Moderna is striving to be the first to offer a COVID-19 vaccine to America’s youngest children, asking the Food and Drug Administration Thursday to clear low-dose doses of infants, young children and preschoolers.
Frustrated families are anxiously waiting for a chance to protect young children in the country as people around them throw away masks and other public health precautions – even though the highly contagious coronavirus mutations continue to spread. About three-quarters of children of all ages already show signs of this injured At some point during the pandemic.
Moderna has submitted data to the US Food and Drug Administration that it hopes will demonstrate that two low doses can protect children younger than 6 years old — although the efficacy was not nearly as high in children tested during the omicron increase as earlier in the epidemic.
“There is an important unmet medical need here with these young children,” Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two baby-sized shots “will protect them safely. I think it’s possible that over time they will need additional doses. But we are working on that.”
Moderna said two pediatric doses were 40% to 50% effective in preventing symptoms of COVID-19, which is not a home trial but for many parents, any protection would be better than nothing.
This efficacy is ‘less than optimal. We were hoping for better efficacy but this is a first step,’ said Dr. Niemi Rajagopal of Cook County Health in Chicago. She is anxiously awaiting vaccinations for her youngest patients and her 3-year-old son who is ready to enter school. Introductory.
“It gives me peace of mind to know that by the fall I will have him in school and fully vaccinated,” she said.
Now, only children age 5 and older can be vaccinated in the United States, using the competing vaccine, Pfizer, leaving 18 million younger children unprotected.
Moderna’s vaccine isn’t the only one in the race. Pfizer is soon expected to announce whether three smaller doses of its own work for the youngest children, months after A disappointing finding that the two doses were not strong enough.
Whether it’s one company’s shots or both, FDA Vaccine Head Dr. Peter Marks said the agency would “move quickly without sacrificing our standards” in determining whether large-volume doses are safe and effective.
While questions swirl about what takes so long, Marks told lawmakers earlier this week that the Food and Drug Administration cannot evaluate the product until the manufacturer completes its order. In a statement Thursday, the FDA said it would schedule a meeting to publicly discuss Moderna’s evidence with its independent scientific advisors, but the company still had to provide some additional data. Moderna expects to do so next week.
“It is very important that we have the proper evaluation so that parents have confidence in any vaccines we allow,” Marks told a Senate committee.
If the FDA clears vaccinations for younger children, the Centers for Disease Control and Prevention would then have to recommend those who need them — all children or only those at risk of contracting the COVID-19 virus.
“It is very important that young children are vaccinated” but “moving fast does not mean moving slowly,” said Dr. Philip Landrigan, a pediatrician and public health expert at Boston College. The FDA has to “see if it’s safe. They need to see if it’s effective. And they need to do it fast. But they won’t get in the way.”
Many parents desperately need any vaccine that reaches the scientific finish line first.
Megan Dunphy Daly, a marine biologist at Duke University whose 6-year-old daughter—but his 3-year-old, 18-month-old daughter—was vaccinated as part of the Pfizer trial.
The family continues to mask and take other precautions until it is clear whether the boys received a real vaccine or a dummy injection. If it turns out they weren’t protected in the Pfizer study and Moderna’s shots were cleared first, Dunphy Daly said she would look for her for her sons.
“I will feel such relief knowing that my children have been vaccinated and that their risk of serious infection is very low,” she said.
The Food and Drug Administration will face some complex questions.
In a study of 6,700 children aged 6 months to 5 years, two shots of Moderna — each a quarter of the normal dose — elicited high levels of antiviral antibodies, the same amount that has been shown to protect young adults. There were no serious side effects, and the injection caused lower high temperatures than other routine vaccinations.
But depending on how the researchers measure it, the vaccine has proven to be at best about 51% effective in preventing cases of COVID-19 in infants and young children and about 37% in children ages 2 to 5. Burton blamed the ability of the omicron variant to partially evade vaccine immunity, noting that unstimulated adults similarly showed lower efficacy against milder omicron infections. While no children became severely ill during the study, he said high levels of the antibodies are a protective agent against more serious illnesses — and the company will test a booster dose for children.
“This is not entirely outside of what we were expecting,” said Dr. Bill Muller of Northwestern University, who assisted with Moderna’s child studies. “On the way I expect it will be a three-shot series.”
Another problem: So far in the United States, Moderna’s vaccine is limited to adults. Other countries have extended the shot to include children as young as 6 years old. But while Moderna has filed FDA applications for older children as well, the FDA has not issued a ruling on them. Months ago, the agency expressed concern about a rare side effect, carditis, in teenage boys, a concern that has not been reported in younger children.
It’s not clear whether the FDA will now consider Moderna’s vaccine for children of all ages or focus first on the youngest. But Mueller has already had plenty of parents asking why shots are tested in children before older children are vaccinated — and they say pediatricians and pharmacists should be ready with the answers.
Burton said safety data from the millions of older children who have received Moderna vaccines abroad should help reassure parents.
While COVID-19 in general is not as dangerous to young adults as adults, some get very sick or even die. About 475 children under the age of 5 have died from COVID-19 since the beginning of the pandemic, according to the Centers for Disease Control and Prevention, and the number of children in hospitalizations rose at the peak of Omicron.
However, it is not clear how many parents plan to vaccinate young children. Less than a third of children ages 5 to 11 have had two vaccines, and 58% of those ages 12 to 17.
Associated Press reporters Matthew Perrone and Lindsey Tanner contributed to this report.
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