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BumRushDaShow

(129,662 posts)
Mon Aug 22, 2022, 04:09 PM Aug 2022

Pfizer seeks OK of updated COVID vaccine booster for fall

Source: AP

Pfizer asked U.S. regulators Monday to authorize its combination COVID-19 vaccine that adds protection against the newest omicron relatives — a key step toward opening a fall booster campaign. The Food and Drug Administration ordered vaccine makers to tweak their shots to target BA.4 and BA.5 that are better than ever at dodging immunity from earlier vaccination or infection.

If the FDA quickly clears the combo shots made by Pfizer and its partner BioNTech, boosters could be offered within weeks. The U.S. has a contract to buy 105 million of the updated Pfizer doses as soon as health authorities greenlight them, and the company said doses are ready to ship. Moderna is expected to file a similar application soon, and the U.S. has a contract to buy 66 million doses of its updated vaccine.

“It’s going to be really important that people this fall and winter get the new shots. It’s designed for the virus that’s out there,” White House COVID-19 coordinator Dr. Ashish Jha said last week.

For now at least. BA.5 currently is causing nearly all COVID-19 infections in the U.S., and much of the world. There’s no way to know if it still will be a threat this winter -- or if another mutant will have replaced it.

Read more: https://apnews.com/article/covid-science-health-1cff3358922388f2461d74f8dc46f3e6



The initial data was discussed back on June 28 by both Pfizer and Moderna when the subject for Omicron-specific boosters came up. FDA gave approval to go ahead with bivalents.

Pfizer (which is subject of the OP for their EUA submission) looked at their current 2-dose vax series + same booster vs the current 2-dose series + a monovalent booster vs the current 2-dose series + a bivalent booster.


PFIZER



The article also mentions the UK's approval of one of Moderna's earlier bivalents (that included the original and I believe a BA.1-targeted as a combo), the U.S. wanted their bivalent with the BA.5 focus. I.e., I believe the UK approved the mRNA-1273.211 version where the U.S. is looking to review/approve the mRNA-127.214 one.


MODERNA

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Pfizer seeks OK of updated COVID vaccine booster for fall (Original Post) BumRushDaShow Aug 2022 OP
Thanks for posting this! WA-03 Democrat Aug 2022 #1
Good. I'll be camped out in front of Walgreen's Ocelot II Aug 2022 #2
I hope this can happen soon. House of Roberts Aug 2022 #3
Wooooo Hoooo! SheltieLover Aug 2022 #4
... BumRushDaShow Aug 2022 #6
Oooooops SheltieLover Aug 2022 #7
.... BumRushDaShow Aug 2022 #10
Great news. brer cat Aug 2022 #5
Ikr! SheltieLover Aug 2022 #8
Good news will get that along with my flu shot. sheshe2 Aug 2022 #9
Wish it was available now. Got COVID again, less then three months since I last got it. nattyice Aug 2022 #11
Sounds like this Pfizer vax is more up to date wnylib Aug 2022 #12
They are running parallel and really haven't submitted much related specifically to BA.4/BA.5 BumRushDaShow Aug 2022 #13
Thanks. wnylib Aug 2022 #15
I'll get this one ASAP Novara Aug 2022 #14

Ocelot II

(115,898 posts)
2. Good. I'll be camped out in front of Walgreen's
Mon Aug 22, 2022, 04:12 PM
Aug 2022

like I'm waiting in line for BTS tickets or the newest iPhone.

wnylib

(21,656 posts)
12. Sounds like this Pfizer vax is more up to date
Tue Aug 23, 2022, 12:29 AM
Aug 2022

on omicron variants than Moderna's new omicron vax that covers the B1 variant.

All my shots so far have been Moderna, but I might get Pfizer this time.

BumRushDaShow

(129,662 posts)
13. They are running parallel and really haven't submitted much related specifically to BA.4/BA.5
Tue Aug 23, 2022, 07:17 AM
Aug 2022

This is Pfizer's press release - https://www.businesswire.com/news/home/20220822005376/en/

Moderna's mRNA-1273.214was shown to be very effective against BA.4/BA.5 without needing to explicitly put a "BA.4/BA.5" component in it.

https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Bivalent-Booster-mRNA-1273.214-Demonstrates-Potent-Neutralizing-Antibody-Response-Against-Omicron-Subvariants-BA.4-And-BA.5/default.aspx

And they have been doing a rolling data submission on that although there is mention of this in that news release -

Company simultaneously developing mRNA-1273.222, a bivalent candidate based on BA.4/5, consistent with recent FDA guidance


So it's possible that Moderna will go with mRNA-1273.222 IF it provides anything appreciably more effective than 1273.214.

Novara

(5,857 posts)
14. I'll get this one ASAP
Tue Aug 23, 2022, 09:56 AM
Aug 2022

I'm scheduled for hip replacement in early October and I want to be protected when I get to the hospital.

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