease and diabetes, socioeconomic disadvantages, and barriers to accessing timely care. Prior studies have also found that people with SMI are less likely to receive preventive care interventions, including vaccination, said Dr. Nemani.
However, these factors are unlikely to fully account for the increased risk found in the study, she said.
“Our study population was limited to people who had received treatment within the NYU Langone Health System. We took a comprehensive list of sociodemographic and medical risk factors into account, and our research was conducted prior to the availability of COVID-19 vaccines,” she said.
Further research is necessary to understand what underlies the increase in susceptibility to severe infection among patients with schizophrenia and to identify interventions that may mitigate risk, said Dr. Nemani.
“This includes evaluating systems-level factors, such as access to preventive interventions and treatment, as well as investigating underlying immune mechanisms that may contribute to severe and fatal infection,” she said.
The researchers could not validate psychiatric diagnoses or capture deaths not documented in the electronic health record. In addition, the limited sample size precluded analysis of the use of individual antipsychotic medications, which may differ in their associated effects.
“It’s possible individual antipsychotic medications may be associated with harmful or protective effects,” said Dr. Nemani.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antipsychotics are not responsible for the increased COVID-related death rate among patients with serious mental illness (SMI), new research shows.
The significant increase in COVID-19 mortality that continues to be reported among those with schizophrenia and schizoaffective disorder “underscores the importance of protective interventions for this group, including priority vaccination,” study investigator Katlyn Nemani, MD, research assistant professor, department of psychiatry, New York University, told this news organization.
The study was published online September 22 in JAMA Psychiatry.
Threefold increase in death
Previous research has linked a diagnosis of a schizophrenia spectrum disorder, which includes schizophrenia and schizoaffective disorder, to an almost threefold increase in mortality among patients with COVID-19.
Some population-based research has also reported a link between antipsychotic medication use and increased risk for COVID-related mortality, but these studies did not take psychiatric diagnoses into account.
“This raised the question of whether the increased risk observed in this population is related to underlying psychiatric illness or its treatment,” said Dr. Nemani.
The retrospective cohort study included 464 adults (mean age, 53 years) who were diagnosed with COVID-19 between March 3, 2020, and Feb. 17, 2021, and who had previously been diagnosed with schizophrenia spectrum disorder or bipolar disorder. Of these, 42.2% were treated with an antipsychotic medication.
The primary endpoint was death within 60 days of COVID-19 diagnosis. Covariates included sociodemographic characteristics, such as patient-reported race and ethnicity, age, and insurance type, a psychiatric diagnosis, medical comorbidities, and smoking status.
Of the total, 41 patients (8.8%) died. The 60-day fatality rate was 13.7% among patients with a schizophrenia spectrum disorder (n = 182) and 5.7% among patients with bipolar disorder (n = 282).
Antipsychotic treatment was not significantly associated with mortality (odds ratio, 1.00; 95% confidence interval, 0.48-2.08; P = .99).
“This suggests that antipsychotic medication is unlikely to be responsible for the increased risk we’ve observed in this population, although this finding needs to be replicated,” said Dr. Nemani.
Surprise finding
A diagnosis of a schizophrenia spectrum disorder was associated with an almost threefold increased risk for mortality compared with bipolar disorder (OR, 2.88; 95% CI, 1.36-6.11; P = .006).
“This was a surprising finding,” said Dr. Nemani.
She noted that there is evidence suggesting the immune system may play a role in the pathogenesis of schizophrenia, and research has shown that pneumonia and infection are among the leading causes of premature mortality in this population.
As well, several potential risk factors disproportionately affect people with serious mental illness, including an increase in the prevalence of medical comorbidities such as cardiovascular disease and diabetes, socioeconomic disadvantages, and barriers to accessing timely care. Prior studies have also found that people with SMI are less likely to receive preventive care interventions, including vaccination, said Dr. Nemani.
However, these factors are unlikely to fully account for the increased risk found in the study, she said.
“Our study population was limited to people who had received treatment within the NYU Langone Health System. We took a comprehensive list of sociodemographic and medical risk factors into account, and our research was conducted prior to the availability of COVID-19 vaccines,” she said.
Further research is necessary to understand what underlies the increase in susceptibility to severe infection among patients with schizophrenia and to identify interventions that may mitigate risk, said Dr. Nemani.
“This includes evaluating systems-level factors, such as access to preventive interventions and treatment, as well as investigating underlying immune mechanisms that may contribute to severe and fatal infection,” she said.
The researchers could not validate psychiatric diagnoses or capture deaths not documented in the electronic health record. In addition, the limited sample size precluded analysis of the use of individual antipsychotic medications, which may differ in their associated effects.
“It’s possible individual antipsychotic medications may be associated with harmful or protective effects,” said Dr. Nemani.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antipsychotics are not responsible for the increased COVID-related death rate among patients with serious mental illness (SMI), new research shows.
The significant increase in COVID-19 mortality that continues to be reported among those with schizophrenia and schizoaffective disorder “underscores the importance of protective interventions for this group, including priority vaccination,” study investigator Katlyn Nemani, MD, research assistant professor, department of psychiatry, New York University, told this news organization.
The study was published online September 22 in JAMA Psychiatry.
Threefold increase in death
Previous research has linked a diagnosis of a schizophrenia spectrum disorder, which includes schizophrenia and schizoaffective disorder, to an almost threefold increase in mortality among patients with COVID-19.
Some population-based research has also reported a link between antipsychotic medication use and increased risk for COVID-related mortality, but these studies did not take psychiatric diagnoses into account.
“This raised the question of whether the increased risk observed in this population is related to underlying psychiatric illness or its treatment,” said Dr. Nemani.
The retrospective cohort study included 464 adults (mean age, 53 years) who were diagnosed with COVID-19 between March 3, 2020, and Feb. 17, 2021, and who had previously been diagnosed with schizophrenia spectrum disorder or bipolar disorder. Of these, 42.2% were treated with an antipsychotic medication.
The primary endpoint was death within 60 days of COVID-19 diagnosis. Covariates included sociodemographic characteristics, such as patient-reported race and ethnicity, age, and insurance type, a psychiatric diagnosis, medical comorbidities, and smoking status.
Of the total, 41 patients (8.8%) died. The 60-day fatality rate was 13.7% among patients with a schizophrenia spectrum disorder (n = 182) and 5.7% among patients with bipolar disorder (n = 282).
Antipsychotic treatment was not significantly associated with mortality (odds ratio, 1.00; 95% confidence interval, 0.48-2.08; P = .99).
“This suggests that antipsychotic medication is unlikely to be responsible for the increased risk we’ve observed in this population, although this finding needs to be replicated,” said Dr. Nemani.
Surprise finding
A diagnosis of a schizophrenia spectrum disorder was associated with an almost threefold increased risk for mortality compared with bipolar disorder (OR, 2.88; 95% CI, 1.36-6.11; P = .006).
“This was a surprising finding,” said Dr. Nemani.
She noted that there is evidence suggesting the immune system may play a role in the pathogenesis of schizophrenia, and research has shown that pneumonia and infection are among the leading causes of premature mortality in this population.
As well, several potential risk factors disproportionately affect people with serious mental illness, including an increase in the prevalence of medical comorbidities such as cardiovascular disease and diabetes, socioeconomic disadvantages, and barriers to accessing timely care. Prior studies have also found that people with SMI are less likely to receive preventive care interventions, including vaccination, said Dr. Nemani.
However, these factors are unlikely to fully account for the increased risk found in the study, she said.
“Our study population was limited to people who had received treatment within the NYU Langone Health System. We took a comprehensive list of sociodemographic and medical risk factors into account, and our research was conducted prior to the availability of COVID-19 vaccines,” she said.
Further research is necessary to understand what underlies the increase in susceptibility to severe infection among patients with schizophrenia and to identify interventions that may mitigate risk, said Dr. Nemani.
“This includes evaluating systems-level factors, such as access to preventive interventions and treatment, as well as investigating underlying immune mechanisms that may contribute to severe and fatal infection,” she said.
The researchers could not validate psychiatric diagnoses or capture deaths not documented in the electronic health record. In addition, the limited sample size precluded analysis of the use of individual antipsychotic medications, which may differ in their associated effects.
“It’s possible individual antipsychotic medications may be associated with harmful or protective effects,” said Dr. Nemani.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID vaccination rates among pregnant people remain low
COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.
About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.
The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.
“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.
“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”
Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.
Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.
“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.
Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.
“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.
“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”
A version of this article first appeared on Medscape.com.
COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.
About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.
The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.
“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.
“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”
Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.
Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.
“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.
Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.
“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.
“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”
A version of this article first appeared on Medscape.com.
COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.
About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.
The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.
“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.
“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”
Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.
Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.
“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.
Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.
“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.
“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”
A version of this article first appeared on Medscape.com.
Age, C-reactive protein predict COVID-19 death in diabetes
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
COVID-19 hospitalization 80% more likely for smokers
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Children and COVID: New cases topped 200,000 after 3 weeks of declines
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Polyethylene glycol linked to rare allergic reactions seen with mRNA COVID-19 vaccines
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
These schools use weekly testing to keep kids in class – and COVID out
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.