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FDA greenlights Pfizer booster shots for elderly & those aged 18+ at ‘high risk’ from Covid-19, leaving room for interpretation

Heeding advice from its special panel on vaccines, the FDA on Wednesday moved to approve a third dose of the US drugmaker’s Covid-19 vaccine to be used on seniors as well as “individuals 18 through 64 years of age and at high risk of severe Covid-19” and adults “whose frequent institutional or occupational exposure” to the virus ostensibly puts them at a heightened risk of “serious complications of Covid-19, including severe Covid-19.”

The announcement has left plenty of room for interpretation, with epidemiologist and Senior Fellow at the Federation of American Scientists Eric Feigl-Ding pointing out that it “gives enormous leeway for many people” to get the vaccine, and “not just elderly or healthcare workers.”  

Indeed, while the FDA fell short of approving booster shots for the US population as a whole – a view that has been championed by the US President Joe Biden administration – acting FDA Commissioner Janet Woodcock signalled that the athorization could cover large portions of the population due to the nature of their work.

“The FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” Woodcock said.

The decision can still come as a disappointment for Biden who has rallied behind the idea that everybody 18 and older should be able to get a booster shot within eight months from the second dose, promising to start rolling out the revaccination program as early as September.

The FDA said that its decision was based on “scientific evidence,” “currently available data” on the effectiveness of the vaccine as well as on its advisory committee’s recommendation.

Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic

Prior to voting in favour of booster shots, the advisory committee reviewed a number of studies submitted by Pfizer that showed that the efficacy of the vaccine decreases with time. One study found that the jab’s efficacy plunged from 93% to 53% against the Delta strain after four and more months following the second dose. 

Doubts, however, have been raised about the accuracy of Pfizer’s observational studies. Even before the advisory board backed the proposed booster shots, FDA officials 

Doubts, however, have been raised about the accuracy of Pfizer’s own observational studies. Even before the advisory board backed the proposed booster shots, FDA officials released a document, stating that there were “known and unknown biases that can affect their reliability” of the findings, and noting that available data “indicate” that vaccines “still afford protection against severe Covid-19 disease and death” in the US.

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