said on Sunday that the regulatory approval of Covid-19 for use in adolescents aged 12 to 17 could be delayed until January, after the Food and Drug Administration said it needed additional time to assess the data.
The Cambridge-based pharmaceutical manufacturer, Mass., Also said it would delay filing an application for emergency approval of a half-dose vaccine for children ages 6 to 11. while the FDA completes its review for adolescents.
In a Sunday press release, Moderna (tag: MRNA) said the FDA informed her on Friday night that she needed time to assess international analyzes of the risk of rare heart inflammation after the vaccine.
Moderna has asked the agency for permission to use in an emergency for its mRNA vaccine in children aged 12 to 17 years. The news comes from the FDA approved the vaccine from
(BNTX) for children aged 5 to 11 years.
The Centers for Disease Control and Prevention is expected to discuss Pfizer’s application for this lower age group on Tuesday.
The FDA told Modern that its additional review may not be completed before January 2022, the company said in a statement. Moderna said security is “of paramount importance” and that she is “completely committed” to working with the FDA.
Moderna shares have risen 230 percent this year. The S&P 500 index has risen 22% to date.
Moderna said the increased risk of myocarditis or heart inflammation is attributed to Covid-19, including Moderna, especially in young men and after the second dose. He added that the CDC and the World Health Organization said the cases were rare and generally mild.
It is estimated that 1.5 million adolescents received the Moderna Covid vaccine. The company said the observed rate of myocarditis in those under 18 years of age does not indicate an increased risk in this age group.
Modern published data last week that his vaccine elicited a strong antibody response in young children.
Write to Liz Moyer at [email protected]