The Food and Drug Administration authorized a smaller dose of Pfizer's COVID-19 vaccine for children ages 5 to 11, a critical step for the more than 28 million children that .
The authorized dose is a third of the size of the dose for other age groups, and was found to be nearly 91% effective against symptomatic disease in a clinical trial.
Advisers for the Centers for Disease Control and Prevention will meet Tuesday, November 2, to review the data and vote on their own recommendation, and if the CDC director agrees, shots could be available as soon as the following day.
In a statement, acting FDA Commissioner Dr. Janet Woodcock said vaccinating younger children "will bring us closer to returning to a sense of normalcy."
"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," she said.
The emergency use authorization granted by the FDA comes after a near-unanimouson Tuesday endorsing the benefits of the vaccine. While most members of the Vaccines and Related Biological Products Advisory Committee ultimately coalesced around supporting the shot, some voiced concerns about the need for more data on potential side effects, specifically the risk of myocarditis and pericarditis, inflammation of different parts of the heart. No cases were reported during the clinical trial in kids, but some have been seen in older age groups.
"This is a much tougher one I think than we had expected coming into it," said Dr. Eric Rubin during the committee meeting. "Data show that the vaccine works and it's pretty safe, at least by immuno-bridging and even by some early clinical data, and yet we're worried about a side effect that we can't measure yet but it's probably real."
Data from the CDC shows that myocarditis is most common among men under 30 after the second dose of Pfizer or Moderna mRNA vaccines, but severe outcomes are rare and no deaths have been reported.
But the FDA's advisers also said they felt compelled to act on behalf of children at higher risk of severe illness from COVID-19, and to help address racial disparities in COVID's impact on children. Black and Hispanic kids have made up a disproportionate share of COVID-related hospitalizations among kids 5 to 11 and cases of multi-system inflammatory syndrome — a condition tied to COVID-19 infection that can result in inflammation of certain organs — are also more common among Black children.
Dr. Matthew Oster, a pediatric cardiologist and member of CDC's COVID-19 response team, said during a presentation to FDA advisers that the risk to Black children was "a double-hit."
The regulatory work now moves to the CDC, whose vaccine advisers are slated to meet November 2 to review the data. They will decide whether to issue their own recommendation for the vaccine in this age group, and may consider the option to further narrow its use to a smaller subset of the population, such as children with higher-risk medical conditions. CDC Director Dr. Rochelle Walensky will then decide whether to sign off on the recommendations.
In a statement, Pfizer CEO Albert Pourla called the FDA authorization welcome news for parents around the country.
"Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week," he said. "With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control."
With the FDA's decision today, 15 millions of doses of the vaccine for children will be shipped to states, which have already placed their initial orders.
The Biden administration says the vaccine rollout for kids will focus on smaller, more familiar sites such as schools, pediatricians' offices, children's hospitals and rural health clinics. The pediatric vaccine will come with smaller needles and different color caps to distinguish it from the one meant for other ages.
A September Gallup poll found that 55% of parents with children under 12 said they planned to vaccinate their children against COVID-19, with Democrats far more likely than Republicans. A new survey from the Kaiser Family Foundation found that 27% of parents are eager to get it right away, while another third say they want to wait and see and 30% say they don't plan to get their kids vaccinated.
At a Wednesday briefing with federal health officials, Jeff Zients, the White House coronavirus response coordinator, said the administration was going to be launching a multi-faceted media outreach campaign to educate families about the shots and promote vaccination.
"You know, we've learned throughout that what matters most is local trusted messengers that, in this instance, parents and kids can turn to to get their questions answered," he said. "And we'll also be out with a full range of channels of media, including robust paid media campaigns across television, radio, print, social, and digital."
Pfizer is still awaiting clinical data among children 6 months to 4 years of age, which a company spokesperson said could come as early as the end of this year. The company currently has no plans to test its vaccine in babies under 6 months old.
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