US authorities officially approve Pfizer BioNTech COVID-19 vaccine, the first new coronavirus vaccine

The US Food and Drug Administration (FDA) has officially approved the new Coronavirus Infection (COVID-19) vaccine from Pfizer BioNTech, which was approved for emergency use on December 11, 2020. This is the first time the COVID-19 vaccine has been officially approved by the FDA and will be marketed under the name 'Cominati' in the future.

FDA Approves First COVID-19 Vaccine | FDA

Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full US FDA Approval for Individuals 16 Years and Older | pfpfizeruscom
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full

'Cominati' is a vaccine containing messenger RNA (mRNA) and received an emergency use authorization from the UK pharmaceutical and medical product regulatory authority on December 2, 2020. On December 11th, we obtained an emergency use authorization from the FDA .

The FDA's approval review analyzed efficacy data from approximately 22,000 subjects who did not have a viral infection within a week of receiving the second vaccine and 22,000 who received placebo. .. The effectiveness of COVID-19 prophylaxis has been shown to be 91%.

The official approval is for vaccinations for people aged 16 and over, and vaccinations for people aged 12 to 15 will continue to be operated under an emergency use authorization.