A Centers for Disease Control and Prevention (CDC) advisory committee has blessed the Pfizer-BioNTech COVID-19 vaccine with no restrictions for children ages 5 to 11, setting up the shot to be distributed in the U.S. later this week.
By a unanimous vote of its 14 members, the Advisory Committee on Immunization Practices (ACIP) signed off on the Comirnaty vaccine. A few hours later on Tuesday, CDC Director Rochelle Walensky added her endorsement, accepting the ACIP's recommendation.
The FDA granted the shot emergency use approval for kids in the age group on Friday, making Pfizer’s the first COVID-19 vaccine available to children as young as 5. The two other jabs that have been authorized in the U.S., by Moderna and Johnson & Johnson, have been endorsed only for those 18 and older.
There are 28.7 million children aged 5 to 11 in the U.S. who are set to become eligible to receive the shot.
For children in the age group, the dose will be a third of the size provided to people 12 and older. The two-shot series may be administered 21 days apart. Vaccine vials for children aged 5-11 will have an orange cap as opposed to the purple- and gray-capped vials for those 12 and older.
“I think it’s important to reiterate that many of us are parents and we have given (vaccinations) to our children because we've seen the devastation of this disease,” committee member Helen Talbot, M.D., of the Vanderbilt University Medical Center, said.
Since the beginning of the pandemic, among U.S. children ages 5 to 11, there have 1.9 million cases, 8,300 hospitalizations and 94 deaths, the CDC said. A risk/benefit assessment made by the CDC shows that for every million children in the age group who would be vaccinated with the Pfizer shot, 50,000 cases of the virus would be prevented over six months.
“Ninety-four parents have had to bury their child,” said committee member Veronica McNally, a law professor at Michigan State University. “And 2,300 have experienced a child with multiple organ failure. To say that this disease is not impacting kids is not an accurate statement.”
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In addition, CDC modeling has determined vaccination of 5- to 11 year-olds would accelerate a decline in cases, reducing them by 8%, which would account for 600,000 fewer cases over a five-month span.
Last week, the FDA approved the shot in the age group after Pfizer presented data showing efficacy of 90.7% and a strong safety profile in a trial of 2,268 children between 5 and 11 years old. There were no cases of the rare heart inflammation condition, myocarditis, in the trial, though the CDC said a larger population would need to be tested to establish a true risk profile.
The CDC committee also weighed survey data showing considerable resistance by parents in the U.S. to vaccinate their children. Only 34% of parents in the U.S. said they would vaccinate their children “right away,” according to a poll conducted last month by the Kaiser Family Foundation. The survey was done after Pfizer released its data in this age group. In the same poll, 24% of parents said they definitely would not vaccinate their children, while 32% would “wait and see” how the vaccine is working.
“We all have a lot of enthusiasm for this vaccine in this age group. But we also understand that parents have legitimate concerns and legitimate questions,” said committee member Beth Bell, M.D., a clinical professor at the University of Washington’s School of Public Health. “We really encourage people to ask their providers, to visit the CDC website, to talk to their friends, their parents and do what they need to do to feel comfortable with their decision.”
Moderna's rival mRNA vaccine is awaiting an FDA nod for use of its shot by those aged 12 to 17. A decision was due earlier this month but was delayed after four Nordic countries suspended use of the Moderna shot in those under age 30 because of myocarditis concerns. In the company's study of 3,700 children between the ages of 12 and 17, there were no reports of myocarditis. The company followed with its request for authorization in this age group in June.
Last week, Moderna announced positive data from a trial testing the shot in kids between the ages of 6 and 11. The company added it will submit the data to regulators soon.