WASHINGTON, (AFP):- US biotech firm Moderna said Sunday that American officials have delayed approving its Covid-19 vaccine for teenagers to allow more time to better assess the potential risk of developing myocarditis, or heart inflammation.
The US Food and Drug Administration (FDA) on Friday “informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination,” the biotech company said Sunday in a statement.
The evaluation on whether to recommend Moderna’s vaccine for 12- to 17-year-olds could last until January 2022, the company said.
Myocarditis and an associated risk, pericarditis (inflammation around the heart) have previously been linked to the Pfizer and Moderna Covid-19 vaccines themselves, particularly among adolescent boys and young men.
But the risk is far higher after infection with Covid-19, according to a study published in August by the US Centers for Disease Control and Prevention (CDC).
The CDC found that “myocarditis following vaccination with mRNA vaccines has been rare and generally mild,” Moderna said.
Another mRNA Covid-19 vaccine, by Pfizer-BioNTech, on Friday received US authorization for children aged five to 11, in smaller doses than for adults.
Moderna had previously said it was waiting for the FDA to decide on whether to approve its vaccine for adolescents under age 18 before seeking regulator approval for younger age groups.
Comment here !
CHITWAN:- The Maulakalika Hospital in Chitwan district has begun offering pediatric intensive care unit (PICU) services from today. Inaugurating the
By MICHELLE L. PRICE and BOBBY CAINA CALVAN, NEW YORK (AP):- The omicron variant of COVID-19, which had been undetected
N24 Correspondent, KATHMANDU:- Nepal Government has decided to bar citizens from nine countries, including South Africa and Hong Kong, from
KATHMANDU:- The COVID-19 Unified Central Hospital (Bir Hospital) has launched the ‘National Teleconsultation Centre’ targeting COVID-19 patients. Prior to this,