- Advisers to the Centers for Disease Control and Prevention unanimously recommended Pfizer and BioNTech's coronavirus vaccine for use in children between 5 and 11 years old, setting up a new wave of immunizations to begin shortly in the U.S.
- The recommendation, set by a 14-0 vote Tuesday, comes days after the Food and Drug Administration authorized the vaccine for the roughly 28 million children in that age group, the youngest Americans eligible to date. While advisers to the FDA signaled lingering concerns around potential side effects, the CDC panel was supportive of the vaccine's risk-benefit profile.
- Parents are now able to seek out the vaccine for their children of eligible age after CDC director Rochelle Walensky signed the committee's recommendation Tuesday night. The Biden administration has already laid out plans for distribution and administration, which relies heavily on community health centers and providers. Rollout will be up and running by next week, Jeffrey Zients, a coronavirus coordinator for the White House, said in a press conference Monday.
The CDC meeting Tuesday emphasized COVID-19's cost on young children, who, while less at risk than older adults, are still susceptible to disease, hospitalization and death. At least 94 children between the ages of 5 and 11 have died from COVID-19 since the beginning of the pandemic, numbers cited by the CDC showed.
"I am really doing this to prevent number 95, the 95th death. Ninety-four parents have had to bury their child ... To say that this disease is not impacting kids is not an accurate statement," said Veronica McNally, a committee member and CEO of the Franny Strong Foundation.
By comparison, an average of 16 children aged 5 to 9 years old died of chickenpox in the years before a vaccine for that disease was made available, according to a presentation from Sara Oliver, who leads the CDC's work group that prepares the committee. Twenty children under 5 years old, on average, died each year of rotavirus infection prior to that vaccine's introduction.
Regulators and health officials hope to prevent similar COVID-19 deaths with the vaccine's authorization and recommendation, as well as minimize other pandemic-related impacts on children.
"I think it [the vaccine] can have a huge positive impact on their health, their social and emotional well being, their educational outcomes and their long-term trajectory," Grace Lee, the committee's chair and a professor of pediatrics at Stanford University, said.
In the 2021 school year alone, over 2,000 schools have had unplanned closures, impacting nearly 1.2 million students, according to Oliver's presentation.
Many parents across the country, who have handled additional caregiving responsibilities during these closures, are eager to see their children vaccinated, noted Beth Bell, a clinical professor at the University of Washington and CDC adviser.
"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," she said.
CDC officials and advisers dug into data from Pfizer and from the agency's own research to weigh the benefits and risks for 5- to 11-year olds, who will receive a dose one-third the size of what's given to adolescents and adults. A chief focus, as it was with advisers to the FDA last week, was the risk of myocarditis, an inflammatory condition of the heart that is associated in rare cases with Pfizer and BioNTech's vaccine.
The reaction has occurred most frequently in younger men, making it a top concern for officials weighing use of the vaccine in children.
But data suggest the condition is less likely to occur in the younger group. No cases of myocarditis were reported among the more than 3,000 children between 5 and 11 years old who were vaccinated in Pfizer's trial and had at least a week of follow-up. Myocarditis is linked to COVID-19 as well.
"We also understand that people have legitimate concerns and legitimate questions," said Bell. "Our vote is a way of telling the American public that, based on our expertise and the information that we have, we're all very enthusiastic."
Walensky made a similar point in Tuesday's announcement, encouraging parents to discuss the vaccine with their "pediatrician, school nurse or local pharmacist."
The U.S. government has already secured enough supply of the vaccine for all U.S. children in the age group, recently buying another 50 million pediatric doses from Pfizer and BioNTech. Vaccine doses for children will be packaged differently than those for adults.
While that will help distinguish doses of different strengths, new packaging means supplies already in pharmacies and clinics can't be used for children. The Biden administration is working with states and territories on their orders and began moving 15 million doses to distribution centers last Friday after the FDA authorized their use in children.
On Monday's press conference call, Biden aide Zients said the White House had enlisted more than 20,000 pediatricians, family doctors, pharmacies and other providers to administer the shots to young kids.