FDA Authorizes Pfizer COVID-19 Booster Shots For Older People And High-risk Workers

The U.S. Food and Drug Administration has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people over 65 years of age, healthcare workers, and others at high risk of severe COVID-19.

The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series.

“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,” said Acting FDA Commissioner Janet Woodcock.

Under the EUA in the U.S., a third dose of the vaccine was previously authorized for individuals at least 12 years of age who have undergone solid organ transplant, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The authorization of a third dose for immunocompromised individuals – administered at least 28 days following the second dose – is separate and distinct from the booster dose authorized Wednesday, the companies said in a statement.

As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of boosters to Americans.

A U.S. Food and Drug Administration advisory panel on Friday had voted 18-0 in emergency approval for the Pfizer-BioNTech’s COVID-19 vaccine booster shot at least six months following the second dose among people ages 65 and older and those at high risk.

However, the panel had voted to reject the recommendation of Pfizer’s booster vaccine in people ages 16 and older. The panel had voted 2-16 against the recommendation.

Pfizer and BioNTech said Wednesday that they continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022.

The companies do not expect the introduction of booster doses in the U.S. to impact the existing supply agreements in place with governments and international health organizations around the world.

Pfizer and BioNTech have pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022 – at least one billion doses each year.

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