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Pfizer Asks FDA To Expand Use Of COVID Booster Vaccine

Pfizer on Tuesday called on U.S. regulatory bodies to authorize booster doses of its COVID-19 vaccine for anyone 18 years of age or older, a step that comes amid concerns about the possibility of increasing the spread of the coronavirus with travel and Christmas gatherings.

Older Americans and other groups especially vulnerable to the virus have had access to a third dose of the vaccine from Pfizer and BioNTech since September. But the Food and Drug Administration (FDA) has said it will act quickly to expand booster doses to younger ages if warranted.

Pfizer presented the first results of a study in 10,000 people to argue that it is time to expand the booster campaign.

Although the three vaccines Used in the United States continue to offer strong protection against severe illness and death from COVID-19, the effectiveness of vaccines against milder infections may decline over time.

The new Pfizer study concluded that a booster could restore protection against symptomatic infection to nearly 96%, even when the delta variant was spreading. Side effects were similar to those seen with the first two injections of the vaccine.

An average of 11 months after the last Pfizer vaccination, trial participants received a third dose or a placebo. Researchers tracked infections that occurred at least a week later, and so far have counted five cases of symptomatic COVID-19 among booster vaccine recipients, compared with 109 cases among people who received the placebo.

The Biden administration had originally planned boosters for all adults, but faced a severe setback in September when FDA scientific advisers rejected additional Pfizer doses for all. The group was not convinced that healthy youth they will need another doseespecially when most of the world’s population remains unvaccinated.

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