The US-based firm sought a variation to the CMA from the European Medicines Agency (EMA) to assess a 25µg two-dose series of its Covid-19 vaccine in children aged six months to below six years
The company is seeking the same authorisations from several other regulatory agencies. (Credit: mufidpwt from Pixabay)
Moderna has applied to expand conditional marketing authorisation (CMA) for its Covid-19 vaccine, Spikevax (mRNA-1273), to include children aged six months to below six years in the European Union.
The US-based firm sought a variation to the CMA from the European Medicines Agency (EMA) to assess a 25µg two-dose series of its Covid-19 vaccine.
At present, the biotechnology company is seeking the same authorisations from several other regulatory agencies and is based on a 25μg initial vaccine regimen of the vaccine.
As per the positive interim data from the Phase II/III KidCOVE clinical trial, the vaccine showed a strong neutralising antibody response in subjects aged six months to below six years following the initial vaccine regimen and a favourable safety profile.
Also, the antibody titers in the pre-specified six months to 23 months and two years to under six years age sub-groups matched the statistical requirements for resemblance to the adults in the COVE Study, meeting the trial’s primary objective.
Moderna said the initial efficacy evaluation on cases mostly gathered during the Omicron wave showed vaccine efficacy was 51% for individuals aged six months to less than two years and 37% for children aged two years to below six years.
The tolerability profile was consistent with those seen in individuals aged six years and above.
Previously, the vaccine secured CMA from the European Commission (EC) following a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use. It is intended for active immunisation to prevent Covid-19 in people aged six years and above.
Additionally, a booster dose is indicated for use in people aged 18 years and above for a minimum of three months after the second dose.
Moderna CEO Stéphane Bancel said: “We are proud to announce this filing for the use of our Covid-19 vaccine in children six months to under six years of age in the European Union.
“We believe our vaccine will be able to safely protect this important age group against SARS-CoV-2, which is vital in our continued fight against Covid-19 and will be particularly welcomed by the parents and caregivers of these children.”
At present, the company is assessing booster vaccine doses for all paediatric patients.
Last month, Moderna and Rovi Pharma recalled a batch of 764,900 doses of Spikevax.