Moderna hopes to seek Canadian approval of COVID-19 vaccine for children under 6 ‘shortly’ | CBC News

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.

10% of Canadian cases in children under 11 years of age

The Pfizer-BioNTech Comirnaty vaccine is available for children ages five to 11, and Moderna Spikevax is available for children ages six to 11. About 41 percent of Canadian children in this cohort have received two injections, according to federal data, while 56 percent have received at least one dose.

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.”

As in Canada, children aged five and older in the US can be vaccinated 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.

Questions spinning about what’s taking so long

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 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.”

‘A little left behind’

Many parents are desperate for the vaccine that reaches the scientific goal first.

“We’ve fallen 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 daughter and 18-month-old son are part of the lawsuit. 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 getting a serious infection is very low,” he said.

The FDA will be faced with some complex questions.

CLOCK | Moderna says its low-dose vaccine is safe for young children:

Moderna’s low-dose vaccine is safe for children under 6, company says

Early results show promising signs for Moderna’s low-dose COVID-19 vaccine in children under 6, with study participants developing a high level of antibodies. Moderna plans to apply for authorization of the vaccine in Canada later this spring. 1:54

In a study of children ages six months to five years, two injections of Moderna, each a quarter of the normal 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 less fever than other routine vaccinations.

But the vaccine proved to be 40 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: Until now, in the US, Moderna’s vaccine is restricted to adults. Other countries have expanded the vaccine to children up to six years old. But months ago, the FDA raised concerns about a rare side effect, heart inflammation, in adolescent boys, and has not commented on Moderna’s previous pediatric applications.

Burton said the FDA may consider its vaccine for children of all ages, but could also open it first to younger children who have no other choice. He said the safety data on millions of older children who received Moderna’s vaccines abroad should help reassure parents.

A fight to vaccinate children

Vaccinating eligible children against the coronavirus has been a struggle for many developed countries, with most countries in North America and Europe starting their childhood vaccination campaigns between November and January.

Immunization rates are below 15 percent among European children aged five to nine, the youngest age group for which COVID-19 vaccines have been licensed there.

In the US, 28 percent of children ages five to 11 as of April 20 were considered fully vaccinated, and 35 percent had received at least one dose.

Canada has fared better than most Western countries in vaccinating the youngest eligible children, but federal and provincial health officials have said they would like to see the rate rise further.