A pharmacist holds a vial of the moderna coronavirus disease (COVID-19) vaccine in West Haven, Connecticut, U.S. February 17, 2021. REUTERS/Mike Segar
June 14 (Reuters) – Advisers to the US Food and Drug Administration unanimously recommended on Tuesday that the agency recommend Moderna Inc’s COVID-19 vaccine (MRNA.O) for children and adolescents ages 6 to 17 approved.
Around 77 million people in the United States have received at least two doses of Moderna’s vaccine, which has long been available to people ages 18 and older.
The committee of external experts is scheduled to review the Moderna vaccine for children under the age of 6 and the COVID vaccine from Pfizer (PFE.N) and BioNTech (22UAy.DE) for children under the age of 5 on Wednesday – and in both cases as early as 6 months .
The Moderna shots for 6-17 year olds are unlikely to be in immediate demand. The Pfizer/BioNTech vaccine was approved in October for children ages 5 to 11, and approvals for teens came months ahead.
Yet only about 30% of 5- to 11-year-olds and 60% of 12- to 17-year-olds in the US are fully vaccinated, according to data from the US Centers for Disease Control and Prevention (CDC).
“I want to give parents as many choices as possible and let them make those decisions for their children,” said committee member and UC Berkeley professor Dr. Arthur Reingold at the meeting.
The FDA — which generally follows the recommendations of its advisers, but is not required to do so — is likely to approve the Moderna vaccine for children ages 6 to 17 soon. The CDC must also recommend the use of the vaccine. A committee of his advisors is scheduled to meet on Friday and Saturday.
There has long been concern that the Moderna vaccine, given at a higher dose than the Pfizer/BioNTech vaccine, could be more likely to cause types of heart inflammation known as myocarditis and pericarditis, especially in younger men.
Some countries in Europe restricted the use of Moderna’s vaccine for younger age groups after surveillance suggested it was associated with a higher risk of heart inflammation and the FDA delayed its review of the vaccine to assess risk of myocarditis.
US regulators presented data at Tuesday’s meeting suggesting that Moderna’s vaccine may put young men at higher risk of heart inflammation, but said the results across different safety databases were inconsistent and not statistically significant, which means they could be random.
Reporting by Manas Mishra in Bengaluru; Additional reporting by Michael Erman in New Jersey; Edited by Jason Neely and Bill Berkrot
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