Food and Drug Administration officials say they are going to scrutinize the vaccines more rigorously.
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The Food and Drug Administration intends to take a tougher stance on vaccine approval as top officials raise concerns about the risks of Covid vaccines to children.
Speaking on Fox News on Saturday morning, FDA Commissioner Marty Macri Said the agency would no longer “rubber-stamp new products that don’t work,” claiming it was a “mockery of science.”
Macri’s comments came a day after the FDA’s top vaccine regulator, Dr Vinay PrasadAccording to the contents of an internal email reviewed by NPR, he told his team that the agency would change its annual flu vaccine framework, make vaccine labels “honest” and make other changes to the way it reviews vaccines. first reported by a pbs news hour reporter and later by Washington Post.
Prasad wrote that the FDA will no longer authorize vaccines for pregnant women without strict requirements. And for pneumonia vaccines, manufacturers must prove that they prevent disease, rather than showing that they generate antibodies. He also questioned giving multiple vaccines at the same time, which is standard practice.
These changes could make it more difficult and expensive for vaccines to be approved, limiting the availability of vaccines, which are considered one of the safest and most effective tools for protecting people from infectious diseases.
While all vaccines carry some risks, most public health experts argue that the existing process of examining vaccines before marketing has long assured that the benefits of the vaccines outweigh their risks. Including necessary studies and monitoring systems once the vaccines are approved. Vaccine Adverse Event Reporting System (VAERS), also flags potential safety issues once the vaccines come into use.
FDA says an analysis links COVID shots to some deaths
Macri said on Fox News that 10 children had died from COVID shots during the Biden administration, but he did not provide specifics about how the FDA reached that conclusion. millions of children Have received the vaccine.
Officials at the Department of Health and Human Services and the Food and Drug Administration did not immediately respond to requests for comment on the changes to COVID analysis and vaccine review standards.
According to Prasad’s FDA email, he asked the agency’s biostatistics and pharmacovigilance team to analyze 96 reported deaths from 2021 to 2024, and they determined that 10 children died “after and because of the COVID vaccine.” But Prasad said the actual number was likely higher.
Dr. Paul Offit, who Directs the Vaccine Education Center at the Children’s Hospital of Philadelphiasaid in a text message that Prasad has not shared evidence that these vaccines have caused the deaths of 10 children.
“Since he provides no evidence, he is asking us to trust him on an important issue,” the office said. “All this would do is scare people unnecessarily. At the very least, they should provide all the evidence they have so that experts in the field can review it and decide whether they have enough data to prove their case.”
Dr. Jesse Goodman, A professor at Georgetown University Prasad, who held the job 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 globally as a gold standard regulator.” Goodman defended “immunological endpoints such as antibody levels” for accelerated approval of pneumonia and influenza vaccines. He said science supports their use and they are confirmed by studies after approval: “These approaches have helped provide children and adults timely access to safe and effective vaccines, saving many lives.”
Michael OsterholmAn epidemiologist at the University of Minnesota reviewed Prasad’s email and challenged his statement that “COVID-19 was never highly lethal to children.” Osterholm also questioned the FDA’s latest analysis of adverse event reports, which blames 10 deaths on Covid vaccines.
“Prasad’s email is full of factual inaccuracies and misrepresents both the severity of COVID in children (1597 deaths in 2020-2022) and how the US responded to the first signs of possible vaccine-related pediatric deaths in May 2021,” Osterholm wrote in an email to NPR.
Osterholm added, “Although Prasad’s email mentions 10 such deaths, these cases were never submitted for review by the medical and public health communities or published in the medical literature.” “Given this administration’s record of misrepresenting scientific data regarding vaccines, until these cases are reviewed by an expert third party such as the National Academy of Sciences(s), we cannot accept the fact that these are vaccine-related deaths.”
Monitoring system collects reports on vaccines
The FDA makes public data from the VAERS surveillance system co-sponsored by the Centers for Disease Control and Prevention. But FDA cautions“It is important to note that for any reported incidents, 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. This scale ranges from definite to unlikely – definite, possible/probable, and probable are considered largely product related.”
Macri said on Fox News that when the COVID shot was first rolled out, it was “surprising” for people at high risk of suffering severe disease, but things have changed.
“In 2020, we saw a reduction in the severity of disease and lives saved, but now recommending that a 6-year-old girl get 70 million additional COVID shots — one every 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 some scientific evidence.”
The claim is the latest move by Trump administration health officials to question the safety and effectiveness of the vaccines and how the government has regulated them. Health Secretary Robert F. Kennedy Jr. has long raised questions about vaccines.
fda restricted eligibility Agency updates plans for COVID vaccines in August after announcement more evidence needed More about the safety and effectiveness of the shots.
CDC committee to meet to review vaccine policies
FDA email on vaccine policy comes just before important CDC meeting two day meeting That agency’s influential advisory committee on vaccination practices meets on December 4-5. The committee is in the process of carrying out 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 overturn the childhood vaccination program. This could delay the timing of some vaccinations, create space in vaccinations and demand revival of some vaccines. Overall, these measures may result in fewer children being protected and diseases that were once eliminated may reemerge.
Asked about Makri and Prasad’s claims that the Covid vaccine caused the deaths of 10 children, Moderna, whose Covid vaccine is approved for children under 6 months of age, pointed out Statement given in SeptemberThe company says published, peer-reviewed studies from a variety of sources show its shot is safe and it is “not aware of any deaths in the past year or relevant new information from previous years,”
Moderna says it monitors the safety of its vaccine with regulators in more than 90 countries. “With more than a billion doses distributed globally, these systems – which include national health systems across Europe, the United Kingdom, Canada, Australia and the US – have not reported any new or unknown safety concerns in children or pregnant women.”
Pfizer did not immediately respond to requests for comment.
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