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The US Food and Drug Administration (FDA) has put Moderna’s Emergency Use Authorisation (EUA) request for its COVID-19 vaccine (mRNA-1273) for the adolescents on hold, as it needs more time to review and complete its assessment about the safety and efficacy of the jab for 12 to 17 years old. In an official release, Moderna said, “FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination.” It added that the FDA has notified the pharmaceutical firm that the review related to minute risks of an adverse event may not be completed before January 2022. The announcement comes as earlier yesterday, the Food and Drug administration authorised the use of Pfizer-BioNTech’s COVID-19 vaccine for children ages 5 to 11.
“The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence,” Moderna said on 31 October release.
An increased risk of myocarditis among the younger population has been reported for COVID-19 vaccines, including the Moderna COVID-19 vaccine. These instances have been occurring particularly in young men following the second shot of the mRNA vaccine. Although the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have agreed that the myocarditis cases following inoculation with mRNA vaccines have been “rare and generally mild", the company informed on Sunday.
It is estimated that over 1.5 million adolescents have received the Moderna COVID-19 vaccine thus far, and 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,” the company said in a press release. “Moderna will delay filing a request for EUA of mRNA-1273 at the 50 µg dose level in the pediatric population (6-11 years of age) while the FDA completes its review of the adolescent EUA request,” said the pharmaceutical firm, adding that the firm will conduct its own “careful review of new external analyses” once they are made available.
US CDC’s Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical Work Group (VaST) was first alerted about the cases of myocarditis from the mRNA vaccine several months ago. The health agency stated that myocarditis was a rare but serious inflammation of the heart which was being reported in adolescents and young adults mostly after the Pfizer-BioNTech or Moderna jab. The US has been monitoring the VAERS and the VSD for cases of myocarditis which it said occurred more in males than females.