21:47
Making these decisions can be difficult and nerve-wracking, but they’re not made “when you know everything,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “The question is when do you know enough.”
In this case, he said, the benefits of recommending the Pfizer coronavirus vaccine outweigh the risks, especially since myocarditis as a side effect tends to be less common in pre-adolescent children.
“Our kids are going to be dealing with this virus for many years to come,” said Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City School of Medicine. “Getting the vaccine is just the first step that they’re going to take towards being able to protect themselves.”
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), highlighted the harms of the pandemic.
“Far from being spared from this harm of Covid-19, in the five-to-11 year-old age range, there have been over 1.9 million infections, over 8,300 hospitalizations (about a third of which have required intensive care unit stays), and over 2,500 cases of multisystem inflammatory disorder from Covid-19,” Marks said.
Nearly 100 children in this age group have died, making it the eighth leading cause of death in the past year for this group.
21:30
FDA advisers vote to authorize the Pfizer vaccine for children aged five to 11
Independent advisers for the US Food and Drug Administration (FDA) on Tuesday recommended the Pfizer-BioNTech Covid-19 vaccine for children aged five to 11 — the first vaccine available for younger children in the US.
Of 18 members, 17 voted yes and one abstained.
Vaccines for children have been seen as crucial for protecting kids from the virus as well as slowing its spread, in addition to reducing the social and educational effects of school closing and attendance — and related economic concerns, such as caregivers’ ability to work.
The advisers weighed the vaccine’s effectiveness, the social and physical effects of the pandemic, and the potential risk of rare side effects like myocarditis, a type of heart inflammation.
Data from Pfizer-BioNTech indicate the vaccine is 90.7% effective at preventing symptomatic illness among this age group.
The benefits of vaccination “clearly outweigh” the risks of myocarditis and pericarditis, FDA scientists concluded in an analysis, an assessment the independent advisers agreed with.
19:50
Several FDA advisers repeatedly pointed to the importance of vaccinating children in order to reduce cases throughout the country. Arnold Monto, acting chair of the advisory committee, acknowledged that the “very important topic” of child Covid vaccination “affects a lot of people”.
While it is not yet clear how well the vaccine keeps children from transmitting the virus, data among vaccinated adults show this is likely, and reducing the number of overall Covid cases through vaccination would help reduce spread.
But serious rare side effects like myocarditis may be “the principal concern people have regarding use of these mRNA vaccines and in children,” H Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, said.
Matthew Oster, a medical officer for the CDC, differentiated between different types of myocarditis caused by the vaccine, by Covid-19, and by other causes. The rare cases of vaccine-induced myocarditis tend to be more mild than myocarditis caused by Covid-19, for instance, and patients usually return to normal “within a few days,” he said.
The FDA, in its scientific analysis, said the risks of Covid outweighed the risks of myocarditis.
19:38
FDA advisers weigh benefits and risks of Covid vaccines for young children
The Food and Drug Administration advisory committee is weighing the social, emotional, and physical risks of Covid-19 to children’s health against the risk of potential side effects like myocarditis, a swelling of the heart muscle.
The dangers of the virus are clear, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“Far from being spared from this harm of Covid-19, in the five-to-11 year-old age range, there have been over 1.9 million infections, over 8,300 hospitalizations (about a third of which have required intensive care unit stays), and over 2,500 cases of multisystem inflammatory disorder from Covid-19,” Marks said.
Nearly 100 children in this age group have died, making it the eighth leading cause of death in the past year for this group.
Children between five and 11 have one of the highest case rates of any age group, accounting for about one in ten of all Covid cases in the country. They’re also the most frequently affected by MIS-C, an inflammatory disorder that affects organs.
Children are “at least as likely” to be infected as adults, said Fiona Havers, medical officer at the CDC. But at the same time, cases among kids are more likely to go unnoticed, according to seroprevalence data.