Pfizer Inc. and BioNTech SE’s Covid-19 vaccine was cleared by U.S. regulators for children ages 5 to 11, a long-awaited pandemic milestone that opens a new phase of the immunization campaign.
The emergency authorization, announced Friday in a statement by the Food and Drug Administration, brings the U.S. a step closer to shots being administered at schools, pediatricians’ offices and pharmacies around the country. The formulation for young kids is one-third the dose of the adult shot.
Before youngsters can begin to receive the vaccine, the Centers for Disease Control and Prevention’s immunization advisory committee will also meet to make more specific recommendations about who should get it and how to administer it. The panel is currently scheduled to convene on Nov. 2 and 3. CDC director Rochelle Walensky will then need to sign off on the advisers’ guidance.
The FDA’s action on Friday allows shipments of the doses to begin — the first time the U.S. has distributed anything other than the regular Pfizer dose for teens and adults. The shipments would position the shots at pediatricians’ offices, pharmacies and other locations across the country so that inoculations can begin promptly after any CDC clearance.
“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock said in the statement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
Pfizer shares rose 1.3% at the close in New York. BioNTech’s American depositary receipts lost 1.9%.
Officials at hospitals and clinics have been discussing the rollout for children. In Washington, for example, health officials plan to make newly authorized doses for kids available at clinics and pharmacies such as those of CVS Health Corp. and Walmart Inc. The city will also host pop-up clinics at elementary schools and Children’s National Hospital plans to distribute the shots to children at its eight primary care locations and via a mobile unit canvassing the community.
New York’s Westchester Medical Center has served as a coordinator for the distribution of vaccines throughout the Hudson Valley. Michael Gewitz, physician-in-chief at the center’s Maria Fareri Children’s Hospital, said the process of vaccinating 5- to 11-year-olds will be different from earlier campaigns. That means they’ll focus vaccination efforts on pediatricians’ offices in their network as well as at a small vaccine site on the medical center’s campus.
“For the children in the 5-to-11 age bracket, we want to administer it in a more friendly, personal environment,” Gewitz said. “We think it will be a better environment for children, especially young children.”
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CDC experts
Many doctors are looking to hear what the experts on the CDC’s Advisory Committee on Immunization Practices recommend for the vaccine’s use, said Buddy Creech, director of the Vanderbilt Vaccine Research Program.
“I think the desire is for pediatricians to begin having those conversations with families, answering questions that the parents might have, and then waiting for what the ACIP provides guidance on next week,” said Creech, who’s helped conduct a trial of Moderna Inc.’s Covid vaccine in children.
Megan Ranney’s son Clark is anxiously awaiting his shot. Her 10-year-old is jealous of an elder sister who’s already been vaccinated and can do more socializing, said Ranney, an emergency physician and researcher at Brown University in Rhode Island.
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Sleepover key
“Our family rule is you could do sleepovers the summer going into third grade, and he missed that because of Covid,” she said. “He’s never done a sleepover and he really wants to.”
She didn’t make the decision on immunization lightly, she said, given the risk of a rare form of heart inflammation called myocarditis that’s associated with the vaccine in some adults, particularly males. The data show the shot is safe, she said.
“The risk of myocarditis from the vaccine, even for boys, is lower than the risk of myocarditis from Covid itself,” she said. “Covid is one of the top 10 leading causes of death this year in children. I do a lot of things to protect my kids from injury and illness that are less common than Covid. This seems like a no brainer.”
President Joe Biden’s administration has said they have enough vaccine for all 28 million kids in the 5 to 11 age group, and they’re ready to ship the shots.
“Upon FDA authorization of the vaccine, millions of doses will be shipped immediately to tens of thousands of pediatricians, family doctors, children’s hospitals, community health centers, rural health clinics, and pharmacies –– providers parents and kids know and trust,” Jeff Zients, Biden’s Covid-19 response coordinator, said Wednesday at a press briefing.
“We will be ready immediately following FDA and CDC’s decisions so that parents can get their kids vaccinated quickly, easily, and conveniently.”
The recent surge in infections fueled by the delta variant and the return of in-person learning have increased calls for younger children to be immunized. While FDA advisers unanimously recommended approval of the shot, some expressed concern about a lack of data on side effects, the prevalence of Covid in children, and other issues.
The advisers supported the vaccine in part because so many children with Covid don’t show risk factors before catching the disease, said Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, during a media briefing following the announcement.
“Trying to limit it to just a high risk group could create issues, including issues of making sure that the general population was protected,” he said. It may be a few months until authorities consider shots for children under age 5, Marks said.
“As we get down to younger children the benefit-risk gets to be even more of a careful consideration because the youngest children are affected the least directly in terms of severe Covid-19,” he said.
The U.S. has been focusing on ways to bolster its defenses and prevent another virus surge. Just last week, the FDA paved the way for millions of recipients of Moderna Inc. and Johnson & Johnson vaccines to receive their Covid boosters.—Bloomberg
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