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New boosters FDA approved, may be available next week
Posted by: Lemon Drop
Date: August 31, 2022 09:07AM
Woot!

WASHINGTON — The Food and Drug Administration on Wednesday authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.

The agency cleared two options aimed at the BA.5 variant of Omicron that is now dominant: one made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older. The doses can be given at least two months since people last received a booster dose or completed their initial series of vaccinations.

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F.D.A. Authorizes Updated Covid Booster Shots, Targeting Omicron Subvariants [www.nytimes.com]
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Re: New boosters FDA approved, may be available next week
Posted by: Tiangou
Date: August 31, 2022 10:18AM
Based on testing on 10 mice.

Notoriously unreliable.



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Re: New boosters FDA approved, may be available next week
Posted by: Diana
Date: August 31, 2022 10:41AM
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Tiangou
Based on testing on 10 mice.

Notoriously unreliable.

Mouse strains evolve and change, even when you try to hold their genome stable. Add in the fact that people are not mice, as the immune system is somewhat different (but close enough, maybe), and the fact that people are … odd … when it comes to variability from one person to the next, and the job becomes that much more difficult. And I’m meaning “odd” in that the more we study the immune system, the more we realize that genetic variability is huge in humans. Translation between the two species can be hard to do. There is enough similarities to make it worthwhile to do the work, but there is a reason that human trials are necessary.

Immortal cell lines do the same.
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Re: New boosters FDA approved, may be available next week
Posted by: Lemon Drop
Date: August 31, 2022 11:43AM
Human trials were done earlier on these vaccines and FDA has all that data. Moderna does their trials in the US under the auspices of their partner NIH (Dr. Fauci) right?


I'm not worried.

But if you are, the European Agency is doing more trials before approval, so you could wait for their results.

 "per the Food and Drug Administration (FDA), vaccine makers do not need to submit updated clinical trial data for the BA.4/BA.5 adapted shots. The agency will instead approve the modified vaccines using clinical data from the BA.1 vaccine trials. This will allow the updated vaccines to be approved quicker. However, the European Medicines Agency has said it doesn’t intend to follow the path of its American counterpart and will instead require vaccine makers to submit clinical data for each of the new updated shots."



Edited 1 time(s). Last edit at 08/31/2022 11:48AM by Lemon Drop.
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Re: New boosters FDA approved, may be available next week
Posted by: Speedy
Date: August 31, 2022 01:23PM
We’ll be amongst the first in line.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: New boosters FDA approved, may be available next week
Posted by: Lemon Drop
Date: August 31, 2022 02:32PM
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Speedy
We’ll be amongst the first in line.

Ditto
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Re: New boosters FDA approved, may be available next week
Posted by: Diana
Date: August 31, 2022 02:48PM
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Lemon Drop
Quote
Speedy
We’ll be amongst the first in line.

Ditto

Yep. Right in front of you.

Since these are based on previous approved vaccines with changes made to its ability to pick up the new changes to the viral genome, additional testing, while appropriate, may be outweighed by the severity of the disease. Tough call either way. If you do more testing and wait until done, unnecessary deaths will have occurred; if you rush it through then any unforeseen issues will be blamed on the “rush”.

These are version 2, so yes I will be the “Guinea pig” for you.
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Re: New boosters FDA approved, may be available next week
Posted by: RgrF
Date: August 31, 2022 03:10PM
Two more "Guinea Pigs" here.
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Re: New boosters FDA approved, may be available next week
Posted by: DinerDave
Date: August 31, 2022 03:14PM
Quote
Lemon Drop
Quote
Speedy
We’ll be amongst the first in line.

Ditto

Can we car pool?

Dave



Welcome to Dave's BBQ!

Many have eaten here....

Few have died
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Re: New boosters FDA approved, may be available next week
Posted by: AllGold
Date: August 31, 2022 06:35PM
I'll get it as soon as I can find it. My guess is the worst that can happen with a small modification of something already approved is it will be ineffective at stopping BA.5.
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Re: New boosters FDA approved, may be available next week
Posted by: rgG
Date: September 01, 2022 01:57PM
I’ll probably get mine around the end of September or first of October.
My last booster was in April, I think.





Roswell, GA (Atlanta suburb)
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Re: New boosters FDA approved, may be available next week
Posted by: Janit
Date: September 01, 2022 10:02PM
So for, I haven't seen any discussion of whether people who have had the complete series of 4 original shots (2 initial series and 2 boosters) will be eligible to get the new bivalent shot as a third booster. Given the reasons for this new formulation, it seems to me that they should be eligible if it has been long enough since the second booster.
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Re: New boosters FDA approved, may be available next week
Posted by: Lemon Drop
Date: September 01, 2022 10:20PM
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Janit
So for, I haven't seen any discussion of whether people who have had the complete series of 4 original shots (2 initial series and 2 boosters) will be eligible to get the new bivalent shot as a third booster. Given the reasons for this new formulation, it seems to me that they should be eligible if it has been long enough since the second booster.

In the CDC meeting today, they said anyone who had the 2 shot series and had their last booster at least 2 months ago could get this new bivalent shot. Doesn't matter if you had one booster or two, or none.

They should have the full recs out by tomorrow I believe.
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Re: New boosters FDA approved, may be available next week
Posted by: Acer
Date: September 01, 2022 10:26PM
Mrs. Acer was scheduled for a booster tomorrow, arranged a week or so ago, at the hospital where she works. They called to cancel the appointment today, saying the FDA has placed a hold on inoculating with the current booster. YMMV.



Edited 1 time(s). Last edit at 09/01/2022 10:26PM by Acer.
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Re: New boosters FDA approved, may be available next week
Posted by: Janit
Date: September 01, 2022 10:48PM
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Acer
Mrs. Acer was scheduled for a booster tomorrow, arranged a week or so ago, at the hospital where she works. They called to cancel the appointment today, saying the FDA has placed a hold on inoculating with the current booster. YMMV.

Yes, my county vaccination program has also put a hold on them.
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