On Monday, Aug. 23, 2021, the Food and Drug Administration (FDA) gave full approval to the Pfizer-BioNTech coronavirus vaccine, now known as Comirnaty.

It is the first full approval of any coronavirus vaccine in the United States. The other vaccines, Moderna and Johnson & Johnson, are still available under emergency use authorization (EUA) granted by the FDA. The Moderna vaccine is currently under review for full approval, and the Johnson & Johnson vaccine is expected to begin the process soon.

The Pfizer-BioNTech vaccine is fully approved for individuals aged 16 and older. The vaccine also continues to be available under the EUA for children ages 12 to 15 and for the administration of a third dose in certain immunocompromised individuals.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

– Dr. Janet Woodcock, the acting FDA commissioner

The approval comes as the coronavirus Delta variant continues to spread across the United States. Federal and state governments have been issuing renewed guidance as a way to rein in the infections, including implementing stringent mask-wearing requirements.

What’s Next?

Authorizing the Pfizer-BioNTech vaccine is expected to open the floodgates for employers considering their own vaccine requirements. Many colleges, hospitals, corporations and even the federal government have announced tentative plans to require proof of vaccination as a condition of employment. United Airlines, for example, recently announced they will require vaccine proof among their employees. Other businesses are using vaccine cards to verify whether patrons need to wear face masks.

It is unclear how many organizations will require vaccination among employees in the near future, but employers should continue to monitor the situation as it evolves. 

If you’re interested in implementing a mandatory vaccination program, contact your Valent consultant to discuss considerations.


Information abstracted from Zywave’s “News Brief: Pfizer-BioNTech Vaccine Fully Approved by FDA” article. 

This blog and its contents are not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel for legal advice.