An advisory panel to the FDA recommends Pfizer's vaccine for kids ages 5 to 11
NOEL KING, HOST:
COVID vaccines for kids ages 5 through 11 are one step closer to getting an OK from regulators. Advisers to the FDA voted in favor of authorizing the Pfizer-BioNTech vaccine for kids. A decision from the FDA either agreeing with or rejecting that recommendation could come at any time. NPR's Allison Aubrey is following this story. Good morning, Allison.
ALLISON AUBREY, BYLINE: Good morning, Noel.
KING: OK, what's the evidence, Allison, that the vaccine will be effective for littler kids?
AUBREY: Well, the advisers considered data from a Pfizer clinical trial that included more than 2,000 children that found the vaccine was about 91% effective against symptomatic infection. Now, throughout the pandemic, there have been more than 8,600 young children hospitalized with COVID, more than 5,000 cases of multisystem inflammatory syndrome in children - which has struck otherwise healthy kids - and nearly a hundred children aged 5 to 11 have died from COVID. So when it came time for a vote yesterday, one committee member did abstain, but all others voted that the benefits of vaccinating this age group outweigh the risks. Dr. Amanda Cohn explained her vote.
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AMANDA COHN: COVID-19 now is a vaccine-preventable disease, from my perspective. And COVID is also the eighth-highest killer of kids in this age group over the past year. And so the use of this vaccine will prevent deaths, will prevent ICU admissions and will prevent significant long-term adverse outcomes in children.
AUBREY: Now, some committee members said they think for now, giving a COVID vaccine should be the parents' choice, not a mandate.
KING: Based on your reporting, do you think the FDA will agree with those advisers and authorize the vaccine?
AUBREY: The FDA does typically follow the advice of its advisory committee. And the agency's own scientists have weighed in. They concluded that the vaccine's benefit in preventing hospitalizations and deaths would outweigh the risks of any potential rare side effects. So yes, the agency's analysis does support authorization.
KING: A question that I imagine many parents will be interested in - what are the side effects for kids who got the shot in these trials?
AUBREY: The common side effects tend to be the same seen in adults - sore arm, headache, maybe aches, chills. Now, when it comes to serious side effects, the main concern is myocarditis, which is inflammation in the heart. There have been rare instances following vaccination, mostly in young men. Now, no children in the Pfizer trial developed myocarditis, but some older kids have. Dr. Matthew Oster of the CDC outlined what is known from 10 cases among 12- to 17-year-olds who developed the condition after receiving the Pfizer vaccine.
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MATTHEW OSTER: About 30% of those 12 to 17 have been given a status of recovered, meaning no medications, no exercise restrictions, no ongoing symptoms.
AUBREY: This was one month after vaccination. Now, typically, he says, the long-term outlook of children who get myocarditis is good. But this is something that the CDC will track very closely through surveillance if the vaccine is authorized.
KING: And let's say it is authorized. How likely is it that parents will be on board? What is the data telling us?
AUBREY: Well, about 44% of 12- to 17-year-olds have been fully vaccinated in the U.S., so that's one data point. And a recent poll from the COVID-19 Vaccine Education and Equity Project found about two-thirds of parents of 5- to 11-year-olds say they are likely to get their children vaccinated if it's authorized. Typically, adults who have been vaccinated themselves are more likely to say they'll vaccinate their kids. Among those who say they're unlikely, many say full approval from the FDA or a school mandate may prompt them to change their minds. So bottom line on timing of authorization - FDA likely to make a decision this week, CDC advisers would then weigh in with recommendations early next week.
KING: NPR health correspondent Allison Aubrey. Thank you, Allison.
AUBREY: Thank you, Noel.
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