FDA blames COVID shots for 10 kids’ deaths and will tighten vaccines reviews : Shots
Food and Drug Administration officials say they will examine vaccines more rigorously.
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The Food and Drug Administration intends to become stricter about approving vaccines, as top officials have raised concerns about the risk of COVID vaccines to children.
Speaking on Fox News Saturday morning, FDA Commissioner Marty Makary said the agency would no longer accept new products that don’t work, saying it was a “parody of science.”
Makary’s comments came a day after the FDA’s top vaccine regulator, Dr Vinay Prasadtold his team that the agency would change its annual flu vaccination framework, update vaccine labels to be “honest” and make other changes to how it reviews vaccines, according to the contents of an internal email reviewed by NPR and reported first by a PBS News Hour corresponding and later by The Washington Post.
Prasad wrote that the FDA would no longer authorize vaccines for pregnant women without stricter requirements. And for pneumonia vaccines, manufacturers will have to prove that they reduce disease rather than showing that they generate antibodies. He also raised questions about administering multiple vaccines simultaneously, which is common practice.
These changes could make vaccine approval much more difficult and costly, further limiting the availability of vaccines, which are considered one of the safest and most effective tools to protect people against infectious diseases.
Although all vaccines carry some risks, most public health experts say the current process of vetting vaccines before they are released has long ensured that the benefits of vaccines outweigh their risks. Studies required after vaccine approval and surveillance systems, including Vaccine Adverse Event Reporting System (VAERS), also point out potential safety issues once vaccines are used.
FDA says analysis links COVID shots to some deaths
Makary said on Fox News that 10 children had died from the COVID vaccine under the Biden administration, but did not provide details on how the FDA reached that conclusion. Millions of children received the vaccine.
Officials 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 Prasad’s FDA email, he asked the agency’s biostatistics and pharmacovigilance team to analyze 96 deaths reported between 2021 and 2024, and they determined that 10 children died “after and because of” the COVID vaccine. But Prasad said the real number was likely higher.
Dr. Paul Offit, who directs the Vaccine Education Center at Children’s Hospital of Philadelphiasaid in a text message that Prasad did not share proof that these vaccines killed 10 children.
“Because he provides no evidence, he is asking us to trust him on an important issue,” Office said. “All this will do is scare people unnecessarily. At a minimum, he should provide whatever evidence he has so that subject matter experts can review it and decide whether he has enough data to prove his point.”
Dr. Jesse Goodman, professor at Georgetown University who served in Prasad’s position 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, has been “recognized globally as a gold standard regulatory agency.” Goodman championed “immunological parameters such as antibody levels” for accelerated approval of pneumonia and flu vaccines. He said science supports their use and they are confirmed by post-approval studies: “These approaches have helped provide children and adults with rapid access to safe and effective vaccines, saving many lives.”
Michael Osterholmepidemiologist at the University of Minnesota, reviewed Prasad’s email and disputed his statement that “COVID-19 has never been highly deadly to children.” Osterholm also questioned the FDA’s latest analysis of adverse event reports attributing the 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 United States responded to early signals of possible vaccine-associated pediatric deaths in May 2021,” Osterholm wrote in an email to NPR.
“Although Prasad’s email records 10 such deaths, these cases were never presented for review by the medical and public health communities or published in the medical literature,” Osterholm continued. “Given the fact that this administration misrepresented the science surrounding vaccines until these cases were reviewed by a third-party expert, such as the National Academy of Sciences[s]we cannot accept that these are vaccine-associated deaths. »
Surveillance system collects vaccine reports
The FDA makes public data from the VAERS surveillance system co-sponsored by the Centers for Disease Control and Prevention. But FDA warns“It is important to note that for any reported event, no cause and effect relationship has been established.” In his email, Prasad wrote that “in case reports, causality is generally assessed on a subjective scale. Within this scale ranging from certain to improbable – certain, possible/probable and probable are widely considered to be product-related.”
Makary said on Fox News that when the COVID vaccine was first rolled out, it was “amazing” for people at high risk of severe illness, but things have changed.
“In 2020, we saw a reduction in the severity of illness and lives saved, but recommending today that a 6-year-old girl receive 70 million additional COVID vaccines – one per year for the rest of her life – is not based on science. And so we are not going to just rubber stamp approvals without seeing scientific evidence.”
The assertion is the latest move by Trump administration health officials who are questioning the safety and effectiveness of vaccines and how the government has regulated them. Health Secretary Robert F. Kennedy Jr. has long questioned vaccines.
The FDA restricted eligibility for COVID vaccines updated in August after announcing that the agency planned to demand more evidence on the safety and effectiveness of shots in the future.
CDC committee to meet to review vaccine policies
FDA email on vaccine policy comes just before CDC convenes crucial meeting. two day meeting of the agency’s influential Advisory Committee on Immunization Practices on December 4 and 5. The committee is conducting a comprehensive study on how children are vaccinated against dangerous infectious diseases such as measles, mumps, rubella, polio and hepatitis B.
Many public health experts fear the committee could upend the childhood vaccination schedule. He could decide to delay the schedule of certain vaccinations, space out vaccinations and call for the reformulation of certain vaccines. Together, these measures could result in fewer children being protected and a resurgence of once-conquered diseases.
Asked about Makary and Prasad’s claims that the COVID vaccine caused the deaths of 10 children, Moderna, whose COVID vaccine is approved for children as young as 6 months, pointed out a statement made in September. The company says several published and peer-reviewed studies from various sources show its vaccine is safe and that it is “not aware of any deaths in the last year or relevant new information from previous years.”
Moderna says it is monitoring the safety of its vaccine with regulators in more than 90 countries. “With more than 1 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 concerns in children or pregnant women.”
Pfizer did not immediately respond to requests for comment.
