The Food and Drug Administration (FDA) on Oct. 12 amended the emergency use authorizations of both the bivalent Moderna COVID-19 vaccine and the bivalent Pfizer-BioNTech COVID-19 vaccine, authorizing their use as a single booster dose in younger age groups. The bivalent formulations of the vaccines target not only the original SARS-CoV-2 variant, but also the current BA.4 and BA.5 subvariants, which are more transmissible and immune-evading.
The Moderna bivalent booster now is authorized for administration in children ages 6 and older, while the Pfizer-BioNTech booster now is authorized for children ages 5 and older. Both vaccines require at least two months between the primary vaccine series or last booster vaccination and the bivalent dose.
Following the FDA’s authorization, Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, signed a decision memo expanding the use of bivalent COVID-19 vaccines to children ages 5 through 11 years.
Additionally, Pfizer and BioNTech reported on Oct. 13 positive early data from a recent clinical trial, stating that a booster dose of their bivalent vaccine demonstrated a substantial increase in the BA.4 and BA.5 neutralizing antibody response above pre-booster levels in individuals 18 and older.
Cases caused by the BA.4 and BA.5 subvariants of SARS-CoV-2 make up nearly 80 percent of all current COVID-19 cases, and many health leaders fear cases will continue to rise with possible fall and winter surges.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” says Peter Marks, MD, PhD, director of the FDA’S Center for Biologics Evaluation and Research. “Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death.”
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.
