FDA delays approval of Moderna’s Covid-19 vaccine for teens
US drugmaker Moderna has confirmed that the Food and Drug Administration (FDA) has delayed granting emergency use authorization (EUA) for its Covid vaccine for adolescents aged 12 to 17 years at risk of myocarditis – heart disease. Inflammation of muscles.
The FDA needs more time to complete its evaluation and the review may not be completed until January 2022, the drugmaker said in a statement late Sunday.
“The FDA has notified the company to complete its evaluation of Moderna’s emergency use authorization request for the use of Moderna’s Covid-19 Vaccine (mRNA-1273) at a dose level of 100 in adolescents 12 to 17 years of age.” of age”, the statement said.
On Friday evening, the FDA informed Moderna that “the agency needs additional time to evaluate recent international analyzes of the risk of myocarditis after vaccination”, it added.
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 will delay filing a request for emergency use authorization for a smaller dose of the vaccine for young children aged six to 11 while the FDA completes its review.
Earlier in May, the drugmaker had said that its Covid vaccine was 100 percent effective in a study 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 Moderna Covid-19 Vaccine, particularly in young men and after a 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 over 1.5 million adolescents have received the Moderna 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.
FDA delays approval of Moderna’s Covid-19 vaccine for teens
FDA delays approval of Moderna’s Covid-19 vaccine for teens
US drugmaker Moderna has confirmed that the Food and Drug Administration (FDA) has delayed granting emergency use authorization (EUA) for its Covid vaccine for adolescents aged 12 to 17 years at risk of myocarditis – heart disease. Inflammation of muscles.
The FDA needs more time to complete its evaluation and the review may not be completed until January 2022, the drugmaker said in a statement late Sunday.
“The FDA has notified the company to complete its evaluation of Moderna’s emergency use authorization request for the use of Moderna’s Covid-19 Vaccine (mRNA-1273) at a dose level of 100 in adolescents 12 to 17 years of age.” of age”, the statement said.
On Friday evening, the FDA informed Moderna that “the agency needs additional time to evaluate recent international analyzes of the risk of myocarditis after vaccination”, it added.
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 will delay filing a request for emergency use authorization for a smaller dose of the vaccine for young children aged six to 11 while the FDA completes its review.
Earlier in May, the drugmaker had said that its Covid vaccine was 100 percent effective in a study 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 Moderna Covid-19 Vaccine, particularly in young men and after a 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 over 1.5 million adolescents have received the Moderna 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.
Read more: At G20, leaders pledge to boost supply of COVID-19 vaccines to developing countries
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