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Thu Oct 14, 2021, 02:20 PM

An F.D.A. panel recommends a Moderna booster for many Americans.

Source: New York Times

A key advisory committee to the Food and Drug Administration voted on Thursday to recommend a booster shot of the Moderna coronavirus vaccine for many of the vaccine’s recipients, at least six months after a second dose. The panel endorsed a half-dose as a third injection for people 65 and older as well as younger adults at high risk because of their medical conditions or jobs, the same groups of people who became eligible for a Pfizer-BioNTech booster last month.

While regulators are not obligated to follow the panel’s recommendations, they typically do. Committee members said that while they hoped for far more robust data, a number of them said that F.D.A. had already sent a precedent by authorizing booster shots on an emergency basis for many recipients of the Pfizer-BioNTech vaccine. The panel voted after hearing from Moderna officials, agency scientists and a top public health official from Israel, which began offering boosters to Pfizer recipients two and a half months ago.

Dr. Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T. H. Chan School of Public Health, questioned whether Moderna has enough data showing whether a booster shot will create adverse side effects. Like Pfizer, “Moderna is presenting the results of a relatively small trial,” he said. But “Pfizer had all those real-world data from Israel” on its booster campaign, showing results from “millions of people who received the vaccine,” he said.

Johnson & Johnson has asked the Food and Drug Administration to issue emergency use authorization for a booster for recipients of their vaccines, and the panel will vote Friday on the company’s request. They will also hear then about the initial results of an ongoing federal study that found Johnson & Johnson recipients may benefit more from a booster of Moderna’s or Pfizer’s vaccine. The committee will discuss, but not vote on, whether to consider broader eligibility for boosters of both Pfizer and Moderna’s vaccines, allowing people younger than 65 but not at especially high risk to get them.

Read more: https://www.nytimes.com/2021/10/14/us/moderna-boosters-fda.html



Have been watching since they started at 8:30 am EDT. The vote below - unanimous (even with some of them having concerns but I think weighing on some of them was the fact that since Pfizer is approved, it would be a bit of a mess to wait).



EDIT TO NOTE: CDC would still need to give the final "okay".

38 replies, 2642 views

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Reply An F.D.A. panel recommends a Moderna booster for many Americans. (Original post)
BumRushDaShow Oct 14 OP
DownriverDem Oct 14 #1
BumRushDaShow Oct 14 #2
sheshe2 Oct 14 #6
BumRushDaShow Oct 15 #29
zanana1 Oct 15 #26
BumRushDaShow Oct 15 #27
Lunabell Oct 14 #3
lark Oct 14 #4
I_UndergroundPanther Oct 14 #16
The_REAL_Ecumenist Oct 14 #18
I_UndergroundPanther Oct 14 #21
The_REAL_Ecumenist Oct 14 #22
I_UndergroundPanther Oct 14 #23
riversedge Oct 15 #32
Raftergirl Oct 14 #5
JT45242 Oct 14 #7
BumRushDaShow Oct 14 #9
mainer Oct 14 #8
BumRushDaShow Oct 14 #10
RussBLib Oct 14 #11
Farmer-Rick Oct 14 #15
ananda Oct 14 #12
BumRushDaShow Oct 14 #14
ananda Oct 14 #19
BumRushDaShow Oct 14 #20
Farmer-Rick Oct 14 #13
marie999 Oct 14 #17
BlueIdaho Oct 14 #24
BumRushDaShow Oct 15 #25
BlueIdaho Oct 15 #33
BumRushDaShow Oct 15 #34
BlueIdaho Oct 15 #35
BumRushDaShow Oct 15 #36
BlueIdaho Oct 15 #37
BumRushDaShow Oct 15 #38
Buckeye_Democrat Oct 15 #28
BumRushDaShow Oct 15 #30
Buckeye_Democrat Oct 15 #31

Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 02:22 PM

1. Oh good

We've been waiting for this.

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Response to DownriverDem (Reply #1)

Thu Oct 14, 2021, 02:24 PM

2. Me too!



I still have a week or so to get to 6 months post dose 2 of Moderna but now I can plan to try to get a flu shot and Moderna booster at the same time.

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Response to BumRushDaShow (Reply #2)

Thu Oct 14, 2021, 02:41 PM

6. I got my Pfizer booster and flu shot yesterday!

Glad you are next up.

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Response to sheshe2 (Reply #6)

Fri Oct 15, 2021, 07:35 AM

29. I would be at the 6 months point

sometime next week. Since Moderna is sortof in limited circulation around here (most places near me do Pfizer), I would probably try to schedule back at the same pharmacy I had my first doses at (I had checked last month and they offer both - originally only had Moderna).

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Response to BumRushDaShow (Reply #2)

Fri Oct 15, 2021, 07:04 AM

26. Please don't get both at the same time.

My BIL did that (with a Pfizer booster) and was flat on his back for two days. His doctor wondered why the pharmacist would give him both on the same day. (BIL doesn't usually have side effects to vaccines).

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Response to zanana1 (Reply #26)

Fri Oct 15, 2021, 07:26 AM

27. The whole vaccine thing

whether it is the flu shot or now the COVID-19 shots, have so many different reactions by different people during different doses, that I don't know if it is applicable to even broad brush how one would respond.

When I had my first Moderna shot, aside from the soreness around the injection site, I had a fatigue reaction and foggy-headedness response a couple days after it (over a weekend) that resolved the next day. I had no headache or fever.

The 2nd shot had a bit longer injection site soreness, but little else.

Meanwhile the Moderna shots that one of my BILs had (the other BIL had Pfizer) laid him on his back miserable for a few days according to my sister.

I know early on there were some observational trials of the flu shot with the COVID one that seemed to show there wasn't much of an issue. Note too that there are different types of flu shots that are given out depending on the recipient's age. I.e.,

Quadrivalent Influenza Vaccine
Fluzone High-Dose Seasonal Influenza Vaccine (only for 65+)

So I don't know the age of your BIL but that might have made a difference too - particularly with the "high dose" flu shot (which I wouldn't be eligible for)...

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 02:28 PM

3. I got the Moderna and have been waiting for this

I'm a nurse and will absolutely be in line for this.

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Response to Lunabell (Reply #3)

Thu Oct 14, 2021, 02:36 PM

4. Not a nurse, but absolutely believe in science & will get mine ASAP!

YAY~

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Response to Lunabell (Reply #3)

Thu Oct 14, 2021, 03:58 PM

16. I have diabeties

I'll be in line right behind you,for a shot of moderna.

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Response to I_UndergroundPanther (Reply #16)

Thu Oct 14, 2021, 04:39 PM

18. Hi friend.. I have Sarcoidosis AND am a "terminal" cancer survivor & definitely WILL

be getting this!

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Response to The_REAL_Ecumenist (Reply #18)

Thu Oct 14, 2021, 05:05 PM

21. Better

Get the booster ,If you dont I would be worried you gone psychotic on me.

Yes,do get the booster.

Other than that I'm glad to hear from ya.
Hope all's well.

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Response to I_UndergroundPanther (Reply #21)

Thu Oct 14, 2021, 05:48 PM

22. Thank you and appreciate your sweet wishes. You'll be relieved to learn that I may be

reliably guilty of many things but not stupidity nor horrifically painful suicide. Went through CoV19 beginning December 28 2019 for 5.5 months. Ain't doing it again. How things going for you-Everything good?

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Response to The_REAL_Ecumenist (Reply #22)

Thu Oct 14, 2021, 07:52 PM

23. Its okay

The aloneness of my life these days sometimes gets hard to take. Still going to therapy working shit out.

Sometimes this whole republicans are fascists wanting to rule this country freaks me out.. I am just the kind of person they'd want to ruin.

So yeah I get worried about this country going fascist,not looking forward to civil war or a damn theocracy

I hope like hell our dems start prosecuting these fanatics seriously and puts them away.

I really hope orange asshole is put in a matching orange jumpsuit and frogmarched to a gurney,strapped down to get the death penalty.

I think hard jail time and mango butthole being put on death row would change this situation.

At least I hope it does,if they dare do another insurrection,
order the capital police to shoot them on sight when they pass the first police line.

And show it on tv.

People need to see what happens to traitors.

Ya know play fascist games win awful prizes..

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Response to Lunabell (Reply #3)

Fri Oct 15, 2021, 07:58 AM

32. I care for my very eldly mom and am glad to hear this also.

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 02:39 PM

5. Hurrah!

I’ll be 65 next month and 7 months out from 2nd dose.

Already got my flu shot so I’ll be good to go!

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 02:59 PM

7. Mix and match study shows good stuff too --

[link:https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95035|

"A so-called "mix and match" COVID vaccine series using a different booster than the primary series was safe and produced an increase in immune response comparable to or greater than when the primary series and booster were the same vaccine, researchers found.

Adults who were vaccinated with Pfizer, Moderna or Johnson & Johnson vaccines produced an increase in serum binding antibody levels following a booster dose of a different vaccine, with a 4.6-fold to 56-fold increase in geometric mean titers (GMT) at day 15, reported Robert Atmar, MD, of Baylor College of Medicine in Houston, and colleagues.
Moreover, the greatest increase in immune response was among those who had a Johnson & Johnson one-dose primary series, followed by a Pfizer or Moderna booster, with a 33-fold and 56-fold increase, the authors wrote in a highly anticipated preprint on medRxiv, which has not undergone peer-review."

I got J&J and would love to get a Moderna booster with those numbers.

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Response to JT45242 (Reply #7)

Thu Oct 14, 2021, 03:05 PM

9. They are supposed to discuss the "mix/match" and Janssen (J&J) tomorrow (with votes I believe)

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 02:59 PM

8. When does this translate to Walgreens doing it?!!

I'm still waiting for them to say yes.

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Response to mainer (Reply #8)

Thu Oct 14, 2021, 03:07 PM

10. FDA's (Acting) Commissioner has to give the final okay from the agency's perspective

and then CDC would need to give their final okay, and then they should be good to go.

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 03:25 PM

11. what a coincidence

I got my 3rd Moderna today (at CVS). Decided to wait 2 more weeks for the flu shot, as my doc recommended. And then, 2 more weeks for the Shingles vaccine! Sheesh!

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Response to RussBLib (Reply #11)

Thu Oct 14, 2021, 03:42 PM

15. Way to keep up with your vaccines

You are being very responsible. If everyone were like you, we would have all these viruses under control.

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 03:36 PM

12. I'm getting mine tomorrow!

This is weird. Tomorrow is exactly six months
from my second shot.

Hurray!

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Response to ananda (Reply #12)

Thu Oct 14, 2021, 03:37 PM

14. There are technically still a couple of "official approvals" that still need to happen

but I expect some places might not bother with the technicality.

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Response to BumRushDaShow (Reply #14)

Thu Oct 14, 2021, 04:41 PM

19. I just now got it at CVS, full dose.

What a relief!

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Response to ananda (Reply #19)

Thu Oct 14, 2021, 04:56 PM

20. Yeah the Moderna (and Pfizer) "full dose" (3rd in a series) EUA was approved back in August

for certain conditions.

Today's vote was to expand to a broader set of people - but as a "1/2 dose" formulation to be truer (for the term) "booster" (vs as a 3rd dose, which basically would make the vaccine course a 3-dose regime vs a 2-dose one with a possible "booster" ). The Moderna rep. noted that they would be sending out quite a bit of literature along with their usual "Dear Doctor" letters to help the providers distinguish who gets what dose.

They had also started discussing the "booster for the general population" question but haven't voted on that yet (I am thinking they won't agree to that - at least for now).

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 03:37 PM

13. Oh good news

I'm 6 months away from 65, got some blood clot issues and it's been 7 months since I was fully vaccinated. I think I can convince my doctor to give it to me.....I hope.

I live in TN so there is plenty of vaccine not being used.

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 04:34 PM

17. Good, I had my flu shot today and the VA will give Moderna boosters as soon as FDA says yes.

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Response to BumRushDaShow (Original post)

Thu Oct 14, 2021, 08:00 PM

24. I'd be surprised if we don't see

Authorization for Moderna and J&J this week or early next. I think the vaccine cocktail idea will be set for further study. I’m interested to see if Merk’s anti-viral oral medication will get the nod this time around. This is a big week for a covid treatment advances!

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Response to BlueIdaho (Reply #24)

Fri Oct 15, 2021, 03:31 AM

25. They are supposed to report the results on the "mix/match" studies today

during the meeting.

It seems some of the data reported ahead of this seemed to be positive.

The one issue that might come up is the dosage amount for what would be a "booster" at the end of each vaccine's "standard" series - i.e., if someone got 2 Pfizers and wants to mix with a Moderna "3rd" shot - would that 3rd one be a "full, 100ug" dose of it or the "half, 50ug" one? Same if a Janssen (J&J) recipient wants a Moderna "2nd" shot - would that be the full dose or the half dose?

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Response to BumRushDaShow (Reply #25)

Fri Oct 15, 2021, 10:19 AM

33. I'm looking forward to the decision

Thanks for the info on dosing. We need the best and most effective solution possible!

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Response to BlueIdaho (Reply #33)

Fri Oct 15, 2021, 10:22 AM

34. I've been listening to today's meeting since 8:30 am EDT

They are currently doing the "public" remarks - edit, just finished that, and will go on a break to 11:30 am EDT, and go back to the Committee meeting with member questions to the presenters (FDA's and the firm's).

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Response to BumRushDaShow (Reply #34)

Fri Oct 15, 2021, 10:25 AM

35. Impressive commitment

Any guesses from the meeting so far?

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Response to BlueIdaho (Reply #35)

Fri Oct 15, 2021, 10:30 AM

36. The main takeaway so far

is that Janssen (J&J) submitted data with very small sample sizes but did do small, overlapping studies of 2 months after initial dose, and I think 3 months, and then 6 months.

This is the feed for their meeting -



All the presentation materials (slide decks) are here (PDFs) - https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement

ETA =

Janssen's presentation (PDF) - https://www.fda.gov/media/153129/download
Part of FDA's presentation in response (PDF) - https://www.fda.gov/media/153130/download

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Response to BumRushDaShow (Reply #36)

Fri Oct 15, 2021, 10:32 AM

37. Thanks Again! nt.

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Response to BlueIdaho (Reply #37)

Fri Oct 15, 2021, 10:43 AM

38. You are welcome

The other thing that came up in response to a question from Janssen to FDA was about how they were doing reviews and FDA indicated that it would take months to actually review, in detail, what was submitted.

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Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 07:32 AM

28. This is me, in regard to Moderna boosters.

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Response to Buckeye_Democrat (Reply #28)

Fri Oct 15, 2021, 07:38 AM

30. ...



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Response to BumRushDaShow (Reply #30)

Fri Oct 15, 2021, 07:41 AM

31. Lol!

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