Children under the age of five could start receiving COVID-19 vaccines in the United States within days, after federal regulators took a major step towards approving shots from Pfizer and Moderna.
Advisors to the US Food and Drug Administration (FDA) found both products were safe and effective for kids as young as six months.
The recommendations still need to be signed off by the FDA and the Centers for Disease Control (CDC), however, authorities hope shots could start going into arms from next week.
Kawsar Talaat — an associate professor at Johns Hopkins Bloomberg school of public health, who led one of Pfizer's trial sites — said: "I think it's going to be a game-changer for parents with small children."
"This means that kids can go and stay in daycare, do their normal activities, have play dates and have fun and visit elderly relatives without the same concerns [as] before."
Children under the age of five years remain the only cohort not eligible for COVID-19 vaccines in the US, frustrating many parents, who are still having to deal with issues such as childcare closures.
The decision of US regulators is likely to be watched closely by Australian health officials, who are already evaluating an application from Moderna to extend its COVID-19 vaccine to children as young as six months.
What's the difference between the Pfizer and Moderna vaccines for young kids?
The panel has recommended Pfizer's vaccine be made available to children between the ages of six months and four years.
It would be delivered in three doses, each at one-tenth the amount given to adults.
The first two shots would be administered three weeks apart, followed by a third at least two months later.
Moderna hopes to deliver its vaccine to children between the ages of six months and five years in a two-dose series, each at a quarter of the adult dose, about four weeks apart.
Data submitted to the FDA suggested Pfizer's vaccine was around 80 per cent effective in preventing symptomatic COVID-19 infections, however, that was based on just 10 COVID-19 cases.
Moderna said its vaccine was 51 per cent effective in preventing symptomatic infections in children between six months and two years old, and 37 per cent effective in children aged two to five.
It is also testing a booster shot.
Peter Marks — who oversees the FDA's vaccines division — told the advisory meeting that children were still less likely to experience severe illness from COVID-19 than adults.
However, he described child hospital admission rates during the Omicron wave as "quite troubling" and said 442 children under the age of four had died from COVID-19 in the US over the course of the pandemic.
"Granted, it's a population that has been much less affected than the older population … but one, nonetheless, that has also been affected," he said. "Each child that's lost essentially fractures a family."
Encouraging parents to take up vaccines for young kids could prove a challenge
While some parents are anxiously awaiting the opportunity to get their young kids vaccinated, many others are expected to hold off or decline the shots altogether.
Only around one third of children in the US between the ages of five and 11 have been vaccinated so far and surveys suggest the rate among the new cohort could be lower.
As first-time parents to a baby born in the middle of the pandemic, Jason Vanterpool and Mara Frisch have spent months worrying about their daughter's safety.
"If someone had a cough, my first thought was, 'I can't bring that cough home to her because she's not vaccinated,'" Mr Vanterpool said.
"I was very concerned about just keeping her safe at all times."
He does not intend to get 11-month-old Mila vaccinated as soon as the doses become available, preferring instead to watch how the rollout goes, but says it will happen eventually.
"It's part of our daily life, it has to happen," he said.
"If it's the flu shot, the COVID vaccine, let's just get it done with and move forward."
Kentucky mum of three Alexis Sabino has already had her seven-year-old son, Ethan, vaccinated and is looking forward to doing the same for her four-year-old daughter, Nora.
"Anything to help us to continue on, to stay healthy, we're more than happy to get it," she said as her family cooled down at a water park during a holiday in Washington.
However, she also plans on waiting a bit longer when it comes to her two-year-old son, Alan.
Professor Talaat said it was up to each family to make their own decisions.
"I think that it's important to have these vaccines available to those who want them and to educate everybody about the risks of COVID, for all age groups," she said.
"Even though, in general, children do better with COVID and it's milder, it can be severe.
"And I think I think it's important … to have as much education available so that people can learn the facts for themselves and make the decision that they think is best for their kids."
