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 panels 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 In briefing materials, regulators suggested that such a design is already somewhat outdated.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)...
bucolic_frolic
(43,044 posts)BumRushDaShow
(128,441 posts)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)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)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)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.
Baitball Blogger
(46,682 posts)get us all excited now?
BumRushDaShow
(128,441 posts)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.
Baitball Blogger
(46,682 posts)BumRushDaShow
(128,441 posts)Dysfunctional
(452 posts)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)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.