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

An influential Food and Drug Administration advisory panel voted Friday against approving vaccine booster shoots to most Americans but recommended administering them to people aged 65 or older, and those who are at high-risk of developing severe COVID-19.

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Update 4:55 p.m. EDT Sept. 17: An FDA advisory panel voted 16-2 on Friday against recommending booster vaccine doses for most Americans, expressing frustration that Pfizer had provided little data on the safety of extra doses.

The decision dealt a heavy blow to a sweeping plan announced last month by the Biden administration and aimed at shoring up people’s defense amid the continued spread of the highly contagious delta variant of the virus.

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The FDA advisory panel was the first major hurdle that the Biden administration plan faced. The FDA itself has yet to make its own determination but typically follows the recommendations of its expert panel.

Update 4:45 p.m. EDT Sept. 17: A Centers for Disease Control and Prevention advisory panel will next debate whether to recommend booster shots following the vote Friday by the FDA’s Vaccines and Related Biological Products Advisory Committee.

The CDC’s Advisory Committee on Immunization Practices is set to meet for a day and a half next week to explore the issue, Stat News reported. The group is set to meet for seven hours on Wednesday and for three hours on Thursday.

Update 4:25 p.m. EDT Sept. 17: The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend booster shots for people aged 65 and older and those who are at high-risk of severe COVID-19.

The panel recommended approving an emergency use authorization to allow for booster shots for those aged 65 and older and people who are at high-risk of severe COVID-19 aged 16 and older.

>> Related: Moderna, Pfizer say boosters needed; FDA’s not sure

Original report: Members of the Food and Drug Administration spent Friday debating whether or not to approve the use of a COVID-19 booster shot six months after a second dose has been administered.

The majority of board members have voted not to approve vaccine boosters at this time.

Both Moderna and Pfizer have suggested that a booster shot would be needed. However, not everyone supports the two companies’ findings.

The meeting focused on Pfizer-BioNTech’s need for a booster shot for people 16 and older, The New York Times reported.

Dr. Phil Krause, deputy director of the FDA’s Office of Vaccine Research and Review, said Pfizer was using information that has not been reviewed.

“One of the issues in this is that much of the data that’s been presented and being discussed today is not peer-reviewed and has not been reviewed by the FDA,” Krause said during Friday’s meeting, according to CNN.

The debate came after President Joe Biden announced last month that he intended to make booster shots available to most adults eight months after they received their second dose, the Times reported.

The administration delayed Moderna vaccine boosters and had planned on providing boosters to those who received the Pfizer shot, but the rollout of a booster program is dependent on the FDA’s advisory committee’s vote, the Times reported.

The Centers for Disease Control and Prevention had advised local and state health officials to pause giving booster shots until both the FDA and CDC make a decision, CNN reported.

A Pfizer-BioNTech said the research supports the use of booster shots when it comes to the risk analysis of getting a booster shot.

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The Associated Press contributed to this report.

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