The Pfizer-BioNTech was approved on August 23, 2021 by the U.S. FDA for the prevention of COVID-19 for individuals 16 years of age and older and is now marketed as Comirnaty. The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
The U.S. Food and Drug Administration has also authorized the Moderna and Janssen (Johnson & Johnson) vaccines for Emergency Use Authorization.
Comic artist: MK Czerwiec, RN, MA
Developed resources reported in this Graphic Medicine project are supported by the National Library of Medicine (NLM), National Institutes of Health (NIH) under cooperative agreement number UG4LM012346. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Please consult your doctor with any questions or concerns you have regarding the COVID-19 Vaccines.
The U.S. Food and Drug Administration’s advisory committee met on December 10 to review the safety and efficacy of the first COVID-19 vaccine candidate for Emergency Use Authorization (EUA): Pfizer-BioNTech. Following an affirmative vote by the vaccine advisory panel, the FDA granted emergency authorization of the vaccine for people 16 and older. The vaccinations started being administered on December 14, 2020. On December 18, 2020, the FDA issued an emergency use authorization for the Moderna vaccine as well, for individuals 18 and older. On February 27, 2021, the FDA issued emergency use authorization for the Janssen COVID-19 Vaccine (of Johnson & Johnson) to be distributed for adults 18 and older. On May 10, 2021, the FDA issued authorization for Pfizer-BioNTech vaccinations to be administered to adolescents, aged 12-15.
Operation Warp Speed (OWS), an initiative of the Department of Health and Human Services (HHS), has a goal of producing and delivering 300 million doses of safe and effective vaccines, with initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
For more information on OWS, see the HHS Fact Sheet.