By LAURAN NEERGAARD
Moderna seeks to be the first to offer the COVID-19 vaccine for the youngest American children, as it asked the Food and Drug Administration (FDA) on Thursday to authorize low-dose vaccines for infants, toddlers and preschool children.
Frustrated families are eagerly awaiting a chance to protect the nation’s youngest children as people around them remove masks and other public health precautions, even as highly contagious coronavirus mutants continue to spread. Already around three-quarters of children of all ages show signs of having been infected at some point during the pandemic.
Moderna submitted data to the Food and Drug Administration that hopes to prove that two low-dose injections can protect children under 6, although effectiveness was not as high in children tested during the omicron surge as it was earlier in the pandemic. .
“There is 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 is likely that over time they will need additional doses. But we are working on it.”
Moderna said that two doses for children were 40% to 50% effective in 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 expected greater efficacy, but this is a first step,” said Dr. Nimmi Rajagopal of Cook County Health in Chicago. She eagerly awaits vaccinations for her youngest patients and her own 3-year-old son who is ready to enter preschool.
“It gives me such peace of mind to know that hopefully by the fall I’ll get him back to school and he’ll be fully vaccinated,” she said.
Now only children age 5 and older can be vaccinated in the US with Pfizer’s rival vaccine, leaving 18 million young children unprotected.
Moderna’s vaccine is not the only one in the race. Pfizer is expected to announce soon whether three of its even smaller dose injections work for younger children, months after the disappointing discovery that two doses weren’t 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 whether small doses are safe. and effective.
As questions arise about why it’s taking so long, Marks told lawmakers earlier this week that the FDA can’t evaluate a product until a manufacturer completes its application. In a statement Thursday, the FDA said it will schedule a meeting to publicly discuss Moderna’s evidence with its independent scientific advisers, but that the company still needs to submit some additional data. Moderna hopes to do so next week.
“It’s critically important that we have the proper testing so that parents have confidence in any vaccine that we authorize,” Marks told a Senate committee.
If the FDA approves vaccines for the very young, the Centers for Disease Control and Prevention would have to recommend who needs them: all young children or only those at higher risk of COVID-19.
“It’s very important to vaccinate younger children,” but “moving fast doesn’t mean doing it carelessly,” said Dr. Philip Landrigan, a pediatrician and public health expert at Boston College. The FDA must “see if it is safe. They need to see if it’s effective. And they need to do it quickly. But they will spare no effort.”
Many parents are desperate for the vaccine that reaches the scientific goal first.
“We’ve fallen a little behind while everyone else is moving forward,” said Meagan Dunphy-Daly, a marine biologist at Duke University whose 6-year-old daughter is vaccinated, but whose 3-year-old and 18-month-old sons are part of the trial. from Pfizer.
The family continues to wear masks and take other precautions until it is clear whether the children received the real vaccine or the dummy shots. If it turns out they weren’t protected in the Pfizer study and Moderna’s vaccines clear first, Dunphy-Daly said she would look into them for her children.
“I will feel a great sense of relief when I know that my children are vaccinated and that the risk of them contracting a serious infection is very low,” he said.
The FDA will be faced with some complex questions.
In a study of 6,700 children ages 6 months to 5 years, two injections of Moderna, each a quarter of the regular dose, triggered high levels of virus-fighting antibodies, the same amount shown to protect young adults Burton said. There were no serious side effects, and the shots caused fewer high fevers than other routine vaccinations.
But depending on how the researchers measured it, the vaccine was, at best, about 51% effective in preventing cases of COVID-19 in infants and young children, and about 37% effective in children from 2 to 5 years. Burton blamed the omicron variant’s ability to partially evade vaccine immunity, noting that unboosted adults showed similar effectiveness against milder omicron infections. While no children became seriously ill during the study, he said high antibody levels are an indicator of protection against more serious illness, and the company will test a booster dose for children.
“That’s not totally out of the realm of what we would have expected,” said Dr. Bill Muller of Northwestern University, who helped with Moderna’s children’s studies. “Going forward, I would anticipate it to be a three-shot series.”
Another problem: Until now, in the US, Moderna’s vaccine is restricted to adults. Other countries have extended the vaccine to children from 6 years of age. But while Moderna has also filed applications with the FDA for older children, the FDA has not commented on the matter. Months ago, the agency cited concerns about a rare side effect, heart inflammation, in adolescents, a concern that has not been reported in much younger children.
It’s unclear whether the FDA will consider Moderna’s vaccine for children of all ages now or focus on the youngest first. But Muller has already had many parents ask why the shots were tested in young children before vaccinating older children, and she says pediatricians and pharmacists should be ready with answers.
Burton said the safety data on millions of older children who received Moderna’s vaccines abroad should help reassure parents.
While COVID-19 is generally not as dangerous for young people as it is for adults, some do get very sick or even die. Some 475 children under the age of 5 have died from COVID-19 since the start of the pandemic, according to the CDC, with childhood hospitalizations soaring at omicron’s peak.
However, it is unclear how many parents intend to vaccinate younger children. Less than a third of children aged 5 to 11 years have received two vaccines, and 58% of those aged 12 to 17 years.
AP Writers Matthew Perrone and Lindsey Tanner contributed to this report.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.