www.fdanews.com/articles/208279-moderna-making-plans-to-study-covid-19-vaccine-in-babies-three-to-six-months-old
Moderna Making Plans to Study COVID-19 Vaccine in Babies Three to Six Months Old
June 17, 2022
Moderna is planning a study designed to identify the appropriate dose of COVID-19 vaccine for babies between three months and six months old.
Moderna’s COVID-19 vaccine Spikevax is currently FDA-approved for adults 18 years and older. However, the FDA’s Vaccines and Related Biological Products Advisory Committee has voted to recommend Emergency Use Authorization of the vaccine in children between six months and 17 years old.
Enrollment for the infant study is set to begin in September, with as many as 700 participants expected, the company said.