Pfizer's COVID-19 booster shot data: 5 things to know

The FDA released a 53-page analysis from Pfizer Sept. 15 in which the drugmaker outlines data it says supports the authorization of a third dose of its COVID-19 vaccine. 

The report comes in advance of the FDA's Vaccines and Related Biological Products Advisory Committee meeting set to take place Sept. 17. The advisory committee will discuss a third dose of Pfizer's vaccine in people ages 16 and older. The FDA isn't required to follow the advice of the committee, but it typically does. 

Five things to know about Pfizer's booster shot analysis: 

  1. The analysis was based on real-world data collected from Israel between July 1 and Aug. 30, when the delta variant was the dominant strain of the virus in the country, according to CNBC.

  2. The analysis suggested that the Pfizer shot's protection against COVID-19 infection wanes about six to eight months after the second dose, NPR reported.

  3. A third dose of Pfizer's shot six months after a second dose boosted protection from infection back up to 95 percent in Israel, the data showed.

  4. Based on the data, Pfizer is requesting that the FDA authorize a booster of its shot about six months after a second dose for people ages 16 and older, CNBC reported.

  5. The FDA declined to take a stance on whether to back Pfizer's booster shots, saying regulators haven't been able to verify all available data, CNBC reported.

    In a 23-page document published Sept. 15, the agency wrote: "There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions. Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting."

    The agency said some observational studies have suggested that Pfizer's COVID-19 vaccine's efficacy declines over time against symptomatic infection or against the delta variant, but other studies have not.

    "Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” the agency wrote.

Find Pfizer's full analysis here


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