"We [FDA] have determined that [normal reporting] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis... Therefore we have determined you are required to conduct the following studies... [lists several studies due 2024 and 2025]." (pg 6-8)
They then also list the pregnancy study at bottom of page 9.
It's already approved on the condition that Pfizer submits in future the 13 safety studies mentioned in the pdf. This was already known long ago, follow Dr Malone on twitter (inventor of mRNA vaccine technology and various mRNA vaccines) and try to keep up.
We did not refer your application to the Vaccines and Related Biological Products
Advisory Committee because our review of information submitted in your BLA, including
the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion.
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
Also from FDA approval letter see:
The review of this product was associated with the following National Clinical Trial
(NCT) numbers: NCT04368728 and NCT04380701.
Well here's the source: https://www.fda.gov/media/151710/download
Thank you!!!
"We [FDA] have determined that [normal reporting] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis... Therefore we have determined you are required to conduct the following studies... [lists several studies due 2024 and 2025]." (pg 6-8)
They then also list the pregnancy study at bottom of page 9.
Welcome.
source? this is a heck of a redpill to keep in my collection
What is the implication here? Do we assume the results must be submitted the the FDA for review before approval?
It's already approved on the condition that Pfizer submits in future the 13 safety studies mentioned in the pdf. This was already known long ago, follow Dr Malone on twitter (inventor of mRNA vaccine technology and various mRNA vaccines) and try to keep up.
the sarcasm is not helpful, useful or friendly
Would like to know where these dates and requirements come from, besides a random tweet.
the FDA, the link was on this page 1 hour before you asked for it
https://www.fda.gov/media/151710/download
TY!
Guess who are the test subjects for it to be this late.
https://www.fda.gov/media/151710/download
https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee
Also from FDA approval letter see:
https://clinicaltrials.gov/ct2/show/NCT04368728
https://clinicaltrials.gov/ct2/show/study/NCT04380701
They only have “approval” for 16 and up hence the studies required for under 16 and/or pregnant