Moderna wants to be first to offer COVID-19 vaccine for America’s youngest children, as it asked the Food and Drug Administration on Thursday to release low-dose shots for babies, toddlers and preschoolers.
Moderna submitted data to the Food and Drug Administration that it hopes will prove that two low-dose shots can protect children under the age of 6 — although effectiveness in children tested during the Omicron surge was nowhere near as high like earlier in the pandemic.
“There is an important unmet medical need here in these youngest children,” said Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two child-sized shots “safely protect them. I think it’s likely they’ll need extra doses over time. But we are working on it.”
According to Moderna, two doses for children were about 40% to 50% effective in preventing symptomatic COVID-19, not a home run, but for many parents any protection would be better than none.
This 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 is eagerly awaiting vaccinations for her youngest patients and her own 3 year old son who is ready to start preschool.
“It gives me so much peace of mind knowing that hopefully by the fall I’ll get him into school and he’ll be fully vaccinated,” she said.
Now, in the US, only children as young as 5 can be vaccinated with competitor Pfizer’s vaccine, leaving 18 million younger toddlers unprotected.
Moderna’s vaccine isn’t the only one in the race. Pfizer is expected to soon announce whether three of its even smaller doses work for the youngest of children, months after the disappointing discovery that two doses weren’t strong enough.
Whether it’s one company’s vaccines or both, FDA vaccine chief Dr. Peter Marks said the agency will “move quickly without sacrificing our standards” to decide whether large doses are safe and effective.
While questions arise about why it’s taking so long, Marks told lawmakers earlier this week clearly that the FDA can’t evaluate a product until a manufacturer has completed 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 the company has yet to provide some additional data. Moderna expects this next week.
“It’s critical that we have the right assessment so that parents have confidence in any vaccine that we approve,” Marks told a Senate committee.
If the FDA approves vaccines for the youngest, the next step for the Centers for Disease Control and Prevention would be to recommend who needs them — all young children or just those at higher risk from COVID-19.
Many parents are desperate for the vaccine that will reach the scientific finish line first.
“We’ve kind of been left behind while everyone else moves on,” said Meagan Dunphy-Daly, a Duke University marine biologist whose 6-year-old daughter is vaccinated – but whose 3-year-old and 18-month-old sons are part of Pfizer’s process.
The family continues to mask themselves and take other precautions until it is clear whether the boys have received a real vaccine or sham injections. If it turns out they weren’t protected in the Pfizer trial and Moderna’s shots are cleared first, Dunphy-Daly said she would seek them out for her sons.
“I will feel so relieved to know that my boys are vaccinated and that the risk of them catching a serious infection is so low,” she said.
The FDA will face some complex questions.
In a study of 6,700 children ages 6 months to 5 years, two shots of Moderna — each a quarter of the regular dose — elicited high levels of virus-fighting antibodies, the same amount shown to protect young adults, Burton said. There were no serious side effects, and the vaccines produced less high fever than other routine vaccines.
But depending on how the researchers measured, the vaccine was found to be about 51% effective at best in preventing COVID-19 cases in babies and young children, and about 37% in 2- to 5-year-olds. Burton blamed the Omicron variant’s ability to partially evade vaccine immunity, noting that unboosted adults showed similarly reduced efficacy against milder Omicron infections. Although no children became seriously ill during the study, he said high levels of antibodies are an indicator of protection against more serious diseases – and the company will test a booster dose for children.
“This is not entirely outside of our expectations,” said Dr. Bill Muller of Northwestern University, who helped with Moderna’s children’s studies. “In the end, I would assume it’s going to be a three-shot streak.”
Another problem: in the United States, Moderna’s vaccine has so far been limited to adults. Other countries have extended injections to children as young as 6 years old. But while Moderna has submitted FDA applications for older children, the FDA hasn’t ruled on them. Months ago, the agency cited concerns about a rare side effect, heart inflammation, in teenagers, a concern that hasn’t been reported in much younger children.
It’s not clear if the FDA will now consider Moderna’s vaccine for children of all ages, or will focus on tots first. But Muller has already had many parents questioning why vaccines were tested in young children before older children were vaccinated – and says pediatricians and pharmacists must be ready with answers.
Burton said safety data from millions of older children who were given Moderna vaccines abroad should help reassure parents.
While COVID-19 is generally not as dangerous in adolescents as it is in adults, some become seriously ill or even die. About 475 children under the age of 5 have died from COVID-19 since the pandemic began, according to the CDC, and child hospitalizations skyrocketed at the height of Omicron.
However, it is not clear how many parents intend to vaccinate the youngest children. Less than a third of children aged 5 to 11 had had two vaccinations, and 58% of children aged 12 to 17.
AP journalists 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.