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New boosters FDA approved, may be available next week - Lemon Drop - 08-31-2022
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.
Gift link
F.D.A. Authorizes Updated Covid Booster Shots, Targeting Omicron Subvariants https://www.nytimes.com/2022/08/31/us/politics/covid-booster-shots-variants.html?unlocked_article_code=AAAAAAAAAAAAAAAACEIPuonUktbfqYhkQFUYAibIRp8_qRmHmfnE2_s3gWH_IG2fTjFZ0-kPRpOA_FvWILRqfdo62SiAAt9dNbtlDNpD8thiBW0_AQ-5vsnD350fPyQ-rY_0UGg6hMrGA-h9-GPgMizkcLdxgbe1sxnDOzTqUPaL1H1wJV0xsoIlIQ_xoQEAz6_PF-Rx0tJsj7x2Vt0hG2B2NGTdtOLoCh5-JNyMchvfjwEwUOpeUjrQ9sWOv_NCKE4BTAKbEw4spDo0-9heO9gIPabgLxNGeMf2grkZCWcAP57ippSCz710yfVXInz0wTjA
Re: New boosters FDA approved, may be available next week - Tiangou - 08-31-2022
Based on testing on 10 mice.
Notoriously unreliable.
Re: New boosters FDA approved, may be available next week - Diana - 08-31-2022
Tiangou wrote:
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.
Re: New boosters FDA approved, may be available next week - Lemon Drop - 08-31-2022
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."
Re: New boosters FDA approved, may be available next week - Speedy - 08-31-2022
We’ll be amongst the first in line.
Re: New boosters FDA approved, may be available next week - Lemon Drop - 08-31-2022
Speedy wrote:
We’ll be amongst the first in line.
Ditto
Re: New boosters FDA approved, may be available next week - Diana - 08-31-2022
Lemon Drop wrote:
[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.
Re: New boosters FDA approved, may be available next week - RgrF - 08-31-2022
Two more "Guinea Pigs" here.
Re: New boosters FDA approved, may be available next week - DinerDave - 08-31-2022
Lemon Drop wrote:
[quote=Speedy]
We’ll be amongst the first in line.
Ditto
Can we car pool?
Dave
Re: New boosters FDA approved, may be available next week - AllGold - 08-31-2022
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.