Digital Desk, Washington. US drugmaker Moderna has confirmed that the Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for its COVID vaccine for adolescents aged 12 to 17 years at risk of myocarditis (inflammation of the heart muscle). Delay in giving. The drugmaker said in a statement late Sunday that the FDA needs more time to complete its evaluation and the review may not be completed until January 2022.
The FDA has notified the company that Moderna’s Emergency Use Authorization request for the use of Moderna COVID-19 Vaccine (mRNA-1273) at a dosage level of 100 in adolescents aged 12 to 17 years has been issued, the statement said. Additional time will be required to complete your assessment of On Friday evening, the FDA informed Moderna that the agency needed additional time to evaluate recent international analyzes of the risk of myocarditis after vaccination.
Moderna said the company is fully committed to working closely with the FDA and will also carefully review its new external analyses. Moderna also said it would delay filing a request for emergency use authorization for a smaller dose of the vaccine for young children between the ages of six and 11 while the FDA has completed its review. Earlier in May, the drugmaker said that its COVID vaccine has been 100 percent effective in studies of 12 to 17-year-olds. The company then applied in June to expand emergency use of its vaccine to teens.
An increased risk of myocarditis has been described for COVID-19 vaccines, including the modern COVID-19 vaccine, particularly in young men and concerns have been raised about the risks after the second dose. The US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) state that myocarditis is rare and usually mild after vaccination with mRNA vaccines. It is estimated that more than 1.5 million adolescents have received the modern COVID-19 vaccine. The observed rates of myocarditis reported in Moderna’s global safety database in people younger than 18 years of age do not suggest an increased risk of myocarditis in this population.