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FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.
FDA announced in a Nov. 19, 2021, press release that it has officially amended its Emergency Use Authorization (EUA) for both Pfizer-BioNTech’s and Moderna’s COVID-19 single-shot booster vaccinations to now include all adults. To qualify, individuals must be 18 or older and be at least six months removed from completion of their primary vaccination series of the Pfizer-BioNTech or Moderna shots. If they received the Janssen single-shot vaccine, this limit is reduced to two months.
Prior to this announcement, booster vaccinations were only made available to individuals aged 65 or older, individuals aged 18 through 64 at high risk of severe COVID-19, and individuals aged 18 through 64 with frequent institutional or occupational exposure to SARS-CoV-2.
“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” said Janet Woodcock, acting FDA commissioner, in an agency press release. “Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death.”
According to the release, this decision was made following an evaluation of immunity data from clinical trials of both the Pfizer-BioNTech and Moderna vaccines. The Pfizer-BioNTech trial evaluated 200 participants aged 18 through 55 who received a single booster dose at least six months after their second dose relative to peers who only completed the two-dose series, while the Moderna trial did a similar evaluation of 149 individuals aged 18 or older. Both studies found an increased immune response in the booster group one month after vaccination.
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the press release. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”