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Fact check: Why an FDA panel didn't recommend Pfizer's booster shot for all Americans

Ella Lee, USA TODAY
·5 min read

The claim: The Food and Drug Administration didn't approve Pfizer's third shot because people are dying from its COVID-19 vaccine

A key advisory committee within the Food and Drug Administration said Sept. 17 there isn’t sufficient evidence to recommend a booster shot of Pfizer-BioNTech’s COVID-19 vaccine for all Americans.

On social media, some took that to mean the vaccine isn't safe.

“FDA did not approve the Pfizer 3rd shot because they know hospitals are full of people dying from the 1st and 2nd shots with blood clots and brain aneurysms,” reads text in a Sept. 17 Facebook post.

The post received more than 400 likes and 100 shares in one day. But the claim is wrong.

The advisory committee determined there is not enough evidence to suggest a booster shot for all Americans, but it did recommend the shot for people 65 and older and people at high risk of severe COVID-19 infections. There’s ample evidence Pfizer's vaccine is safe and effective at preventing severe illness.

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USA TODAY reached out to the Facebook user who shared the post for comment.

Third shot recommended for older, high-risk Americans

The FDA’s Vaccines and Related Biological Products Advisory Committee was tasked with determining whether a COVID-19 booster shot should be made available to everyone over 16 years old. It determined there’s not enough evidence to suggest all Americans would benefit from a third dose.

“We may need it, but we don’t have the data yet,” Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, previously told USA TODAY.

Christoffer Knight prepares a dose of the Pfizer COVID-19 vaccine during "Play date to vaccinate" for pregnant women to get vaccinated at Palm Beach Children's Hospital at St. Mary's Medical Center in West Palm Beach, Florida, on Aug. 31.
Christoffer Knight prepares a dose of the Pfizer COVID-19 vaccine during "Play date to vaccinate" for pregnant women to get vaccinated at Palm Beach Children's Hospital at St. Mary's Medical Center in West Palm Beach, Florida, on Aug. 31.

The committee also declined to recommend the booster for everyone because it wants people to receive their first two doses of the vaccine and it wants to weigh the benefits for young adults and teens who may not need it, according to CNN.

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Still, the committee determined people 65 and older and those at high risk of severe COVID-19 – like health care workers, first responders and people likely to be exposed to the virus at work – should receive a third dose of Pfizer’s vaccine six months after full vaccination.

On Sept. 22, the FDA authorized Pfizer booster shots but only for some people.

On Sept. 23, an advisory committee of the Centers for Disease Control and Prevention recommended Pfizer booster shots for older people and high-risk patients.

Pfizer vaccine safe, effective

The fact that the FDA panel did not recommend a COVID-19 booster shot for all Americans doesn’t mean the shot is unsafe. In August, the Pfizer vaccine became the first COVID-19 vaccine to receive full FDA approval.

“The FDA’s approval of (Pfizer’s) vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Janet Woodcock, acting FDA commissioner, said in an Aug. 23 statement. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

Fact check: There is no evidence 45,000 people died from vaccine-related complications

The Facebook post raised specific fears of blood clots and aneurysms brought on by the vaccine. But research indicates those side effects are not common.

An Oxford University study of nearly 540,000 COVID-19 cases found that about 4 in 1 million people experience cerebral venous thrombosis, otherwise known as blood clots, after receiving the Pfizer or Moderna vaccine. The risk is higher with the AstraZeneca vaccine, with 5 in 1 million patients expected to experience clots after inoculation.

But the risk of blood clots is significantly higher for those who are diagnosed with COVID-19 – 39 in 1 million, according to the study.

The ties between COVID-19 and aneurysms are murkier. USA TODAY found no documented cases where a COVID-19 vaccine was determined to be the cause of a ruptured aneurysm.

It's important to note that getting the vaccine significantly increases the chance that a COVID-19 infection won’t result in death. The Centers for Disease Control and Prevention said Sept. 17 that people who are not vaccinated against the virus were 11 times more likely to die from it.

Our rating: False

Based on our research, we rate FALSE the claim that the FDA didn't approve Pfizer's third shot because people are dying from its COVID-19 vaccine. An FDA advisory committee determined there is not enough evidence to recommend a third booster shot for everyone – but it did recommend the shot for people 65 and older, as well as people at high risk of serious illness. There’s ample evidence the vaccine is safe and effective at preventing death from COVID-19.

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This article originally appeared on USA TODAY: Fact check: Claim misleads on FDA panel's recommendation on booster