FDA Grants Approval to First COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) on August 23 approved the Pfizer-BioNTech COVID-19 vaccine for people 16 years of age and older— the first approval of a vaccine for the pandemic virus.

This vaccine continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals, which may include patients with rheumatic and autoimmune diseases being treated with some types of immunosuppressive medication.

The FDA approved the vaccine through its Priority Review process, under which the agency’s goal is to take action on an application within 6 months rather than the usual 10-month timeline. Priority Review is granted when a drug is deemed to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.”

The agency stated, “To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.”

The Pfizer-BioNTech vaccine was shown to be 91% effective in preventing COVID-19 disease in the clinical trial, FDA stated.

Previously called the Pfizer-BioNTech COVID-19 Vaccine, the vaccine will now be marketed as Comirnaty.