An F.D.A. analysis suggests that J.&J. has not presented robust evidence for booster shots.
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 didnt 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 agencys 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 agencys 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 didnt have time to vet much of Johnson & Johnsons 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 Sponsors 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
Merlot
(9,696 posts)J&J has issued glowing reports about its own vaccine - but so far these reports have not been validated.
BumRushDaShow
(128,836 posts)where some results from the NIH "mix/match" study were due to be released shortly (the article speculated it would happen around now but I haven't seen it yet - it might end up being discussed at the FDA meetings at the end of this week).
Merlot
(9,696 posts)BumRushDaShow
(128,836 posts)BlueIdaho
(13,582 posts)As drug companies are petitioning the government for permission to add boosters and Merck is requesting approval for the first oral covid antiviral. The question of mix and match vaccines should also be decided. This will be a big week for the next step in Covid protection.
If I had to guess, Id say the vaccines will all gain approval along the lines of Pfizers restricted use approval of a third jab. The question of mix and match will need further study and the oral covid antiviral will get a much broader use approval.
The meetings begin today and run through Friday.
PoindexterOglethorpe
(25,841 posts)Wouldn't that be interesting.
LisaL
(44,973 posts)NT
Igel
(35,300 posts)I think that Pfizer after 6 months still has better outcomes than the J&J at 3 months, but there's a larger drop-off in immunity. Could be wrong, but you really need to read what the criteria is.
Not that the criteria and science matter. It'll be approved for for booster shots, at least for some groups (my prediction: The same as for Pfizer).
Igel
(35,300 posts)I think that Pfizer after 6 months still has better outcomes than the J&J at 3 months, but there's a larger drop-off in immunity. Could be wrong, but you really need to read what the criteria is.
Not that the criteria and science matter. It'll be approved for for booster shots, at least for some groups (my prediction: The same as for Pfizer).