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Advisers to the U.S. Food and Drug Administration on Tuesday unanimously recommended that the agency approve Moderna Inc’s COVID-19 vaccine for children and teens ages 6 to 17.
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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 aged 18 and over.
The Committee of External Experts is scheduled to consider the Moderna vaccine for children under 6 years of age and the Pfizer and BioNTech COVID vaccine for children under 5 years of age on Wednesday – in both cases at 6 months of age.
There is unlikely to be a significant immediate demand for Moderna photos for 6- to 17-year-olds. The Pfizer / BioNTech vaccine was approved for children aged 5 to 11 in October, and approval for teenagers was months ahead.
Yet only about 30 percent of those ages 5 to 11 and 60 percent of those ages 12 to 17 are fully vaccinated in the United States, according to the US Centers for Disease Control and Prevention (CDC).
“I would like to give parents as many choices as possible and let them make decisions for their children,” said UC Berkeley committee member and professor Arthur Reingold at the meeting.
The FDA – which usually follows the advice of its advisers but is not obliged to do so – will likely soon approve the Moderna vaccine for ages 6-17. The CDC should also recommend the use of the vaccine. A meeting of the commission by its advisers is scheduled for Friday and Saturday.
There have long been concerns that Moderna, which is given at a higher dose than Pfizer / BioNTech, can cause higher types of heart inflammation, known as myocarditis and pericarditis, especially in younger men.
Some countries in Europe have limited use of the Moderna vaccine for younger age groups, as monitoring suggests it is associated with a higher risk of heart inflammation, and the FDA has delayed review of the vaccine to assess the risk of myocarditis.
U.S. regulators unveiled data at Tuesday’s meeting that suggested Moderna’s vaccine may have a higher risk of heart inflammation in young men, but said the findings were inconsistent across safety databases and not statistically significant. which means they may be due to chance.
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