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Scientists query the FDA about “poor” J&J booster information and a fast evaluation

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Syringes and a box of Johnson & Johnson vaccine.

Paul Hennessy | SOPA pictures | LightRakete | Getty Images

Members of the Food and Drug Administration’s key vaccine advisory committee criticized the speed with which the agency was reviewing Johnson & Johnson’s Covid booster studies, as well as the lack of verified data presented to the panel on Friday.

Their comments came before the panel of external experts unanimously voted to recommend the company’s booster for anyone over the age of 18. J&J submitted its refresh data to the FDA 10 days prior to the meeting of the Advisory Committee on Vaccines and Related Biological Products.

Agency officials confirmed in their presentations that they had not yet verified all of the data submitted by J&J.

“Is there any way to say that it is still a little early? There are a number of questions that remain open,” asked committee member Dr. Cody Meissner FDA official. “There’s a lot of uncertainty at this point that makes it difficult to vote for or against tonight.”

FDA doctor Dr. Timothy Brennan told the advisory committee that one of the studies looking at the side effects of J & Js Booster had only 17 participants ages 18 to 55 that the numbers seemed to show fewer side effects after the booster than after the first dose.

Brennan’s presentation also said the data had not been confirmed by J&J. J&J reported that 47% of the 17 participants reported headache, while 26% reported fatigue and 21% reported muscle pain after receiving a booster.

“What puzzled me was that in the briefing documents and in their presentations today, they repeatedly talked about data not being reviewed by the FDA,” said committee member Dr. Archana Chatterjee on J&J. “And the question I had about that is [what is] the reason for bringing this to VRBPAC without being able to verify the data. “

The chairman of the committee, Dr. Arnold Monto stated that the lower performance of the J&J vaccine compared to that of Pfizer and Moderna played a role in the rapid pace of the review.

“There’s a public health imperative here,” said Monto, “because we’re seeing this is a group with an overall lower level of effectiveness than we’ve seen with the mRNA vaccines, so there is some urgency to act to do.”

Dr. Peter Marks, director of the FDA’s Center for Biologics and Research, asked the panel to continue the session before addressing members’ outstanding concerns. He said the FDA reviewed immunogenicity data from thousands of J&J participants before Friday’s meeting, a process that would normally have taken months.

“I would suggest that we work our way through the process, go through the questions, and if at the end of the day the committee feels that this is not done yet, I think we can make some comments afterward about what could be done to make this acceptable in the future, “said Marks.

Although committee member Dr. Michael Nelson said that J & J’s data were “a bit immature and a little sparse in several areas,” he said that the safety and efficacy data they had so far were sufficient to support the emergency application in the US

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