FDA blames COVID shots for 10 kids’ deaths and will tighten vaccines reviews : Shots

The Food and Drug Administration is set to tighten vaccine approval rules as top officials raised concerns about the risk of COVID vaccines to children.

Speaking on Fox News Saturday morning, FDA Commissioner Marty Macari said the agency would no longer “churn out new products that don't work,” arguing that it “makes a mockery of science.”

Makary's comments come a day after the FDA's top vaccine regulator said: Dr. Vinay Prasadtold his team that the agency would change its annual flu vaccination structure, update vaccine labels to be “fair” and make other changes to how it tests vaccines, according to the contents of an internal email reviewed by NPR and reported the first By PBS News Hour correspondent and Later Washington Post.

Prasad wrote that the FDA will also no longer authorize vaccinations for pregnant women without stricter requirements. And for pneumonia vaccines, manufacturers will have to prove that they reduce disease, rather than demonstrate that they produce antibodies. He also raised questions about vaccinating with multiple vaccines at the same time, which is standard practice.

These changes could make the vaccine approval process significantly more complex and costly, further limiting the availability of vaccines that are considered among the safest and most effective tools for protecting people from infectious diseases.

While all vaccines carry some risk, most public health experts say the current vaccine review process, even before marketing, has long convinced them that the vaccines' benefits outweigh their risks. Research required after vaccine approval and surveillance systems, including Vaccine Adverse Event Reporting System (VAERS) also note potential safety concerns with the use of vaccines.

FDA says analysis links COVID vaccinations to some deaths

Macari said on Fox News that 10 children have died from COVID vaccinations under the Biden administration, but did not say how the FDA came to that conclusion. Millions of children received the vaccine.

Representatives from the Department of Health and Human Services and the Food and Drug Administration did not immediately respond to requests for comment on the COVID analysis and changes to vaccine review standards.

According to an FDA email from Prasad, he directed the agency's biostatistics and pharmacovigilance team to review 96 reported deaths between 2021 and 2024, and they found that 10 children died “after and due to” the COVID vaccine. But Prasad said the true number is likely higher.

Dr. Paul Offit, who directs the Vaccine Education Center at the Children's Hospital of Philadelphia.said in a text message that Prasad did not share evidence that these vaccines killed 10 children.

“Because he does not provide any evidence, he asks us to trust him on an important matter,” the Office said. “All of this will lead to people being unnecessarily scared. At the very least, he should present all the evidence he has so that experts in the field can look at it and decide whether he has enough data to prove his point.”

Dr. Jesse Goodman professor at Georgetown University who served as Prasad at the FDA from 2003 to 2009, said in an email that the FDA's Center for Biologics Evaluation and Research, which oversees vaccine approval, is “recognized worldwide as the gold standard regulator.” Goodman defended “immunologic endpoints such as antibody levels” for accelerated approval of pneumonia and influenza vaccines. He said science supports their use and they are supported by post-approval studies: “These approaches have helped ensure children and adults have timely access to safe and effective vaccines, saving many lives.”

Michael Osterholmepidemiologist at the University of Minnesota, reviewed Prasad's email and disputed his claim that “COVID-19 has never been fatal to children.” Osterholm also questioned the FDA's latest analysis of side-effect reports attributing 10 deaths to COVID vaccines.

“Prasad's email is filled with factual errors and misrepresents both the severity of COVID in children (1,597 deaths in 2020-2022) and how the US responded to the first signals of possible vaccine-related childhood deaths in May 2021,” Osterholm wrote in an email to NPR.

“Although Prasad's email noted 10 such deaths, these cases were never presented to the medical and public health communities or published in the medical literature,” Osterholm continued. “Given the administration is misrepresenting the science behind the vaccines until these cases are reviewed by a third party expert such as the National Academy of Sciences.[s]we cannot accept the fact that these deaths are related to vaccination.”

Surveillance system collects reports on vaccines

The FDA publishes data from the VAERS surveillance system, sponsored by the Centers for Disease Control and Prevention. But FDA warns“It is important to note that no cause-and-effect relationship has been established for any of the events reported.” In his email, Prasad wrote that “in case reports, causation is usually assessed on a subjective scale. On this scale it ranges from certain to unlikely: definite, possible/probable and likely are generally considered to be associated with the product.”

Macarius said on Fox News that when the COVID vaccine was first introduced, it was “amazing” for people at high risk of severe disease, but that has changed.

“Back in 2020, we saw disease severity fall and lives saved, but now recommending that a six-year-old girl get another 70 million COVID vaccinations – one per year for the rest of her life – is not based on science. And so we're not going to just rubber stamp approval without seeing any scientific evidence.”

The announcement is the latest move by Trump administration health officials to question the safety and effectiveness of the vaccines and how the government regulates them. Health Secretary Robert F. Kennedy Jr. has long questioned vaccines.

FDA limited eligibility updated COVID vaccines in August following an announcement that the agency plans require more evidence about the safety and effectiveness of vaccinations in the future.

CDC committee to meet to review vaccine policy

The FDA's vaccine policy letter comes just before the CDC convenes a crucial meeting. two-day meeting the agency's influential Advisory Committee on Immunization Practices on Dec. 4-5. The committee is in the process of conducting a major review of how children are vaccinated against dangerous infectious diseases such as measles, mumps, rubella, polio and hepatitis B.

Many public health experts are concerned that the committee will cancel the childhood vaccination schedule. He could delay the timing of some shots, delay vaccinations and call for reformulation of some vaccines. Taken together, these steps could lead to fewer children being protected and a resurgence of once-eradicated diseases.

When asked about Makari and Prasad's claims that the COVID vaccine has caused the deaths of 10 children, a spokeswoman for Moderna, whose COVID vaccine is approved for children as young as 6 months, pointed to statement made in September. The company says multiple published peer-reviewed studies from various sources show its shot is safe and that it is “not aware of any deaths in the past year or relevant new information in previous years.”

Moderna says it is monitoring the safety of its vaccine with regulators in more than 90 countries. “With more than one billion doses distributed worldwide, these systems, including national health systems in Europe, the UK, Canada, Australia and the US, have not reported any new or undisclosed safety issues in children or pregnant women.”

Pfizer did not immediately respond to requests for comment.