Scientists questioned the FDA about the “lack” of Johnson & Johnson accelerator data and rapid review

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Syringe and a box of Johnson & Johnson vaccine.

Paul Hennessy | SOPA Image | Light Rocket | Getty Images

Members of the U.S. Food and Drug Administration’s Vaccine Critical Advisory Committee criticized the agency’s review of the speed at which Johnson & Johnson Covid’s enhanced trials and the validated data submitted to the expert panel on Friday.

Their comments came before an external panel of experts voted unanimously to recommend the company’s booster shots to all people over 18 years of age. Johnson & Johnson submitted the enhanced injection data to the FDA 10 days before the meeting of the Vaccine and Related Biological Products Advisory Committee.

Agency officials admitted in their statement that they have not verified all the data submitted by Johnson & Johnson.

“Can it be said that it is a bit early? There are still many issues that have not been resolved,” committee member Dr. Cody Meissner asked FDA officials. “There is a lot of uncertainty at this point, and it is difficult to vote for or against tonight.”

FDA medical officer Dr. Timothy Brennan told the advisory committee that one of the trials examining the side effects of Johnson & Johnson enhancers had only 17 participants between the ages of 18 and 55. Brennan said that the sample size of the trial prevented him from drawing any conclusions on the data, but he pointed out that the data showed that the side effects after the booster injection were less than those after the first injection.

Brennan’s introduction also said that Johnson & Johnson’s data has not been confirmed. Johnson & Johnson reported that 47% of the 17 participants reported headaches, 26% reported fatigue, and 21% reported muscle pain after receiving a booster.

“What confuses me is that in the briefing paper and their speech today, they repeatedly talked about unverified data from the FDA,” committee member Dr. Archana Chatterjee said of Johnson & Johnson. “my question is [what is] The reason for submitting the data to VRBPAC when the data cannot be verified. ”

Committee Chair Dr. Arnold Monto explained that the lower performance of Johnson & Johnson vaccine compared with Pfizer and Moderna is the reason for the accelerated review.

“There is a public health priority here,” Monto said, “because what we see is that this is a group whose overall efficacy is lower than what we see in mRNA vaccines, so some measures are urgently needed.”

Dr. Peter Marks, director of the FDA’s Center for Biologics and Research, asked the team to advance the meeting before resolving any member’s outstanding issues. He said the FDA reviewed the immunogenicity data of thousands of Johnson & Johnson participants before Friday’s meeting, a process that usually takes several months to complete.

“I suggest that we go through the whole process in our own way and pass the questions. If at the end of the day the committee feels that this is not ready yet, I think we can post some comments after that and what can be done to make this possible in the future. Accepted,” Max said.

Although committee member Dr. Michael Nelson said that Johnson & Johnson’s data is “a bit immature and a bit lacking in many areas,” he said he believes the safety and effectiveness data they have so far are sufficient to support emergency use in the United States.

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