Nov 2 (Reuters) – The director of the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday backed broad use of Pfizer’s (PFE.N) and BioNTech’s COVID-19 vaccine in children ages 5 to 11, clearing the way for shots to go into young arms as soon as Wednesday.
The announcement comes hours after the advisers to the U.S. 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 U.S. Food and Drug Administration granted emergency use authorization of the vaccine in 5- to 11-year-olds on Friday.
The FDA authorized 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 hospitalizations 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.
U.S. President Joe Biden described the authorization 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,” Biden said in a statement.
‘WE ALL HAVE A RESPONSIBILITY’
The CDC presented data suggesting that every million shots of the vaccine administered could prevent between 80 to 226 hospitalizations in children age 5 to 11. Once authorized, some 28 million children will be eligible for the shot.
The panel members spoke enthusiastically in favor of vaccination of the age group ahead of the vote. Many said they were eager for their children or grandchildren in the age range to get the shots.
“I feel that I have a responsibility – we all have a responsibility – to make this vaccine available to children and to their parents,” said panel member Dr. Beth Bell of the University of Washington School of Public Health. “We have excellent evidence of efficacy and safety. We have a favorable risk/benefit analysis. And we have many parents out there who really are clamoring and want to have their children vaccinated.”
Pfizer and BioNTech said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
“The vote was unanimous because the evidence is so clear. Kids 5 to 11 are better off vaccinated,” Ashish Jha, dean of the Brown University School of Public Health who was not a panel member, said in a Twitter post after the vote.
The U.S. 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.
“We’ve shipped to dozens of states already over the weekend and Monday,” Pfizer Chief Executive Albert Bourla said in an interview. “There is a Herculean effort so there will be doses available everywhere.”
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 U.S. 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 United States, around 58% of the population is fully vaccinated, lagging other nations such as the UK and France.
The share of young children who receive the shots may be even lower. Only about 47% of U.S. youth aged 12 to 15 are vaccinated.
U.S. states with the highest adult COVID-19 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.