To continue fighting the COVID-19 omicron variant, the U.S. Food and Drug Administration has amended an Emergency Use Authorization for bivalent COVID-19 vaccine for booster doses to include children starting at five years of age. The bivalent boosters are authorized for administration at least two months following completion of primary or booster vaccination in adults and children over the age of five years.
The bivalent vaccines contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant. The Moderna COVID-19 Vaccine, Bivalent is now authorized for use as a single booster dose in individuals 6 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use as a single booster dose in individuals 5 years of age and older. With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as a booster dose for individuals 5 to 11 years of age.
The authorization of the Moderna COVID-19 Vaccine, Bivalent was based on a previous analysis of immune response and safety data from a clinical study in adults 18 years of age and older who received a booster dose of Moderna’s investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1. Booster effectiveness was also based on data from studies evaluating individuals 6 to 17 years of age who received a single booster dose of the monovalent Moderna COVID-19 Vaccine. The safety of the booster dose of the monovalent Moderna COVID-19 Vaccine was evaluated in approximately 2600 pediatric participants 6 to 17 years old.
“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.,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “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.”
“This milestone is important to be able to provide access to variant-adapted vaccines to a broader population,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In addition, we have started a clinical trial to evaluate the adapted vaccine based on the BA.4 and BA.5 subvariants in children six months through 11 years of age aiming to offer all age groups the opportunity to immunize against Omicron variants and subvariants.”
What can you do to get a booster appointment? You have several options:
1. Book an appointment through your medical provider
2. Go to your county’s vaccination site
3. Book an appointment through CVS website
4. Book an appointment through your local pharmacies
