By IDSE News Staff

The FDA amended the emergency use authorizations of both the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a single booster dose in younger age groups, according to an FDA press release.

Based on previous analyses and data collected by the FDA, the Moderna vaccine is now authorized for administration at least two months after completion of primary or booster vaccination in children as young as 6 years of age, and the Pfizer-BioNTech vaccine can now be administered in children as young as 5 years old, following completion of primary or booster vaccination.

Both bivalent COVID-19 vaccines include a messenger RNA (mRNA) component of the original SARS-CoV-2 strain to provide an immune response that is broadly protective against COVID-19, as well as an mRNA component that is shared between the omicron variant lineages BA.4 and BA.5. The mRNA in these two vaccines is a specific part of genetic material that instructs cells to make the distinctive spike protein of the original virus strain and omicron variant lineages BA.4 and BA.5.

The omicron component in these vaccines should provide better protection against infection from the omicron variants, as BA.5 is now the dominant strain, according to the CDC.

While most children are back to in-person learning and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk for exposure to the virus that causes COVID-19, said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research at the FDA.

“Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” Dr. Marks added.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease,” he explained.

Dr. Marks encouraged parents to consider primary vaccination and an updated booster dose for children when eligible.

The CDC also expanded its recommended use of bivalent COVID-19 vaccines to include use in children aged 5 through 11 years. The CDC said the addition of the omicron BA.4 and BA.5 components to the current vaccine composition helps to restore waning protection from previous vaccination and targets recent, more transmissible and immune-evading omicron variants.

Based on press releases from the FDA and CDC.