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BumRushDaShow

(128,441 posts)
Tue Jun 28, 2022, 04:54 PM Jun 2022

F.D.A. advisers recommend updated boosters that target forms of Omicron.

Source: New York Times

An expert committee recommended Tuesday that the Food and Drug Administration plan on an updated booster shot of the coronavirus vaccines that targets some form of the Omicron variant that has dominated for months. The panel’s vote paves the way for F.D.A. regulators to authorize a new formulation for the boosters that the Biden administration hopes to offer later this year, before an expected winter resurgence of the virus.

The committee debated but did not specify which formulation might work best. The F.D.A. appeared to be leaning toward a combination of the existing vaccine and two subvariants of Omicron, known as BA.4 and BA.5. According to new estimates from the Centers for Disease Control and Prevention, those two subvariants together now make up more than half of new cases in the country.

Dr. Peter Marks, who oversees the F.D.A.’s vaccine division, displayed a timeline suggesting that regulators would decide on a new vaccine composition by early July, and that a fall booster campaign could begin in October. Manufacturers of the mRNA vaccines, made by Moderna and Pfizer-BioNTech, require roughly three months to begin producing doses with a new composition.

Clinical trial results on a combination of the so-called “prototype,” or existing, vaccines and Omicron itself have received mixed reviews so far. In briefing materials, regulators suggested that such a design is “already somewhat outdated.” The panel struggled with what one member called “trying to predict the future” of where the virus is headed. Another panelist called the data “uncomfortably scant.”

Read more: https://www.nytimes.com/2022/06/28/us/politics/covid-vaccines-omicron-fda.html



Have been streaming this while the J6 Committee was on my TV.

They are discussing their votes at post time (Vote was 19 YES, 2 NO)...

11 replies = new reply since forum marked as read
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F.D.A. advisers recommend updated boosters that target forms of Omicron. (Original Post) BumRushDaShow Jun 2022 OP
For me a conundrum on when to get Pfizer #4 bucolic_frolic Jun 2022 #1
I got my 2nd Moderna booster last month (May), about 6 months after my first (November 2021) BumRushDaShow Jun 2022 #2
struggled with what one member called "trying to predict the future" groundloop Jun 2022 #3
Well we know how the hits and misses happen with the annual flu shot BumRushDaShow Jun 2022 #6
Yes, please. SergeStorms Jun 2022 #4
If they are not going to make an Omicron booster available until October, why Baitball Blogger Jun 2022 #5
From what I heard during their discussions BumRushDaShow Jun 2022 #7
Thank you! Baitball Blogger Jun 2022 #8
You're welcome! BumRushDaShow Jun 2022 #9
As long as so many people don't get vaccinated and wear a mask, Dysfunctional Jun 2022 #10
I have been very careful for 2 years. Wear a mask, had my 4th booster as soon as I vsrazdem Jun 2022 #11

BumRushDaShow

(128,441 posts)
2. I got my 2nd Moderna booster last month (May), about 6 months after my first (November 2021)
Tue Jun 28, 2022, 05:28 PM
Jun 2022

and was looking to get any new "bivalent" (or however they want to do them) booster this fall - November 2022 - which would then be a 6 months point for me after that last booster in that case.

groundloop

(11,513 posts)
3. struggled with what one member called "trying to predict the future"
Tue Jun 28, 2022, 05:33 PM
Jun 2022

Well hell, in my puny little non molecular biologist brain I have to believe that a new vaccine/booster based on one of the latest variants will be worlds better than the current vaccines.

I'm fully vaxxed and got my second booster a bit over a month ago yet still managed to contract Covid recently. While my symptoms are considered "mild" it's still no fun. I really wonder if I'd have had much milder symptoms had the most recent booster been based on an Omicron variant.

BumRushDaShow

(128,441 posts)
6. Well we know how the hits and misses happen with the annual flu shot
Tue Jun 28, 2022, 05:59 PM
Jun 2022

so I think similar is going on here as it's difficult to predict which variant might become dominant.

The one BIG difference between doing these COVID-19 variant-specific vaxes vs the flu ones is that the mRNA types are much faster to engineer and then manufacture once VOCs are determined (3 months to get enough dose to distribute) vs the Influenza ones where they ID which ones to include and start manufacturing (6 months to get enough doses to distribute).

SergeStorms

(19,186 posts)
4. Yes, please.
Tue Jun 28, 2022, 05:36 PM
Jun 2022

I had my 4th shot April 13th and I can't wait for my next one! October would be 6 months, so I'm hoping I'm eligible.

BumRushDaShow

(128,441 posts)
7. From what I heard during their discussions
Tue Jun 28, 2022, 06:17 PM
Jun 2022

They have already started manufacturing doses of what they had been working on and would be ready by around the end of July ahead of an expected fall surge of Omicron BA.4/BA.5.

Since the vaccine approval is a 4-step/2-agency process, FDA initiated this first step and at some point, CDC's ACIP will need to look at any additional clinical trial data that is still being collected on these amended types of vaccines, and would make a recommendation/approval of the new type of booster for distribution to the public.

The CDC ACIP doesn't have another meeting scheduled until October although I expect they might actually schedule one before October to get ahead of the fall/school year.

 

Dysfunctional

(452 posts)
10. As long as so many people don't get vaccinated and wear a mask,
Tue Jun 28, 2022, 06:35 PM
Jun 2022

we will need more shots. I have had 4 Moderna shots, I don't even call them booster shots, and I still wear a mask.

vsrazdem

(2,177 posts)
11. I have been very careful for 2 years. Wear a mask, had my 4th booster as soon as I
Wed Jun 29, 2022, 10:16 AM
Jun 2022

could, work at home, order grocery delivery. I finally traveled, went to my daughter's law school graduation in Minnesota, (which was outside) and the day after I got back I was sick and tested positive for covid. Thank God, it was not as bad as I expected and am recovering, starting to feel better after about 7 days. I can't imagine what it would have been without 4 shots. I think eventually no matter how hard we try, sooner or later we are going to get it.

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