<mediadc-video-embed data-state="{"cms.site.owner":{"_ref":"00000161-3486-d333-a9e9-76c6fbf30000","_type":"00000161-3461-dd66-ab67-fd6b93390000"},"cms.content.publishDate":1655472125596,"cms.content.publishUser":{"_ref":"00000162-07af-d172-a563-4fefeeac0001","_type":"00000161-3461-dd66-ab67-fd6b933a0007"},"cms.content.updateDate":1655472125596,"cms.content.updateUser":{"_ref":"00000162-07af-d172-a563-4fefeeac0001","_type":"00000161-3461-dd66-ab67-fd6b933a0007"},"rawHtml":"
var _bp = _bp||[]; _bp.push({ "div": "Brid_55400009", "obj": {"id":"27789","width":"16","height":"9","video":"1034158"} }); ","_id":"00000181-71d3-db25-adf7-79dbf09c0000","_type":"2f5a8339-a89a-3738-9cd2-3ddf0c8da574"}”>Video EmbedThe Food and Drug Administration on Friday authorized the Moderna and Pfizer-BioNTech COVID-19 vaccines for children as young as 6 months.
The decision paves the way for that age group to begin getting the shots as soon as next week. However, they will not be shipped out until Centers for Disease Control and Prevention Director Rochelle Walensky signs off. The committee within the CDC responsible for reviewing vaccine candidates, the Advisory Committee on Immunization Practices, will discuss and vote on the authorization over the weekend.
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“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” said FDA Commissioner Robert Califf. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death. Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”
The Biden administration has made 10 million doses of pediatric vaccines available to states for preorder, with the first shots in arms expected to be administered on Tuesday, as Juneteenth is observed on Monday.
The authorization applies to the Moderna vaccine for children 6 months to 6 years and the Pfizer-BioNTech vaccine for children 6 months to 5 years old. The Pfizer vaccine has already been available for children as young as 5, while the Moderna vaccine was restricted to adults 18 and older.
The FDA’s regulators worked quickly to issue the authorization. The agency’s panel of vaccine experts voted unanimously just two days ago to recommend approval of the shots. Many parents have been hoping to vaccinate their youngest children, particularly in the run-up to the school year.
“We know that many parents, caregivers, and clinicians have been anxiously awaiting today’s authorizations,” Califf said. “We’re acutely aware of the importance of having vaccines available for our youngest children.”
Still, many parents are hesitant to get their young children vaccinated out of concern that the shots have not yet gone through a sufficiently rigorous review process. Roughly 18% of parents of children under 5 are anxious to get them vaccinated, compared to 38% who say they want to “wait and see,” according to a survey by the Kaiser Family Foundation last month. As of June 9, just 29% of children 5 to 11 have completed the vaccination course. The FDA’s panel of vaccine experts insisted on Wednesday, though, that the vaccines have been vetted thoroughly and gave evidence of their efficacy and safety profile.
“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.
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Children are also known to be less susceptible than adults, particularly seniors, to severe cases of COVID-19, and many parents do not consider them necessary. Roughly 75% of children under 11 have antibodies to the coronavirus present in their blood, indicating that the vast majority of children have some measure of immunity to COVID-19 through exposure to the pathogen. But over 1,500 children ages 5 to 18 have died due to COVID-19, according to federal data. The federal government, Califf said, will redouble its efforts to boost vaccination rates across age groups, especially among children as young as 5.
“It’s a real tragedy when you have something that’s free, and with so few side effects that prevents death and hospitalization,” Califf said. “Although the numbers as we’ve stressed are not large in children, I mean, children shouldn’t have these outcomes. It’s just an unnecessary, tragic event that could have been prevented.”
