Covid-19: Moderna seeks to be first with vaccine shots for children younger than six

Moderna on Thursday asked US regulators to authorise low doses of its Covid-19 vaccine for children younger than six, a long-awaited move toward potentially opening shots for millions of tots by summer.

Frustrated families are waiting impatiently for a chance to protect the nation’s youngest kids as all around them people shed masks and other public health precautions -- even though highly contagious coronavirus mutants continue to spread.

Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect babies, toddlers and preschoolers -- albeit not as effectively during the Omicron surge as earlier in the pandemic.

“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.”

Now, only children ages five or older can be vaccinated in the US, using rival Pfizer’s vaccine, leaving 18 million younger tots unprotected.

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 kids, months after the disappointing discovery that two doses weren’t quite strong enough.

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.

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.

“It’s critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize,” Marks told a Senate committee.

If FDA clears vaccinations for the youngest, 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.

Many parents are desperate for whichever vaccine gets to the scientific finish line first.

Some parents even have urged the government to let families choose shots before all the evidence is in.

“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.”

Yet it’s not clear how many parents intend to vaccinate the youngest kids. Less than a third of children ages 5 to 11 have had two vaccinations, and 58 per cent of those ages 12 to 17.