FDA’s Vaccines and Related Biological Products Advisory Committee is on a virtual meeting Friday to discuss whether the data presented by Pfizer support the safety and effectiveness of a booster dose of COMIRNATY administered 6 months post-primary vaccination series
The committee is under discussion on Pfizer-BioNTech’s supplemental Biologics License Application for the administration of a third dose, or “booster” dose, of the COVID-19 vaccine, Comirnaty, in individuals 16 years of age and older.
Following the meeting, the committee will vote on whether to recommend a third dose of the Pfizer vaccine for widespread use in the United States.
In documents posted online, the FDA took note of conflicting data concerning boosters.
The FDA said in a briefing document, “Some observational studies have suggested declining efficacy of COMIRNATY overtime against symptomatic infection or against the Delta variant, while others have not.”
Comirnaty, which refers to Pfizer’s COVID-19 vaccine, represents a combination of the terms COVID-19, mRNA, community, and immunity.
Data submitted to the FDA by Pfizer break down side effects experienced after the boosters. Pfizer asked its trial participants to submits their symptoms using an electronic diary.
The company said injection site pain was the most common side effect.
Pfizer said most side effects lasted up to two days.
It said severe side effects were rarely reported but when they were, it was severe fatigue and muscle pain. Trial participants ages 18 to 55 were the most likely to report any side effects.
Other side effects felt less frequently were chills and new/worsened joint pain.
Several studies supporting boosters have been conducted in Israel, something the FDA also took note of saying US-based studies “may most accurately represent vaccine effectiveness in the US population.”
The FDA said data available to them showed the vaccines were still effective in preventing severe illness.
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