The Food and Drug Administration (FDA) has revised the Emergency Use Authorizations (EUAs) of the bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 Vaccines to include use as a single booster dose at least 2 months following completion of primary or booster vaccination in younger age groups.
The Moderna and Pfizer bivalent boosters target two strains of COVID-19 – the original strain of the virus and the currently circulating omicron variants (BA.4 and BA.5). Individuals ages 5 years and older who have completed any FDA-approved or -authorized monovalent primary series (Pfizer, Moderna, Novavax or Johnson & Johnson) or previously received monovalent booster doses are eligible to receive one age-appropriate bivalent (Pfizer for those aged five years and up; or Moderna for those aged six years and up) COVID-19 booster.
“We are proud to have received authorization for our updated, bivalent COVID-19 booster for children and adolescents 6 to 17 years of age,” said Stéphane Bancel, Chief Executive Officer of Moderna. “With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings. We are grateful for the FDA for their thorough and timely review.”
Last month, mRNA-1273.222, which targets the BA.4/BA.5 subvariants of Omicron, received FDA EUA for adults over the age of 18. The pediatric and adolescent EUA application is based upon clinical trial booster data for Moderna’s original vaccine, Spikevax, which was administered to over a thousand participants in each cohort. In addition, the EUA application included pre-clinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying mRNA-1273.214, another Omicron-targeting bivalent booster vaccine developed by Moderna.
Scheduling an appointment is preferred and available starting today via the Walgreens app, 1-800-WALGREENS, or online at Walgreens.com/ScheduleVaccine. Walgreens offers convenient, neighborhood locations and appointments that fit family schedules, including evenings and weekends.