Moderna seeks to be first company with COVID shots for kids under age 6

Moderna says it’s working on a submission to Health Canada for the approval a COVID-19 vaccine for children under the age of six.

The biotech company on Thursday asked

U.S. regulators to authorize low doses of its vaccine for children between six months and five years of age.

The long-awaited move is another stride towards potentially opening shots for millions of tots by summer.

In Canada, Moderna says it hopes 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 vaccine, Comirnaty, is available for children aged 5 to 11, and Moderna Spikevax is available for children six to 11 years old. About 41 per cent of Canadian children in this cohort have had two shots according to federal data.

Frustrated families are waiting impatiently for a chance to protect the littlest kids as all around them people shed masks and other public health precautions -- even though highly contagious coronavirus mutants continue to spread.

Already about three-quarters of U.S. children of all ages show signs they’ve been infected at some point during the pandemic.

In Canada, federal data states 10.8 per cent of reported infections were in children up to 11 years old. However this is likely an underestimate due to COVID-19 testing policy changes since last December, when many jurisdictions stopped offering PCR tests in most cases.

Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect children younger than 6 - although the effectiveness wasn’t nearly as high in kids tested during the omicron surge as earlier in the pandemic.

“There is an important unmet medical need here with these youngest kids,” Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two kid-size shots “will safely protect them. I think it is likely that over time they will need additional doses. But we’re working on that.”

Moderna said two kid doses were about 40% to 50% effective at preventing symptomatic COVID-19, not a home run but for many parents, any protection would be better than none.

While COVID-19 generally isn’t as dangerous in youngsters as adults, some do become severely ill or even die. About 475 children younger than 5 have died from COVID-19 since the pandemic’s start, according to the CDC, and child hospitalizations soared at omicron’s peak.

Yet it’s not clear how many parents intend to vaccinate the youngest kids. Less than a third of U.S. children ages 5 to 11 have had two vaccinations, and 58% of those ages 12 to 17.