USA – FDA expands bivalent COVID boosters to kids as young as 5

The US Food and Drug Administration (FDA) has updated the emergency use authorizations (EUA) for the bivalent Pfizer-BioNTech and Moderna COVID-19 boosters to expand their use to include children.

On 12 October, FDA announced that children as young as five are now eligible to receive Pfizer’s bivalent booster, while children as young as six may receive Moderna’s updated shot. The shots include a component of the original SARS-CoV-2 virus and a component of the Omicron BA.4 and BA.5 subvariants. The agency emphasized that while the bivalent vaccines were not studied in pediatric clinical trials, the decisions were based on data from clinical studies in adults to conclude the vaccines are safe and effective for children.

“For each of the bivalent COVID-19 vaccines authorized today, the FDA 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 BA.1,” FDA said. “The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages.”…