FDA remains skeptical about booster shots despite new Pfizer data suggesting ...

FDA remains skeptical about booster shots despite new Pfizer data suggesting ...
FDA remains skeptical about booster shots despite new Pfizer data suggesting ...

The U.S. Food and Drug Administration (FDA) remains skeptical of COVID-19 vaccine booster shots ahead of an advisory committee meeting on Friday despite Pfizer-BioNTech releasing new data suggesting the need for them.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet at the end of the week to discuss data on potential third doses.

Members will vote on whether or not booster doses are safe and effective and if they should be approved for all Americans.

Currently, third doses are only approved for immunocompromised people in the U.S. aged 12 and older.

New data from Pfizer published on Wednesday suggests that efficacy of the regular two-dose regimen declines from 96.2 percent to 83.7 percent after six months, but that a booster dose increased immune responses.

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However, in a separate briefing document also published Wednesday, FDA officials expressed doubt about the need for extra doses.

Documents ahead of an FDA advisory committee about COVID-19 vaccine booster shots were published on Wednesday. Pictured: A nurse administers a COVID-19 booster shot to Lana Sellers in Altamonte Springs, Florida, August 18

Documents ahead of an FDA advisory committee about COVID-19 vaccine booster shots were published on Wednesday. Pictured: A nurse administers a COVID-19 booster shot to Lana Sellers in Altamonte Springs, Florida, August 18

Pfizer released new data suggesting efficacy of two doses declines from 96.2% to 83.7% after six months but that third doses appeared to boost antibody levels (above) between five-fold and 12-fold, particularly among older adults

Pfizer released new data suggesting efficacy of two doses declines from 96.2% to 83.7% after six months but that third doses appeared to boost antibody levels (above) between five-fold and 12-fold, particularly among older adults

Last month, boosters were approved for immunocompromised Americans who had received either the Pfizer or Moderna vaccine after data showed they were less likely to develop high antibody levels after two doses.

At the time, Pfizer said its early data suggested people who received booster doses between six and 12 months after their final dose had high levels of protection. 

The company filed for emergency use authorization for booster doses in late August and submitted data, made public on Wednesday.  

The documents suggest that protection from two doses of the Pfizer vaccine declines from 96.2 percent at seven days after dose 2 to 90.1 percent two months later to 83.7 percent up to six months later. 

What's more, they cited data from Israel showing people fully vaccinated in January 2021 had a 2.26-fold increased risk for breakthrough

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