The U.S. Food and Drug Administration has approved Pfizer's request to include children as young as 12-years-old to participate in COVID-19 vaccine trials. Previously, only children above the age of 16 were able to participate in the ongoing trials.
"I think this is a really big deal," Immunization Action Coalition Chief Strategy Officer L.J. Tan said.
"Without clinical trials actually done in children, the only way to actually extend the use of the COVID-19 vaccine into children would be to rely on the adult data."
Prior to the FDA's approval, pediatricians had supported Pfizer's request to include younger children. Doctors had explained that children needed to be included in vaccine trials to address certain unforeseen concerns with the vaccination.
"Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns," American Academy of Pediatricians President Sara Goza wrote in a letter to Secretary of the U.S. Department of Health and Human Services Alex Azar and FDA Commissioner Stephen Hahn.
Later in her letter, Goza pointed out how the virus has impacted young children. She also explained that removing children from the vaccine trials would delay the possibility for a child-friendly vaccine.
"More than two-thirds of the children who died were Black and Latinx children," she wrote.
"[It would be unethical] to allow children to take on great burdens during this pandemic but not have the opportunity to benefit from a vaccine, or to delay that benefit for an extended period of time, because they have not been included in vaccine trials."
Pfizer aims to put forth the first vaccine to gain approval in North America and Europe. If approved, the company hopes to administer 100 million doses before the end of the year and 1.3 billion by the end of 2021.
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