HealthDay Reporter
MONDAY, Nov. 1, 2021 (HealthDay News) -- The U.S. Food and Drug Administration has delayed a determination connected whether to o.k. exigency usage of Moderna's COVID-19 vaccine successful 12- to 17-year-olds until astatine slightest January, the institution announced Sunday.
That's due to the fact that the bureau told the institution connected Friday that it needs much clip to measure emerging planetary information connected whether the vaccine increases the hazard of a uncommon heart broadside effect called myocarditis, Moderna said successful a statement.
"On Friday evening, the FDA informed Moderna that the bureau requires further clip to measure caller planetary analyses of the hazard of myocarditis aft vaccination. The FDA notified Moderna that this reappraisal whitethorn not beryllium completed earlier January 2022," the institution said. "The information of vaccine recipients is of paramount value to Moderna. The institution is afloat committed to moving intimately with the FDA to enactment their reappraisal and is grateful to the FDA for their diligence."
Myocarditis is an inflammation of the bosom musculus that occurs successful uncommon cases aft vaccination, typically aft the 2nd changeable and peculiarly successful young males.
Several countries person raised concerns that the Moderna vaccine increases the hazard of myocarditis successful men aged 18-30, and officials successful Finland and Sweden person recommended against the usage of Moderna for men younger than 30, the Washington Post reported.
But Moderna said Sunday that the "U.S. Centers for Disease Control and Prevention [CDC] and the World Health Organization [WHO] person stated that myocarditis pursuing vaccination with mRNA vaccines has been uncommon and mostly mild."
"It is estimated that implicit 1.5 cardinal adolescents person received the Moderna COVID-19 vaccine. To date, the observed complaint of myocarditis reports successful those little than 18 years of property successful Moderna's planetary information database does not suggest an accrued hazard of myocarditis successful this population," the institution connection added. "The institution does not yet person entree to information from immoderate caller planetary analyses."
The Moderna vaccine is authorized successful the United States for radical 18 and older, and the institution asked the FDA successful June to authorize it for adolescents.
On Sunday, the institution besides said it volition hold seeking FDA authorization of its vaccine for children ages 6-11.
Moderna's main competitor, Pfizer, has fared amended with its FDA approvals.
In May, the FDA authorized the exigency usage of the Pfizer vaccine for adolescents aged 12 to 15. And connected Friday, the bureau cleared the vaccine for children aged 5 to 11, administered successful 2 doses of 10 micrograms each. That dose is one-third of the teen and big dose. The Pfizer vaccine is expected to beryllium disposable for younger children aboriginal this week, pursuing a reappraisal by CDC vaccine advisors and a apt proposal for support from CDC Director Rochelle Walensky.
More information
Visit the U.S. Food and Drug Administration for much connected COVID vaccines.
SOURCE: Washington Post
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