A panel of experts convened by the US Food and Drug Administration recommended the Covid-19 vaccines by Moderna and Pfizer-BioNTech on Wednesday for the nation's youngest children.
Formal authorisations should follow quickly, with the first shots expected by next week after expected approvals by the Centres for Disease Control and Prevention.
“This recommendation does fill a significant unmet need for a really ignored younger population,” said Michael Nelson, a professor of medicine at the University of Virginia.
Prof Nelson was one of the 21 experts who unanimously said the benefits of the Moderna vaccine outweighed the risks.
Opening the meeting, senior FDA scientist Dr Peter Marks said that despite studies showing most children had now been infected with coronavirus, the high rate of hospital admissions among infants, toddlers and young children during last winter's Omicron wave showed the urgent need for vaccination.
“We are dealing with an issue where we have to be careful we don't become numb to the paediatric deaths because of the overwhelming number of older deaths,” Dr Marks said.
The US has recorded 480 Covid-19 deaths in the 0-4 age group so far in the pandemic, official data shows, far higher than even a “terrible flu season”, he said.
As of May, there had been 45,000 hospital admissions in that age group, nearly a quarter of whom required intensive care.
Both vaccines were tested in trials of thousands of children. They were found to bring on similar levels of mild side effects as in older age groups and caused similar levels of antibodies.
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Italian sculptor Sergio Furnari poses for pictures in front of 'The Hero Monument' heart sculpture on October 25, 2021, in New York. AP -
The Washington Monument where US President Joe Biden hosts a memorial to honour those who died from Covid-19 at the Lincoln Memorial in Washington, January 19, 2021. Reuters -
A woman takes selfies with her daughter in front of 'The Hero Monument' in New York. AP -
Italian sculptor Sergio Furnari stands next to his car near 'The Hero Monument' sculpture in Manhattan, New York. AP -
Christopher Edwards holds up a memorial to those who died from Covid-19, including his grandmother, Brenda Meadows, in Washington, May 5, 2021. AFP -
A woman and child look at the 'Naming the Lost Memorials' at the Green-Wood Cemetery in Brooklyn, New York. Reuters -
Faces of victims of Covid-19 are projected on to the Brooklyn Bridge on March 14, 2021, in New York. Getty Images via AFP -
Artist Suzanne Firstenberg's temporary art installation, 'In America: Remember' in Washington, September 17, 2021. AP -
A cyclist rides past the 'In America: Remember' memorial. Reuters -
One of the flags that make up the 'In America: Remember' installation. AP -
Visitors mourn at the 'In America: Remember' memorial. AP -
The memorial with the Washington Monument in the background. AP -
An aerial view of the memorial. AP -
A flag with a message for a loved one. AP -
The installation consisted of more than 600,000 flags. AP -
A mourner visits the memorial. AP -
A visitor sits on a bench near the memorial. AP -
Two people hug as they look at the thousands of white flags. Reuters -
Part of artist Suzanne Firstenberg's temporary art installation. AP -
Hundreds of Covid survivors march across the Brooklyn Bridge on Saturday, August 7, 2021, in New York. AP -
A woman holds an image of her husband as hundreds of Covid survivors gather at Cadman Plaza in Brooklyn. AP -
A sign at a Covid survivors' march in New York. AP -
US President Joe Biden and first lady Jill Biden arrive for a memorial for victims of Covid-19 in Washington. Getty Images / AFP -
The Washington Covid-19 Memorial. Photo: National Parks Service -
The Washington Covid-19 Memorial. Photo: National Parks Service
Efficacy against infection was higher for Pfizer, with the company placing it at 80 per cent, compared to Moderna's estimates of 51 per cent for children aged six months to 2 years and 37 per cent for those aged between 2 and 5.
But the Pfizer figure is based on very few cases and is thus considered preliminary.
It also takes three doses to achieve its protection, with the third shot given eight weeks after the second, and 11 weeks after the first.
Moderna's vaccine should provide strong protection against severe disease after two doses, given four weeks apart, and the company is studying a booster that would raise efficacy levels against mild disease.
But Moderna's decision to go with a higher dose is associated with higher levels of fever in reaction to the vaccine compared to Pfizer.
White House officials last week said the distribution of 10 million shots to pharmacies and doctors' offices could begin as soon as June 21.
