Breaking: FDA Amends EUA to Expand COVID-19 Vaccine Booster Eligibility

The EUA amendment was granted for both the Pfizer-BioNTech and Moderna vaccines.

All American adults who have previously been fully vaccinated against COVID-19 are now eligible to receive a COVID-19 booster shot following an amendment to prior emergency use authorizations (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines. 

“The FDA has determined that currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” he added.

All adults who received a full 2-dose series of either the Pfizer-BioNTech or Moderna COVID-19 vaccine are eligible to receive a booster 6 months after their primary vaccination series. Adults who received the single-dose Janssen COVID-19 vaccine are eligible for a booster 2 months after their primary vaccine was administered. 

Immune response data from both Moderna and Pfizer-BioNTech were evaluated prior to amending the EUA. Both datasets showed antibody responses against SARS-CoV-2 in small groups of participants who received a third shot. 

Both companies are conducting postauthorization and postmarketing studies to evaluate known serious risks of myocarditis and pericarditis. 

Reference

1. Coronavirus (COVID-19) Update: FDA expands eligibility for COVID-19 vaccine boosters. News Release. FDA. November 19, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-covid-19-vaccine-boosters