An F.D.A. analysis suggests that J.&J. has not presented robust evidence for booster shots. [View all]

[BumRushDaShow]

Source: New York Times

In a new analysis, the Food and Drug Administration questioned the strength of evidence Johnson & Johnson provided in its application for booster shots. A key test used by the company was likely not sensitive enough, the agency suggested, adding that it didn’t have enough time to independently review much of the raw data from the trials.

The document, released in advance of a Friday meeting of the agency’s vaccine advisers, could have significant influence on whether the 15 million Americans who have received the one-dose vaccine will be allowed to get a second shot, or if they will instead be urged to get a different brand of vaccine for added protection. The agency’s analysis follows a report released on Tuesday, in which Johnson & Johnson argued in favor of a booster, presenting data from a number of trials. “A booster dose is recommended at 6 months or later, based on the strength of the immune responses,” the company wrote.

But on Wednesday, the F.D.A. said that the test used by the company to measure the immune response of a six-month-boost — known as a psVNA assay — is not sensitive enough for the task. The agency also questioned whether the increase in immune response was as big as the data suggested. “It is likely that the results seen are due to the low sensitivity of the psVNA assay used,” the F.D.A. stated in its report. The F.D.A. saw a potential improvement in protection from a J. & J. booster given two months after the first shot, based on a large trial sponsored by the company. “Although not independently confirmed by F.D.A. from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose,” the agency said in its report.

The fact that the F.D.A. had not independently confirmed key data was a departure from past briefing documents for other vaccines. The F.D.A. said that it didn’t have time to vet much of Johnson & Johnson’s material before the meeting later in the week. The agency scheduled the meeting of its outside advisers before the company had even submitted its application for a booster dose — an unusual move, some public health experts said. “Except where noted, datasets were not submitted in sufficient time for FDA to conduct an independent review to verify the Sponsor’s analyses,” the F.D.A. said in its report. A spokesman for Johnson & Johnson did not immediately respond to a request for comment.

Read more: https://www.nytimes.com/2021/10/13/health/johnson-vaccine-booster-fda.html?smid=tw-nytimes&smtyp=cur