FDA Being Questioned On Insufficient J&J Booster Data & Speedy Review

The Food and Drug Administration appointed vaccine expert committee has raised questions on the speed at which the FDA has been evaluating Johnson & Johnson’s Coronavirus booster trials.

It has also criticized the lack of valid data that was presented to the panel on Friday.

These comments had come before the vaccine experts’ panel unanimously decided to vote for recommending Johnson & Johnson’s booster dose for everyone over the age of 18.

FDA Being Questioned On Insufficient J&J Booster Data & Speedy Review

Johnson & Johnson had submitted its booster vaccine data to the Food and Drug Administration ten days prior to the vaccine’s advisory committee’s meeting.

The Food and Drug Administration’s officials did acknowledge in their presentations that they were yet to verify all the data that was submitted by Johnson & Johnson.

One of the Vaccines and Related Biological Products Advisory Committee’s members, Dr. Cody Meissner, questioned the speed at which the data had been reviewed by claiming it was a bit too early to vote against or for the booster shots as there are still a lot of uncertainties and a few pending issues to be addressed.

Dr. Timothy Brennan, an FDA medical officer, said in their defense that even though the sample size of the trial did not allow drawing a clear conclusion on the data, the figures claimed that the side effects of the booster dose were less compared to the first dose.

He also said that Johnson & Johnson’s booster vaccine trials only had 17 participants in the age group of 18 to 55 years.

Dr. Brennan further added that Johnson & Johnson’s data was yet to be confirmed. Johnson & Johnson’s data reported 47% of participants experiencing headache, 21% experiencing muscle pain, and 26% experienced fatigue after getting their booster shots.

Another vaccine committee member, Dr. Archana Chatterjee also expressed her surprise at the fact that when all of the company’s presentations and briefing documents repeatedly claimed that the data had not been verified by the FDA, there was no purpose of bringing it to the Vaccines and Related Biological Products Advisory Committee.

VRBPAC committee chairman Dr. Arnold Monto was of the opinion that the weaker performance of Johnson & Johnson’s vaccine in comparison to Moderna and Pfizer had played a part in the speedy reviews of their booster dose.

Dr. Monto further explained that the public’s health is at risk here and from what we have observed thus far since the overall efficiency of the J&J vaccine has been lower compared to mRNA vaccines, there is a sense of urgency to make some progress.

FDA’s center for biologics and research director, Dr. Peter Marks had suggested that the panel should go ahead with the meeting before addressing the pending concerns of any members.

He further claimed that the Food and Drug Administration had evaluated the immunogenicity data submitted by Johnson & Johnson of thousands of participants prior to Friday’s committee meeting, a process which would have otherwise taken months to get through.

Dr. Mark suggested that they could work their way through this process by addressing all the member’s concerns and if, after that, the general opinion is that it is too early to give a green signal to anything yet, they could figure out what needs to be done to make the booster vaccine acceptable in the future.

Another committee member, Dr. Michael Nelson suggested that even though J&J’s data did seem a bit immature and lacking in a few areas, the efficiency and safety data that was submitted so far was enough to recommend emergency use in the U.S.