On August 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine for individuals older than 16, making it the first COVID-19 vaccine to receive full FDA approval. It will now be marketed as “Comirnaty” alongside other approved vaccines and drugs. While Pfizer and other COVID-19 manufacturers have met the FDA’s standards for Emergency Use Authorization (EUA), full FDA approval means the vaccine has undergone the agency’s standard process for reviewing its quality, safety and effectiveness. 

The FDA issues EUAs during public health emergencies to provide access to medical products, such as vaccines, that are effective at preventing or treating a disease. Both Pfizer and Moderna were issued an EUA in December 2020, while Johnson & Johnson received one in February 2021. Additionally, as the FDA receives more data, it can amend its EUAs, just as it did in extending the Pfizer EUA to include children aged 12-15 and authorizing an additional dose of the Pfizer and Moderna vaccines for certain immunocompromised individuals.

Children between the ages of 12 and 15 are eligible to receive the Pfizer vaccine under an EUA while children under 12 are still ineligible to receive any COVID-19 vaccine. Additional research and clinical trials for children under 12 are ongoing, with early estimates for an EUA to be announced late this fall or early winter. Although Pfizer is the currently the only COVID-19 vaccine manufacturer to receive full approval, Moderna completed their application on August 25 for its vaccine while Johnson & Johnson announced its plan to submit later this year. Vaccine clinics will still administer both the Moderna and Johnson & Johnson vaccine to individuals older than 16, as both manufacturers received an EUA earlier this year.

Following the FDA’s full approval of the Pfizer COVID-19 vaccine, President Biden called on companies to require employees be vaccinated. While many universities and private organizations had already announced vaccine requirements for in-person attendance, several more private and public organizations, as well as some local governments, announced new mandates after Pfizer received full FDA approval.

Full FDA approval may lead to an increase of COVID-19 vaccinations in eligible individuals, an effort that is often spearheaded by local health departments. Counties have been on the front lines of our nation’s response to the coronavirus pandemic and play an essential role in administering COVID-19 vaccines. As of June 29, counties have assisted in the administration of more than 325 million COVID-19 vaccine doses.

Additional Resources

• NACo Brief: The County Role in Vaccines
• FDA Report: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
• CDC Report: Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitals Among Adults