Moderna seeks approval for vaccine use in children under six

The vaccine could be the first shot approved for children under 5 in the U.S.



On Wednesday Moderna stated that it will be pursuing approval from regulators for its COVID-19 vaccine for use in children under the age of six. Clinical trial data showed that 25 micrograms of the vaccine given to the same age group elicited a similar immune response in adults administered 100 micrograms. The trial consisted of 11,700 participants in Canada and the United States (U.S), including 4,200 children aged two to six and 2,500 aged six to two months. The vaccine showed to be 37.5% effective in preventing a COVID-19 infection in children aged two to five years and 43.7% effective in children aged six months to under two years. Stephane Bancel, Moderna’s Chief Executive Office stated that the results "are good news for parents of children under six years of age."


Bancel said in a statement, "Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible.” The pharmaceutical company noted that the doses, which were spaced four weeks apart were well tolerated and the adverse events experienced were generally mild to moderate. The approval would mark Moderna’s vaccine as the first shot authorised for children aged five and under in the United States. Authorization requests will be submitted to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators. Dr. Jacqueline Miller, Moderna’s Senior Vice President, therapeutic area head noted that the company was "a couple of weeks away" from filing the authorisation request.