Members of the Food and Drug Administration’s key advisory committee on vaccines criticized the speed with which the agency was reviewing Johnson & Johnson’s Covid booster trials as well as the lack of verified data presented before the panel Friday.
Their comments came before the panel of outside experts unanimously voted to recommend the company’s booster shots for all individuals over 18. J&J submitted its booster data to the FDA 10 days before the Vaccines and Related Biological Products Advisory Committee’s meeting.
Agency officials acknowledged in their presentations that they had not yet verified all the data submitted by J&J.
“Is there an option of saying it’s a little early? There are a number of issues that are still outstanding,” committee member Dr. Cody Meissner asked FDA offiicals. “There are a lot of uncertainties at this point, making it hard to vote for or against this tonight.”
FDA medical officer Dr. Timothy Brennan told the advisory committee that one of the trial’s examining the side effects of J&J’s booster had just 17 participants ages 18 to 55. Brennan said the trial’s sample size prevented him from drawing any conclusions on the data, but noted that the figures appeared to be show fewer side effects after the booster than after the first dose.
Brennan’s presentation also said the data from J&J had not been confirmed. J&J reported that 47% of the 17 participants reported headache, while 26% reported fatigue and 21% reported muscle pain after getting a booster.
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