FDA expected to announce COVID-19 booster shot decision soon

The Food and Drug Administration is expected to announce a decision this week on whether to authorize Pfizer-BioNTech COVID-19 vaccine booster shots for some Americans, according to multiple reports.

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The FDA is expected to meet this week to make its decision.

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The meeting comes after an influential FDA advisory panel voted Friday against recommending booster shots for all people aged 16 and older, saying that there was not enough evidence to widely support a third vaccine dose. The Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend booster shots for people aged 65 and older, and for those who are at high-risk of severe COVID-19.

The FDA does not have to accept the recommendations made by the advisory committee, though the agency usually does.

>> Related: FDA advisers recommend Pfizer booster shots for people aged 65+, at high-risk

The New York Times reported the FDA is likely this week to accept the recommendations and authorize Pfizer-BioNTech booster doses for people 65 years of age and older, and for people at high-risk of severe illness. Citing two unidentified sources familiar with the matter, Bloomberg News reported the decision could be announced as soon as Wednesday.

The timing could align with meetings scheduled Wednesday and Thursday of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The group began meeting Wednesday morning to discuss the vaccine, though a draft agenda showed no votes scheduled during the session. If the FDA decides to authorize Pfizer-BioNTech booster vaccine shots before Thursday, ACIP could vote on whether to recommend use of the third shots, according to CNN.

President Joe Biden last month announced a plan that would have made people who got the Pfizer-BioNTech or Moderna COVID-19 vaccines eligible for booster shots beginning this month. However, the FDA advisory committee’s decisions Friday hampered the plan.

It was not immediately clear when booster shots would be available widely.

>> Related: Coronavirus: Booster shots to be available to fully vaccinated Americans beginning in September

Last month, the CDC’s Advisory Committee on Immunization Practices recommended a third dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for some people with weak immune systems after the FDA approved of the additional dose. Data shows moderately and severely immunocompromised people got less protection from the two-dose series of the mRNA vaccines, prompting the recommendation, though enough evidence did not exist at the time to make any recommendations regarding additional doses of the Johnson & Johnson COVID-19 vaccine.

>> Related: Coronavirus: CDC committee recommends additional vaccine dose for immunocompromised people

Nearly 55% of all Americans, or 182 million people, have been fully vaccinated as of Tuesday morning, according to the latest data available from the CDC. Almost 64% of the population, or 212.2 million people, has gotten at least one dose of any of the available vaccines, CDC data shows.

Since the start of the pandemic, 42.4 million COVID-19 cases have been identified nationwide, resulting in over 679,000 deaths, according to a count from Johns Hopkins University. Globally, officials have reported 229.8 million COVID-19 cases, resulting in 5.9 million deaths, according to Johns Hopkins.