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The U.S. Food and Drug Administration will need more time to decide whether to approve Moderna’s COVID-19 vaccine for use in children ages 12 to 17, the company said. Announced Sunday.
The extended timeline is because the FDA can look at reports of rare side effects – myocarditis, or myocardial infarction – in shot takers. The FDA notified the company of the delay on Friday, Moderna said.
“The safety of vaccine recipients is of paramount importance to Moderna. The company is fully committed to working with the FDA to support their review,” Moderna said in a statement. Moderna said in a statement.
The company said the review of Moderna’s request for the government’s emergency use of the corona virus vaccine in adolescents could not be completed before January. Moderna requested FDA permission for use in adolescents. In june.
According to Moderna, the FDA is reviewing “recent international analyzes” of possible side effects.
A recent unpublished study by the Swedish Public Health Agency found a slight increase in the risk of heart muscle inflammation and Indicated Four countries stop giving shots to young men and boys. The company’s vaccine had already been given. Approved For use in children ages 12 and 17 by the European Medicines Agency.
Moderna said he does not yet have access to recent international analysis. The company estimates that more than 1.5 million young people have been vaccinated and says the risk of myocarditis is not higher than under 18 years of age.
Both the Modern and Pfizer-BioNTech COVID-19 vaccines have been shown to produce myocarditis as a rare side effect. However, viral infections, including COVID-19, can also cause myocarditis. Most children and adolescents who experience myocarditis recover.
The FDA recently Authorized Pfizer-BioNTech’s COVID-19 vaccine is used on an emergency basis in children aged 5 to 11 years. The benefits of protecting children from COVID-19 far outweigh the potential increased risk of rare side effects, experts from the advisory panel said.
Moderna has. Already granted Emergency use of the COVID-19 vaccine in adults.
The company said Sunday it would delay applying for emergency clearance for the vaccine for children aged 6 to 11 until the FDA completes its current review.