Moderna on Thursday asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially...
FILE - Syringes and a vial of the Moderna COVID-19 vaccine are displayed at a mass COVID-19 vaccination site in Batavia, Ill., on March 19, 2021.Moderna on Thursday asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer.
“There is an important unmet medical need here with these youngest kids,” Dr. Paul Burton, Moderna's chief medical officer, told The Associated Press. Two kid-size shots “will safely protect them. I think it is likely that over time they will need additional doses. But we're working on that.” While questions are swirling about what's taking so long, Marks pointedly told lawmakers this week that the FDA can't evaluate a product until a manufacturer completes its application. FDA will publicly debate the evidence with its scientific advisers before making a decision, and Marks said multiple meetings would be set to cover several expected applications.
The family continues to mask and take other precautions until it’s clear if the boys got real vaccine or dummy shots. If it turns out they weren't protected in the Pfizer study and Moderna's shots are cleared first, Dunphy-Daly said she'd seek them for her sons. “This strain of COVID feels almost impossible to dodge," Dana Walker, a mother of an 8-month-old, tearfully told a CDC meeting last week. “Cut red tape and allow parents to protect their kids.”In a study of kids ages 6 months through 5 years, two Moderna shots — each a quarter of the regular dose — triggered high levels of virus-fighting antibodies, the same amount proven to protect young adults, Burton said.
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