FDA grants Emergency Use Authorisation of mRNA-1273 vaccine for children 6 months and older.
Moderna, Inc. announced that it has received emergency use authorization (EUA) from the FDA for its COVID-19 vaccine (mRNA-1273) in young children ages 6 months through 5 years of age at a dose level of 25 µg.
The company has also received emergency use authorization for a 50 ug two-dose regimen of mRNA-1273 for children ages 6 through 11 years old and a 100 ug two-dose regimen for adolescents aged 12 through 17 years old.
The two-dose regimens, with doses tailored for each age group given one month apart, are well-timed to initiate protection for the start of the school year, as children return to higher-risk classroom and daycare settings. mRNA-1273 for children and adolescents showed protection starting 14 days after the second dose. Protection was statistically significant, with data coming from large, well-controlled trials of more than 14,000 children and adolescents and a median follow-up of more than 2 months for 6 months through 5 years of age, 5.6 months for 6 through 11 years of age, and 11.1 months for adolescents.
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