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Pfizer requests authorization from FDA for COVID-19 booster shot for ALL Americans 18 and older 


BREAKING NEWS: Pfizer requests authorization from FDA for COVID-19 booster shot for ALL Americans 18 and older

  • Pfizer has submitted data to the FDA in hopes of getting its Covid booster shot authorized for use in all American adults
  • Shot is currently available to Americans over the age of 65, with serious comorbidities, or a job that puts them at risk of Covid exposure 


Pfizer has submitted data to the U.S. Food and Drug Administration seeking authorization for its Covid booster shot for all American 18 or older.

The company issued a joint statement with BioNTech, the German based company it is partnering with to develop and distribute the vaccine, announcing the submission on Tuesday.

If authorization is given, the Pfizer booster will be the first to receive authorization for all American adults.

Currently, anyone who received their second vaccine dose six months ago – or two months ago for those who got the one-shot Johnson & Johnson vaccine – and is over 65, has a serious comorbidity or a job that puts them at risk of Covid exposure is eligible for the Pfizer booster shot.

Pfizer has submitted data to the FDA in hopes of getting its Covid booster shot authorized for use in all American adults. Pictured: A vial of Pfizer COVID-19 vaccine, November 2021

‘In October, the companies announced positive topline results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95 percent when compared to those who did not receive a booster,’ a statement released by the companies reads.

‘Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial.’

The statement notes that there were no new changes to the adverse event profile of the jab in clinical trials of the booster.

It also notes that the booster has received approval from European Union regulators for all residents over the age of 18.

The Phase 3 clinical trial data that is being submitted to regulators is based off of a study conducted in the U.S., Brazil and South Africa.

More than 10,000 people aged 16 or older were included in the trial, and each were previously fully vaccinated using Pfizer’s shot – named Comirnaty.

Half of participants were given a 30 microgram dose of the booster, and the others were given a placebo.

After following up with each participant around two months later, researchers determined the booster reduced risk of infection of people of all age groups.   

The Pfizer COVID-19 booster is the most popular among Americans so far, with more than half of the 25 million Americans who have received booster shots thus far opting for the jab.

More than 98 percent of Pfizer recipients for their first two shots decided to receive the same shot again for their booster, along with 32 percent of J&J recipients.

 

This is a breaking news story and will be updated.

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