Shots for tots
Moderna seeks OK for under-6 vax
Moderna is seeking to be the first to offer COVID-19 vaccines for the youngest American children, asking the Food and Drug Administration to clear low-dose shots for babies, toddlers and preschoolers.
Cambridge-based Moderna submitted data Thursday to the FDA that it hopes will prove two low-dose shots can protect children younger than 6 — although the effectiveness wasn’t nearly as high in kids tested during the omicron surge as earlier in the pandemic.
“There is an important unmet medical need here with these youngest kids,” said Dr. Paul Burton, Moderna’s chief medical officer. 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.”
Moderna said two kid doses were about 40% to 50% effective at preventing symptomatic COVID-19, not a home run but for many parents, any protection would be better than none.
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.
“It gives me such peace of mind to know that hopefully by fall I’ll get him in school and he’ll be fully vaccinated,” she said.
Now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine, leaving 18 million younger tots unprotected.
Whether 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 COVID19.
“It’s very important to get
the youngest children vaccinated” but “moving quickly doesn’t mean moving sloppily,” said Dr. Philip Landrigan, a pediatrician and public health expert at Boston College. FDA must “see if it’s safe. They need to see if it’s effective. And they need to do so swiftly. But they won’t cut corners.”
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.
But depending on how researchers measured, the vaccine proved at best about 51% effective at preventing COVID-19 cases in babies and toddlers and about 37% effective in the 2- to 5-yearolds.