The US regulator looked at 10 times more data on the BioNTech / Pfizer vaccine than in an emergency procedure at the end of 2020. The decision could lead to mandatory vaccination in a number of areas.
BioNTech / Pfizer vaccine
The Comirnaty vaccine, developed by the German company BioNTech and the American corporation Pfizer, is the first of its kind to receive final approval in the United States. On Monday, August 23, the Food and Drug Administration (FDA) announced its decision to fully approve the vaccine for people over 16 years of age. This is the first COVID-19 pneumonia vaccine to be finalized in the United States.
Today, FDA approved the first COVID-19 vaccine for the prevention of # COVID19 disease in individuals 16 years of age and older. https://t.co/iOqsxXV1fj
– US FDA (@US_FDA) August 23, 2021
The US department called the decision a “landmark event” in the fight against the pandemic. For the final certification of the drug, the agency needed to study about 10 times more data than the fast-track procedure for emergency use. In particular, we are talking about information obtained during the mass vaccination in the United States over the past months.
The final certification of a vaccine may be followed by a mandatory vaccination
According to many experts, the final certification of the coronavirus vaccine will entail decisions on mandatory vaccination in a number of institutions, in particular in medical institutions, universities and city administrations. In addition, they hope for a new shift in the mass vaccination campaign, writes dpa.
The BioNTech / Pfizer vaccine will continue to be available for adolescents 12-15 years old under an emergency authorization. In addition, the authorization to use the third dose of the drug for immunocompromised patients will continue to be valid.
An mRNA vaccine developed by a German company in Mainz was approved by the FDA in December 2020 as part of an emergency procedure. In addition, vaccines from the Moderna and Johnson & Johnson concerns later received a similar permit in the United States.
See also:
British scientist calls herd immunity from COVID-19 impossible
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