FDA, Pfizer, BioNTech
FDA approves booster dose of Pfizer vaccine. Specific populations eligible for booster dose.
Where: United States
On September 22nd, the FDA revised the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose for eligible individuals, including those aged 65 and above.
Other eligible individuals comprise people aged 18-64 at high risk of contracting severe COVID-19, including those with frequent institutional and occupational exposure to the SARS-CoV-2 virus.
As per the amended EUA, a single booster dose will be available for the eligible individuals after at least six months of completion of the primary two-dose vaccination series.
Acting Commissioner of the FDA, Dr. Janet Woodcock, tweeted, “As we learn more about the efficacy of #COVID19 vaccines and the use of boosters, we will continue to react to the rapidly changing science and keep the public informed.”
On September 17th, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend the FDA issue EUA for a single booster dose of the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) for eligible populations.
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