Moderna says it is working on a submission to Health Canada for approval of a COVID-19 vaccine for children under the age of six.
The biotech company on Thursday asked US regulators to authorize low doses of its vaccine for children between six months and five years of age.
The long-awaited move is another step toward potentially opening up millions of children for the summer.
In Canada, Moderna says it expects to complete the application for regulatory approval of its COVID-19 vaccine, Spikevax, “shortly.”
To date, Health Canada has only approved mRNA COVID-19 vaccines for children over the age of five.
The Pfizer-BioNTech, Comirnaty vaccine is available for children ages 5 to 11 years, and Moderna Spikevax is available for children ages 6 to 11 years. About 41 percent of Canadian children in this cohort have received two vaccinations according to federal data.
Frustrated families eagerly await the opportunity to protect younger children as people around them remove masks and other public health precautions, even as highly contagious coronavirus mutants continue to spread.
About three-quarters of American children of all ages show signs of having been infected at some point during the pandemic.
In Canada, federal data indicates that 10.8 percent of reported cases were in children up to 11 years of age.
Moderna submitted data to the Food and Drug Administration that hopes to prove that two low-dose injections can protect infants, toddlers and preschool children, though not as effectively during the Omicron surge as earlier in 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 shots for children “will safely protect them. I think they’ll probably need additional doses over time. But we’re working on that.”
Now only children five and older can be vaccinated in the United States, using 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 review 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 it in a few weeks.
“It is critically important that we have the proper screening for parents to 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’s safe. They need to see if it’s effective. And they need to do it quickly. But they won’t spare any 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 ahead,” said Meagan Dunphy-Daly, a marine biologist at Duke University, whose 6-year-old daughter is vaccinated, but whose son is 3 years and 18 months. the older children are part of the Pfizer lawsuit.
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 getting a serious infection is very low,” he said.
The FDA will be faced with some complex questions.
In a study of children ages six months to five years, two injections of Moderna, each a quarter of the regular dose, triggered high levels of virus-fighting antibodies, the same amount that has been 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 the vaccine proved 40 percent to 50 percent effective in preventing symptomatic COVID-19 during the trial. 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: So far in the United States, Moderna’s vaccine is restricted to adults. Other countries have expanded the vaccine to children up to six years old. 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 adolescent boys, a concern that has not been reported in much younger boys.
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 vaccines were tested in younger children before 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 five 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 ages 5 to 11 have received two vaccines, and 58 percent of children ages 12 to 17.
— With archives from The Associated Press
This report from The Canadian Press was first published on April 28, 2022.