FDA Authorizes mRNA Bivalent Boosters for Younger Pediatric Groups

The federal agency announced today it had authorized both mRNA vaccines for younger children. In the statement released, the FDA said the Moderna bivalent booster vaccine could be given to children as young as six years and that the Pfizer-BioNTech vaccine could be given to kids as young as five years old.
 
“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. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

The FDA said it relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA1.

The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA4 and BA5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.

With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine continue to be authorized for primary series administration in individuals six months of age and older.