Moderna to ask US regulators to approve COVID-19 vaccine for children under 6

WASHINGTON (AP) – On Thursday, Moderna asked U.S. regulators to allow low doses of its COVID-19 vaccine for children under 6, a long-awaited step toward potentially opening vaccinations for millions of toddlers by summer.

Frustrated families are looking forward to protecting the country’s youngest children as people around them drop masks and other health precautions – even though highly contagious coronavirus mutants continue to spread.

Moderna has provided the Food and Drug Administration with data that hopes to prove that two low-dose injections can protect infants, toddlers and preschoolers – though not as effectively during the omicron outbreak as before during the pandemic.

“With these youngest children, there is an important unmet medical need,” said Dr. Paul Burton, Moderna’s chief physician, to the Associated Press. The two children’s shots “will protect them. I think they’ll probably need extra doses over time. But we’re working on it.”

Now only children ages 5 and older can be vaccinated in the U.S. using Pfizer’s rival vaccine, leaving 18 million young children unprotected.

The Moderna vaccine is not the only one in the race. Pfizer is expected to announce soon if three of its even smaller doses of the drug will work for the youngest children, months after a disappointing finding that the two doses were not strong enough.

Whether it’s injections from one company or both, FDA vaccine chief Dr. Peter Marx said the agency would “move fast without sacrificing our standards” to decide whether doses are safe and effective for toddlers.

While questions about what takes so long, Marx clearly told lawmakers this week that the FDA cannot evaluate the product until the manufacturer completes its application. The FDA will publicly discuss the evidence with its scientific advisers before making a decision, and Marx said several meetings will be scheduled to cover several expected applications.

“It is critical that we have a proper assessment so that parents can trust any vaccine we allow,” Marx said in a Senate committee.

If the FDA cancels vaccinations for the youngest, then the Centers for Disease Control and Prevention will have to recommend who needs them – all toddlers or just those who are at higher risk of contracting COVID-19.

Many parents are desperately looking for which vaccine will reach the scientific finish line first.

“We were kind of abandoned because everyone else was moving on,” said Megan Dunphy-Daly, a marine biologist at Duke University whose 6-year-old daughter has been vaccinated but whose 3-year-old and 18-month-old sons are part of the trial. over Pfizer.

The family continues to hide in masks and take other precautions until it becomes clear whether the boys made a real vaccine or fictitious vaccinations. If it turns out they weren’t protected in the Pfizer study, and the pictures of Modern will be cleared first, Dunphy-Daly said she would look for them for her sons.

“I will be so relieved to know that my boys have been vaccinated and that the risk of getting a serious infection is so low,” she said.

Some parents have even called on the government to allow families to choose pictures before all the evidence is presented.

“This strain of COVID is almost impossible to avoid,” Dana Walker, the mother of an 8-month-old baby, said at a CDC meeting last week. “Reduce red tape and allow parents to protect their children.”

The FDA will face some difficult issues.

In a study of children aged 6 months to 5 years, two injections of Moderna – each at a quarter of the usual dose – caused high levels of anti-virus antibodies, the same amount of which has been shown to protect young adults, Burton said. There were no serious side effects, and the injections caused less fever than other conventional vaccinations.

But during trials the vaccine proved effective in preventing symptomatic COVID-19 by about 40-50%. Burton blamed the ability of the omicron variant to partially evade immunity against the vaccine, noting that adults without stimulation showed equally less effectiveness against milder omicron infections. Although no children became seriously ill during the study, he said high antibody levels are a proxy to protect against more serious diseases – and the company will test a regulatory dose for children.

Another question: so far in the US, the Moderna vaccine is only available to adults. Other countries have expanded the diagnosis to children as young as 6 years old. But a few months ago, the FDA cited concerns about rare side effects, heart inflammation, in teenage boys, and has not ruled on Moderna’s early pediatric applications.

Burton said the FDA could consider its vaccine for children of all ages, but could also open it first for the youngest children, who have no other option. He said safety data obtained by millions of older children who have received Moderna vaccinations abroad should reassure parents.

Although COVID-19 is not usually as dangerous to young people as it is to adults, some are severely ill or even die. According to the CDC, about 475 children under the age of 5 have died from COVID-19 since the pandemic began, and the number of hospitalizations has increased at the peak of omicron.

It is unclear how many parents intend to vaccinate the youngest children. Less than a third of children aged 5 to 11 received two vaccinations, and 58% of children aged 12 to 17.