FDA Grants Full Approval to First COVID-19 Vaccine

On August 23, 2021, the US Food and Drug Administration (FDA) granted full authorization to the first vaccine against COVID-19 – the Pfizer-BioNTech COVID-19 Vaccine. According to an FDA News Release, the vaccine will now be marketed as Comirnaty, “for the prevention of COVID-19 disease in individuals 16 years of age and older.” The vaccine also 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.

Comirnaty contains messenger RNA (mRNA), a type of genetic material that is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.

To help dental practice owners navigate the COVID-19 vaccination requirements, in early August 2021, the American Dental Association (ADA) published FAQs for dental offices on the COVID-19 vaccine. The FAQs are geared towards dental practice owners, providing information on accommodating employees with disabilities and religious beliefs, proof of vaccination status, and employee refusal of the vaccine.

Since 1992, OSHA Review, Inc. has provided dental professionals with comprehensive programs to support regulatory compliance and infection control. We are a registered continuing education provider in the state of California, specializing in Dental Practice Act, infection control, and OSHA training.