U.S. approves use of Moderna vaccine for children: EU rejects idea due to risk of heart inflammation
FDA advisors on June 14 unanimously recommended that the agency approve Moderna Inc.'s (MRNA.O) vaccine for children and adolescents aged 6 to 17, Reuters reports. strong>
About 77 million people in the United States received at least two doses of the Moderna vaccine , which has long been available to people aged 18 and over.
A committee of outside experts is due June 15 to review the Moderna vaccine for children under 6 years of age, and the Pfizer (PFE.N) and BioNTech (22UAy.DE) COVID vaccine for children under 5 years of age – and in both cases from the age of 6 months.< /p>
Moderna's vaccine for children aged 6 to 17 is unlikely to be in significant demand. The Pfizer/BioNTech vaccine was approved for children ages 5 to 11 in October, and approval for teens preceded it by months.
However, according to the U.S. Centers for Disease Control and Prevention (CDC), only about 30% of children aged 5 to 11 and 60% of children aged 12 to 17 are fully vaccinated in the United States.
“I would like to give parents as many choices as possible and let them make the decisions for their children,” committee member and UC Berkeley professor Dr. Arthur Reingold said at the meeting.
The FDA, which normally follows the advice of its advisors but is not required to do so, will likely soon approve the Moderna vaccine for children ages 6 to 17. The CDC must also recommend the use of the vaccine. His advisory committee is scheduled to meet on June 17 and 18.
There has long been concern that Moderna, which is administered at a higher dose than Pfizer/BioNTech, could cause an inflammation of the heart known as myocarditis and pericarditis , to a higher extent, primarily in young men.
Some countries in Europe have restricted the use of the Moderna vaccine to younger age groups after observations showed it was associated with a higher risk of heart inflammation and The FDA has delayed review of a vaccine to assess myocarditis risk.
U.S. regulators presented data at a June 14 meeting suggesting the Moderna vaccine may have a higher risk of heart inflammation in young men, but said the results are inconsistent in various security databases and are not statistically significant, which means they may be random.