Moderna wants to continue expanding vaccination in the face of the pandemic. The American biotechnology company indicated on Wednesday its willingness to seek approval for its vaccine against Covid-19 in children aged 6 months to 6 years. It is based on the following results: two doses of 25 µg given to children of this age generated antibody levels similar to the levels reached by two doses of 100 µg in young people aged 18 to 25.
Based on this data, Moderna said it would submit applications for authorization to the United States Medicines Agency (FDA), the European Medicines Agency (EMA) and other regulators. in the coming weeks.
Rather low effectiveness against infections
The results “are good news for parents of children under 6,” Moderna CEO Stephane Bancel said in a statement. “We now have clinical data on the performance of our vaccine in children six months old through older adults. Moderna, however, found relatively low efficacy of the vaccine against infections, as its trials were held during the wave of the Omicron variant. The effectiveness of the vaccine in children aged 6 months to 2 years was 43.7%, and 37.5% in those aged 2 to 6 years.
Moderna, which states that these levels are similar to those seen in adults, is evaluating a third dose to raise these levels. The trial involved 11,700 children in the United States and Canada, including 4,200 aged 2 to 6 years and 2,500 aged six months to 2 years.
Pfizer waiting
Moderna adds that after consultations with the FDA, it will also seek approval for two 50 mcg doses in children ages 6-11, and will update its request for approval in children ages 12-12. 17 years. The EMA and other regulators have already authorized Moderna’s vaccine in these groups.
Last month, the FDA postponed its deliberations on licensing Pfizer-BioNTech’s vaccine for children under five, saying it needed additional data on third doses. The companies said they expect the data to be ready by April.