The US Food and Drug Administration (FDA) has authorised the use of the bivalent Covid-19 vaccines of Moderna and Pfizer-BioNTech for use as a single booster dose in younger age groups.
Moderna received Emergency Use Authorization (EUA) from the FDA for mRNA-1273.222, its BA.4/BA.5 Omicron-targeting bivalent Covid-19 booster vaccine, for its use in children and adolescents, six to 17 years of age.
Moderna said that the authorisation is based on booster doses of 25 μg for children aged six to 11 and 50 μg for teenagers aged 12 to 17, administered after the completion of any authorised Covid-19 vaccines or after receiving a prior booster.
Moderna CEO Stéphane Bancel said: “We are proud to have received authorisation for our updated, bivalent Covid-19 booster for children and adolescents 6 to 17 years of age.
“With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings.”
Pfizer and BioNTech received EUA for a 10-µg booster dose of their jointly developed Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children, aged five through 11 years of age.
According to Pfizer, the 30-µg Omicron BA.1-adapted bivalent vaccine, the 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, as well as pre-clinical data from the 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine, all supported the bivalent Covid-19 vaccine’s authorisation for children aged five to 11 years old.
Pfizer said that clinical results from a phase 2/3 study showed that a booster dose of the 30-µg Omicron BA.1-adapted bivalent vaccination evoked a better immune response against the Omicron BA.1 subvariant compared to its original Covid-19 vaccine.
Additionally, pre-clinical data demonstrated a booster dose of the bivalent vaccine giving a strong neutralising antibody response against the Omicron BA.1, BA.2, BA.4, and BA.5 subvariants, as well as the original virus, Pfizer added.
Pfizer chairman and CEO Albert Bourla said: “As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.
“Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”
