US health authorities have given the final go-ahead to allow the Pfizer-BioNTech COVID-19 vaccine to be given to children aged 5-11, a move hailed by President Joe Biden as a "turning point" in the fight against the pandemic.
Days after gaining authorisation from the Food and Drug Administration (FDA), the vaccine was endorsed by the Centers for Disease Control and Prevention (CDC), clearing the way for the vaccination of up to 28 million children.
Drug regulators had already considered giving shots to younger people, but the CDC formally recommends who should receive cleared vaccines.
The CDC had convened a panel of independent scientists on Tuesday to review the available data on the status of the outbreak in children, the effectiveness of Pfizer's vaccine, and its possible side effects during a day of live-streamed discussions.
The panel unanimously recommended the vaccine, which was then approved by the CDC.
The main concern was the risk of myocarditis, an inflammation of the heart muscle, detected in adolescents and young adults (mostly males) after vaccination with the Pfizer or Moderna shots.
Health authorities have confirmed nearly 880 cases in people under 30 years of age, of which approximately 830 required hospitalisation. Nine deaths are suspected to have been related to myocarditis after the vaccine.
But of six cases so far reviewed, vaccine-related myocarditis was ultimately not identified as the cause of death.
There have been more than 1.9 million cases of coronavirus among children aged 5-11 in the United States, and more than 8,300 hospitalisations, and about 100 deaths.
A 'major step forward' for the US vaccination programme
"Today, we have reached a turning point in our battle against COVID-19," Biden said in a statement released by the White House.
Vaccinating younger children will "allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus," Biden continued.
The government was well ahead of the decision, procuring enough doses for the children in the 5-11 age group and beginning to ship them across the country.
The vaccine will still be given in two injections, three weeks apart, with the dosage adjusted to 10 micrograms per injection, compared to 30 micrograms for the older age groups.
The caps on the children's vials will be orange, making them easily recognisable compared to the purple caps on the vials for older groups.