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

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Syringes and a box of Johnson & Johnson vaccine.

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The agency’s review of vaccines was criticized by members of its key advisory committee, the Food and Drug Administration. Johnson & Johnson’sCovid booster trials and the absence of confirmed data were presented to the panel on Friday.

The panel of experts was unanimously satisfied with their comments and voted to endorse the booster shots company for everyone 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 it possible for the FDA to tell me that it is still a little too early?” The committee still has many questions,” Dr. Cody Meissner (member of the FDA) asked. It is difficult to decide whether you support or oppose this motion tonight because of the many uncertainties.

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 stated that while the trial was small in size, he could not draw any conclusions about the data. However, he noted that there appeared to have been fewer side effects with the booster than the initial 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.

“What puzzled me was, in the briefing documents and in their presentations today, they spoke repeatedly about data not being verified by the FDA,” committee member Dr. Archana Chatterjee said of J&J. And the question I asked was: [what is]The reason VRBPAC was not able to verify this data is the “Reporting This Before VRBPAC.”

Dr. Arnold Monto, Chair of the Committee explained that lower performance of J&J’s vaccineThe rapid review was accelerated by Moderna’s and Pfizer being compared.

Monto stated that there was a “public health imperative” because the group is showing lower effectiveness than what has been seen with mRNA vaccines. Therefore, it is urgent to act.  

Director of FDA’s Center for Biologics and Research, Dr. Peter Marks asked the panel to move ahead with the meeting without addressing members’ concerns. He said the FDA reviewed immunogenicity data on thousands of participants from J&J before Friday’s meeting, a process that ordinarily would’ve taken months to complete.

Marks stated, “I suggest that we go through this process and go through all the questions. If at the end the feeling is that it isn’t ready, then I believe we can have comments that would follow that would be along the lines that could help to make this more acceptable in the future.”  

Although committee member Dr. Michael Nelson said J&J’s data was “a little bit immature and somewhat scant in multiple areas,” he said he thought the safety and efficacy data they had so far was enough to support emergency use in the U.S. 

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