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Fri Sep 17, 2021, 02:33 PM

FDA meeting on boosters is live!



I think you can watch it live if you are booster obsessed!

7 replies, 455 views

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Arrow 7 replies Author Time Post
Reply FDA meeting on boosters is live! (Original post)
Tomconroy Sep 17 OP
cilla4progress Sep 17 #1
Tomconroy Sep 17 #2
BumRushDaShow Sep 17 #3
BumRushDaShow Sep 17 #4
Tomconroy Sep 17 #5
BumRushDaShow Sep 17 #6
Tomconroy Sep 17 #7

Response to Tomconroy (Original post)

Fri Sep 17, 2021, 02:53 PM

1. Can't watch.

Any updates?

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Response to cilla4progress (Reply #1)

Fri Sep 17, 2021, 03:03 PM

2. They seem to be specifically considering the issue of boosters

For everyone. The people I've seen talk seem to think we need more info. Seems to be sympathy for boosters for over 65. But I only found this halfway through

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Response to cilla4progress (Reply #1)

Fri Sep 17, 2021, 03:09 PM

3. They are discussing one of the questions that they will vote on

Whether a "booster" (in quotes because some consider it a "3rd dose" ) be approved for age groups 16 plus (my paraphrase).

ETA - here is the slide with the question -



Members are asking some questions to get clarifications on what they are voting on and why - including to get some additional info from Pfizer and FDA reps.

One of the things that is consistently coming up at the moment is the myocarditis in younger people so I think they seem to want to narrow the approval question to limit "boosters" to the older demographic.

I know the younger demographic (12 - 15) only recently got approval for the vaccine as it is, so there is really not much data on them at this point. But Pfizer had submitted the booster approval request down to that younger "16" age (since they were originally included in the Biologics License Approval - BLA - for the "2-dose" regime).

Have to see if they have multiple questions - i.e., whether they have an option to vote to allow for an older demo and immuno-compromised (have to look through the docs to see) only at this time.

Slide deck is here - https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement#event-materials

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Response to Tomconroy (Original post)

Fri Sep 17, 2021, 03:32 PM

4. Vote for booster ("3rd dose" ) for 16 and higher - RESULT NO for that question

16 NO
2 YES


Screen had 16 no but there was an accidental vote.

VOTE WAS JUST CLARIFIED (updated the above)

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Response to BumRushDaShow (Reply #4)

Fri Sep 17, 2021, 03:47 PM

5. Only an advisory vote but that's a lot of nos.

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Response to Tomconroy (Reply #5)

Fri Sep 17, 2021, 03:52 PM

6. They appear to be wanting to change the question

The issue is approving for the younger demographic.

I think if they re-phrase to 60+ or 65+ (including immuno-compromised), then it would probably pass.

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Response to Tomconroy (Original post)

Fri Sep 17, 2021, 04:23 PM

7. So their voting for over 65 and those with high risk of

Severe covid. I missed it but I think it this is a yes.

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