FDA regulators are mad because Moderna did not release all of their study information to the vaccine advisory board, which, upon closer study, shows that 1.9% of people who received Moderna's original vaccination subsequently caught Covid, while the bivalent vaccine - which should have offered increased protection against the Omicron variants - had an infection of 3.2%!
Moderna received $5 billion from the US government to develop this vaccine and then didn't disclose all of the study information, apparently in an effort to get it approved and make more profits.
From the CNN article: "The six FDA and CDC advisers interviewed by CNN said that this infection data wouldn’t have changed how they voted, because the data had such limitations, but it still should have been presented to them."
https://edition.cnn.com/2023/01/11/health/moderna-bivalent-transparency/index.html
New England Journal of Medicine summary of the studies:
https://www.nejm.org/doi/full/10.1056/NEJMc2213907
The NEJM article at least has a disclaimer: "Limitations of our study include the small sample size and follow-up period of our groups. We also note that the between-group comparisons were not controlled for factors such as age, vaccine type, and health status, which may have had an effect on antibody responses. These findings may be indicative of immunologic imprinting, although follow-up studies are needed to determine whether antibody responses will deviate over time, including after the administration of a second bivalent booster."
https://science.slashdot.org/story/23/01/16/1612250/fda-vaccine-advisers-disappointed-and-angry-that-early-data-about-new-covid-19-booster-shot-wasnt-presented-for-review-last-year
Moderna received $5 billion from the US government to develop this vaccine and then didn't disclose all of the study information, apparently in an effort to get it approved and make more profits.
From the CNN article: "The six FDA and CDC advisers interviewed by CNN said that this infection data wouldn’t have changed how they voted, because the data had such limitations, but it still should have been presented to them."
https://edition.cnn.com/2023/01/11/health/moderna-bivalent-transparency/index.html
New England Journal of Medicine summary of the studies:
https://www.nejm.org/doi/full/10.1056/NEJMc2213907
The NEJM article at least has a disclaimer: "Limitations of our study include the small sample size and follow-up period of our groups. We also note that the between-group comparisons were not controlled for factors such as age, vaccine type, and health status, which may have had an effect on antibody responses. These findings may be indicative of immunologic imprinting, although follow-up studies are needed to determine whether antibody responses will deviate over time, including after the administration of a second bivalent booster."
https://science.slashdot.org/story/23/01/16/1612250/fda-vaccine-advisers-disappointed-and-angry-that-early-data-about-new-covid-19-booster-shot-wasnt-presented-for-review-last-year
no subject
Date: 2023-02-05 12:43 am (UTC)Shit.
no subject
Date: 2023-02-05 01:54 am (UTC)My first three Covid vaxes were Moderna, but my fourth was Pfizer - not covalent - and I think I'll try to stick with Pfizer for the future until more AND BETTER info is available re: Moderna.
no subject
Date: 2023-02-05 02:08 am (UTC)Beginning to wonder about other options.
no subject
Date: 2023-02-05 05:12 am (UTC)3 months post virus. Yippy......
Hugs, Jon
no subject
Date: 2023-02-05 06:59 pm (UTC)I'm due my next booster in March, I think. One thing to be aware of, Jon, I've read from many people that when they get a booster post-Covid, it frequently knocks them flat for a couple of days because you have real Covid nastiness in your blood that the vaccination starts attacking immediately!
no subject
Date: 2023-02-05 10:33 pm (UTC)Of course the only time I have two days off from work in a row are the weekends, and they don't do shots on the weekends.
Unless I wait until Mid March when I took a week off. :o
no subject
Date: 2023-02-11 08:03 pm (UTC)no subject
Date: 2023-02-11 08:57 pm (UTC)Most definitely! When the vaccines first became available, I wanted the Pfizer but couldn't get it in my area. I had the Moderna for my first two or three vaccinations, then finally a Pfizer just before the bivalents came out. (I think I'm due another next month) My docs suggested that, though they are both RNA vaccines, that it could be beneficial to mix them up. 'Could be' being the operative phrase, as there are no firm studies to back that up.
Pfizer has gotten in to trouble, too, so it's an industry-wide issue, not limited to one company. But we knew that.
no subject
Date: 2023-02-12 12:31 am (UTC)no subject
Date: 2023-02-12 07:59 pm (UTC)The way Covid mutates, I doubt we'll ever be truly rid of it. But it is softening as they predicted the mutations would do, so with luck it will eventually become a slightly worse common cold. But I'm with you: I'd still prefer to never get it!