Saturday, October 16, 2021

Turns out the Moderna “booster” trials were a complete crock… total farce…

Moderna is looking to get "Booster shots" for their covid vaccine approved by the FDA. so far, it's not going terribly well.

"Overall, 149 adults received the two-dose 100 μg series, which is the dose authorized under EUA, plus the booster dose and were evaluated for immunogenicity. They were a mean age of 53, about three-quarters were between ages 18-65, and 60% were women. Nearly all were white, and 14% had obesity. Median interval between completion of the primary series and the booster dose was about 7 months."

All the actual high risk folks to whom such boosters would be preferentially offered and whose needs such boosters are purported to serve were excluded.

"Interestingly, there were 38 COVID-19 cases of 171 booster recipients reported during the Delta surge in study P201.".

"FDA staff noted a higher rate of lymphadenopathy among adults ages 18-64 after the booster dose versus the primary series, but no evidence of"increased frequency or severity of local or systemic reactions after the booster dose, they said.

If it's not related to vaccination, why does a higher dose of vaccination affect it so much?

"While "Immunobridging analyses against the D614G strain met the pre-specified success criteria for the ratio," FDA staff added that in seroresponse rates after the booster dose compared to dose 2, "The pre-specified success criterion was not met," as the difference in seroresponse rate was -10.5%, and the lower limit of the 95% CI had a criteria of less than -10%". and, amazingly, seeming to remember that you must specify end points BEFORE a trial and then hit them, not fish around for ones that made it look like your drug worked on a post facto basis and p-hack your way to approval. it's a simple system. you say"this is what success looks like.
 

https://boriquagato.substack.com/p/moderna-boosters-at-the-fda 

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