FDA may allow Covid injections for children under 5 years old in June
The Food and Drug Administration may allow the Covid-19 vaccine to be given to children under the age of 5 in June, according to two people familiar with the plan.
The agency asked members of its advisory panel, known as the Vaccines and Related Biologicals Advisory Committee, to set aside a few days in June to be able to meet with the public. know.
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The members of the panel are not yet known what the meeting is expected to talk about, but presumably the discussion will involve the topic of vaccinations among the nation’s youngest cohort, one of the nation’s youngest cohorts. they said. The first potential meeting date is June 1.
The dates are still subject to change, the people said, especially if the trajectory of Covid cases continues to rise in the United States.
The FDA also scheduled advisory committee meetings for May, but those were ultimately scrapped.
According to NBC News data, there are an estimated 19.5 million children under the age of 5 in the US and Puerto Rico.
Children under the age of 5 are the only group in the United States not eligible for the Covid vaccine, but efforts to vaccinate this age group have encountered delays.
In February, Pfizer-BioNTech announced it was postponing its FDA application to expand the use of two-dose Covid. vaccines for children from 6 months to 4 years old.
Drug manufacturers at the time said that two doses does not produce a strong enough immune response in a clinical trial of children 2 to 4 years old, so they will instead pursue a three-dose regimen and submit their findings to the FDA when new results become available.
Meanwhile, Moderna said it plans to file with the FDA for children under the age of 6 by the end of the month. The company announced its test results March. The vaccine has not been found to be particularly effective against infections, although it has prevented serious illness in young children.
FDA officials have struggled over whether to authorize each vaccine, or pause and allow both at the same time. One person said doing things one by one could confuse the public and undermine the vaccination campaign for age groups.
FDA spokeswoman Abby Capobianco said the agency is continuing to work with drug manufacturers to discuss their data.
“But we cannot adjudicate a decision on any vaccine without the full requirements of the EUA, to allow us to scrutinize it,” she said, adding any timeline for the decision. Potential licensing would be “driven by when data is provided to FDA and fully support a regulatory action”
Immunization rates for older children have slowed in the US
Less than 30 percent of children 5 to 11 years old have received two doses of the vaccine, according to data from the Centers for Disease Control and Prevention.
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