Top US Vaccine Official Sparks Alarm with Memo on Child Deaths
The US Food and Drug Administration (FDA) has sparked alarm after its top vaccine official, Vinay Prasad, claimed that Covid vaccines have killed at least 10 children in a memo to staff. The memo was met with criticism from experts who argue that the official's claims are unsubstantiated and lack evidence.
Prasad's memo, reviewed by The Guardian, states that the FDA will revise its guidelines on vaccine approvals, including requiring randomized trials showing clinical outcomes instead of demonstrating immune responses for most new products. However, the changes have been met with skepticism from experts who fear that they may lead to a decline in vaccine uptake and an increase in preventable illnesses.
Dan Jernigan, former director of the National Center for Emerging and Zoonotic Infectious Diseases, warned that the changes could result in "fewer vaccines and more vaccine-preventable illness." Paul Offit, an infectious diseases physician at Children's Hospital of Philadelphia, agreed, stating that Prasad failed to provide any evidence to support his claims.
The memo also raised concerns about the impact on public trust. "I just have never seen anything like this," said Jernigan. "It's highly unusual for the top vaccines regulator to share information in an email to all staff without first convening outside advisers or publishing data."
Experts point out that myocarditis, a rare side-effect of vaccination, is much more common and severe with Covid infection. To link myocarditis to vaccination, it would be necessary to prove that the condition was caused by the vaccine, not by infection with Covid or other viruses.
The memo also made nods to concerns common among anti-vaccine activists, including reducing the number of vaccines given at the same time. However, experts argue that this is a concern without evidence and could lead to harder times for getting vaccines on the market.
Dorit Reiss, professor of law at UC Hastings College of Law, stated, "Changing concomitant vaccines without evidence of harm will make it harder to put vaccines on the market." The memo also briefly addressed measles, mumps, and rubella (MMR) vaccines, which provide benefits to those around them when administered to high enough fractions of society.
The changes have sparked confusion among healthcare professionals and the public. "It's getting harder for them to know which recommendations to follow and who they can trust," said Jernigan.
As Covid vaccines continue to be deployed globally, officials are stepping up communication about adverse events that occur after vaccination. The CDC has established a new system called V-safe, where recently vaccinated people receive text messages asking about side effects and encouraging them to report all symptoms to VAERS.
However, with the deployment of Covid vaccines, it is essential to maintain confidence in vaccine safety and efficacy. "Children are getting hospitalized and children are still dying from this virus," said Offit. Undermining confidence in vaccines was deemed "so dangerous and irresponsible."
The US Food and Drug Administration (FDA) has sparked alarm after its top vaccine official, Vinay Prasad, claimed that Covid vaccines have killed at least 10 children in a memo to staff. The memo was met with criticism from experts who argue that the official's claims are unsubstantiated and lack evidence.
Prasad's memo, reviewed by The Guardian, states that the FDA will revise its guidelines on vaccine approvals, including requiring randomized trials showing clinical outcomes instead of demonstrating immune responses for most new products. However, the changes have been met with skepticism from experts who fear that they may lead to a decline in vaccine uptake and an increase in preventable illnesses.
Dan Jernigan, former director of the National Center for Emerging and Zoonotic Infectious Diseases, warned that the changes could result in "fewer vaccines and more vaccine-preventable illness." Paul Offit, an infectious diseases physician at Children's Hospital of Philadelphia, agreed, stating that Prasad failed to provide any evidence to support his claims.
The memo also raised concerns about the impact on public trust. "I just have never seen anything like this," said Jernigan. "It's highly unusual for the top vaccines regulator to share information in an email to all staff without first convening outside advisers or publishing data."
Experts point out that myocarditis, a rare side-effect of vaccination, is much more common and severe with Covid infection. To link myocarditis to vaccination, it would be necessary to prove that the condition was caused by the vaccine, not by infection with Covid or other viruses.
The memo also made nods to concerns common among anti-vaccine activists, including reducing the number of vaccines given at the same time. However, experts argue that this is a concern without evidence and could lead to harder times for getting vaccines on the market.
Dorit Reiss, professor of law at UC Hastings College of Law, stated, "Changing concomitant vaccines without evidence of harm will make it harder to put vaccines on the market." The memo also briefly addressed measles, mumps, and rubella (MMR) vaccines, which provide benefits to those around them when administered to high enough fractions of society.
The changes have sparked confusion among healthcare professionals and the public. "It's getting harder for them to know which recommendations to follow and who they can trust," said Jernigan.
As Covid vaccines continue to be deployed globally, officials are stepping up communication about adverse events that occur after vaccination. The CDC has established a new system called V-safe, where recently vaccinated people receive text messages asking about side effects and encouraging them to report all symptoms to VAERS.
However, with the deployment of Covid vaccines, it is essential to maintain confidence in vaccine safety and efficacy. "Children are getting hospitalized and children are still dying from this virus," said Offit. Undermining confidence in vaccines was deemed "so dangerous and irresponsible."
what's going on with the FDA? 
Vaccine deaths at least 10 kids? 
No way, experts are saying this is just unsubstantiated claims 
. We need evidence to support these changes, not emotional emails 
. This could lead to fewer vaccines and more preventable illnesses 
. Can't we just stick with what's working? 
Myocarditis is way more common in Covid infections 
. Let's focus on keeping kids safe, not spreading fear 
. V-safe is a good move, but we need transparency and trust 
.
Only 30% of a certain age group have received 3+ doses 
Meanwhile, the number of reported cases of myocarditis has increased dramatically over the past year 
What's really driving these spikes in cases? 
It's clear that vaccination efforts have made a huge impact on slowing down transmission! 
Instead of spreading misinformation and fears, we should be focusing on promoting vaccine confidence and safety. 
I don't know why the FDA has to share this kinda info via memo like it's some kinda secret 
. Can't they just have a proper meeting or something? 
Not sure I trust this move one bit 
come on folks, this is what happens when you put politics over science 
his claims about child deaths are being blown out of proportion, and experts are just trying to protect public trust 
we don't know the full story here, so let's not jump to conclusions just yet 
what really bothers me is that people are starting to question vaccine efficacy based on this memo alone 
we need a fact-based conversation about vaccines, not fear-mongering 
. I mean, reducing the number of vaccines given at once? It's a concern that's been raised by anti-vaxxers before 
. We already have enough misinformation floating around about vaccines, and now we've got some top official spreading unsubstantiated claims 
? It's like pulling the rug out from under our feet.
. But at the same time, we can't just dismiss these concerns without looking into them either 
. It's all about finding that balance between keeping people safe and not perpetuating unnecessary fear 
I think it's totally understandable that experts are skeptical about this memo - Vinay Prasad didn't provide any concrete evidence to back up his claims, and the data just doesn't add up. Myocarditis is super rare and mostly affects young men, not kids 
.
And what's up with nodding to anti-vax concerns without even addressing them head-on? It feels like they're trying to appease everyone at once 
. Can't we just agree that vaccines are important and help prevent illnesses, and then focus on making them better and more effective? 
. I just want to know what's going on and why we need to be cautious with vaccine safety 
And what if it ends up scaring people off from getting vaccinated? 
, which is a big problem given the number of preventable illnesses out there 
. The CDC's V-safe system is a good start, but I think they need to do more to educate people about what's going on and how vaccines work 
. It's not rocket science, folks - we've got to trust the science if we want to stay safe 