Scientists question FDA on ‘scant’ J&J booster data and speedy review

Johnson & Johnson syringes and vaccine kit.

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Members of the Food and Drug Administration’s main advisory committee on vaccines have criticized the speed with which the agency has been reviewing Johnson & Johnson’s Covid booster trials as well as the lack of confirmed data presented to the committee on Friday.

Their comments came before a panel of outside experts voted unanimously to recommend the company’s enhanced shots for all individuals over the age of 18. J&J submitted its enhanced data to the FDA 10 days before the Vaccines and Related Biological Products Advisory Committee meeting.

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

“Is there an option to say it’s a little early? There are a number of issues that are still outstanding,” panel member Dr. Cody Meissner asked FDA officials. “There is a lot of uncertainty at this point, which makes it difficult to vote for or against tonight.”

FDA medical officer Dr. Timothy Brennan told the advisory panel that one of the participants in the trial examining the side effects of the J&J booster was only 17 participants between the ages of 18 and 55. Brennan said the trial’s sample size prevented him from drawing any conclusions about the data, but noted that the numbers seemed to show fewer side effects after the booster dose than after the first dose.

Brennan’s presentation also said that 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 aches after getting a booster dose.

“What puzzled me is that, in their summary documents and in their presentations today, they repeatedly talked about data that had not been verified by the Food and Drug Administration,” panel member Dr. Archana Chatterjee said of J&J. “The question I had about that was [what is] Reason for presenting this before VRBPAC without being able to verify the data.”

Committee Chair Dr. Arnold Munto explained that the lower performance of the J&J vaccine compared to Pfizer and Moderna played a role in the rapid pace of the review.

“There’s a public health imperative here, because what we’re seeing is that this is a combination with less potency overall than we’ve seen with mRNA vaccines, so there’s some urgency to do something,” Monto said.

Dr. Peter Marks, director of the FDA’s Center for Biology and Research, requested that the committee move forward with the meeting before addressing any outstanding concerns the members had. He said the FDA reviewed the immunogenicity data of thousands of J&J participants before Friday’s meeting, a process that would naturally take months to complete.

“I would suggest that we work our way through the process, follow up on the questions, and if the feeling of the committee at the end of the day is that this is not ready, I think we can get some feedback and then lines of what can be done to make this acceptable in the future,” Marks said.

Although panel member Dr Michael Nelson said J&J’s data was “fairly immature and somewhat scarce in multiple areas,” he said he believed the safety and efficacy data they had so far were sufficient to support use in Emergencies in the United States.


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