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FDA set to okay Pfizer vaccine in younger teens
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
Drinking your way to heart failure, and the fringe benefits of COVID-19 vaccination
Energy drink doom
Who doesn’t need some caffeine to get going in the morning and keep moving throughout the day? Whether it’s tea, coffee, or energy drinks, people can get addicted to caffeinated beverages when there are only so many hours in a day and way too much work to get done.
That’s what happened to a 21-year-old college student who powered down four 16-ounce cans of energy drink – each with double the amount of caffeine in an ordinary cup of coffee – every day for 2 years. Now, if you’ve ever overdone it with caffeine, you know there are some uncomfortable side effects, like shaking and anxiety. In this case, the student reported migraines, tremors, and heart palpitations. Instead of being able to focus better on his work, he had trouble concentrating.
Over time, after these side effects took a turn for the worse and became shortness of breath and weight loss, he visited St. Thomas’ Hospital in London, where physicians diagnosed him with both heart and renal failure.
Excessive consumption of energy drinks is known to cause issues such as high blood pressure and irregular heart beat, so if that’s your fuel of choice, it might be worth cutting down. Maybe take a morning run to get the blood pumping – in a good way – instead?
Loneliness may be hazardous to your health
Sometimes loneliness can feel like it affects your physical health, but according to a study there’s a possibility that it actually does.
Back in the 1980s, researchers from the University of Eastern Finland started monitoring almost 3,000 middle-aged men. They’ve kept up with the participants until the present day, and the results have been staggering. After an average follow-up of over 20 years, 25% of participants developed cancer and 11% died from cancer, and the increase in risk from loneliness was about 10%, regardless of age, lifestyle, and BMI.
What does that say about preventive care? The researchers think these data are cause enough to pay attention to loneliness as a health issue along with smoking and weight.
Social interactions and relationships play important roles in human mental health, of course, but this is pretty solid evidence that they play a role in physical health too. As the researchers said, “Awareness of the health effects of loneliness is constantly increasing. Therefore, it is important to examine, in more detail, the mechanisms by which loneliness causes adverse health effects.”
So, as we progress through this pandemic, maybe you should join that social group on Facebook? Who knows what kind of effect it could have on your health?
An ounce of prevention is worth 12 ounces of lager
COVID-19 vaccine refusal is now a thing, and there’s no law that says people have to be immunized against our newest, bestest buddy, SARS-CoV-2, but the folks who skip it are missing out. And no, we’re not talking about immunity against disease.
We’re talking … FREE STUFF!
Corporate America has stepped up and is now rewarding those who get the COVID-19 vaccine:
- Budweiser will give a free beer to anyone – anyone over age 21, that is – with proof of vaccination until May 16.
- Show a vaccination card at a Krispy Kreme and you can get a free glazed doughnut, every day. You don’t even need to buy anything.
- White Castle will give you a free dessert-on-a-stick just for showing proof of vaccination. No purchase is required, but the offer ends May 31.
But wait, there’s more!
Even the public sector is getting in on the giveaway action. Gov. Jim Justice announced April 26 that West Virginia will give a $100 savings bond to any resident aged 16-35 years who receives a COVID-19 vaccine. It must make sense, because the governor broke out a white board to show residents he’s done the math.
One closing thought: How cool would it be if he was named to the Supreme Court, so he could be Justice Justice?
Where no shirt has gone before
Space. The final frontier, for both humanity and for shirts. Specifically, it’s a new frontier for the Bio-Monitor smart shirt, a tank-top filled with sensors that monitor the wearer’s stats, such as heart and breathing rate, oxygen saturation, skin temperature, and blood pressure. And you thought space was just for finding a new human habitat and growing steak.
This shirt is already used by athletes to assess performance and by people with limited mobility to monitor health, so its potential impending usage by astronauts makes sense. Space is a pretty extreme environment, to put it mildly, and there’s a lot we still don’t know about how the human body reacts to it. Traditionally, astronauts hook themselves up to separate devices so their stats can be measured, a method which captures only snapshots of their bodies. By wearing the shirt constantly, the astronauts can be measured constantly, so scientists and doctors can see how the body deals with microgravity during normal activities and sleep. It also reduces stress, as there is no psychological impact of having to report in for constant health checks.
For the test, astronauts wore the shirt for 72 hours before flight and for 72 hours during flight. The shirts passed this first test with flying colors; in addition to providing accurate and more consistent stats monitoring than traditional methods, scientists on the ground determined that the astronauts recorded far less physical activity during flight than preflight, a finding in line with previous studies.
And before you question whether or not a tank top is really appropriate for space, just remember, Picard pulled it off at the end of “First Contact,” and that’s arguably the best Star Trek movie. So there’s certainly precedent.
Energy drink doom
Who doesn’t need some caffeine to get going in the morning and keep moving throughout the day? Whether it’s tea, coffee, or energy drinks, people can get addicted to caffeinated beverages when there are only so many hours in a day and way too much work to get done.
That’s what happened to a 21-year-old college student who powered down four 16-ounce cans of energy drink – each with double the amount of caffeine in an ordinary cup of coffee – every day for 2 years. Now, if you’ve ever overdone it with caffeine, you know there are some uncomfortable side effects, like shaking and anxiety. In this case, the student reported migraines, tremors, and heart palpitations. Instead of being able to focus better on his work, he had trouble concentrating.
Over time, after these side effects took a turn for the worse and became shortness of breath and weight loss, he visited St. Thomas’ Hospital in London, where physicians diagnosed him with both heart and renal failure.
Excessive consumption of energy drinks is known to cause issues such as high blood pressure and irregular heart beat, so if that’s your fuel of choice, it might be worth cutting down. Maybe take a morning run to get the blood pumping – in a good way – instead?
Loneliness may be hazardous to your health
Sometimes loneliness can feel like it affects your physical health, but according to a study there’s a possibility that it actually does.
Back in the 1980s, researchers from the University of Eastern Finland started monitoring almost 3,000 middle-aged men. They’ve kept up with the participants until the present day, and the results have been staggering. After an average follow-up of over 20 years, 25% of participants developed cancer and 11% died from cancer, and the increase in risk from loneliness was about 10%, regardless of age, lifestyle, and BMI.
What does that say about preventive care? The researchers think these data are cause enough to pay attention to loneliness as a health issue along with smoking and weight.
Social interactions and relationships play important roles in human mental health, of course, but this is pretty solid evidence that they play a role in physical health too. As the researchers said, “Awareness of the health effects of loneliness is constantly increasing. Therefore, it is important to examine, in more detail, the mechanisms by which loneliness causes adverse health effects.”
So, as we progress through this pandemic, maybe you should join that social group on Facebook? Who knows what kind of effect it could have on your health?
An ounce of prevention is worth 12 ounces of lager
COVID-19 vaccine refusal is now a thing, and there’s no law that says people have to be immunized against our newest, bestest buddy, SARS-CoV-2, but the folks who skip it are missing out. And no, we’re not talking about immunity against disease.
We’re talking … FREE STUFF!
Corporate America has stepped up and is now rewarding those who get the COVID-19 vaccine:
- Budweiser will give a free beer to anyone – anyone over age 21, that is – with proof of vaccination until May 16.
- Show a vaccination card at a Krispy Kreme and you can get a free glazed doughnut, every day. You don’t even need to buy anything.
- White Castle will give you a free dessert-on-a-stick just for showing proof of vaccination. No purchase is required, but the offer ends May 31.
But wait, there’s more!
Even the public sector is getting in on the giveaway action. Gov. Jim Justice announced April 26 that West Virginia will give a $100 savings bond to any resident aged 16-35 years who receives a COVID-19 vaccine. It must make sense, because the governor broke out a white board to show residents he’s done the math.
One closing thought: How cool would it be if he was named to the Supreme Court, so he could be Justice Justice?
Where no shirt has gone before
Space. The final frontier, for both humanity and for shirts. Specifically, it’s a new frontier for the Bio-Monitor smart shirt, a tank-top filled with sensors that monitor the wearer’s stats, such as heart and breathing rate, oxygen saturation, skin temperature, and blood pressure. And you thought space was just for finding a new human habitat and growing steak.
This shirt is already used by athletes to assess performance and by people with limited mobility to monitor health, so its potential impending usage by astronauts makes sense. Space is a pretty extreme environment, to put it mildly, and there’s a lot we still don’t know about how the human body reacts to it. Traditionally, astronauts hook themselves up to separate devices so their stats can be measured, a method which captures only snapshots of their bodies. By wearing the shirt constantly, the astronauts can be measured constantly, so scientists and doctors can see how the body deals with microgravity during normal activities and sleep. It also reduces stress, as there is no psychological impact of having to report in for constant health checks.
For the test, astronauts wore the shirt for 72 hours before flight and for 72 hours during flight. The shirts passed this first test with flying colors; in addition to providing accurate and more consistent stats monitoring than traditional methods, scientists on the ground determined that the astronauts recorded far less physical activity during flight than preflight, a finding in line with previous studies.
And before you question whether or not a tank top is really appropriate for space, just remember, Picard pulled it off at the end of “First Contact,” and that’s arguably the best Star Trek movie. So there’s certainly precedent.
Energy drink doom
Who doesn’t need some caffeine to get going in the morning and keep moving throughout the day? Whether it’s tea, coffee, or energy drinks, people can get addicted to caffeinated beverages when there are only so many hours in a day and way too much work to get done.
That’s what happened to a 21-year-old college student who powered down four 16-ounce cans of energy drink – each with double the amount of caffeine in an ordinary cup of coffee – every day for 2 years. Now, if you’ve ever overdone it with caffeine, you know there are some uncomfortable side effects, like shaking and anxiety. In this case, the student reported migraines, tremors, and heart palpitations. Instead of being able to focus better on his work, he had trouble concentrating.
Over time, after these side effects took a turn for the worse and became shortness of breath and weight loss, he visited St. Thomas’ Hospital in London, where physicians diagnosed him with both heart and renal failure.
Excessive consumption of energy drinks is known to cause issues such as high blood pressure and irregular heart beat, so if that’s your fuel of choice, it might be worth cutting down. Maybe take a morning run to get the blood pumping – in a good way – instead?
Loneliness may be hazardous to your health
Sometimes loneliness can feel like it affects your physical health, but according to a study there’s a possibility that it actually does.
Back in the 1980s, researchers from the University of Eastern Finland started monitoring almost 3,000 middle-aged men. They’ve kept up with the participants until the present day, and the results have been staggering. After an average follow-up of over 20 years, 25% of participants developed cancer and 11% died from cancer, and the increase in risk from loneliness was about 10%, regardless of age, lifestyle, and BMI.
What does that say about preventive care? The researchers think these data are cause enough to pay attention to loneliness as a health issue along with smoking and weight.
Social interactions and relationships play important roles in human mental health, of course, but this is pretty solid evidence that they play a role in physical health too. As the researchers said, “Awareness of the health effects of loneliness is constantly increasing. Therefore, it is important to examine, in more detail, the mechanisms by which loneliness causes adverse health effects.”
So, as we progress through this pandemic, maybe you should join that social group on Facebook? Who knows what kind of effect it could have on your health?
An ounce of prevention is worth 12 ounces of lager
COVID-19 vaccine refusal is now a thing, and there’s no law that says people have to be immunized against our newest, bestest buddy, SARS-CoV-2, but the folks who skip it are missing out. And no, we’re not talking about immunity against disease.
We’re talking … FREE STUFF!
Corporate America has stepped up and is now rewarding those who get the COVID-19 vaccine:
- Budweiser will give a free beer to anyone – anyone over age 21, that is – with proof of vaccination until May 16.
- Show a vaccination card at a Krispy Kreme and you can get a free glazed doughnut, every day. You don’t even need to buy anything.
- White Castle will give you a free dessert-on-a-stick just for showing proof of vaccination. No purchase is required, but the offer ends May 31.
But wait, there’s more!
Even the public sector is getting in on the giveaway action. Gov. Jim Justice announced April 26 that West Virginia will give a $100 savings bond to any resident aged 16-35 years who receives a COVID-19 vaccine. It must make sense, because the governor broke out a white board to show residents he’s done the math.
One closing thought: How cool would it be if he was named to the Supreme Court, so he could be Justice Justice?
Where no shirt has gone before
Space. The final frontier, for both humanity and for shirts. Specifically, it’s a new frontier for the Bio-Monitor smart shirt, a tank-top filled with sensors that monitor the wearer’s stats, such as heart and breathing rate, oxygen saturation, skin temperature, and blood pressure. And you thought space was just for finding a new human habitat and growing steak.
This shirt is already used by athletes to assess performance and by people with limited mobility to monitor health, so its potential impending usage by astronauts makes sense. Space is a pretty extreme environment, to put it mildly, and there’s a lot we still don’t know about how the human body reacts to it. Traditionally, astronauts hook themselves up to separate devices so their stats can be measured, a method which captures only snapshots of their bodies. By wearing the shirt constantly, the astronauts can be measured constantly, so scientists and doctors can see how the body deals with microgravity during normal activities and sleep. It also reduces stress, as there is no psychological impact of having to report in for constant health checks.
For the test, astronauts wore the shirt for 72 hours before flight and for 72 hours during flight. The shirts passed this first test with flying colors; in addition to providing accurate and more consistent stats monitoring than traditional methods, scientists on the ground determined that the astronauts recorded far less physical activity during flight than preflight, a finding in line with previous studies.
And before you question whether or not a tank top is really appropriate for space, just remember, Picard pulled it off at the end of “First Contact,” and that’s arguably the best Star Trek movie. So there’s certainly precedent.
CDC: Vaccinated people can mostly drop masks outdoors
After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.
It is a minor – but still significant – step toward the end of pandemic restrictions.
“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”
President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.
,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”
President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”
President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.
The CDC has long advised that outdoor activities are safer than indoor activities.
“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”
Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.
The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.
The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.
And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot
The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.
You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.
The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.
Reporter Marcia Frellick contributed to this report.
A version of this article originally appeared on WebMD.com.
After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.
It is a minor – but still significant – step toward the end of pandemic restrictions.
“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”
President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.
,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”
President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”
President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.
The CDC has long advised that outdoor activities are safer than indoor activities.
“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”
Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.
The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.
The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.
And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot
The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.
You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.
The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.
Reporter Marcia Frellick contributed to this report.
A version of this article originally appeared on WebMD.com.
After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.
It is a minor – but still significant – step toward the end of pandemic restrictions.
“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”
President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.
,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”
President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”
President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.
The CDC has long advised that outdoor activities are safer than indoor activities.
“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”
Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.
The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.
The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.
And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot
The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.
You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.
The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.
Reporter Marcia Frellick contributed to this report.
A version of this article originally appeared on WebMD.com.
Helpful giant rodents and our old friend, the hookworm
Rat-ting out coronavirus
Did you know there is a possibility that giant rodents could rat out coronavirus? Not many people are keen on the presence of a 3-foot-long African giant pouched rat, but they have already been trained to sniff out diseases that are dangerous to humans, such as brucellosis and tuberculosis, according to researchers at the University of Glasgow.
Professor Dan Haydon and his associates believe there is a good possibility that the rats can be trained to sniff out COVID-19. Dogs have been helpful in sniffing for COVID-19 at airports and are being trained to detect it through armpit sweat, making detection of the virus easier for travelers and staff. Even robots have gotten into the COVID-19 detecting act.
Since African giant pouched rats can grow to be the size of a small dog and “are easily tamed as companion animals,” it seems likely that they have the potential to do the same. That is, sniffing for COVID-19, not appearing at your local airport. That’s still gross.
Stay healthy, get a parasite bestie
The key to health could actually be swimming around in your gut. Researchers from University College London have found that a parasitic worm could be the answer to longevity and avoidance of chronic diseases.
The seeming immunity from inflammatory diseases such as arthritis, diabetes, and multiple sclerosis may come from helminth parasites, or hookworms – parasites that have been coexisting harmlessly with the human body for thousands of years. The investigators went so far as to call them “old friends,” but the kind that you rarely see at reunions or call up for a favor.
As a result of modern sanitation and improved hygiene, humans and hookworms are seeing much less of each other, which may be a factor in the rise of “aging-associated inflammation” such as COVID-19 symptoms, they suggested. So is there a way to get these old friends back?
“Restorative hookworm treatments” could help with heart disease or dementia, according to the investigators, but maybe you’re not totally on board with getting an actual parasite in your system. We get it. There are helminth-derived proteins that have already been tested to get the job done.
Maybe old friends really do make the best friends.
I love the smell of microbe-infected aerosols in the morning
Have you gone into a public restroom and just stood around for a while appreciating the fine aromas? No? You haven’t? You do your business and get out? Well, it’s a good thing you act like a normal person, because the aerosols released when toilets flush can contain all sorts of nasty bacteria and viruses.
The authors of a new study published in Physics of Fluids came to this groundbreaking conclusion by going to a public bathroom, sticking particle counters above a urinal and a toilet, and letting them sit for a while. After 3 hours and 100 flushes, the ambient level of particles 0.3-3 mcm in diameter had increased dramatically, with particles sized 0.5-1 mcm particularly prone to lingering. For those particles, the level from baseline increased by over 200%.
This is a major concern, the researchers said, because the sort of microbes that are expelled through feces, urine, and vomit can include some pretty nasty things. Ebola, noroviruses that can cause food poisoning, and even good old SARS-CoV-2 can be expelled from the body but remain viable for a time in these aerosols. The researchers recommended improving the ventilation systems in restrooms so that aerosols don’t hang around for hours at a time. Plus, it might make the place not smell like a, uh, public restroom.
Not to question the research and the people behind it, but we’re not sure how necessary it was to give people another reason not to hang out in a place where hundreds, if not thousands, of people come to relieve themselves. There’s a reason we’re supposed to “stop and smell the roses” and not “stop and smell the public bathroom.”
World ends not with a bang but with a cheeseburger
Speaking of old sayings, one of our favorites, “You are what you eat,” may offer a culinary explanation for those who do enjoy the ambiance of a fine, aerosol-infested public restroom.
That explanation involves the high-calorie, high-fat smorgasbord known as the Western diet and some mice who were forced to consume it. Those mice, it turns out, were more anxious and less cognitively advanced than their counterparts who were not eating “highly palatable, energy dense foods (e.g., high saturated fat, high sugar) that are commonly consumed by humans,” according to the authors of a recent literature review.
“Consumption of a Western diet is related to poorer cognitive performance across the lifespan,” the investigators said, adding that consumption of a Western diet “during critical early life stages of development has negative consequences on various cognitive abilities later in adulthood.”
To show their appreciation for the sacrifices these brave test subjects had made in the name of science, the scientists released the Western diet–addled rodents from captivity. Not only did they survive and thrive in the wilds of darkest suburbia, but within 6 months almost half of them were running for Congress.
Rat-ting out coronavirus
Did you know there is a possibility that giant rodents could rat out coronavirus? Not many people are keen on the presence of a 3-foot-long African giant pouched rat, but they have already been trained to sniff out diseases that are dangerous to humans, such as brucellosis and tuberculosis, according to researchers at the University of Glasgow.
Professor Dan Haydon and his associates believe there is a good possibility that the rats can be trained to sniff out COVID-19. Dogs have been helpful in sniffing for COVID-19 at airports and are being trained to detect it through armpit sweat, making detection of the virus easier for travelers and staff. Even robots have gotten into the COVID-19 detecting act.
Since African giant pouched rats can grow to be the size of a small dog and “are easily tamed as companion animals,” it seems likely that they have the potential to do the same. That is, sniffing for COVID-19, not appearing at your local airport. That’s still gross.
Stay healthy, get a parasite bestie
The key to health could actually be swimming around in your gut. Researchers from University College London have found that a parasitic worm could be the answer to longevity and avoidance of chronic diseases.
The seeming immunity from inflammatory diseases such as arthritis, diabetes, and multiple sclerosis may come from helminth parasites, or hookworms – parasites that have been coexisting harmlessly with the human body for thousands of years. The investigators went so far as to call them “old friends,” but the kind that you rarely see at reunions or call up for a favor.
As a result of modern sanitation and improved hygiene, humans and hookworms are seeing much less of each other, which may be a factor in the rise of “aging-associated inflammation” such as COVID-19 symptoms, they suggested. So is there a way to get these old friends back?
“Restorative hookworm treatments” could help with heart disease or dementia, according to the investigators, but maybe you’re not totally on board with getting an actual parasite in your system. We get it. There are helminth-derived proteins that have already been tested to get the job done.
Maybe old friends really do make the best friends.
I love the smell of microbe-infected aerosols in the morning
Have you gone into a public restroom and just stood around for a while appreciating the fine aromas? No? You haven’t? You do your business and get out? Well, it’s a good thing you act like a normal person, because the aerosols released when toilets flush can contain all sorts of nasty bacteria and viruses.
The authors of a new study published in Physics of Fluids came to this groundbreaking conclusion by going to a public bathroom, sticking particle counters above a urinal and a toilet, and letting them sit for a while. After 3 hours and 100 flushes, the ambient level of particles 0.3-3 mcm in diameter had increased dramatically, with particles sized 0.5-1 mcm particularly prone to lingering. For those particles, the level from baseline increased by over 200%.
This is a major concern, the researchers said, because the sort of microbes that are expelled through feces, urine, and vomit can include some pretty nasty things. Ebola, noroviruses that can cause food poisoning, and even good old SARS-CoV-2 can be expelled from the body but remain viable for a time in these aerosols. The researchers recommended improving the ventilation systems in restrooms so that aerosols don’t hang around for hours at a time. Plus, it might make the place not smell like a, uh, public restroom.
Not to question the research and the people behind it, but we’re not sure how necessary it was to give people another reason not to hang out in a place where hundreds, if not thousands, of people come to relieve themselves. There’s a reason we’re supposed to “stop and smell the roses” and not “stop and smell the public bathroom.”
World ends not with a bang but with a cheeseburger
Speaking of old sayings, one of our favorites, “You are what you eat,” may offer a culinary explanation for those who do enjoy the ambiance of a fine, aerosol-infested public restroom.
That explanation involves the high-calorie, high-fat smorgasbord known as the Western diet and some mice who were forced to consume it. Those mice, it turns out, were more anxious and less cognitively advanced than their counterparts who were not eating “highly palatable, energy dense foods (e.g., high saturated fat, high sugar) that are commonly consumed by humans,” according to the authors of a recent literature review.
“Consumption of a Western diet is related to poorer cognitive performance across the lifespan,” the investigators said, adding that consumption of a Western diet “during critical early life stages of development has negative consequences on various cognitive abilities later in adulthood.”
To show their appreciation for the sacrifices these brave test subjects had made in the name of science, the scientists released the Western diet–addled rodents from captivity. Not only did they survive and thrive in the wilds of darkest suburbia, but within 6 months almost half of them were running for Congress.
Rat-ting out coronavirus
Did you know there is a possibility that giant rodents could rat out coronavirus? Not many people are keen on the presence of a 3-foot-long African giant pouched rat, but they have already been trained to sniff out diseases that are dangerous to humans, such as brucellosis and tuberculosis, according to researchers at the University of Glasgow.
Professor Dan Haydon and his associates believe there is a good possibility that the rats can be trained to sniff out COVID-19. Dogs have been helpful in sniffing for COVID-19 at airports and are being trained to detect it through armpit sweat, making detection of the virus easier for travelers and staff. Even robots have gotten into the COVID-19 detecting act.
Since African giant pouched rats can grow to be the size of a small dog and “are easily tamed as companion animals,” it seems likely that they have the potential to do the same. That is, sniffing for COVID-19, not appearing at your local airport. That’s still gross.
Stay healthy, get a parasite bestie
The key to health could actually be swimming around in your gut. Researchers from University College London have found that a parasitic worm could be the answer to longevity and avoidance of chronic diseases.
The seeming immunity from inflammatory diseases such as arthritis, diabetes, and multiple sclerosis may come from helminth parasites, or hookworms – parasites that have been coexisting harmlessly with the human body for thousands of years. The investigators went so far as to call them “old friends,” but the kind that you rarely see at reunions or call up for a favor.
As a result of modern sanitation and improved hygiene, humans and hookworms are seeing much less of each other, which may be a factor in the rise of “aging-associated inflammation” such as COVID-19 symptoms, they suggested. So is there a way to get these old friends back?
“Restorative hookworm treatments” could help with heart disease or dementia, according to the investigators, but maybe you’re not totally on board with getting an actual parasite in your system. We get it. There are helminth-derived proteins that have already been tested to get the job done.
Maybe old friends really do make the best friends.
I love the smell of microbe-infected aerosols in the morning
Have you gone into a public restroom and just stood around for a while appreciating the fine aromas? No? You haven’t? You do your business and get out? Well, it’s a good thing you act like a normal person, because the aerosols released when toilets flush can contain all sorts of nasty bacteria and viruses.
The authors of a new study published in Physics of Fluids came to this groundbreaking conclusion by going to a public bathroom, sticking particle counters above a urinal and a toilet, and letting them sit for a while. After 3 hours and 100 flushes, the ambient level of particles 0.3-3 mcm in diameter had increased dramatically, with particles sized 0.5-1 mcm particularly prone to lingering. For those particles, the level from baseline increased by over 200%.
This is a major concern, the researchers said, because the sort of microbes that are expelled through feces, urine, and vomit can include some pretty nasty things. Ebola, noroviruses that can cause food poisoning, and even good old SARS-CoV-2 can be expelled from the body but remain viable for a time in these aerosols. The researchers recommended improving the ventilation systems in restrooms so that aerosols don’t hang around for hours at a time. Plus, it might make the place not smell like a, uh, public restroom.
Not to question the research and the people behind it, but we’re not sure how necessary it was to give people another reason not to hang out in a place where hundreds, if not thousands, of people come to relieve themselves. There’s a reason we’re supposed to “stop and smell the roses” and not “stop and smell the public bathroom.”
World ends not with a bang but with a cheeseburger
Speaking of old sayings, one of our favorites, “You are what you eat,” may offer a culinary explanation for those who do enjoy the ambiance of a fine, aerosol-infested public restroom.
That explanation involves the high-calorie, high-fat smorgasbord known as the Western diet and some mice who were forced to consume it. Those mice, it turns out, were more anxious and less cognitively advanced than their counterparts who were not eating “highly palatable, energy dense foods (e.g., high saturated fat, high sugar) that are commonly consumed by humans,” according to the authors of a recent literature review.
“Consumption of a Western diet is related to poorer cognitive performance across the lifespan,” the investigators said, adding that consumption of a Western diet “during critical early life stages of development has negative consequences on various cognitive abilities later in adulthood.”
To show their appreciation for the sacrifices these brave test subjects had made in the name of science, the scientists released the Western diet–addled rodents from captivity. Not only did they survive and thrive in the wilds of darkest suburbia, but within 6 months almost half of them were running for Congress.
Seeing is bleeding, and smelling is perceiving
True Blood casting call!
If you’ve seen the show True Blood on HBO, you’re probably familiar with blood coming out instead of tears when any of the vampires start crying. Apparently, this interesting phenomenon isn’t unique to vampires on TV.
If you know about female anatomy, you know that the eyes aren’t usually involved in the menstrual cycle. However, a 25-year-old woman went to the ED when she experienced haemolacria, the term for blood tears, for the second time in 2 months during her cycle. She did not appear to have any injuries or illnesses that caused the eye bleeding, but physicians noted that both times she had eye bleeding, she also had her period.
Menstrual bleeding outside of the uterus, called vicarious menstruation, can occur, and it seems that the patient may have had that condition.
Since there are rumors of a True Blood remake circling, perhaps the show’s writers could blend in a little medical fact with vampire fiction.
What does skinny smell like? Lemons apparently
When you smell a lemon, what comes to your mind? How does it make you feel? Now think of the scent of vanilla. How does that one make you feel? Current research suggests certain smells may have an effect on how you perceive your body image.
Researchers from the University of Sussex (England) have found that certain olfactory stimuli (such as lemons and vanilla) and audio stimuli (light steps vs. heavy steps), have a moderate effect on self-image.
During their study, participants were put through a series of auditory and olfactory tests, from listening to stilettos and boots walking across the floor, to being exposed to certain essential oils with different sound pitches.
Exposure to lemon and higher-pitched sounds (like stilettos) made participants feel lighter and was associated with thin, spiky shapes. Exposure to vanilla and lower-pitched sounds was more associated with thicker, rounded shapes. This made researchers believe that multisensory stimuli, such as scents and sounds, can have a bigger role in treating eating disorders.
Our brain functions with multiple “mental models” of ourselves. Based on sensory stimuli from our day-to-day lives, those images and perceptions of ourselves change. Someone complimenting your snazzy new sweater provokes one self-perception, while someone letting you know that your fly is down provokes another.
Well, the researchers believe that, through a sense of smell, we can alter that perception of ourselves when paired with positive influence. Doing this through wearable “interactive clothes” could help boost the confidence and self-esteem of patients struggling with body image. Light smells equals light feelings. Of course, this won’t help the nearly 5% of the world who have some kind of smell disorder.
The researchers said that more research needs to be done, but you can do your own little experiment at home. Think about yourself and how you react to certain smells. How do they make you feel? If it makes you feel good, stop and smell more often.
Pregnancy with a side of pregnancy
It was a great day when Rebecca Roberts and her partner went to the obstetrician to confirm their positive pregnancy test. They’d been trying for more than a year without success, and now they would be having a baby. Note the usage of the singular there. That will become important in a moment.
When Ms. Roberts went back for her 12-week ultrasound appointment, there was an unexpected complication: Baby had become babies. The original fetus was there and doing fine, but there was now a second, less-developed fetus who’d invited herself in unannounced. While they were technically twins, the second fetus did not form at the same time, like normal fraternal twins, instead forming from an egg that was released weeks after the first egg was fertilized.
The phenomenon, called superfetation, is incredibly rare. Prior to 2008, there were fewer than 10 reported cases in the world, according to the European Journal of Obstetrics & Gynecology and Reproductive Biology. The odds of an egg being released during pregnancy, something that’s not supposed to happen, and then having that egg also become fertilized and successfully implanted in the uterus, is astronomically small.
It was not an easy pregnancy for Ms. Roberts, and at 33 weeks into the first pregnancy, the younger fetus’s umbilical cord began to malfunction, so delivery for both was induced in September 2020. Both infants spent time in the neonatal ICU, with the younger baby being in for 3 months, but after 6 months both are doing well and developing quickly. It’s always nice to have a happy ending to one of these weird medical phenomena, especially one with such an unpleasant-sounding name. If we didn’t know better, we’d think superfetation was something really, really smelly.
What’s a little misinformation among neighbors?
Vaccination will, hopefully, get the COVID-19 pandemic under control at some point, but the related misinformation floating around the Internet is another story. Already rampant in the United States, it’s now spreading … to Canada.
Investigators from that northern land took a look at the Twitter accounts of the platform’s 187,000 most active Canadian users and eventually ended up with a database of 147 million tweets, of which 154,000 contained terms associated with misinformation.
The Canadian social media users had more exposure to information from the United States than from Canada, and the exposure to U.S. outlets was more likely to involve misperceptions about COVID-19. “Most of the misinformation circulating on Twitter shared by Canadians was retweeted from U.S. sources,” the researchers said, and “Canadians who followed more American users were more likely to post misinformation.”
The study’s lead investigator, Aengus Bridgman of McGill University in Montreal, put it this way: “It’s hard for Canadian journalists, scientists, and public health experts to be heard by the average Canadian, given all the noise generated by American sources.”
People generally don’t take the time to read the fine print on contracts, and it looks like the Canadians have fallen into that trap. Not entirely their fault, of course, because most people coming from Canada to America don’t pass the Statue of Liberty, but she’s got some fine print of her own.
That poem written on the pedestal, the one that says, “Give me your tired, your poor, your huddled masses yearning to breathe free”? It’s actually a contract, and at the bottom, in very small print, it says, “In return for acceptance of the aforementioned ‘huddled masses,’ countries of origin agree to accept all of the social media noise generated by American sources.”
Sorry, Canada, but we gotcha.
True Blood casting call!
If you’ve seen the show True Blood on HBO, you’re probably familiar with blood coming out instead of tears when any of the vampires start crying. Apparently, this interesting phenomenon isn’t unique to vampires on TV.
If you know about female anatomy, you know that the eyes aren’t usually involved in the menstrual cycle. However, a 25-year-old woman went to the ED when she experienced haemolacria, the term for blood tears, for the second time in 2 months during her cycle. She did not appear to have any injuries or illnesses that caused the eye bleeding, but physicians noted that both times she had eye bleeding, she also had her period.
Menstrual bleeding outside of the uterus, called vicarious menstruation, can occur, and it seems that the patient may have had that condition.
Since there are rumors of a True Blood remake circling, perhaps the show’s writers could blend in a little medical fact with vampire fiction.
What does skinny smell like? Lemons apparently
When you smell a lemon, what comes to your mind? How does it make you feel? Now think of the scent of vanilla. How does that one make you feel? Current research suggests certain smells may have an effect on how you perceive your body image.
Researchers from the University of Sussex (England) have found that certain olfactory stimuli (such as lemons and vanilla) and audio stimuli (light steps vs. heavy steps), have a moderate effect on self-image.
During their study, participants were put through a series of auditory and olfactory tests, from listening to stilettos and boots walking across the floor, to being exposed to certain essential oils with different sound pitches.
Exposure to lemon and higher-pitched sounds (like stilettos) made participants feel lighter and was associated with thin, spiky shapes. Exposure to vanilla and lower-pitched sounds was more associated with thicker, rounded shapes. This made researchers believe that multisensory stimuli, such as scents and sounds, can have a bigger role in treating eating disorders.
Our brain functions with multiple “mental models” of ourselves. Based on sensory stimuli from our day-to-day lives, those images and perceptions of ourselves change. Someone complimenting your snazzy new sweater provokes one self-perception, while someone letting you know that your fly is down provokes another.
Well, the researchers believe that, through a sense of smell, we can alter that perception of ourselves when paired with positive influence. Doing this through wearable “interactive clothes” could help boost the confidence and self-esteem of patients struggling with body image. Light smells equals light feelings. Of course, this won’t help the nearly 5% of the world who have some kind of smell disorder.
The researchers said that more research needs to be done, but you can do your own little experiment at home. Think about yourself and how you react to certain smells. How do they make you feel? If it makes you feel good, stop and smell more often.
Pregnancy with a side of pregnancy
It was a great day when Rebecca Roberts and her partner went to the obstetrician to confirm their positive pregnancy test. They’d been trying for more than a year without success, and now they would be having a baby. Note the usage of the singular there. That will become important in a moment.
When Ms. Roberts went back for her 12-week ultrasound appointment, there was an unexpected complication: Baby had become babies. The original fetus was there and doing fine, but there was now a second, less-developed fetus who’d invited herself in unannounced. While they were technically twins, the second fetus did not form at the same time, like normal fraternal twins, instead forming from an egg that was released weeks after the first egg was fertilized.
The phenomenon, called superfetation, is incredibly rare. Prior to 2008, there were fewer than 10 reported cases in the world, according to the European Journal of Obstetrics & Gynecology and Reproductive Biology. The odds of an egg being released during pregnancy, something that’s not supposed to happen, and then having that egg also become fertilized and successfully implanted in the uterus, is astronomically small.
It was not an easy pregnancy for Ms. Roberts, and at 33 weeks into the first pregnancy, the younger fetus’s umbilical cord began to malfunction, so delivery for both was induced in September 2020. Both infants spent time in the neonatal ICU, with the younger baby being in for 3 months, but after 6 months both are doing well and developing quickly. It’s always nice to have a happy ending to one of these weird medical phenomena, especially one with such an unpleasant-sounding name. If we didn’t know better, we’d think superfetation was something really, really smelly.
What’s a little misinformation among neighbors?
Vaccination will, hopefully, get the COVID-19 pandemic under control at some point, but the related misinformation floating around the Internet is another story. Already rampant in the United States, it’s now spreading … to Canada.
Investigators from that northern land took a look at the Twitter accounts of the platform’s 187,000 most active Canadian users and eventually ended up with a database of 147 million tweets, of which 154,000 contained terms associated with misinformation.
The Canadian social media users had more exposure to information from the United States than from Canada, and the exposure to U.S. outlets was more likely to involve misperceptions about COVID-19. “Most of the misinformation circulating on Twitter shared by Canadians was retweeted from U.S. sources,” the researchers said, and “Canadians who followed more American users were more likely to post misinformation.”
The study’s lead investigator, Aengus Bridgman of McGill University in Montreal, put it this way: “It’s hard for Canadian journalists, scientists, and public health experts to be heard by the average Canadian, given all the noise generated by American sources.”
People generally don’t take the time to read the fine print on contracts, and it looks like the Canadians have fallen into that trap. Not entirely their fault, of course, because most people coming from Canada to America don’t pass the Statue of Liberty, but she’s got some fine print of her own.
That poem written on the pedestal, the one that says, “Give me your tired, your poor, your huddled masses yearning to breathe free”? It’s actually a contract, and at the bottom, in very small print, it says, “In return for acceptance of the aforementioned ‘huddled masses,’ countries of origin agree to accept all of the social media noise generated by American sources.”
Sorry, Canada, but we gotcha.
True Blood casting call!
If you’ve seen the show True Blood on HBO, you’re probably familiar with blood coming out instead of tears when any of the vampires start crying. Apparently, this interesting phenomenon isn’t unique to vampires on TV.
If you know about female anatomy, you know that the eyes aren’t usually involved in the menstrual cycle. However, a 25-year-old woman went to the ED when she experienced haemolacria, the term for blood tears, for the second time in 2 months during her cycle. She did not appear to have any injuries or illnesses that caused the eye bleeding, but physicians noted that both times she had eye bleeding, she also had her period.
Menstrual bleeding outside of the uterus, called vicarious menstruation, can occur, and it seems that the patient may have had that condition.
Since there are rumors of a True Blood remake circling, perhaps the show’s writers could blend in a little medical fact with vampire fiction.
What does skinny smell like? Lemons apparently
When you smell a lemon, what comes to your mind? How does it make you feel? Now think of the scent of vanilla. How does that one make you feel? Current research suggests certain smells may have an effect on how you perceive your body image.
Researchers from the University of Sussex (England) have found that certain olfactory stimuli (such as lemons and vanilla) and audio stimuli (light steps vs. heavy steps), have a moderate effect on self-image.
During their study, participants were put through a series of auditory and olfactory tests, from listening to stilettos and boots walking across the floor, to being exposed to certain essential oils with different sound pitches.
Exposure to lemon and higher-pitched sounds (like stilettos) made participants feel lighter and was associated with thin, spiky shapes. Exposure to vanilla and lower-pitched sounds was more associated with thicker, rounded shapes. This made researchers believe that multisensory stimuli, such as scents and sounds, can have a bigger role in treating eating disorders.
Our brain functions with multiple “mental models” of ourselves. Based on sensory stimuli from our day-to-day lives, those images and perceptions of ourselves change. Someone complimenting your snazzy new sweater provokes one self-perception, while someone letting you know that your fly is down provokes another.
Well, the researchers believe that, through a sense of smell, we can alter that perception of ourselves when paired with positive influence. Doing this through wearable “interactive clothes” could help boost the confidence and self-esteem of patients struggling with body image. Light smells equals light feelings. Of course, this won’t help the nearly 5% of the world who have some kind of smell disorder.
The researchers said that more research needs to be done, but you can do your own little experiment at home. Think about yourself and how you react to certain smells. How do they make you feel? If it makes you feel good, stop and smell more often.
Pregnancy with a side of pregnancy
It was a great day when Rebecca Roberts and her partner went to the obstetrician to confirm their positive pregnancy test. They’d been trying for more than a year without success, and now they would be having a baby. Note the usage of the singular there. That will become important in a moment.
When Ms. Roberts went back for her 12-week ultrasound appointment, there was an unexpected complication: Baby had become babies. The original fetus was there and doing fine, but there was now a second, less-developed fetus who’d invited herself in unannounced. While they were technically twins, the second fetus did not form at the same time, like normal fraternal twins, instead forming from an egg that was released weeks after the first egg was fertilized.
The phenomenon, called superfetation, is incredibly rare. Prior to 2008, there were fewer than 10 reported cases in the world, according to the European Journal of Obstetrics & Gynecology and Reproductive Biology. The odds of an egg being released during pregnancy, something that’s not supposed to happen, and then having that egg also become fertilized and successfully implanted in the uterus, is astronomically small.
It was not an easy pregnancy for Ms. Roberts, and at 33 weeks into the first pregnancy, the younger fetus’s umbilical cord began to malfunction, so delivery for both was induced in September 2020. Both infants spent time in the neonatal ICU, with the younger baby being in for 3 months, but after 6 months both are doing well and developing quickly. It’s always nice to have a happy ending to one of these weird medical phenomena, especially one with such an unpleasant-sounding name. If we didn’t know better, we’d think superfetation was something really, really smelly.
What’s a little misinformation among neighbors?
Vaccination will, hopefully, get the COVID-19 pandemic under control at some point, but the related misinformation floating around the Internet is another story. Already rampant in the United States, it’s now spreading … to Canada.
Investigators from that northern land took a look at the Twitter accounts of the platform’s 187,000 most active Canadian users and eventually ended up with a database of 147 million tweets, of which 154,000 contained terms associated with misinformation.
The Canadian social media users had more exposure to information from the United States than from Canada, and the exposure to U.S. outlets was more likely to involve misperceptions about COVID-19. “Most of the misinformation circulating on Twitter shared by Canadians was retweeted from U.S. sources,” the researchers said, and “Canadians who followed more American users were more likely to post misinformation.”
The study’s lead investigator, Aengus Bridgman of McGill University in Montreal, put it this way: “It’s hard for Canadian journalists, scientists, and public health experts to be heard by the average Canadian, given all the noise generated by American sources.”
People generally don’t take the time to read the fine print on contracts, and it looks like the Canadians have fallen into that trap. Not entirely their fault, of course, because most people coming from Canada to America don’t pass the Statue of Liberty, but she’s got some fine print of her own.
That poem written on the pedestal, the one that says, “Give me your tired, your poor, your huddled masses yearning to breathe free”? It’s actually a contract, and at the bottom, in very small print, it says, “In return for acceptance of the aforementioned ‘huddled masses,’ countries of origin agree to accept all of the social media noise generated by American sources.”
Sorry, Canada, but we gotcha.
FDA, CDC urge pause of J&J COVID vaccine
The Food and Drug Administration and Centers for Disease Control and Prevention on April 13 recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies have announced.
In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.
The pause is intended to give time to alert the public to this "very rare" condition, experts said during a joint CDC-FDA media briefing April 13.
"It was clear to us that we needed to alert the public," Janet Woodcock, MD, acting FDA commissioner, said. The move also will allow "time for the healthcare community to learn what they need to know about how to diagnose, treat and report" any additional cases.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the cases.
"I know the information today will be very concerning to Americans who have already received the Johnson & Johnson vaccine," said Anne Schuchat, MD, principal deputy director at the CDC.
"For people who got the vaccine more than one month ago, the risk is very low at this time," she added. "For people who recently got the vaccine, in the last couple of weeks, look for symptoms."
Headache, leg pain, abdominal pain, and shortness of breath were among the reported symptoms. All six cases arose within 6 to 13 days of receipt of the Johnson & Johnson vaccine.
Traditional treatment dangerous
Importantly, treatment for traditional blood clots, such as the drug heparin, should not be used for these clots. "The issue here with these types of blood clots is that if one administers the standard treatment we give for blood clots, one can cause tremendous harm or it can be fatal," said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research.
If health care providers see people with these symptoms along with a low platelet count or blood clots, they should ask about any recent vaccinations, Dr. Marks added.
Headache is a common side effect of COVID-19 vaccination, Dr. Marks said, but it typically happens within a day or two. In contrast, the headaches associated with these blood clots come 1 to 2 weeks later and were very severe.
Not all of the six women involved in the events had a pre-existing condition or risk factor, Dr. Schuchat said.
Severe but 'extremely rare'
To put the numbers in context, the six reported events occurred among millions of people who received the Johnson & Johnson vaccine to date.
"There have been six reports of a severe stroke-like illness due to low platelet count and more than six million doses of the Johnson & Johnson vaccine have been administered so far," Dr. Schuchat said.
"I would like to stress these events are extremely rare," Dr. Woodcock said, "but we take all reports of adverse events after vaccination very seriously."
The company response
Johnson & Johnson in a statement said, "We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine."
The company said they are also reviewing these cases with European regulators and "we have made the decision to proactively delay the rollout of our vaccine in Europe."
Overall vaccinations continuing apace
"This announcement will not have a significant impact on our vaccination plan. Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date," Jeff Zients, White House COVID-19 Response Coordinator, said in a statement.
"Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine," he added.
The likely duration of the pause remains unclear.
"I know this has been a long and difficult pandemic, and people are tired of the steps they have to take," Dr. Schuchat said. "Steps taken today make sure the health care system is ready to diagnose, treat and report [any additional cases] and the public has the information necessary to stay safe."
A version of this article first appeared on WebMD.com.
This article was updated 4/13/21.
The Food and Drug Administration and Centers for Disease Control and Prevention on April 13 recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies have announced.
In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.
The pause is intended to give time to alert the public to this "very rare" condition, experts said during a joint CDC-FDA media briefing April 13.
"It was clear to us that we needed to alert the public," Janet Woodcock, MD, acting FDA commissioner, said. The move also will allow "time for the healthcare community to learn what they need to know about how to diagnose, treat and report" any additional cases.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the cases.
"I know the information today will be very concerning to Americans who have already received the Johnson & Johnson vaccine," said Anne Schuchat, MD, principal deputy director at the CDC.
"For people who got the vaccine more than one month ago, the risk is very low at this time," she added. "For people who recently got the vaccine, in the last couple of weeks, look for symptoms."
Headache, leg pain, abdominal pain, and shortness of breath were among the reported symptoms. All six cases arose within 6 to 13 days of receipt of the Johnson & Johnson vaccine.
Traditional treatment dangerous
Importantly, treatment for traditional blood clots, such as the drug heparin, should not be used for these clots. "The issue here with these types of blood clots is that if one administers the standard treatment we give for blood clots, one can cause tremendous harm or it can be fatal," said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research.
If health care providers see people with these symptoms along with a low platelet count or blood clots, they should ask about any recent vaccinations, Dr. Marks added.
Headache is a common side effect of COVID-19 vaccination, Dr. Marks said, but it typically happens within a day or two. In contrast, the headaches associated with these blood clots come 1 to 2 weeks later and were very severe.
Not all of the six women involved in the events had a pre-existing condition or risk factor, Dr. Schuchat said.
Severe but 'extremely rare'
To put the numbers in context, the six reported events occurred among millions of people who received the Johnson & Johnson vaccine to date.
"There have been six reports of a severe stroke-like illness due to low platelet count and more than six million doses of the Johnson & Johnson vaccine have been administered so far," Dr. Schuchat said.
"I would like to stress these events are extremely rare," Dr. Woodcock said, "but we take all reports of adverse events after vaccination very seriously."
The company response
Johnson & Johnson in a statement said, "We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine."
The company said they are also reviewing these cases with European regulators and "we have made the decision to proactively delay the rollout of our vaccine in Europe."
Overall vaccinations continuing apace
"This announcement will not have a significant impact on our vaccination plan. Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date," Jeff Zients, White House COVID-19 Response Coordinator, said in a statement.
"Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine," he added.
The likely duration of the pause remains unclear.
"I know this has been a long and difficult pandemic, and people are tired of the steps they have to take," Dr. Schuchat said. "Steps taken today make sure the health care system is ready to diagnose, treat and report [any additional cases] and the public has the information necessary to stay safe."
A version of this article first appeared on WebMD.com.
This article was updated 4/13/21.
The Food and Drug Administration and Centers for Disease Control and Prevention on April 13 recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies have announced.
In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.
The pause is intended to give time to alert the public to this "very rare" condition, experts said during a joint CDC-FDA media briefing April 13.
"It was clear to us that we needed to alert the public," Janet Woodcock, MD, acting FDA commissioner, said. The move also will allow "time for the healthcare community to learn what they need to know about how to diagnose, treat and report" any additional cases.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the cases.
"I know the information today will be very concerning to Americans who have already received the Johnson & Johnson vaccine," said Anne Schuchat, MD, principal deputy director at the CDC.
"For people who got the vaccine more than one month ago, the risk is very low at this time," she added. "For people who recently got the vaccine, in the last couple of weeks, look for symptoms."
Headache, leg pain, abdominal pain, and shortness of breath were among the reported symptoms. All six cases arose within 6 to 13 days of receipt of the Johnson & Johnson vaccine.
Traditional treatment dangerous
Importantly, treatment for traditional blood clots, such as the drug heparin, should not be used for these clots. "The issue here with these types of blood clots is that if one administers the standard treatment we give for blood clots, one can cause tremendous harm or it can be fatal," said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research.
If health care providers see people with these symptoms along with a low platelet count or blood clots, they should ask about any recent vaccinations, Dr. Marks added.
Headache is a common side effect of COVID-19 vaccination, Dr. Marks said, but it typically happens within a day or two. In contrast, the headaches associated with these blood clots come 1 to 2 weeks later and were very severe.
Not all of the six women involved in the events had a pre-existing condition or risk factor, Dr. Schuchat said.
Severe but 'extremely rare'
To put the numbers in context, the six reported events occurred among millions of people who received the Johnson & Johnson vaccine to date.
"There have been six reports of a severe stroke-like illness due to low platelet count and more than six million doses of the Johnson & Johnson vaccine have been administered so far," Dr. Schuchat said.
"I would like to stress these events are extremely rare," Dr. Woodcock said, "but we take all reports of adverse events after vaccination very seriously."
The company response
Johnson & Johnson in a statement said, "We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine."
The company said they are also reviewing these cases with European regulators and "we have made the decision to proactively delay the rollout of our vaccine in Europe."
Overall vaccinations continuing apace
"This announcement will not have a significant impact on our vaccination plan. Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date," Jeff Zients, White House COVID-19 Response Coordinator, said in a statement.
"Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine," he added.
The likely duration of the pause remains unclear.
"I know this has been a long and difficult pandemic, and people are tired of the steps they have to take," Dr. Schuchat said. "Steps taken today make sure the health care system is ready to diagnose, treat and report [any additional cases] and the public has the information necessary to stay safe."
A version of this article first appeared on WebMD.com.
This article was updated 4/13/21.
Life after death, and the case of the disappearing digit
It’s alive!!!
Calling all “The Walking Dead” fans! Did you know that, after death, certain cells in the brain can stay active and even become colossal?
Researchers evaluated brain tissue to feign the gene expression during autopsy and death. By doing this, they found that these inflammatory cells, called glial cells, can increase gene expression and “grow and sprout long arm-like appendages for many hours after death.”
According to Dr. Jeffrey Loeb, the study’s senior author, the continued growth after death doesn’t come as a shock since these are the cells that do damage control after certain brain injuries, such as stroke.
Maybe those mindless zombies aren’t so mindless after all. We’re not sure if we should be more scared of a zombie that can think, or a zombie that can’t. We’re sensing a spin-off!
Beam me up, Doc!
In the realm of Star Trek, Dr. Leonard “Bones” McCoy isn’t the only physician who seems to find merit in the adventures of the starship Enterprise.
Pediatric cardiologist Victor Grech, it was reported, has been so influenced by the generational hit that the show made special guest appearances in his medical writing.
The alarm was sounded by a student at Oxford University who had suspicions about more than 100 articles published in Early Human Development. Of the articles eventually withdrawn by the journal’s publisher, Elsevier, 26 were on COVID-19 alone.
Just like a Romulan cloaking device, where the stories once stood Elsevier has left a “withdrawn” statement, making the articles vanish out of thin air.
Along with articles on COVID-19, Dr. Grech’s 48-article series with coauthors on how to write a scientific paper rightfully came into question. Elsevier’s statement on the incident says that the journal’s editorial work flow has been redesigned “to ensure that this will not happen again in the future.”
The number of retracted articles boldly puts Dr. Grech in a lane where few men have gone before.
Something’s wrong, but I can’t put my finger on it
Mixed martial arts is not a sport for the faint of heart. However, we doubt fans who were watching the Khetag Pliev/Devin Goodale fight on April 1 were prepared for the announcement that a search was commencing for a missing finger. Not broken, in case you think that was a misprint. Completely 100% removed from the rest of the hand.
One would think that pinpointing the exact moment when the finger, belonging to Mr. Pliev, was severed would be easy, but the video evidence is unclear, with the best guess being that a kick in the first round broke the finger and a grapple in the second severed it completely. Mr. Pliev was not helpful in clearing up the matter; not only did he fail to immediately notice the fact that his finger had broken or severed, he tried to keep the fight going after the second round when the referee noticed some blood where his left ring finger should have been. He thought he was winning. Unfortunately, the doctor on hand, who was clearly a complete drag, felt differently, ending the fight and awarding it to Mr. Goodale in a technical knockout.
Rest assured, there is a happy ending to this gruesome story. After a frantic search, the missing finger was found deep within Mr. Pliev’s glove and was successfully reattached in a Philadelphia emergency room.
The LOTME team commends Mr. Pliev’s commitment to his craft by wanting to continue the fight, but we respectfully disagree with his assertion that he was winning. We’re fairly confident that body part removal is an automatic loss (pun intended), unless you’re the Black Knight from “Monty Python and the Holy Grail.” Then it’s a draw.
Take two cookies and call me in the morning
The placebo effect is a well-known phenomenon. A pharmacologically inactive treatment can help people if they don’t know it’s pharmacologically inactive. But what if they did know? Would it still work?
That’s what researchers at Beth Israel Deaconess Medical Center in Boston wanted to find out. They divided a cohort of patients with irritable bowel syndrome into three groups. One group got pill bottles containing “open-label placebo,” so the subjects knew they were getting a placebo. The second received bottles labeled “double-blind placebo or peppermint oil.” The third got no pills but followed the rest of the study protocol.
Can you see where this is going? Two-thirds of the open-label placebo group had meaningful improvement of their symptoms, there was no difference in improvement between the two placebo groups, and both did significantly better than the no-pill group.
“If the presumption that deception is necessary for placebos to be effective is false, then many theories about the mechanisms that drive placebo effects may need modification,” investigator Ted J. Kaptchuk said in a written statement.
In other words, this changes everything. Who needs real drugs when anything that a doctor gives to a patient will help? Someone who has trouble swallowing pills can get a milkshake instead. Kid doesn’t like the taste of amoxicillin? Prescribe a slice of therapeutic pizza. Vaccine deniers can get a shot of vitamin C … or bourbon. And just imagine all the good that can be done in this crazy, mixed up world with a batch of chocolate chip cookies.
It’s alive!!!
Calling all “The Walking Dead” fans! Did you know that, after death, certain cells in the brain can stay active and even become colossal?
Researchers evaluated brain tissue to feign the gene expression during autopsy and death. By doing this, they found that these inflammatory cells, called glial cells, can increase gene expression and “grow and sprout long arm-like appendages for many hours after death.”
According to Dr. Jeffrey Loeb, the study’s senior author, the continued growth after death doesn’t come as a shock since these are the cells that do damage control after certain brain injuries, such as stroke.
Maybe those mindless zombies aren’t so mindless after all. We’re not sure if we should be more scared of a zombie that can think, or a zombie that can’t. We’re sensing a spin-off!
Beam me up, Doc!
In the realm of Star Trek, Dr. Leonard “Bones” McCoy isn’t the only physician who seems to find merit in the adventures of the starship Enterprise.
Pediatric cardiologist Victor Grech, it was reported, has been so influenced by the generational hit that the show made special guest appearances in his medical writing.
The alarm was sounded by a student at Oxford University who had suspicions about more than 100 articles published in Early Human Development. Of the articles eventually withdrawn by the journal’s publisher, Elsevier, 26 were on COVID-19 alone.
Just like a Romulan cloaking device, where the stories once stood Elsevier has left a “withdrawn” statement, making the articles vanish out of thin air.
Along with articles on COVID-19, Dr. Grech’s 48-article series with coauthors on how to write a scientific paper rightfully came into question. Elsevier’s statement on the incident says that the journal’s editorial work flow has been redesigned “to ensure that this will not happen again in the future.”
The number of retracted articles boldly puts Dr. Grech in a lane where few men have gone before.
Something’s wrong, but I can’t put my finger on it
Mixed martial arts is not a sport for the faint of heart. However, we doubt fans who were watching the Khetag Pliev/Devin Goodale fight on April 1 were prepared for the announcement that a search was commencing for a missing finger. Not broken, in case you think that was a misprint. Completely 100% removed from the rest of the hand.
One would think that pinpointing the exact moment when the finger, belonging to Mr. Pliev, was severed would be easy, but the video evidence is unclear, with the best guess being that a kick in the first round broke the finger and a grapple in the second severed it completely. Mr. Pliev was not helpful in clearing up the matter; not only did he fail to immediately notice the fact that his finger had broken or severed, he tried to keep the fight going after the second round when the referee noticed some blood where his left ring finger should have been. He thought he was winning. Unfortunately, the doctor on hand, who was clearly a complete drag, felt differently, ending the fight and awarding it to Mr. Goodale in a technical knockout.
Rest assured, there is a happy ending to this gruesome story. After a frantic search, the missing finger was found deep within Mr. Pliev’s glove and was successfully reattached in a Philadelphia emergency room.
The LOTME team commends Mr. Pliev’s commitment to his craft by wanting to continue the fight, but we respectfully disagree with his assertion that he was winning. We’re fairly confident that body part removal is an automatic loss (pun intended), unless you’re the Black Knight from “Monty Python and the Holy Grail.” Then it’s a draw.
Take two cookies and call me in the morning
The placebo effect is a well-known phenomenon. A pharmacologically inactive treatment can help people if they don’t know it’s pharmacologically inactive. But what if they did know? Would it still work?
That’s what researchers at Beth Israel Deaconess Medical Center in Boston wanted to find out. They divided a cohort of patients with irritable bowel syndrome into three groups. One group got pill bottles containing “open-label placebo,” so the subjects knew they were getting a placebo. The second received bottles labeled “double-blind placebo or peppermint oil.” The third got no pills but followed the rest of the study protocol.
Can you see where this is going? Two-thirds of the open-label placebo group had meaningful improvement of their symptoms, there was no difference in improvement between the two placebo groups, and both did significantly better than the no-pill group.
“If the presumption that deception is necessary for placebos to be effective is false, then many theories about the mechanisms that drive placebo effects may need modification,” investigator Ted J. Kaptchuk said in a written statement.
In other words, this changes everything. Who needs real drugs when anything that a doctor gives to a patient will help? Someone who has trouble swallowing pills can get a milkshake instead. Kid doesn’t like the taste of amoxicillin? Prescribe a slice of therapeutic pizza. Vaccine deniers can get a shot of vitamin C … or bourbon. And just imagine all the good that can be done in this crazy, mixed up world with a batch of chocolate chip cookies.
It’s alive!!!
Calling all “The Walking Dead” fans! Did you know that, after death, certain cells in the brain can stay active and even become colossal?
Researchers evaluated brain tissue to feign the gene expression during autopsy and death. By doing this, they found that these inflammatory cells, called glial cells, can increase gene expression and “grow and sprout long arm-like appendages for many hours after death.”
According to Dr. Jeffrey Loeb, the study’s senior author, the continued growth after death doesn’t come as a shock since these are the cells that do damage control after certain brain injuries, such as stroke.
Maybe those mindless zombies aren’t so mindless after all. We’re not sure if we should be more scared of a zombie that can think, or a zombie that can’t. We’re sensing a spin-off!
Beam me up, Doc!
In the realm of Star Trek, Dr. Leonard “Bones” McCoy isn’t the only physician who seems to find merit in the adventures of the starship Enterprise.
Pediatric cardiologist Victor Grech, it was reported, has been so influenced by the generational hit that the show made special guest appearances in his medical writing.
The alarm was sounded by a student at Oxford University who had suspicions about more than 100 articles published in Early Human Development. Of the articles eventually withdrawn by the journal’s publisher, Elsevier, 26 were on COVID-19 alone.
Just like a Romulan cloaking device, where the stories once stood Elsevier has left a “withdrawn” statement, making the articles vanish out of thin air.
Along with articles on COVID-19, Dr. Grech’s 48-article series with coauthors on how to write a scientific paper rightfully came into question. Elsevier’s statement on the incident says that the journal’s editorial work flow has been redesigned “to ensure that this will not happen again in the future.”
The number of retracted articles boldly puts Dr. Grech in a lane where few men have gone before.
Something’s wrong, but I can’t put my finger on it
Mixed martial arts is not a sport for the faint of heart. However, we doubt fans who were watching the Khetag Pliev/Devin Goodale fight on April 1 were prepared for the announcement that a search was commencing for a missing finger. Not broken, in case you think that was a misprint. Completely 100% removed from the rest of the hand.
One would think that pinpointing the exact moment when the finger, belonging to Mr. Pliev, was severed would be easy, but the video evidence is unclear, with the best guess being that a kick in the first round broke the finger and a grapple in the second severed it completely. Mr. Pliev was not helpful in clearing up the matter; not only did he fail to immediately notice the fact that his finger had broken or severed, he tried to keep the fight going after the second round when the referee noticed some blood where his left ring finger should have been. He thought he was winning. Unfortunately, the doctor on hand, who was clearly a complete drag, felt differently, ending the fight and awarding it to Mr. Goodale in a technical knockout.
Rest assured, there is a happy ending to this gruesome story. After a frantic search, the missing finger was found deep within Mr. Pliev’s glove and was successfully reattached in a Philadelphia emergency room.
The LOTME team commends Mr. Pliev’s commitment to his craft by wanting to continue the fight, but we respectfully disagree with his assertion that he was winning. We’re fairly confident that body part removal is an automatic loss (pun intended), unless you’re the Black Knight from “Monty Python and the Holy Grail.” Then it’s a draw.
Take two cookies and call me in the morning
The placebo effect is a well-known phenomenon. A pharmacologically inactive treatment can help people if they don’t know it’s pharmacologically inactive. But what if they did know? Would it still work?
That’s what researchers at Beth Israel Deaconess Medical Center in Boston wanted to find out. They divided a cohort of patients with irritable bowel syndrome into three groups. One group got pill bottles containing “open-label placebo,” so the subjects knew they were getting a placebo. The second received bottles labeled “double-blind placebo or peppermint oil.” The third got no pills but followed the rest of the study protocol.
Can you see where this is going? Two-thirds of the open-label placebo group had meaningful improvement of their symptoms, there was no difference in improvement between the two placebo groups, and both did significantly better than the no-pill group.
“If the presumption that deception is necessary for placebos to be effective is false, then many theories about the mechanisms that drive placebo effects may need modification,” investigator Ted J. Kaptchuk said in a written statement.
In other words, this changes everything. Who needs real drugs when anything that a doctor gives to a patient will help? Someone who has trouble swallowing pills can get a milkshake instead. Kid doesn’t like the taste of amoxicillin? Prescribe a slice of therapeutic pizza. Vaccine deniers can get a shot of vitamin C … or bourbon. And just imagine all the good that can be done in this crazy, mixed up world with a batch of chocolate chip cookies.
Asthma not an independent risk factor for severe COVID-19, hospitalization
Asthma is not an independent risk factor for more severe disease or hospitalization due to COVID-19, according to recent research presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“In our cohort of patients tested for SARS-CoV-2 at Stanford between March and September, asthma was not an independent risk factor in and of itself for hospitalization or more severe disease from COVID,” Lauren E. Eggert, MD, of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, said in a poster presentation at the meeting. “What’s more, allergic asthma actually decreased the risk of hospitalization by nearly half.”
Dr. Eggert noted that there have been conflicting data on whether comorbid asthma is or is not a risk factor for more severe COVID-19. “The general thought at the beginning of the pandemic was that because COVID-19 is predominantly a viral respiratory illness, and viral illnesses are known to cause asthma exacerbations, that patients with asthma may be at higher risk if they got COVID infection,” she explained. “But some of the data also showed that Th2 inflammation downregulates ACE2 receptor [expression], which has been shown to be the port of entry for the SARS-CoV-2 virus, so maybe allergy might have a protective effect.”
The researchers at Stanford University identified 168,190 patients at Stanford Health Care who had a positive real-time reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 between March and September 2020 and collected data from their electronic medical records on their history of asthma, if they were hospitalized, comorbid conditions, and laboratory values. Patients who had no other data available except for a positive SARS-CoV-2 result, or were younger than 28 days, were excluded from the study. Dr. Eggert and colleagues used COVID-19 treatment guidelines from the National Institutes of Health to assess disease severity, which grades COVID-19 severity as asymptomatic or presymptomatic infection, mild illness, moderate illness, severe illness, and critical illness.
In total, the researchers analyzed 5,596 patients who were SARS-CoV-2 positive, with 605 patients (10.8%) hospitalized within 14 days of receiving a positive test. Of these, 100 patients (16.5%) were patients with asthma. There were no significant differences between groups hospitalized and not hospitalized due to COVID-19 in patients with asthma and with no asthma.
Among patients with asthma and COVID-19, 28.0% had asymptomatic illness, 19.0% had moderate disease, 33.0% had severe disease, and 20.0% had critical COVID-19, compared with 36.0% of patients without asthma who had asymptomatic illness, 12.0% with moderate disease, 30.0% with severe disease, and 21.0% with critical COVID-19. Dr. Eggert and colleagues performed a univariate analysis, which showed a significant association between asthma and COVID-19 related hospitalization (odds ratio, 1.53; 95% confidence interval, 1.2-1.93; P < .001), but when adjusting for factors such as diabetes, obesity coronary heart disease, and hypertension, they found there was not a significant association between asthma and hospitalization due to COVID-19 (OR, 1.12; 95% CI, 0.86-1.45; P < .40).
In a univariate analysis, asthma was associated with more severe disease in patients hospitalized for COVID-19, but the results were not significant (OR, 1.21; 95% CI, 0.8-1.85; P = .37). When analyzing allergic asthma alone in a univariate analysis, the researchers found a significant association between allergic asthma and lower hospitalization risk, compared with patients who had nonallergic asthma (OR, 0.55; 95% CI, 0.31-0.92; P = .029), and this association remained after they performed a multivariate analysis as well.
“When we stratified by allergic asthma versus nonallergic asthma, we found that having a diagnosis of allergic asthma actually conferred a protective effect, and there was almost half the risk of hospitalization in asthmatics with allergic asthma as compared to others, which we thought was very interesting,” Dr. Eggert said.
“Eosinophil levels during hospitalization, even when adjusted for systemic steroid use – and we followed patients out through September, when dexamethasone was standard of care – also correlated with better outcomes,” she explained. “This is independent of asthmatic status.”
The researchers noted that confirmation of these results are needed through large, multicenter cohort studies, particularly with regard to how allergic asthma might have a protective effect against SARS-CoV-2 infection. “I think going forward, these findings are very interesting and need to be looked at further to explain the mechanism behind them better,” Dr. Eggert said.
“I think there is also a lot of interest in how this might affect our patients on biologics, which deplete the eosinophils and get rid of that allergic phenotype,” she added. “Does that have any effect on disease severity? Unfortunately, the number of patents on biologics was very small in our cohort, but I do think this is an interesting area for exploration.”
This study was funded in part by the Sean N. Parker Center for Allergy & Asthma Research, Stanford University, Sunshine Foundation, Crown Foundation, and the Parker Foundation.
Asthma is not an independent risk factor for more severe disease or hospitalization due to COVID-19, according to recent research presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“In our cohort of patients tested for SARS-CoV-2 at Stanford between March and September, asthma was not an independent risk factor in and of itself for hospitalization or more severe disease from COVID,” Lauren E. Eggert, MD, of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, said in a poster presentation at the meeting. “What’s more, allergic asthma actually decreased the risk of hospitalization by nearly half.”
Dr. Eggert noted that there have been conflicting data on whether comorbid asthma is or is not a risk factor for more severe COVID-19. “The general thought at the beginning of the pandemic was that because COVID-19 is predominantly a viral respiratory illness, and viral illnesses are known to cause asthma exacerbations, that patients with asthma may be at higher risk if they got COVID infection,” she explained. “But some of the data also showed that Th2 inflammation downregulates ACE2 receptor [expression], which has been shown to be the port of entry for the SARS-CoV-2 virus, so maybe allergy might have a protective effect.”
The researchers at Stanford University identified 168,190 patients at Stanford Health Care who had a positive real-time reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 between March and September 2020 and collected data from their electronic medical records on their history of asthma, if they were hospitalized, comorbid conditions, and laboratory values. Patients who had no other data available except for a positive SARS-CoV-2 result, or were younger than 28 days, were excluded from the study. Dr. Eggert and colleagues used COVID-19 treatment guidelines from the National Institutes of Health to assess disease severity, which grades COVID-19 severity as asymptomatic or presymptomatic infection, mild illness, moderate illness, severe illness, and critical illness.
In total, the researchers analyzed 5,596 patients who were SARS-CoV-2 positive, with 605 patients (10.8%) hospitalized within 14 days of receiving a positive test. Of these, 100 patients (16.5%) were patients with asthma. There were no significant differences between groups hospitalized and not hospitalized due to COVID-19 in patients with asthma and with no asthma.
Among patients with asthma and COVID-19, 28.0% had asymptomatic illness, 19.0% had moderate disease, 33.0% had severe disease, and 20.0% had critical COVID-19, compared with 36.0% of patients without asthma who had asymptomatic illness, 12.0% with moderate disease, 30.0% with severe disease, and 21.0% with critical COVID-19. Dr. Eggert and colleagues performed a univariate analysis, which showed a significant association between asthma and COVID-19 related hospitalization (odds ratio, 1.53; 95% confidence interval, 1.2-1.93; P < .001), but when adjusting for factors such as diabetes, obesity coronary heart disease, and hypertension, they found there was not a significant association between asthma and hospitalization due to COVID-19 (OR, 1.12; 95% CI, 0.86-1.45; P < .40).
In a univariate analysis, asthma was associated with more severe disease in patients hospitalized for COVID-19, but the results were not significant (OR, 1.21; 95% CI, 0.8-1.85; P = .37). When analyzing allergic asthma alone in a univariate analysis, the researchers found a significant association between allergic asthma and lower hospitalization risk, compared with patients who had nonallergic asthma (OR, 0.55; 95% CI, 0.31-0.92; P = .029), and this association remained after they performed a multivariate analysis as well.
“When we stratified by allergic asthma versus nonallergic asthma, we found that having a diagnosis of allergic asthma actually conferred a protective effect, and there was almost half the risk of hospitalization in asthmatics with allergic asthma as compared to others, which we thought was very interesting,” Dr. Eggert said.
“Eosinophil levels during hospitalization, even when adjusted for systemic steroid use – and we followed patients out through September, when dexamethasone was standard of care – also correlated with better outcomes,” she explained. “This is independent of asthmatic status.”
The researchers noted that confirmation of these results are needed through large, multicenter cohort studies, particularly with regard to how allergic asthma might have a protective effect against SARS-CoV-2 infection. “I think going forward, these findings are very interesting and need to be looked at further to explain the mechanism behind them better,” Dr. Eggert said.
“I think there is also a lot of interest in how this might affect our patients on biologics, which deplete the eosinophils and get rid of that allergic phenotype,” she added. “Does that have any effect on disease severity? Unfortunately, the number of patents on biologics was very small in our cohort, but I do think this is an interesting area for exploration.”
This study was funded in part by the Sean N. Parker Center for Allergy & Asthma Research, Stanford University, Sunshine Foundation, Crown Foundation, and the Parker Foundation.
Asthma is not an independent risk factor for more severe disease or hospitalization due to COVID-19, according to recent research presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“In our cohort of patients tested for SARS-CoV-2 at Stanford between March and September, asthma was not an independent risk factor in and of itself for hospitalization or more severe disease from COVID,” Lauren E. Eggert, MD, of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, said in a poster presentation at the meeting. “What’s more, allergic asthma actually decreased the risk of hospitalization by nearly half.”
Dr. Eggert noted that there have been conflicting data on whether comorbid asthma is or is not a risk factor for more severe COVID-19. “The general thought at the beginning of the pandemic was that because COVID-19 is predominantly a viral respiratory illness, and viral illnesses are known to cause asthma exacerbations, that patients with asthma may be at higher risk if they got COVID infection,” she explained. “But some of the data also showed that Th2 inflammation downregulates ACE2 receptor [expression], which has been shown to be the port of entry for the SARS-CoV-2 virus, so maybe allergy might have a protective effect.”
The researchers at Stanford University identified 168,190 patients at Stanford Health Care who had a positive real-time reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 between March and September 2020 and collected data from their electronic medical records on their history of asthma, if they were hospitalized, comorbid conditions, and laboratory values. Patients who had no other data available except for a positive SARS-CoV-2 result, or were younger than 28 days, were excluded from the study. Dr. Eggert and colleagues used COVID-19 treatment guidelines from the National Institutes of Health to assess disease severity, which grades COVID-19 severity as asymptomatic or presymptomatic infection, mild illness, moderate illness, severe illness, and critical illness.
In total, the researchers analyzed 5,596 patients who were SARS-CoV-2 positive, with 605 patients (10.8%) hospitalized within 14 days of receiving a positive test. Of these, 100 patients (16.5%) were patients with asthma. There were no significant differences between groups hospitalized and not hospitalized due to COVID-19 in patients with asthma and with no asthma.
Among patients with asthma and COVID-19, 28.0% had asymptomatic illness, 19.0% had moderate disease, 33.0% had severe disease, and 20.0% had critical COVID-19, compared with 36.0% of patients without asthma who had asymptomatic illness, 12.0% with moderate disease, 30.0% with severe disease, and 21.0% with critical COVID-19. Dr. Eggert and colleagues performed a univariate analysis, which showed a significant association between asthma and COVID-19 related hospitalization (odds ratio, 1.53; 95% confidence interval, 1.2-1.93; P < .001), but when adjusting for factors such as diabetes, obesity coronary heart disease, and hypertension, they found there was not a significant association between asthma and hospitalization due to COVID-19 (OR, 1.12; 95% CI, 0.86-1.45; P < .40).
In a univariate analysis, asthma was associated with more severe disease in patients hospitalized for COVID-19, but the results were not significant (OR, 1.21; 95% CI, 0.8-1.85; P = .37). When analyzing allergic asthma alone in a univariate analysis, the researchers found a significant association between allergic asthma and lower hospitalization risk, compared with patients who had nonallergic asthma (OR, 0.55; 95% CI, 0.31-0.92; P = .029), and this association remained after they performed a multivariate analysis as well.
“When we stratified by allergic asthma versus nonallergic asthma, we found that having a diagnosis of allergic asthma actually conferred a protective effect, and there was almost half the risk of hospitalization in asthmatics with allergic asthma as compared to others, which we thought was very interesting,” Dr. Eggert said.
“Eosinophil levels during hospitalization, even when adjusted for systemic steroid use – and we followed patients out through September, when dexamethasone was standard of care – also correlated with better outcomes,” she explained. “This is independent of asthmatic status.”
The researchers noted that confirmation of these results are needed through large, multicenter cohort studies, particularly with regard to how allergic asthma might have a protective effect against SARS-CoV-2 infection. “I think going forward, these findings are very interesting and need to be looked at further to explain the mechanism behind them better,” Dr. Eggert said.
“I think there is also a lot of interest in how this might affect our patients on biologics, which deplete the eosinophils and get rid of that allergic phenotype,” she added. “Does that have any effect on disease severity? Unfortunately, the number of patents on biologics was very small in our cohort, but I do think this is an interesting area for exploration.”
This study was funded in part by the Sean N. Parker Center for Allergy & Asthma Research, Stanford University, Sunshine Foundation, Crown Foundation, and the Parker Foundation.
FROM AAAAI
FDA grants emergency use authorization to Johnson & Johnson COVID-19 vaccine
And then there were three.
More vaccine availability at a time of high demand and limited supply could help officials vaccinate more Americans, more quickly. In addition, the J&J vaccine offers one-dose convenience and storage at conventional refrigeration temperatures.
Initial reactions to the EUA for the J&J vaccine have been positive.
“The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements, will be a major contribution in getting the general public vaccinated sooner, both in the U.S. and around the world,” Phyllis Tien, MD, professor of medicine in the division of infectious diseases at the University of California, San Francisco, told Medscape Medical News.
“It’s great news. We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID,” said Paul Goepfert, MD. It’s a “tremendous boon for our country and other countries as well.”
“This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa,” added Dr. Goepfert, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama at Birmingham.
The EUA “is indeed exciting news,” Colleen Kraft, MD, associate chief medical officer at Emory University Hospital and associate professor at Emory University School of Medicine in Atlanta, said during a February 25 media briefing.
One recent concern centers on people aged 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the J&J immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.
The more the merrier
The scope and urgency of the COVID-19 pandemic necessitates as many protective measures as possible, said Raj Shah, MD, geriatrician, and associate professor of family medicine and codirector of the Center for Community Health Equity at Rush University in Chicago.
“Trying to vaccinate as many individuals living in the United States to prevent the spread of COVID is such a big project that no one company or one vaccine was going to be able to ramp up fast enough on its own,” Dr. Shah told Medscape Medical News.“This has been the hope for us,” he added, “to get to multiple vaccines with slightly different properties that will provide more options.”
Experience with the J&J vaccine so far suggests reactions are less severe. “The nice thing about the Johnson and Johnson [vaccine] is that it definitely has less side effects,” Dr. Kraft said.
On the other hand, low-grade fever, chills, or fatigue after vaccination can be considered a positive because they can reflect how well the immune system is responding, she added.
One and done?
Single-dose administration could be more than a convenience — it could also help clinicians vaccinate members of underserved communities and rural locations, where returning for a second dose could be more difficult for some people.
“In a controlled setting, in a clinical trial, we do a lot to make sure people get all the treatment they need,” Dr. Shah said. “We’re not seeing it right now, but we’re always worried when we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine.”
This group could include the needle-phobic, he added. “For them, having it done once alleviates a lot of the anxiety.”
Looking beyond the numbers
The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines.
However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.
“One of the things that these vaccines do very well is they minimize severe disease,” Dr. Kraft said. “As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our armamentarium to fight this virus.”
“If you can give something that prevents people from dying, that is a true path to normalcy,” Dr. Goepfert added.
More work to do
“The demand is strong from all groups right now. We just have to work on getting more vaccines out there,” Dr. Shah said.
“We are at a point in this country where we are getting better with the distribution of the vaccine,” he added, “but we are nowhere close to achieving that distribution of vaccines to get to everybody.”
Dr. Goepfert, Dr. Shah, and Dr. Kraft disclosed no relevant financial relationships. Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA Health Care System.
A version of this article first appeared on Medscape.com.
And then there were three.
More vaccine availability at a time of high demand and limited supply could help officials vaccinate more Americans, more quickly. In addition, the J&J vaccine offers one-dose convenience and storage at conventional refrigeration temperatures.
Initial reactions to the EUA for the J&J vaccine have been positive.
“The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements, will be a major contribution in getting the general public vaccinated sooner, both in the U.S. and around the world,” Phyllis Tien, MD, professor of medicine in the division of infectious diseases at the University of California, San Francisco, told Medscape Medical News.
“It’s great news. We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID,” said Paul Goepfert, MD. It’s a “tremendous boon for our country and other countries as well.”
“This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa,” added Dr. Goepfert, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama at Birmingham.
The EUA “is indeed exciting news,” Colleen Kraft, MD, associate chief medical officer at Emory University Hospital and associate professor at Emory University School of Medicine in Atlanta, said during a February 25 media briefing.
One recent concern centers on people aged 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the J&J immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.
The more the merrier
The scope and urgency of the COVID-19 pandemic necessitates as many protective measures as possible, said Raj Shah, MD, geriatrician, and associate professor of family medicine and codirector of the Center for Community Health Equity at Rush University in Chicago.
“Trying to vaccinate as many individuals living in the United States to prevent the spread of COVID is such a big project that no one company or one vaccine was going to be able to ramp up fast enough on its own,” Dr. Shah told Medscape Medical News.“This has been the hope for us,” he added, “to get to multiple vaccines with slightly different properties that will provide more options.”
Experience with the J&J vaccine so far suggests reactions are less severe. “The nice thing about the Johnson and Johnson [vaccine] is that it definitely has less side effects,” Dr. Kraft said.
On the other hand, low-grade fever, chills, or fatigue after vaccination can be considered a positive because they can reflect how well the immune system is responding, she added.
One and done?
Single-dose administration could be more than a convenience — it could also help clinicians vaccinate members of underserved communities and rural locations, where returning for a second dose could be more difficult for some people.
“In a controlled setting, in a clinical trial, we do a lot to make sure people get all the treatment they need,” Dr. Shah said. “We’re not seeing it right now, but we’re always worried when we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine.”
This group could include the needle-phobic, he added. “For them, having it done once alleviates a lot of the anxiety.”
Looking beyond the numbers
The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines.
However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.
“One of the things that these vaccines do very well is they minimize severe disease,” Dr. Kraft said. “As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our armamentarium to fight this virus.”
“If you can give something that prevents people from dying, that is a true path to normalcy,” Dr. Goepfert added.
More work to do
“The demand is strong from all groups right now. We just have to work on getting more vaccines out there,” Dr. Shah said.
“We are at a point in this country where we are getting better with the distribution of the vaccine,” he added, “but we are nowhere close to achieving that distribution of vaccines to get to everybody.”
Dr. Goepfert, Dr. Shah, and Dr. Kraft disclosed no relevant financial relationships. Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA Health Care System.
A version of this article first appeared on Medscape.com.
And then there were three.
More vaccine availability at a time of high demand and limited supply could help officials vaccinate more Americans, more quickly. In addition, the J&J vaccine offers one-dose convenience and storage at conventional refrigeration temperatures.
Initial reactions to the EUA for the J&J vaccine have been positive.
“The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements, will be a major contribution in getting the general public vaccinated sooner, both in the U.S. and around the world,” Phyllis Tien, MD, professor of medicine in the division of infectious diseases at the University of California, San Francisco, told Medscape Medical News.
“It’s great news. We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID,” said Paul Goepfert, MD. It’s a “tremendous boon for our country and other countries as well.”
“This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa,” added Dr. Goepfert, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama at Birmingham.
The EUA “is indeed exciting news,” Colleen Kraft, MD, associate chief medical officer at Emory University Hospital and associate professor at Emory University School of Medicine in Atlanta, said during a February 25 media briefing.
One recent concern centers on people aged 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the J&J immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.
The more the merrier
The scope and urgency of the COVID-19 pandemic necessitates as many protective measures as possible, said Raj Shah, MD, geriatrician, and associate professor of family medicine and codirector of the Center for Community Health Equity at Rush University in Chicago.
“Trying to vaccinate as many individuals living in the United States to prevent the spread of COVID is such a big project that no one company or one vaccine was going to be able to ramp up fast enough on its own,” Dr. Shah told Medscape Medical News.“This has been the hope for us,” he added, “to get to multiple vaccines with slightly different properties that will provide more options.”
Experience with the J&J vaccine so far suggests reactions are less severe. “The nice thing about the Johnson and Johnson [vaccine] is that it definitely has less side effects,” Dr. Kraft said.
On the other hand, low-grade fever, chills, or fatigue after vaccination can be considered a positive because they can reflect how well the immune system is responding, she added.
One and done?
Single-dose administration could be more than a convenience — it could also help clinicians vaccinate members of underserved communities and rural locations, where returning for a second dose could be more difficult for some people.
“In a controlled setting, in a clinical trial, we do a lot to make sure people get all the treatment they need,” Dr. Shah said. “We’re not seeing it right now, but we’re always worried when we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine.”
This group could include the needle-phobic, he added. “For them, having it done once alleviates a lot of the anxiety.”
Looking beyond the numbers
The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines.
However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.
“One of the things that these vaccines do very well is they minimize severe disease,” Dr. Kraft said. “As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our armamentarium to fight this virus.”
“If you can give something that prevents people from dying, that is a true path to normalcy,” Dr. Goepfert added.
More work to do
“The demand is strong from all groups right now. We just have to work on getting more vaccines out there,” Dr. Shah said.
“We are at a point in this country where we are getting better with the distribution of the vaccine,” he added, “but we are nowhere close to achieving that distribution of vaccines to get to everybody.”
Dr. Goepfert, Dr. Shah, and Dr. Kraft disclosed no relevant financial relationships. Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA Health Care System.
A version of this article first appeared on Medscape.com.
J&J COVID-19 vaccine wins unanimous backing of FDA panel
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.