Pfizer is seeking emergency use authorization for its booster for all American adults (Pictures: Getty Images)
Pfizer has announced 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. The companies are requesting that the FDA amend emergency use authorization of its booster to include all adults.
If the FDA grants approval, Pfizer will be the first to have its booster authorized for 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 underlying health conditions or jobs that puts them at risk for catching Covid-19. They must also have received their second dose of the Pfizer or Moderna vaccine six months ago or the one-shot Johnson & Johnson vaccine two months ago.
Pfizer also shared data from its Phase 3 trail with the European Medicines Agency, among other regulatory bodies. The European Union and other countries have already approved a booster dose of Pfizer’s vaccine for people 18 years and older ‘based on previously submitted safety, tolerability and immunogenicity data, with recommendations for populations varying based on local health authority guidance’, according to the statement.
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