2021-08-23
FDA Approves First COVID-19 Vaccine
"Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the
body to make a mimic of one of the proteins in the virus that causes COVID-19."
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from
approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have
evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of
Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people
who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19
disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four
months after the second dose. Overall, approximately 12,000 recipients have been followed for at least
6 months.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
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FDA Approves First COVID-19 Vaccine
"Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the
body to make a mimic of one of the proteins in the virus that causes COVID-19."
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from
approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have
evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of
Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people
who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19
disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four
months after the second dose. Overall, approximately 12,000 recipients have been followed for at least
6 months.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine