The Food and Drug Administration on Friday cleared Pfizer-BioNTech’s low-dose Covid-19 vaccine for children aged 5 to 11, making it available to 28 million children in the United States.
The FDA’s move comes days after its advisory committee voted 17-0, with one abstention, in favor of recommending the vaccine for children. The committee concluded that the benefits of vaccination outweigh its risks.
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The committee’s vote on Tuesday had closed a vigorous debate over the potential risks and benefits of injections for young children, with councilors citing concerns about unknown rates of an inflammatory heart disease called myocarditis, and whether children would even need it. ‘protection against Covid.
“It’s always scary, I think, when you are asked to make a decision for millions of children based on studies of just a few thousand children,” Committee member Dr Paul Offit, vaccine researcher at Children’s Hospital in Philadelphia said Tuesday during the discussion. “The question is, when do you know enough? And I think we certainly know that there are a lot of children between the ages of 5 and 11 who are susceptible to this disease who could very well be sick and be hospitalized or die from it. “
Committee member Oveta 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 have to take a step and say that we want to make this option available for what she could do to help children, as well as others in this pandemic. “
In a presentation to the FDA on Tuesday, Pfizer said its vaccine was nearly 91% effective in preventing symptomatic illnesses in children, adding that it appears to be resistant to the highly transmissible delta variant.
Dr Michael Kurilla, an infectious disease expert from the National Institutes of Health, abstained from voting.
In a statement explaining his abstention, he said: “While there are clearly high-risk groups in the 5-11 age group for whom this vaccine would significantly reduce serious illness, I don’t expect that the protection against infection lasts more than a few months. and this can have a negative impact on public perception of vaccines. “
Although children are less susceptible to serious illnesses from Covid, more than 1.9 million children aged 5 to 11 have tested positive for the coronavirus during the pandemic, and more than 8,400 have been hospitalized, said Dr. Fiona Havers, a physician with the Centers for Disease Control and Prevention, the FDA advisory committee said Tuesday.
Ninety-four children have died from Covid, making it the eighth leading cause of death in this age group, she said.
Children who test positive for Covid are also at risk for multisystem inflammatory syndrome in children, or MIS-C, a rare inflammatory disease. As of Oct. 4, up to 5,217 children of all ages had developed MIS-C and 46 have died, Havers said, adding that the disease was most common in children between the ages of 5 and 11.
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The decision will now rest with a CDC advisory committee, which will meet to make additional recommendations on who should get the vaccines, for example, whether vaccines should be restricted to certain groups of children.
Once CDC director Dr. Rochelle Walensky approves these recommendations, young children can begin to be immunized.
The vaccine for children aged 5 to 11 is a lower dose than that given to children 12 years and older – 10 micrograms of mRNA versus 30 micrograms. As in adults, the complete vaccination series consists of two doses given three weeks apart. Children’s doses will be presented in vials with an orange cap and an orange label. Adult and adolescent doses 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 and older, and can be given as part of an emergency use authorization for 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 on Tuesday. , According to the CDC.
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Meg tirrell contributed.