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Pfizer wants the FDA to authorize booster doses for all adults

2021-11-09T20:19:52.009Z


Pfizer and BioNTech are seeking the FDA to authorize boosters of their covid-19 vaccines for all adults 18 years of age and older.


Pfizer profits increase due to covid-19 vaccine 0:50

(CNN) -

Pfizer and BioNTech reported Tuesday that they are seeking the Food and Drug Administration (FDA) to authorize the emergency use of a booster dose of their covid-19 vaccine for all people 18 years of age and older.

The companies' goal is for the FDA to amend the current emergency use authorization, which covers some adults.

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The companies said the request is based on the results of a phase 3 trial that included more than 10,000 participants.

In that trial, booster doses were found to be safe and 95% effective against symptomatic COVID-19 compared to the two-dose schedule of the vaccine in the period when the highly contagious delta variant was the dominant.

Pfizer released the data on the effectiveness of the boosters last month, but they have not yet been reviewed or published.

This authorization would bring the country closer to the prediction made by President Joe Biden in mid-August, when he said there would be boosters available to all adults in the United States.

Who will be able to get the booster shot in the US?

2:58

This authorization would bring the country closer to the prediction made by President Joe Biden in mid-August, when he said there would be boosters available to all adults in the United States.

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Who can get the Pfizer booster today?

When Pfizer initially sought a green light from the FDA for booster doses, it requested full approval of boosters for everyone age 16 and older.

Instead, the FDA authorized the boosters for a more limited group of adults who had already received both doses.

Since then, eligibility has expanded to include most adults, including people who received other types of vaccines.

People who received the Pfizer / BioNTech or Moderna vaccines six months or more ago may receive a booster if they are 65 years of age or older, are at risk of a serious post-vaccination infection from an underlying medical condition such as diabetes, kidney disease, or pregnancy , or are at risk because of their living conditions or their work.

Anyone who was vaccinated with the Johnson & Johnson vaccine (which is only licensed for those over 18) two months or more ago can opt for the booster two months after the injection.

The FDA and the Centers for Disease Control and Prevention also authorized the mixing and matching of boosters.

Source: cnnespanol

All news articles on 2021-11-09

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