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How did the FDA arrive at the decision to approve Comirnaty?

The vaccine was 95% reliable in avoiding COVID-19 illness amongst these scientific trial individuals with 8 COVID-19 cases in the vaccine group and 162 in the placebo group. The FDA carried out an extensive assessment of the post-authorization security monitoring information relating to myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 Vaccine and identified that the information show increased dangers, especially within the 7 days following the 2nd dosage. In general, in blinded and unblinded follow-up, roughly 12,000 Pfizer-BioNTech COVID-19 Vaccine receivers have actually been followed for at least 6 months.

How did the FDA arrive show up the decision choice approve Comirnaty (COVID-19 Vaccine mRNA)? The vaccine was 95% efficient in avoiding COVID-19 illness amongst these scientific trial individuals with 8 COVID-19 cases in the vaccine group and 162 in the placebo group. The FDA performed an extensive assessment of the post-authorization security monitoring information relating to myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 Vaccine and identified that the information show increased dangers, especially within the 7 days following the 2nd dosage. After issuance of the EUA, scientific trial

participants were unblinded in individuals phased manner over a period way months to duration the authorized Pfizer-BioNTech COVID-19 Vaccine licensed placebo participants. In general, in blinded and unblinded follow-up, roughly 12,000 Pfizer-BioNTech COVID-19 Vaccine receivers have actually been followed for at least 6 months.

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2 thoughts on “How did the FDA arrive at the decision to approve Comirnaty?”

  1. Pingback: The Largest Civil Fraud Settlement in History | Real News Cast

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