CDC Gives Final Go-Ahead for Pfizer’s Pediatric Covid Vaccine
(Bloomberg) -- Younger children across the U.S. are now eligible to receive Pfizer Inc.’s Covid-19 vaccine, after the head of the Centers for Disease Control and Prevention granted the final clearance needed for shots to begin.
CDC Director Rochelle Walensky recommended the vaccine for children from 5 to 11 years old. The decision ushers in a new phase in the U.S. pandemic response, widening access to vaccines to some 28 million more people at the same time that Americans who received shots earlier in the pandemic are lining up for booster doses.
The CDC’s Advisory Committee on Immunization Practices, a group of outside experts, earlier voted 14-0 in favor of giving children the shot, developed by Pfizer and BioNTech SE, after it was cleared on Friday by U.S. regulators. Administered in two injections three weeks apart, the vaccine is one-third the dose authorized for adults.
“Today is a monumental day in the course of this pandemic, and one that many of us have been very eager to see,” Walensky said at the opening of the panel’s all-day meeting. “For almost two full years, schools have been fundamentally changed; there have been children in second grade who have never experienced a normal school year.”
A surge in infections fueled by the delta variant and the return of in-person learning have increased calls for younger children to be immunized. Although kids generally don’t get as sick as adults from Covid, many parents and caregivers are keen to give children -- as well as older and ill people who interact with them -- a shield against infection.
Safety data in children look very good, said Camille Kotton, an ACIP panel member, adding that she would feel comfortable having her own children immunized if they were in that age group.
“We have accumulated a tremendous amount of safety data with hundreds of millions of Americans,” said Kotton, who is also the clinical director of transplant and immunocompromised host infectious diseases at Massachusetts General Hospital in Boston, in an interview after the vote.
Children should be vaccinated “both to prevent death as well as to prevent major long-term effects of having this devastating infection,” she said.
While CDC advisers recommended approval of the shot, some expressed concern about myocarditis, an inflammatory heart condition that’s been seen in some recipients. Health officials have been paying close attention to the risks posed by myocarditis following the shot compared with the overall risks of Covid.
Matthew Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, said he believes 5- to 11-year-olds have a relatively low risk of developing myocarditis from the shots.
“We will watch and see for sure — and they may have some — but I don’t think it’s nearly to the extent” of cases seen in older adolescents and young adults, said Oster, who’s also on the CDC Covid-19 Response vaccine task force. Oster said he made that determination based on the general epidemiology of myocarditis, since the pediatric trials were too small to make detect such an effect.
Pfizer is working with regulators on the handling and distribution of its children’s vaccine to accommodate pediatricians administering it. The pediatric vaccine can be sent in packs of just 10 vials, compared with the 195-vial packs of standard vaccines. Kids’ vaccine vials contain 10 doses after dilution, while adults carry just six.
Storage is also easier for the children’s vaccine, which can be kept in a refrigerator 10 weeks, or six weeks longer than shots for adolescents and adults. To differentiate the doses from the purple-capped adult vial, pediatric vials have orange caps.
Officials have been preparing for the rollout for weeks, and 15 million doses of the Pfizer vaccine specifically formulated for younger children began shipping within minutes of authorization, Jeff Zients, President Joe Biden’s coronavirus response coordinator, said Monday.
Medical professionals at schools, pediatricians’ offices and pharmacies around the country may begin giving them as early as this week, he said in a press call. The program will be fully up and running the week of Nov. 8, Zients said.
Moderna Inc. said Sunday that the Food and Drug Administration was delaying a decision on authorizing its Covid-19 vaccine for children ages 12 to 17, citing concerns about myocarditis. The FDA review may not be completed before January, the company said in a statement on Sunday.
The delay won’t affect the vaccine rollout for teenagers, because Pfizer’s vaccine is available for the age group, Walensky said at the Monday briefing.
“The thing that’s most important is we have a vaccine for our adolescents that is the age demographic under consideration for Moderna,” she said.
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