US biotech company Moderna said on Wednesday it would seek approval for its Covid vaccine in children aged six months to six years after trials showed its injections were safe and produced a strong response immune.
“Good news for parents”
Two doses of 25 micrograms given to children of this age produced antibody levels similar to the levels achieved by two doses of 100 micrograms 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.
The results “are good news for parents of children under six,” 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 six months to two years was 43.7%, and 37.5% in those aged two to six 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 brought together nearly 12,000 children
The trial involved 11,700 children in the United States and Canada, including 4,200 aged two to six years and 2,500 aged six months to two years. Moderna adds that after consultations with the FDA, it will also seek approval for two 50-microgram doses in children ages six to 11, and will update its request for approval in children ages 12 to 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.