Moderna seeks US approval for COVID-19 injections for children under 6


Moderna on Thursday asked U.S. regulators to allow low doses of its COVID-19 vaccine for children under six, a long-awaited move toward potentially opening up vaccines for millions of children by summer.

Frustrated families anxiously await a chance to protect the smallest children as all around them people throw away masks and other public health precautions – even as highly contagious coronavirus mutants continue to spread.

Moderna has submitted data to the Food and Drug Administration that it hopes will prove that two low-dose injections can protect babies, toddlers and preschoolers – but not as effectively during the flare-up. of Omicron than at the start of the pandemic.

“There is a significant unmet medical need here with these younger children,” Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two injections for children “will safely protect them. I think it’s likely that over time they will need additional doses. But we are working on that.”

Now only children aged five or older can be vaccinated in the United States, using rival Pfizer’s vaccine, leaving 18 million young children unprotected.

Moderna’s vaccine isn’t the only one in the running. Pfizer is expected to announce soon whether three of its even smaller doses work for little ones, months after the disappointing discovery that two doses weren’t strong enough.

Whether it’s one or both company’s vaccines, FDA vaccine chief Dr. Peter Marks said the agency “will move quickly without sacrificing our standards” in deciding whether early doses are safe and effective.

As questions swirl about what’s taking so long, Marks told lawmakers this week that the FDA can’t assess a product until a manufacturer completes its application. The FDA will publicly debate the evidence with its scientific advisers before making a decision, and Marks said several meetings would be held to cover several expected applications.

“It’s extremely important that we have the right evaluation so that parents have confidence in all the vaccines that we authorize,” Marks told a Senate committee.

If the FDA allows vaccinations for toddlers, then the Centers for Disease Control and Prevention should recommend who needs them — all toddlers or just those at higher risk for COVID-19.

“A little left behind”

Many parents are desperate for the vaccine that will reach the scientific finish line first.

“We’ve been kind of left behind as everyone moves on,” said Meagan Dunphy-Daly, a Duke University marine biologist whose six-year-old daughter is vaccinated – but whose children aged three year-old and 18-month-old sons are part of Pfizer’s lawsuit.

The family continues to mask and take other precautions until it’s clear whether the boys received a real shot or dummy shots. If it turns out they weren’t protected in the Pfizer study and Moderna’s vaccines are cleared first, Dunphy-Daly said she would seek them out for her sons.

“I will feel such relief when I know my boys are vaccinated and the risk of them getting a serious infection is so low,” she said.

The FDA will be faced with complex questions.

In a study of children aged six months to five years, two injections of Moderna – each representing a quarter of the usual dose – triggered high levels of anti-virus antibodies, the same amount proven to protect young adults. , Burton said. There were no serious side effects and the injections triggered less fever than other routine vaccinations.

But the vaccine was found to be between about 40 and 50 percent effective in preventing symptomatic COVID-19 during the trial. Burton blamed the ability of the Omicron variant to partially evade vaccine immunity, noting that unboosted adults similarly showed less efficacy against milder Omicron infections.

Although no children became seriously ill during the study, he said high antibody levels are an indicator of protection against more serious illnesses – and the company will test a child booster dose.

Another problem: so far in the United States, Moderna’s vaccine is reserved for adults. Other countries have extended shooting to children as young as six years old. But months ago, the FDA raised concerns about a rare side effect, heart inflammation, in adolescents, and it has not ruled on Moderna’s earlier pediatric applications.

Burton said the FDA may consider its vaccine for children of all ages — but may also open it up first to younger children who have no other choice. He said safety data from millions of older children who received Moderna vaccines abroad should help reassure parents.

A struggle to get children vaccinated

Vaccinating eligible children against the coronavirus has been a struggle for many developed countries, with most North American and European countries beginning their childhood vaccination campaigns between November and January.

Vaccination rates are below 15% among European children aged five to nine, the youngest age group for which COVID-19 vaccines have been authorized there.

In the United States, 28% of children aged 5 to 11 on April 20 were considered fully vaccinated, with 35% having received at least one dose.

Canada has done better than most Western countries in vaccinating the youngest eligible children, but federal and provincial health officials have said they would like to see the rate increase even further.

According to Health Canada, nearly 41% of Canadian children aged 5 to 11 are fully immunized and 56% have received at least one dose.