On Tuesday, a U.S. Food and Drug Administration adviser recommended that the U.S. Food and Drug Administration approve Moderna Inc’s COVID-19 vaccine for children and teens aged 6 to 17 years.
The FDA’s Vaccine and Related Biopharmaceutical Advisory Board, consisting of outside experts, unanimously voted to make vaccines available to that age group.
Approximately 77 million people in the United States have been vaccinated with Moderna vaccine, which has long been used by people over the age of 18, at least twice.
The Commission will review Moderna Shots for children under the age of 6 and Pfizer and BioNTech COVID vaccines for children under the age of 5 on Wednesday. In both cases it is 6 months.
It is unlikely that a 6-17 year old Moderna will request a shot immediately. The Pfizer / BioNTech vaccine was approved for children aged 5 to 11 years in October, months prior to approval for teens.
However, according to data from the Centers for Disease Control and Prevention (CDC), only about 30% of ages 5-11 and 60% of ages 12-17 are fully vaccinated in the United States.
The FDA generally follows the advisor’s recommendations, but is not obliged to do so, but may soon approve the Moderna vaccine for ages 6-17. The CDC should also recommend the use of vaccines. The advisory board will meet on Friday and Saturday.
There is concern that the Moderna vaccine, given at higher doses than Pfizer / BioNTech shots, may cause a higher proportion of heart inflammation of the type known as myocarditis or pericarditis, primarily in young men. It’s been around for a long time.
In some European countries, the use of Moderna vaccines for younger age groups has been restricted after surveillance suggests an increased risk of heart inflammation, and the FDA will assess the risk of myocarditis. The review of the shot has been postponed to.
U.S. regulators presented data at a meeting on Tuesday, suggesting that Moderna vaccines may be at increased risk of heart inflammation in young men, but findings are consistent across different safety databases. He said it was not statistically significant and could be due to chance.