Pfizer and BioNTech’s jointly developed Omicron BA.4/BA.5 bivalent COVID-19 booster, Comirnaty Original/Omicron BA.4/BA.5, has been recommended for conditional marketing authorisation (CMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) as a 10µg dose 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 authorised in the EU as a booster dose in individuals aged 12 years and older.
The CHMP’s recommendation is supported by safety and immunogenicity data from the Pfizer/BioNTech 30µg Omicron BA.1 adapted bivalent vaccine in individuals 12 years and older, as well as data from the initially approved 10µg paediatric formulation of the companies’ original COVID-19 vaccine.
Manufacturing data from the Pfizer/BioNTech paediatric formulation of the Omicron BA.4/BA.5-adapted bivalent vaccine and preclinical data from this same vaccine also support the recommendation.
Recent clinical data from an ongoing phase 2/3 trial demonstrated a booster dose of the Pfizer/BioNTech Omicron BA.4/BA.5-adapted bivalent vaccine in adults aged 18 years and older generated a strong immune response against the Omicron BA.4/BA.5 subvariants.
The companies also outlined in a statement that a phase 1/2/3 paediatric study is also currently ongoing to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.
Data from both these trials will be shared with regulatory authorities around the world as soon as they become available, the companies said.
The companies have already been granted Emergency Use Authorisation by the US Food and Drug Administration 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 companies said last month that the doses will be shipped immediately, pending recommendation from the Centers for Disease Control and Prevention.
At the time of the October announcement, similar regulatory applications for this age group around the world were already planned.