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> "The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent Covid-19 vaccines meet our rigorous safety, effec

> "The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent Covid-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization," Dr. Peter Marks, the agency's top vaccine regulator, said in a statement. Are there safety/efficacy studies someone is aware of and can link?

ceejayoz 4y ago
Flu shots don't get a full set of studies every year; there's ongoing monitoring for safety events, but tweaking the strains each time is an expedited process. That's the right model for COVID boosters, I'd say. They've shared data with regulators; not sure if it's published yet. https://www.pharmacytimes.com/view/moderna-bivalent-booster-candidate-mrna-1273-214-shows-higher-response-to-omicron-variants-compared-with-current-booster https://www.pharmacytimes.com/view/moderna-bivalent-booster-... > This clinical data adds to results shared last month from Moderna’s ongoing phase 2/3 study in approximately 800 participants. Previous results showed a 50-µg booster dose of mRNA-1273.214 met all pre-specified primary end points. The booster does was generally well tolerated by patients, with a reactogenicity and safety profile considered consistent with the currently authorized booster.
- peteradio 4y ago
  I've shared this report a few times, wondering if you had an opinion on it: https://www.cidrap.umn.edu/news-perspective/2017/02/studies-shed-light-effects-serial-flu-shots-current-vaccines-benefits https://www.cidrap.umn.edu/news-perspective/2017/02/studies-... It could be taken as motivation for updating the booster so don't get me wrong, but is it possible the flu vaccine schedule is problematic if some years we can expect negative efficacy?
  - ceejayoz 4y ago
    Possible, but unpredictable; it would appear it depends on which strains are active each year, which we can’t reliably predict. Different virus, too, so not necessarily applicable to COVID.

ceejayoz 4y ago

Flu shots don't get a full set of studies every year; there's ongoing monitoring for safety events, but tweaking the strains each time is an expedited process. That's the right model for COVID boosters, I'd say. They've shared data with regulators; not sure if it's published yet. https://www.pharmacytimes.com/view/moderna-bivalent-booster-candidate-mrna-1273-214-shows-higher-response-to-omicron-variants-compared-with-current-booster https://www.pharmacytimes.com/view/moderna-bivalent-booster-... > This clinical data adds to results shared last month from Moderna’s ongoing phase 2/3 study in approximately 800 participants. Previous results showed a 50-µg booster dose of mRNA-1273.214 met all pre-specified primary end points. The booster does was generally well tolerated by patients, with a reactogenicity and safety profile considered consistent with the currently authorized booster.

peteradio 4y ago
I've shared this report a few times, wondering if you had an opinion on it: https://www.cidrap.umn.edu/news-perspective/2017/02/studies-shed-light-effects-serial-flu-shots-current-vaccines-benefits https://www.cidrap.umn.edu/news-perspective/2017/02/studies-... It could be taken as motivation for updating the booster so don't get me wrong, but is it possible the flu vaccine schedule is problematic if some years we can expect negative efficacy?
- ceejayoz 4y ago
  Possible, but unpredictable; it would appear it depends on which strains are active each year, which we can’t reliably predict. Different virus, too, so not necessarily applicable to COVID.