Moderna: FDA delaying decision on its shot for adolescents

Moderna: FDA delaying decision on its shot for adolescents

FILE - In this Sunday, Aug. 15, 2021 file photo, vials of the Moderna COVID-19 vaccine are seen at the Assad Iben El Fourat school in Oued Ellil, outside Tunisa. The European Medicines Agency said a booster dose of Moderna’s coronavirus vaccine “can be considered” in people aged 18 and above. In a statement on Monday, Oct. 25, the EU drug regulator said its analysis had shown that a third dose given of Moderna’s vaccine - which is usually given in a two-dose schedule - at least six months after the second dose, led to an increase in antibody levels in adults whose levels were waning. (AP Photo/Hassene Dridi, file)

CAMBRIDGE, Mass. (AP) — U.S. regulators are delaying their decision on Moderna’s COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation. Moderna said Sunday that the U.S. Food and Drug Administration told the company Friday evening that its review could last until January. The company also says it will delay filing a request for emergency-use authorization of a lower dose of the vaccine for 6- to 11-year-olds. Heart inflammation is an exceedingly rare risk of both the Pfizer and Moderna vaccines, and it more commonly seen in young men or boys. Public health officials have repeatedly stressed that COVID-19 itself can cause heart inflammation.

Photo: FILE – In this Sunday, Aug. 15, 2021 file photo, vials of the Moderna COVID-19 vaccine are seen at the Assad Iben El Fourat school in Oued Ellil, outside Tunisa. (AP Photo/Hassene Dridi, file)