Moderna is seeking to be the first to offer COVID-19 vaccine for the youngest American children, as it asked the Food and Drug Administration Thursday to clear low-dose shots for babies, toddlers and preschoolers.
Frustrated families are waiting impatiently for a chance to protect the nation’s littlest kids as all around them people shed masks and other public health precautions -- even though highly contagious coronavirus mutants continue to spread.
That effectiveness is “less than optimal. We were hoping for better efficacy but this is a first step,” said Dr. Nimmi Rajagopal of Cook County Health in Chicago. She’s anxiously awaiting vaccinations for her youngest patients and her own 3-year-old son who’s ready to enter preschool. Moderna’s vaccine isn’t the only one in the race. Pfizer is soon expected to announce if three of its even smaller-dose shots work for the littlest kids, months after theWhether it’s one company’s shots or both, FDA vaccine chief Dr. Peter Marks said the agency will “move quickly without sacrificing our standards” in deciding if tot-sized doses are safe and effective.
If FDA clears vaccinations for the littlest, next the Centers for Disease Control and Prevention would have to recommend who needs them -- all tots or just those at higher risk from COVID-19. “I will feel such a sense of relief when I know my boys are vaccinated and that the risk of them getting a serious infection is so low,” she said.In a study of 6,700 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. There were no serious side effects, and the shots triggered fewer high fevers than other routine vaccinations.
Another issue: So far in the U.S., Moderna’s vaccine is restricted to adults. Other countries have expanded the shot to kids as young as 6. But while Moderna has filed FDA applications for older kids, too, the FDA hasn’t ruled on them. Months ago the agency cited concern about a rare side effect, heart inflammation, in teen boys, a concern that hasn’t been reported in much younger children.
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