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A dozen former FDA commissioners and other experts weigh in, also debunking false claims about vaccines
By G. A. McNeeley
December 8, 2025 (Washington D.C.) -- In an internal memo obtained by CNN, Dr. Vinay Prasad, the Food and Drug Administration’s (FDA) chief medical & scientific officer said on November 28 that the FDA will change its vaccine approval process. Though Prasaid claimed this was due to 10 deaths of children linked to COVID vaccines, he provided no evidence of this and medical experts dispute those claims. He also issued unsubstantiated changes in recommendations for Hepatitis-B vaccines for infants, a change the American Medical Association calls “reckless.”
These changes could make it more difficult and expensive for vaccines to get approved, further limiting the availability of vaccines, which are considered among the safest and most effective tools for protecting people against infectious diseases, according to NPR.
On December 3, 12 former FDA commissioners said they’re concerned about Prasad’s proposed changes to vaccine regulation, according to Reuters.
NPR also reported that in response to some of Prasad’s claims, Moderna, whose COVID vaccine is approved for children as young as 6 months old, pointed to a statement it made in September. They said that multiple published, peer-reviewed studies from a variety of sources show their shot is safe and that it’s "not aware of any deaths in the last year or pertinent new information from prior years."
More medical experts have debunked COVID vaccine claims
East County Magazine previously interviewed Dr. Mark Sawyer, infectious disease specialist at Rady Children’s Hospital and Biden-era advisor to the FDA on COVID-19 vaccines for children and booster shots.
Dr. Sawyer said hundreds of children have been treated at Rady Children’s Hospital for COVID-19, including 75 treated in the intensive care unit, and another 75 diagnosed with multi-system inflammatory disease, which is a rare and serious complication of COVID-19 in children. “To say that COVID is not serious in children is underestimating the virus,” he added.
Serious complications of the vaccines, such as blood clots and heart problems, have occurred in only a couple of cases per every million shots administered, Dr. Sawyer said. But COVID can cause the same serious conditions and more, so COVID poses a far greater threat to children and others than the vaccines. COVID is also far more dangerous to pregnant women and their unborn babies than the vaccine, which can provide immunities to both mothers and children, he added.
In a separate ECM article, Dr. Sawyer acknowledged that “it is true that there are some very rare but serious side effects from any of the COVID vaccines… but it’s very important to keep the numbers in perspective… we’re talking about a couple of cases of severe side effects per million people getting vaccinated.”
Back in November 2021, another ECM article wrote about an independent panel of local doctors who addressed COVID-19 misinformation brought up by some public speakers at the November 2 County Board of Supervisors meeting.
Some of the facts presented included no children dying from COVID vaccines, no cases of heart inflammation after COVID vaccines were given to children aged 5 to 11, and that the testing of vaccines was safe on children aged 5 to 11.
What did Dr. Prasad say About COVID vaccines?
CNN reported that Prasad claimed that “healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”
However, Prasad didn’t provide any details about those supposed deaths nor how the FDA came to that conclusion. He also claimed that COVID-19 “was never highly lethal for children” and that the effects “are comparable” to respiratory viruses for which there aren’t any annual vaccines–false claims rigorously disputed by medical experts.
CNN reported that as a result of the FDA’s analysis, Prasad said the agency will adopt a new approval process for vaccines that will require more evidence of their safety and value before they can be marketed. These changes include stricter requirements for authorization of vaccines used for pregnant women, and trials for pneumonia vaccines that will need to prove the shots reduce disease, instead of showing that the vaccine produces enough antibodies to fight the illness.
CNN added that Prasad said the agency will also “revise the annual flu vaccine framework,” and “will re-appraise safety and be honest in vaccine labels.” NPR reported that he also raised questions about giving multiple vaccines at the same time, which is a standard practice.
In his memo, Prasad also said he’s open to discussion about the changes, but said those debates should be internal to the FDA. “Some staff may not agree with these core principles and operating principles,” he wrote, before urging those staffers to submit their resignation letters.
What other changes are the FDA and CDC making regarding vaccines?
NPR reported that the FDA makes public data from the Vaccine Adverse Event Reporting System (VAERS), which is a surveillance system co-sponsored by the Centers for Disease Control and Prevention (CDC). However, the FDA cautions that it’s "important to note that for any reported event, no cause and effect relationship has been established."
In his email, Prasad wrote that "with case reports, causality is typically assessed on a subjective scale. In this scale ranging from certain to unlikely -- certain, possible/likely, and probable are broadly considered as related to the product."
NPR reported that the FDA’s email on vaccine policy came just before the CDC’s two-day meeting of that agency's influential Advisory Committee on Immunization Practices (ACIP) on December 4 and 5.
Many public health experts are concerned the committee will upend the childhood vaccination schedule. It could delay the timing of some inoculations, space out vaccinations, and call for the reformulation of some vaccines. Taken together, the moves could result in fewer children getting protected and the resurgence of once-vanquished diseases.
Hepatitis B vaccine for infants
CNBC reported that on Friday, December 5, Health & Human Services Secretary Robert F. Kennedy Jr.'s handpicked ACIP voted to do away with the longstanding, universal recommendation that all babies receive a hepatitis B shot at birth.
The ACIP recommended that parents use individual decision-making in consultation with a health-care provider to determine when or if to give the hepatitis B birth dose to a baby whose mother tested negative for the virus. For babies who don’t receive the birth dose, the committee recommended that they wait to receive a first vaccine until they are at least 2 months old.
CNN reported that for more than 30 years, the first in the series of hepatitis B shots has been recommended for infants shortly after birth; a strategy that nearly eradicated the potentially fatal disease among children in America. Although there’s no new evidence to discredit the vaccine’s safety and effectiveness, the new advisory panel has been considering whether or not to delay the first shots by months or years.
AMA, calls Hepatitis vaccine changes “reckless”
The American Medical Association issued this statement: The Advisory Committee on Immunization Practice’s (ACIP) vote to weaken the birth-dose recommendation for the Hepatitis B vaccine is reckless and undermines decades of public confidence in a proven, lifesaving vaccine. Today’s action is not based on scientific evidence, disregards data supporting the effectiveness of the Hepatitis B vaccine, and creates confusion for parents about how best to protect their newborns.
“Administering the birth dose is crucial for protecting children from both perinatal and early postnatal transmission of Hepatitis B virus—and preventing a lifelong condition that can lead to chronic liver disease, cirrhosis, liver cancer, and death,” the AMA concludes.
What did other health experts say in response?
Not vaccinating infants for Hepatitis B, a fatal disease with no cure, “would be extremely dangerous," Dr. Andrew Pavia told NPR this year. He's a professor of pediatrics and medicine with the University of Utah and a pediatric and adult infectious disease specialist.
Before the U.S. began universally vaccinating newborns in 1991, some 18,000 children a year would become infected with Hepatitis B before age 10. "About 25% of children who develop chronic hepatitis B will die of their infection," says Pavia, who is also a spokesperson for the Infectious Diseases Society of America.
Delaying the birth dose by just two months could result in at least 1,400 additional preventable cases of hepatitis B for each year the revised recommendation is in place, according to a new analysis. Delaying the vaccine until age 12, as President Trump suggested this year, could result in at least 2,700 preventable infections each year, the analysis found.
12 former FDA Commissioners criticize FDA’s vaccine changes
NBC News reported that 12 former FDA officials said the agency’s plans to revamp how life-saving vaccines for the flu, COVID-19, and other respiratory diseases are handled would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”
Reuters reported that the former FDA commissioners wrote in a piece published by The New England Journal of Medicine, that “the proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity.”
NBC News reported that the former FDA leaders also wrote that Prasad’s claim about child deaths related to COVID-19 vaccines had been reported to a surveillance system that doesn’t contain medical records or other information sufficient to prove a link, and that government scientists had carefully combed through those reports in previous years, reaching different conclusions. They also noted that “substantial evidence” shows COVID-19 vaccines reduce children’s risk of severe disease and hospitalization.
"The memo asserts, incorrectly, that 'we do not have reliable data' on the benefits of Covid vaccination in children," the former FDA officials wrote, according to CBS News. "Reasonable scientists should engage in open debate about how best to shape recommendations for children at lower risk for Covid-19, but substantial evidence shows that vaccination can reduce the risk of severe disease and hospitalization in many children and adolescents."
NBC News added that the former FDA leaders argued that new proposals would reject long-standing science about how to evaluate vaccines being updated to better match virus strains, slow innovation to replace older vaccines with newer & potentially better ones, and make the process less transparent to the public.
NPR reported that Dr. Paul Offit, who directs the Vaccine Education Center at the Children's Hospital of Philadelphia, said in a text message that Prasad hasn’t shared any evidence that COVID vaccines killed 10 children.
"Because he doesn't provide any evidence, he is asking us to trust him on an important issue," Offit said. "All this will do is scare people unnecessarily. At the very least, he should provide all the evidence he has so that experts in the field can review it and decide whether he has enough data to prove his point."
NPR reported that Dr. Jesse Goodman, a Georgetown University professor who held Prasad's job at the FDA between 2003 and 2009, said in an email that the FDA's CBER, which oversees vaccine approval, has been "recognized globally as a gold standard regulator."
Goodman defended "immunologic endpoints like antibody levels" for the accelerated approval of pneumonia and influenza vaccines. He said science supports their use, and they’re confirmed with studies after approval. "These approaches have helped provide children and adults with timely access to safe and effective vaccines, saving many lives."
CBS News reported that Dr. Ronald Nahass, president of the Infectious Diseases Society of America, said "vaccines save lives" in a statement. "It is a sad day when the FDA creates confusion and mistrust without supplying evidence, spreading propaganda that makes lifesaving vaccines harder to access and that creates additional confusion and mistrust for the public."
Sources:
https://www.cnn.com/2025/11/29/politics/vaccine-approval-process-fda-official
https://investors.modernatx.com/statement-on-the-safety-of-spikevax
https://www.eastcountymagazine.org/hundreds-protest-school-vaccine-and-mask-mandates-east-county
https://www.cdc.gov/acip/meetings/index.html
https://www.cnbc.com/2025/12/05/hepatitis-b-vaccine-babies-rfk-jr-cdc.html
https://www.ama-assn.org/press-center/ama-press-releases/ama-statement-acip-meeting-0
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