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Moderna said it has requested priority review from the FDA. The company began submitting data for its Biologics License Application, or BLA, to the FDA in June.
US health official recently announced the government planned to make booster doses available to fully vaccinated individuals eight months after receiving their second dose of an mRNA COVID-19 vaccine. They said booster doses would start the week of September 20, pending sign-off from the FDA and US Centers for Disease Control and Prevention.
originally posted by: HawkEyi
a reply to: bobs_uruncle
I am impressed how Pfizer managed to get go at it without providing full samples, the pushbacks in the coming months should be interesting.
originally posted by: bobs_uruncle
a reply to: HawkEyi
In order to get FDA approval, they have to provide samples of the "vax" for analysis, list ALL the ingredients and demonstrate safety in the form of a lack of adverse effects including death. This should go over real well lol.
ETA: I forgot to add, they only have 14 days by law to comply.
Cheers - Dave
Moderna Inc will soon start testing its COVID-19 vaccine on pregnant women.
The Cambridge, Massachusetts-based company announced the trial on Monday, and it expected to begin on July 22.
originally posted by: chr0naut
originally posted by: bobs_uruncle
a reply to: HawkEyi
In order to get FDA approval, they have to provide samples of the "vax" for analysis, list ALL the ingredients and demonstrate safety in the form of a lack of adverse effects including death. This should go over real well lol.
ETA: I forgot to add, they only have 14 days by law to comply.
Cheers - Dave
I would have thought that Pfizer have already provided billions of samples, and that any health or certification authority are at liberty to take an actual sample that is in use and to analyze it 'six ways to Sunday'.
Also, they publish the content of the Pfizer vaccine online. This is from New Zealands' Medsafe Medicines and Medical Devices Safety Authority:
COMIRNATY™ COVID-19 VACCINE Consumer Medicine Information (CMI) summary