On Oct. 31, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had notified the Company that additional time was required to complete its assessment of Modernaﾒs Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 ﾵg dose level in adolescents 12 to 17 years of age.

An increased risk of myocarditis had been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose. It was estimated that over 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population.