Time to include children in COVID-19 vaccine trials, experts say
Currently, none of the COVID-19 vaccines in clinical development are being tested among people aged younger than 18 years, but this could change soon, said Paul A. Offit, MD.
In a presentation during the AAP National Conference & Exhibition, Offit, an Infectious Diseases in Children Editorial Board Member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, noted that the two COVID-19 vaccine trials farthest along in the United States are the trials for Pfizer’s and Moderna’s mRNA vaccines.
Last month, Pfizer submitted an amended protocol to the FDA to expand the enrollment in its phase 3 trial from 30,000 participants to 44,000, and to include adolescents as young as 16, Offit noted.
“I think what we're going to see is this de-escalation in age as we move forward,” Offit said. “We'll study younger and younger people in a sequential manner would be my guess.”
Asked when he felt children should be included in COVID-19 vaccination trials, Offit replied “now.”
“I think we can start to study these vaccines now,” Offit said. “It's going to be important when we consider strategies to get children universally back into schools, which is critical.”
In a recent letter to the HHS and FDA, AAP President Sara H. Goza, MD, FAAP, said children “must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.”
“It would also be less than desirable to have one or more SARS-CoV-2 vaccines licensed or available under emergency use authorization at a time when no data have been collected on the safety, tolerability, dose, and regimen for children,” Goza wrote. “For these reasons, we urge the inclusion of children in vaccine trials as we move forward in the development of a SARS-CoV-2 vaccine.”
In a keynote address for the AAP conference, National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, said it is important to “strike a balance of making sure you get a vaccine — if it’s safe and effective — to children in a timely manner while you’re also very attentive to the extra potential risk you’d see in a child, given the vulnerability of children.”
Offit noted surveys that have showed many Americans said they would not get a COVID-19 vaccine when one is available.
“At some level, I think it's understandable,” he said. “The language that surrounds this vaccine has been a little frightening — phrases like ‘warp speed,’ ‘race to a vaccine,’ ‘who's going to be the vaccine finalist,’ ‘who's going to be across the finish line first’ — in combination with the fact that this will be the fastest vaccine ever made.”
CDC Director Robert R. Redfield, MD, said last month that he expects a COVID-19 vaccine to be ready in November or December but that it would not available to the general public until sometime in 2021. Offit noted that the previous record for developing a vaccine was the mumps vaccine, which took about 4 years to become commercially available to the public.
“I think that to be skeptical about this vaccine is perfectly reasonable,” Offit said. “I think you should be skeptical about anything you put into your body, and I think the way that one can convince skeptics is with data. Data that [are] presented in a clear, passionate, compassionate, compelling way.”
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Offit PA. Strategies to address vaccine hesitancy. Presented at: AAP National Conference & Exhibition; Oct. 2-5, 2020; virtual.
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