The director of the US Centers for Disease Control and Prevention (CDC) has backed broad use of Pfizer's and BioNTech's COVID-19 vaccine in children ages 5 to 11, clearing the way for shots to go into young arms.
The announcement on Tuesday came hours after the advisers to the US CDC unanimously supported the move, saying the benefits of the vaccine outweigh the risks. Much of their discussion stemmed from rare cases of heart inflammation that have been linked to the vaccine, particularly in young men.
The US Food and Drug Administration granted emergency use authorisation of the vaccine in 5- to 11-year-olds on Friday.
The FDA authorised a 10-microgram dose of Pfizer's vaccine in young children. The original shot given to those age 12 and older is 30 micrograms.
"We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine," CDC Director Rochelle Walensky said in the statement.
At the outset of the meeting, Walensky said that pediatric hospitalisations had surged during the recent wave driven by the Delta variant of the coronavirus.
The risk from COVID-19 "is too high and too devastating to our children and far higher than for many other diseases for which we vaccinate children," she said.
Walensky said school closures have had detrimental social and mental health impacts on children.
"Pediatric vaccination has the power to help us change all of that," she said.
President Joe Biden described the authorisation as a turning point in the battle against COVID-19.
"The program will ramp up over the coming days, and fully up and running during the week of November 8. Parents will be able to bring their children to thousands of pharmacies, pediatrician's offices, schools, and other sites to get vaccinated," he said in a statement.
The CDC presented data suggesting that every million shots of the vaccine administered could prevent between 80 to 226 hospitalisations in children age 5 to 11. Once authorised, some 28 million children will be eligible for the shot.
Pfizer and BioNTech said their vaccine showed 90.7 per cent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
The US government and Pfizer have already begun distributing the vaccine in preparation for a widespread rollout for children, many of whom are back in school for in-person learning.
Earlier this week, the White House said the United States has enough supply of the Pfizer/BioNTech vaccine for all 28 million children aged 5 to 11.
While some children may be able to get their first shots as soon as Wednesday, the plans is for the US pediatric vaccine program to be running at full strength by next week, a Biden administration official said.
Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.
In the US, about 58 per cent of the population is fully vaccinated, lagging other nations such as the United Kingdom and France.
The share of young children who receive the shots may be even lower. Only about 47 per cent of US youth aged 12 to 15 are vaccinated.
US states with the highest adult vaccination rates are planning a big vaccine push compared with states where hesitancy remains strong, potentially widening the gaps in protection nationwide, public health officials and experts have said.