Pfizer has announced that it is seeking emergency use authorization from the US Food and Drug Administration (FDA) for its coronavirus vaccine booster for all Americans ages 18 and older.
The submission to the FDA was revealed on Tuesday in a joint statement by Pfizer and BioNTech, its Germany-based partner in developing the vaccine.
If the FDA grants approval, Pfizer will be the first to have its booster authorized for all American adults.
The companies said their request is based on a Phase 3 trial with more than 10,000 participants, finding the booster safe and 95% effective against Covid-19 compared to taking two vaccine doses when the Delta variant was dominant.
‘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,’ the companies stated.
‘Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial.’
The Pfizer booster is currently available to Americans who are older than 65 or have a job that puts them at risk for catching Covid-19, and received their second dose of the Pfizer or Moderna vaccine six months ago or the one-shot Johnson & Johnson vaccine two months ago.
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