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Pfizer Cites 95% Efficacy In Third Vaccine Shots; FDA Staff Skeptical

Pfizer Inc. (PFE) said on Wednesday that data from its Covid vaccination program in Israel where it administered boosters revealed that a third shot showed benefits same as that seen after the receipt of the second primary dose and restores around 95 percent protection against the Coronavirus. These findings were based on data collected from July 1 through August 30 when the delta variant was widespread throughout the country.

Data presented by Pfizer to the Food and Drug Administration revealed that the third dose of Covid vaccine taken six months after a second shot gives around 95 percent protection against the deadly virus.

The company, in a 52-page presentation, put forward the point that a booster shot will bring about the same type of protection as after taking the second dose.

The report prepared by Pfizer is to give details to the FDA's Vaccines and Related Biological Products Advisory Committee, which meets on Friday to review the request by the company and its vaccine partner, BioNTech (BTX), to approve of Covid booster doses for the general public.

Based on the data, Pfizer plans to request for licensure of a booster dose of the vaccine administered intramuscularly approximately 6 months after the second dose in individuals above 16 years.

The Food and Drug Administration staff on Wednesday declined to comment on whether the authority would allow booster shots of Pfizer's Covid-19 vaccine in the United States, citing that the regulators haven't verified all the available data.

The FDA said on its website that "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 VRBPAC meeting."

The FDA staff is of the opinion that the in use COVID-19 vaccines in the country are efficient to protect against severe COVID-19 disease and death in the United States.

The U.S Government has plans to offer booster shots to the general public as early as next week, as soon as it gets approval from the FDA. The move is part of President Joe Biden's wider plan to safeguard against higher number of coronavirus cases brought about by the Delta variant.

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