Pfizer and BioNTech Apply for 2ND Booster EUA

Posted on March 17, 2022 by Kari Everson

This week, the makers of a COVID-19 vaccine applied with the Food and Drug Administration (FDA) for emergency use authorization (EUA) for a second booster dose.

Newly developed vaccines are studied for extended periods to learn if there is a need for boosters and, if so, how often a booster is needed. Because of this research, both Pfizer and Moderna filed for EUA for booster doses of their respective vaccines. Furthermore, Pfizer's continued study indicates older adults aged 65 and older would benefit from a second booster dose. 

Application for the EUA went to the FDA this week. This application will undergo the same process as the applications for the original 2-dose primary vaccine series and the first booster. The FDA will consider the evidence and determine whether to issue the authorization for another booster. If that happens, the Vaccine and other Related Biologicals Committee with review the data and the Centers for Disease Prevention and Control (CDC) will issue formal recommendations for considerations and administration of a second booster. 

LeadingAge Minnesota will continue to follow this process and provide updates on the progress of an EUA and any subsequent CDC recommendations.

Moderna also continues to study its vaccine, and its vaccine recipients may need a second booster in the future. However, Moderna has not yet filed an EUA for a second booster.

Scientists from both organizations are studying the possibility of modifying the vaccine for the fall of 2022. With endemic coronaviruses, it is usual for an annual booster, usually given in the fall, to offer protection from winter outbreaks.

Vaccine producers are also considering the development of a bivalent vaccine, which works to stimulate immune protection against two different strains of a virus. Vaccine manufacturers are contemplating adding vaccine against the Omicron variant to subsequent boosters. Studies are still ongoing.

For questions concerning positive healthcare workers and returning to work, please contact Kari Everson.