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FDA expands use of COVID-19 vaccine booster doses in eligible populations

On Wednesday, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations.

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

The FDA amended emergency use authorizations (EUA) for COVID-19 vaccines to allow for single booster doses of the vaccines. For the Moderna vaccine, a single-use booster dose could be administered six months after completion of the primary series for those 65 years old or older, at high risk of severe COVID-19 between the ages of 18 and 64, and those with an increased risk of exposure to COVID between the ages of 18 and 64.

The Pfizer booster shot could be given to anyone between 18 and 64 with frequent exposure to the COVID virus, at least six months after their primary doses.

For the Johnson and Johnson booster shot, a single dose could be administered at least two months after completion to anyone 18 or older.

Additionally, the FDA said, eligible individuals – those 65 years of age and older, those 18 through 64 years of age at high-risk of severe COVID-19, and those 18 through 64 years of age with frequent exposure to the COVID-19 virus – could “mix and match” vaccines from different providers once the primary vaccination had been completed.

“This emergency use authorization is supported by robust clinical evidence that a 50 µg booster dose induces a strong immune response against COVID-19. We thank the FDA for their review and for this EUA, including for those people who have completed a primary vaccination with a different COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We believe that mRNA vaccines are uniquely positioned to adapt to the evolving epidemiology of SARS-CoV-2. We’re grateful for the opportunity to provide individuals with another layer of protection.”

Liz Carey

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