Moderna begins testing COVID-19 vaccine on children as young as six months
The study will assess the safety and effectiveness of two doses of mRNA-1273 given 28 days apart and intends to enroll about 6,750 children in the United States and Canada, says Moderna
Moderna Inc has begun dosing patients in a mid-to-late stage study of its COVID-19 vaccine, mRNA-1273, on children aged six months to less than 12 years, the company said on Tuesday.
"We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna.
The study will assess the safety and effectiveness of two doses of mRNA-1273 given 28 days apart and intends to enroll about 6,750 children in the United States and Canada.
Each child in Moderna’s study will receive two shots, 28 days apart. The study will have two parts. In the first, children aged 2 years to less than 12 may receive two doses of 50 or 100 micrograms each. Those under 2 years may receive two shots of 25, 50 or 100 micrograms.
In each group, the first children inoculated will receive the lowest doses and will be monitored for reactions before later participants are given higher doses. An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination.
The vaccine has already been authorized for emergency use in Americans who are aged 18 and older.
In a separate study which began in December, Moderna is also testing mRNA-1273 in adolescents between 12 and 18 years old.
The latest study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority.
The bulk of the U.S. Covid-19 vaccination campaign so far has focused on protecting adults, who are at higher risk of severe disease caused by the coronavirus than children. Moderna’s and Johnson & Johnson’s vaccines are authorized for use in adults 18 and older, while the vaccine from Pfizer Inc. and BioNTech SE is cleared for use in people 16 and older.
Efforts have begun to test the Covid-19 vaccines in children, who can still become infected, both to protect them from the virus and further build the population-level immunity to move past pandemic restrictions.
Federal health officials have suggested that if studies are positive, junior-high and senior-high students could get access to vaccines in the fall, followed by children of elementary-school age in early 2022.
Both Pfizer and Moderna last year started clinical trials testing their vaccines in adolescents aged 12 years and older. Both trials have fully enrolled subjects and the results are pending. J&J is planning to start pediatric testing of its vaccine.
With agency inputs
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First Published:16 Mar 2021, 06:27 PM IST
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