The Food and Drug Administration Pfizer-BioNTech on Friday approved a low-dose Covid-19 vaccine for children ages 5 to 11, making it available to 28 million children in the United States.
The FDA’s move comes several days after its advisory panel voted 17-0, with one abstention, to recommend a vaccine for children. The committee concluded that the benefits of vaccination outweigh the risks.
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Tuesday’s committee vote capped a vigorous debate about the potential risks and benefits of shots for younger children, with advisers citing concerns about the unknown rates of the inflammatory heart condition called myocarditis, and whether children would even need protection from Covid.
“I think it’s always nerve-wracking, when you’re asked to make a decision for millions of children based on studies of only a few thousand children,” panel member Dr. Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia, said Tuesday during the discussion. The question is, when do you know enough? And I think we know for sure that there are many children between the ages of 5 and 11 who are susceptible to this disease and can get very sick and be hospitalized or die from it.”
Committee member Uvita Fuller, associate professor of microbiology and immunology at the University of Michigan, agreed.
“The benefits of this option far outweigh the known risks,” she said during the discussion. “We certainly can’t anticipate all the risks ahead, but we know we have systems in place that can help us do that. So, I think we should take a step and say we want to make that choice of what it can do to help children, as well as others in this pandemic.”
In a presentation to the U.S. Food and Drug Administration on Tuesday, Pfizer said its vaccine was about 91 percent effective in preventing symptomatic diseases in children, adding that it appears to hold up well against the highly contagious delta variant.
Dr. Michael Corella, an infectious disease expert at the National Institutes of Health, abstained from the vote.
In a statement explaining his abstention, he said: “While there are clearly high-risk groups within the 5- to 11-year age group that this vaccine would significantly reduce serious disease, I do not expect protection against infection to last more than a few. months. This may negatively affect the public’s perception of vaccines.”
Although children are less likely to develop severe illness from Covid, more than 1.9 million children between the ages of 5 and 11 have tested positive for the coronavirus over the course of the pandemic, and more than 8,400 have been hospitalized, according to Dr. medical staff with the Centers for Disease Control and Prevention, the Food and Drug Administration’s advisory committee told Tuesday.
She said 94 children have died from Covid, making it the eighth leading cause of death in this age group.
Children who test positive for Covid are also at risk of developing pediatric multisystem inflammatory syndrome, or MIS-C, a rare inflammatory condition. As of October 4, up to 5,217 children of all ages have contracted MIS-C, and 46 have died, Havers said, adding that the condition was more common in children ages 5 to 11.
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The decision will now go to the Centers for Disease Control and Prevention’s advisory committee, which will meet to make additional recommendations about who should receive the vaccines, for example, whether the vaccines should be restricted to certain groups of children.
Once the director of the CDC, Dr. Rochelle Walinsky, On these recommendations, young children can start getting their shots.
The vaccine for children aged 5 to 11 years is a smaller dose than for those 12 and older – 10 micrograms of mRNA versus 30 micrograms. As in adults, the complete vaccination series consists of two doses three weeks apart. Pediatric doses come in vials with an orange cap and an orange label. Doses for adults and adolescents come in vials with a purple cap and a purple label.
Pfizer’s Covid vaccine is fully approved for adolescents and adults 16 years of age or older and may be given under an emergency use authorization to children and adolescents 12 to 15 years of age. It is the most widely used vaccine in the United States, with more than 243 million doses administered as of Tuesday and According to the Center for Disease Control and Prevention.
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Meg Terrell Contributed.
