HomeLatest ThreadsGreatest ThreadsForums & GroupsMy SubscriptionsMy Posts
DU Home » Latest Threads » Forums & Groups » Main » Latest Breaking News (Forum) » An F.D.A. analysis sugges...

Wed Oct 13, 2021, 12:00 PM

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 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

9 replies, 1046 views

Reply to this thread

Back to top Alert abuse

Always highlight: 10 newest replies | Replies posted after I mark a forum
Replies to this discussion thread
Arrow 9 replies Author Time Post
Reply An F.D.A. analysis suggests that J.&J. has not presented robust evidence for booster shots. (Original post)
BumRushDaShow Oct 13 OP
Merlot Oct 13 #1
BumRushDaShow Oct 13 #2
Merlot Oct 13 #3
BumRushDaShow Oct 13 #4
BlueIdaho Oct 13 #7
PoindexterOglethorpe Oct 13 #5
LisaL Oct 13 #6
Igel Oct 13 #8
Igel Oct 13 #9

Response to BumRushDaShow (Original post)

Wed Oct 13, 2021, 12:11 PM

1. I'd prefer a different brand for added protection.

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.


J&J has issued glowing reports about its own vaccine - but so far these reports have not been validated.

Reply to this post

Back to top Alert abuse Link here Permalink


Response to Merlot (Reply #1)

Wed Oct 13, 2021, 12:14 PM

2. I saw an article around the end of September

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).

Reply to this post

Back to top Alert abuse Link here Permalink


Response to BumRushDaShow (Reply #2)

Wed Oct 13, 2021, 12:16 PM

3. I'll be on the look out for that, thanks

Reply to this post

Back to top Alert abuse Link here Permalink



Response to Merlot (Reply #3)

Wed Oct 13, 2021, 03:18 PM

7. This is one of the questions the government should be deciding this week

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, I’d say the vaccines will all gain approval along the lines of Pfizer’s 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.

Reply to this post

Back to top Alert abuse Link here Permalink


Response to BumRushDaShow (Original post)

Wed Oct 13, 2021, 12:54 PM

5. Does that mean the J&J shot actually confers better and longer immunity?

Wouldn't that be interesting.

Reply to this post

Back to top Alert abuse Link here Permalink


Response to PoindexterOglethorpe (Reply #5)

Wed Oct 13, 2021, 12:59 PM

6. No, it doesn't.

NT

Reply to this post

Back to top Alert abuse Link here Permalink


Response to PoindexterOglethorpe (Reply #5)

Wed Oct 13, 2021, 05:17 PM

8. No, it means that it doesn't fit the criteria.

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).

Reply to this post

Back to top Alert abuse Link here Permalink


Response to PoindexterOglethorpe (Reply #5)

Wed Oct 13, 2021, 05:17 PM

9. No, it means that it doesn't fit the criteria.

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).

Reply to this post

Back to top Alert abuse Link here Permalink

Reply to this thread