US drug maker Moderna said it will request the Food and Drug Administration (FDA) to grant emergency use authorization for its Covid-19 vaccine to inoculate children under 6 years of age.
The company will submit the request to the FDA, as well as the European Medicines Agency and other global regulators “in the coming weeks”, Xinhua news agency quoted Moderna as saying in a statement on Wednesday.
The submission was based on tests of its Covid-19 vaccine, known as mRNA-1273, in children aged 6 months to under 2 years, and 2 years to under 6 years.
The interim analysis showed a robust neutralising antibody response in both age groups after a 25 microgram two-dose primary series of mRNA-1273 along with a favourable safety profile, according to the company.
In the study, vaccine efficacy in children aged 6 months to 2 years was 43.7 per cent, and 37.5 per cent in the 2 to under 6 years age group, said Moderna.