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Biotech company Moderna  (MRNA) – Get Moderna, Inc. Report may not get approval for emergency use of its COVID-19 vaccine for adolescents until next year after the Food and Drug Administration said it needs more time to assess its request.

Moderna said that the FDA on Friday evening informed it that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination before it can authorize emergency use of the vaccine at a 100 microgram dose for adolescents ages 12 through 17, according to a Sunday statement.

The FDA told Moderna that its review may not be completed before January, the company said.

Moderna said in the statement that the safety of vaccine recipients is of paramount importance to the company, and it is fully committed to working closely with the FDA to support its review. The company added that it is grateful to the FDA for its diligence.

TheStreet RecommendsINVESTINGModerna May Not Get Adolescent Vaccine Approval Before January11 seconds agoPRESS RELEASESNew Research For KEYTRUDA® (pembrolizumab) At Society For Melanoma Research (SMR) 2021 Congress Reinforces Merck’s Commitment To Patients With Melanoma Across Stages Of Disease1 hour agoPRESS RELEASESPrime Minister Concludes Successful G20 Leaders’ Summit In Italy1 hour agoThe Cambridge, Mass., biotech company estimates that over 1.5 million adolescents have received its COVID-19 vaccine, according to the statement. It said the observed rate of myocarditis reports in recipients under 18 years old in Moderna’s global safety database does not suggest an increased risk of myocarditis among the group. 

While Moderna said it is committed to conducting its own review of new external analyses as they become available, it does not yet have access to data from some recent international analyses.

Moderna said it will delay filing a request with the FDA for emergency use authorization of a 50 microgram dose level for children ages 6 through 11 while the agency completes the review of the adolescent request.

Shares of Moderna on Friday fell 0.06% to $345 in after-hours trading. The stock closed 0.8% lower in the regular session.