Today the United States Food and Drug Administration (FDA), the American government body that deals with the regulation of food and pharmaceutical products, has definitively approved the first vaccine against Covid-19. It is Pfizer-BioNTech that will now be marketed as Comirnaty, for the prevention of coronavirus in people aged 16 and over.
“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the approval of a vaccine by the FDA can now instill further confidence,” said FDA Commissioner Janet Woodcock. today’s milestone brings us closer to altering the course of this pandemic in the United States. “
As of December 11, 2020, the Pfizer-BioNTech vaccine has been available with the Emergency Use Authorization (EUA) in individuals aged 16 years and older, and the authorization has been expanded to include those aged 16 years or older. 12 and 15 years on May 10, 2021. The Emergency Use Authorization can be used by the FDA during public health emergencies to provide access to medical products that may be effective in the prevention, diagnosis or treatment of a disease.
The Pfizer-BioNTech vaccine will continue to be available under the Emergency Use Authorization (EUA) for individuals aged 12-15 years and for administration of a third dose in certain immunocompromised individuals.