By Manas Mishra and Michael Erman
(Reuters) – U.S. Food and Drug Administration advisers unanimously recommended Tuesday that the agency authorize Moderna Inc.’s COVID-19 vaccine for children and teens ages 6 to 17.
About 77 million people in the United States have received at least a two-dose course of the Moderna vaccine, which has long been available to people 18 years of age or older.
The External Expert Committee is scheduled to consider the Modern Vaccine for Children Under 6 and the Pfizer and BioNTech VOCID Vaccine for Children Under 5 on Wednesday, and in both cases up to 6 months.
There is unlikely to be a significant immediate demand for Moderna traits for 6-17 year olds. The Pfizer / BioNTech vaccine was approved for children ages 5 to 11 in October, and approval for teens was preceded by months.
However, only about 30 percent of children ages 5 to 11 and 60 percent of 12- to 17-year-olds are fully vaccinated in the United States, according to the Centers for Disease Control and Prevention ( CDC) of the United States.
“I would like to give parents as many options as possible and let them make decisions about it for their children,” committee member and UC Berkeley professor Dr. Arthur Reingold told the meeting.
The FDA, which generally follows the recommendations of its advisors, but is not required to do so, is likely to soon authorize the Modern Vaccine for 6-17 year olds. The CDC should also recommend the use of the vaccine. A committee of his advisers is scheduled to meet Friday and Saturday.
There has long been concern that the Modern vaccine, which is given at a higher dose than the Pfizer / BioNTech vaccine, could cause a type of heart inflammation known as myocarditis and pericarditis at higher rates, mainly in men. teens.
Some European countries have restricted the use of the Moderna vaccine to younger age groups after surveillance suggested it was linked to an increased risk of heart inflammation, and the FDA delayed review of the vaccine. vaccine to assess the risk of myocarditis.
U.S. regulators presented data at Tuesday’s meeting suggesting Moderna’s vaccine may have a higher risk of heart inflammation in young men, but said the findings were inconsistent in several safety databases and they were not statistically significant, meaning they could be due to chance.
(Manas Mishra report in Bangalore; Additional report by Michael Erman in New Jersey; Jason Neely and Bill Berkrot edition)