Moderna says childhood Covid-19 vaccine trial is successful

The American biotechnology company Moderna said on Wednesday (23) that it will apply for approval of its vaccine against Covid-19 in children aged six months to five years after trials proved it is safe and generates a strong immune response. .

Two doses of 25 micrograms given to children in this age group produced antibody levels similar to those achieved by two doses of 100 micrograms in young people aged 18 to 25 years.

Based on this data, Moderna said that in the coming weeks it will submit authorization applications to the US Medicines Agency (FDA), the European Medicines Agency (EMA) and other regulatory bodies.

The results “are good news for parents of children under the age of six,” Moderna CEO Stephane Bancel said in a statement. “We now have clinical data on the yield of our vaccine in children from six months to older adults.”

The company, however, reported relatively low efficacy of the vaccine, relative to cases in its trials, which were done during the wave of the omicron variant.

The effectiveness of the vaccine in children aged six months to two years was 43.7% and 37.5% in children aged two to five years.

Moderna, which says these levels are similar to those seen in adults, is considering a third dose to increase them.

The trial involved 11,700 children in the United States and Canada, 4,200 of them aged between two and six years and 2,500 between six months and two years.

Moderna added that, after consultations with the FDA, it will also seek approval for two 50-microgram doses in children ages six to 11 and update its authorization application for teens ages 12 to 17.

The EMA and other regulators have already authorized Moderna’s vaccine in these groups.

Last month, the FDA postponed its debates over licensing the Pfizer-BioNTech under-five vaccine, arguing that it needed additional data on the third dose. The companies said they expect this data to be ready by April.