Pfizer gets approval to enroll children older than 12 in coronavirus vaccine trial
Pfizer, one of four companies in the United States working to develop a potential coronavirus vaccine, announced on Tuesday that it had received Food and Drug Administration (FDA) approval to include children as young as 12 years old to participate in its ongoing trials.
This expansion follows continued calls from health officials to expand testing to younger populations to ensure an eventual vaccine will be safe and effective for them.
Up until now, people under the age of 16 had not been included in any of the U.S. vaccine trials.
“I think this is a really big deal,” L.J. Tan, chief strategy officer of the Immunization Action Coalition, told NPR on Tuesday. “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.”
Earlier this month, the American Academy of Pediatrics (AAP) wrote a letter to Health and Human Services Secretary Alex Azar and FDA Commissioner Stephen Hahn urging them to authorize the inclusion of children in vaccine testing.
“Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns,” AAP President Sara Goza wrote in the letter.
She added that 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.”
Last month, Evan Anderson, a pediatric infectious disease specialist at the Emory University School of Medicine, told reporters that trials should include children to allow them to be protected from COVID-19 ahead of the 2021 school year.
“We owe it to our children not to delay moving forward with initial studies to evaluate promising vaccine candidates,” Anderson, who is also an investigator for the Moderna-National Institute for Allergy and Infectious Diseases trial of a potential coronavirus vaccine, said.
In addition to Pfizer and Moderna, Johnson & Johnson and AstraZeneca are also conducting late-stage coronavirus vaccine trials.
According to data released by the AAP last week, approximately 697,633 children have contracted COVID-19 in the U.S., making the overall rate 927 cases per 100,000 U.S. children.