The Pfizer-BioNTech vaccine against COVID-19 has been authorised by the US Food and Drug Administration (FDA) for emergency use in children aged five to 11, it was announced on Friday (local time).
It comes after an expert panel on Tuesday voted overwhelmingly to recommend authorisation to the FDA, saying the benefits of inoculation outweigh the risks.
About 28 million US children in the age bracket are now eligible to receive one-third of the adult dose, with two injections three weeks apart. If the Centers for Disease Control and Prevention (CDC) signs off as expected, children could begin receiving their shots as early as Wednesday next week, the New York Times reports.
An advisory panel to the CDC will convene next week to make a recommendation on the administration of the vaccine. The CDC director will make the final call.
The Biden administration has promised that children's jabs will be easily accessible at community health centres, children's hospitals, pharmacies and pediatrician offices, with 15 million doses ready to ship immediately. States began ordering doses last week.
Dr Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and a leader of the COVID-19 Prevention Network, called the development an "incredibly important tool in the return to normalcy".
"To be able to know that your child is protected and not going to get severely ill by going to school is an incredible psychological relief," he said on Friday (local time).
A clinical trial of children aged five to 11 found the vaccine provides significant protection against the virus. While children becoming seriously ill or dying from COVID-19 is relatively rare compared to adults, some develop complications, and infections in unvaccinated children have risen due to the highly infectious Delta variant.
As of this week, 94 kids in the five to 11 age bracket have died from COVID-19 in the US and about 8300 have been hospitalised, according to the CDC.
"To me, the question is pretty clear," Dr Amanda Cohn, a pediatric vaccine expert at the CDC and a voting member of the panel, said earlier this week. "We don't want children to be dying of COVID, even if there are far fewer children than adults, and we don't want them in the ICU."
A survey from the Kaiser Family Foundation released on Thursday (local time) found 27 percent of US parents with children aged five to 11 were eager to vaccinate them immediately, while a third said they would wait and see how the vaccine rollout went.
The Pfizer vaccine became available to children aged 12 to 15 in the US in May, but less than half in the age group are now fully vaccinated, compared to 69 percent of adults, according to the latest data.
The pharmaceutical giants are intending to use a lower, 10-microgram dose of the vaccine in children, versus 30 micrograms for those age 12 and older.
In New Zealand, Pfizer is currently the only vaccine in use against COVID-19 and is available to those aged 12 and over.
As of Friday (NZ time), 87 percent of the eligible population in Aotearoa have received their first dose and 73 percent are fully vaccinated.