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thewayneFDA 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
