Approval of Moderna Teen Vaccines in the United States has been delayed.
Moderna, a biotech company based in the United States, announced on Sunday that the Covid-19 vaccine for teenagers has been delayed in order to properly examine the risk of getting myocarditis, or cardiac inflammation.
The US Food and Drug Administration (FDA) “advised Moderna on Friday that the agency required extra time to study recent international evaluations of the risk of myocarditis after vaccination,” according to a statement released by the biotech company on Sunday.
The firm stated that the decision on whether or not to recommend Moderna’s vaccination for 12- to 17-year-olds might take until January 2022.
Myocarditis and pericarditis (inflammation surrounding the heart) have previously been related to the Pfizer and Moderna Covid-19 vaccines, especially in adolescent boys and young men.
According to a research published in August by the US Centers for Disease Control and Prevention, the risk of infection with Covid-19 is much higher (CDC).
“Myocarditis following vaccination with mRNA vaccines has been rare and generally moderate,” according to the CDC, according to Moderna.
Pfizer-mRNA BioNTech’s Covid-19 vaccination was approved in the United States on Friday for children aged five to eleven, in lower dosages than for adults.
Moderna previously stated that it will wait for the FDA to decide whether or not to approve its vaccine for adolescents under the age of 18 before applying for approval for smaller age groups.