The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the use of Moderna’s Omicron BA.1 targeting bivalent booster – mRNA-1273.214 – in children aged six to 11 years.
The CHMP, which issued a positive opinion for use of the booster in individuals aged 12 years and older earlier this year, recommends that mRNA-1273.214 be administered to children at least three months after the last prior dose of a COVID-19 vaccine.
Its latest decision was supported by the data based on clinical studies, which evaluated a booster dose of the company’s original Spikevax vaccine in participants aged six to 11 years who already had completed a primary series of the Moderna COVID-19 vaccine.
The company’s paediatric application also included clinical trial data from a phase 2/3 trial in which the BA.1 booster met all primary endpoints, including superior neutralising antibody response against Omicron when compared to a dose of the company’s BA.4/BA.5 prototype vaccine – mRNA-1273 – in previously uninfected participants.
A phase 2/3 trial evaluating mRNA-1273.214 as booster and primary series in children aged six months to five years is also currently underway, with initial results expected in early 2023.
Stéphane Bancel, chief executive officer of Moderna, said: “The recommendation to authorise the use of a booster dose of mRNA-1273.214 in children ages six to 11 is crucial to providing protection against Omicron and the emergence of new variants of concern, which is especially important during the winter period in Europe when respiratory diseases are on the rise.
“We are grateful to the CHMP for its review of our submission and look forward to an authorisation decision from the European Commission.”
In July, the company announced the advancement of two bivalent candidates: mRNA-1273.222 to target the BA.4/BA.5 Omicron strain, and mRNA-1273.214 to target BA.1.
Earlier this month, the EMA’s emergency task force concluded that adapted mRNA bivalent COVID-19 vaccines targeting the original strain and the BA.4/BA.5 subvariants may be used for primary vaccination in children and adults.
Two adapted bivalent vaccines targeting BA.4/BA.5 subvariants and the original strain of SARS-CoV-2 are currently authorised for use in the EU as booster doses.
This includes Moderna’s BA.4/BA.5 vaccine, approved as a booster for adults and adolescents, as well as Pfizer and BioNTech’s jointly developed BA.4/BA.5 bivalent COVID-19 vaccine, recently approved by the EMA for booster doses in children and adults.