Pfizer and BioNTech have been granted Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children aged five to 11 years.
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein – present in the original Pfizer/BioNTech COVID-19 vaccine – together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. The booster has already been granted EUA by the FDA for ages 12 years and older.
The doses will be shipped immediately, pending recommendation from the Centers for Disease Control and Prevention (CDC), the companies outlined in a statement.
Albert Bourla, chairman and chief executive officer, Pfizer, 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 US.
“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.”
The authorisation is supported by safety and immunogenicity data from the Pfizer/BioNTech 30µg Omicron BA.1 adapted bivalent vaccine, as well as pre-clinical data which demonstrated a booster dose of the Pfizer/BioNTech Omicron BA.4/BA.5-adapted bivalent vaccine generated a ‘strong neutralising antibody response’ against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain.
“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 immunise against Omicron variants and subvariants,” said Professor Ugur Sahin, chief executive officer and co-founder of BioNTech.
The companies have also submitted an application to the European Medicines Agency (EMA) requesting a variation of the companies’ marketing authorisation in the EU to include a 10µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in this age group. Similar applications are also planned for submission with regulatory authorities around the world in the coming weeks, the companies said in a statement.