FDA Delays Decision on Moderna COVID Vaccine for Younger Teens

By Robert Preidt and Robin Foster

HealthDay Reporter

MONDAY, Nov. 1, 2021 (HealthDay News) — The U.S. Food and Drug Administration has delayed a call on whether or not to approve emergency use of Moderna’s COVID-19 vaccine in 12- to 17-year-olds till not less than January, the corporate introduced Sunday.

That’s as a result of the company informed the corporate on Friday that it wants extra time to evaluate rising worldwide information on whether or not the vaccine will increase the chance of a uncommon coronary heart facet impact referred to as myocarditis, Moderna mentioned in an announcement.

“On Friday night, the FDA knowledgeable Moderna that the company requires extra time to guage current worldwide analyses of the chance of myocarditis after vaccination. The FDA notified Moderna that this assessment is probably not accomplished earlier than January 2022,” the corporate mentioned. “The security of vaccine recipients is of paramount significance to Moderna. The firm is absolutely dedicated to working carefully with the FDA to assist their assessment and is grateful to the FDA for his or her diligence.”

Myocarditis is an irritation of the center muscle that happens in uncommon circumstances after vaccination, usually after the second shot and notably in younger males.

Several nations have raised issues that the Moderna vaccine will increase the chance of myocarditis in males aged 18-30, and officers in Finland and Sweden have advisable in opposition to the usage of Moderna for males youthful than 30, the Washington Post reported.

But Moderna mentioned Sunday that the “U.S. Centers for Disease Control and Prevention [CDC] and the World Health Organization [WHO] have acknowledged that myocarditis following vaccination with mRNA vaccines has been uncommon and usually gentle.”

“It is estimated that over 1.5 million adolescents have acquired the Moderna COVID-19 vaccine. To date, the noticed fee of myocarditis stories in these lower than 18 years of age in Moderna’s international security database doesn’t recommend an elevated threat of myocarditis on this inhabitants,” the corporate assertion added. “The firm doesn’t but have entry to information from some current worldwide analyses.”

The Moderna vaccine is allowed within the United States for individuals 18 and older, and the corporate requested the FDA in June to authorize it for adolescents.

Continued

On Sunday, the corporate additionally mentioned it would delay searching for FDA authorization of its vaccine for youngsters ages 6-11.

Moderna’s most important competitor, Pfizer, has fared higher with its FDA approvals.

In May, the FDA licensed the emergency use of the Pfizer vaccine for adolescents aged 12 to fifteen. And on Friday, the company cleared the vaccine for youngsters aged 5 to 11, administered in two doses of 10 micrograms every. That dose is one-third of the adolescent and grownup dose. The Pfizer vaccine is anticipated to be accessible for youthful youngsters later this week, following a assessment by CDC vaccine advisors and a possible suggestion for approval from CDC Director Rochelle Walensky.

More info

Visit the U.S. Food and Drug Administration for extra on COVID vaccines.

SOURCE: Washington Post

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