FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

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The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.

The FDA amended its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on Sept. 23, 2021. The new guidelines allow for a single booster dose to be given to:

  • Individuals 65 years of age and older;
  • Individuals 18 through 64 years of age at high risk of severe COVID-19;
  • Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19, including severe COVID-19.

While there has been a heated battle about the need for booster doses for COVID-19, this is the first vaccine to officially be granted booster status in the US. While many argued that boosters would be needed very soon, others, such as World Health Organization’s Director-General Tedros Adhanom Ghebreyesus or former FDA scientists Marion Gruber and Phillip Krause, felt the global community might be moving too fast.

This decision was made following an analysis of several key data points concerning the long-term efficacy of the vaccine, numbers of breakthrough cases, and the emergence of the Delta variant. Pfizer’s own original clinical trial, which published its findings days before this announcement, was among the data sets that led to the EUA amendment.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” said Acting FDA Commissioner Janet Woodcock in a FDA press release. “After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers, and those in homeless shelters or prisons, among others.”

Source: FDA