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FDA Rejects Pfizer’s Booster Shot Request

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The FDA has rejected Pfizer’s request for a third booster shot. Credit: Facebook/Pfizer Corporation

A Food and Drug Administration vaccine advisory panel voted against giving Pfizer/BioNTech’s COVID-19 vaccine booster shot to the majority of the population.

The FDA decided that booster shots would only be necessary for those over the age of 65 as well as high risk individuals with severe illness. The Vaccine and Related Biological Products Advisory Committee, or VRBPAC, called the vote during its meeting on Friday.

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The committee was told to decide whether they believed vaccine booster shots would be safe, effective, and necessary for people ages 16 and up. The group of experts voted overwhelmingly that there was not yet enough evidence to show that a third shot would be necessary, especially for younger people:

“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” said voter Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

After firmly establishing that the existing doses of the vaccine were more than sufficient for healthy adults aged 16 to 65, the committee reported their decision to the FDA. The FDA is not required by law to follow the committee’s recommendations, but it is extremely uncommon for them not to.

Surgeon General Vivek Murphy said on Friday at the White House Covid task force briefing that the booster plan would follow the lead of the FDA and the CDC.

“We have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation,” he said. “We will follow that evaluation and their recommendations, we will make sure our final plan reflects it.”

FDA rejects Pfizer’s booster shot request almost a month after granting vaccine full approval

Pfizer’s vaccine had recently received full FDA approval for individuals aged 16 and older this August.

The vaccine had been given priority review treatment by the FDA as of July 20, when it was granted the designation. This step marked the last hurdle that had to be cleared in order for the vaccine — the very first to come onto the world scene, being approved for emergency use back in December of 2020 — to be distributed and marketed like any other inoculation on the market.

Muphy told interviewers from CNN that he thought full FDA approval would have a real impact on millions of Americans who remain wary of the vaccine.

“This may tip them over toward getting vaccinated,” he stated, before adding that he expected corporations, state leaders and schools to impose mandates when the vaccines cleared the final hurdle. “We already know that there are many businesses and universities that have moved toward vaccine requirements,” he said, even before the inoculations were granted final approval.

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