Pfizer to file for full FDA approval of its Covid vaccine this month despite that FDA requires nearly a year or longer to decide if a vaccine is safe for use in the general public

The process of getting a vaccine approved for use in the general public is extensive and rigorous and can take several years. In the United States, for example, all vaccines are regulated by the Food and Drug Administration (FDA). It is the job of the FDA to ensure that all vaccines are safe, effective, and have minimal side effects before they are approved for use in the general public.

On December 11, the FDA gave conditional approval to Pfizer’s COVID-19 vaccine for emergency use authorization (EUA). In the EUA approval letter addressed to Pfizer, the FDA said:

“This letter is in response to a request from Pfizer Inc. that the Food and Drug  Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 16 years of age and older, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3).”

The authorization grants conditional approval to Pfizer based on two months of data. It’s not the same as a Biologic License Application, which requires six months of data and secures full approval. According to the FDA, the EUA is not the same as a full approval

The FDA “also expects manufacturers who receive a EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval).” This approval usually takes the Food and Drug Administration nearly a year or longer to determine whether a drug is safe and effective for use in the general public.

Here is how Pfizer describes the EUA in its earnings report:

“BNT162b2 has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.”

However, less than five months after Pfizer received the EUA, Pfizer said Tuesday it plans to file for full U.S. approval of its Covid-19 vaccine with German drugmaker BioNTech at the end of this month. If the FDA signs off, the company will be able to market the shot directly to consumers.