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Pfizer is now including teens in clinical trials for its COVID-19 vaccine candidate, expanding the participation age to include high schoolers and middle schoolers, according to USA Today.
Pfizer is the only pharmaceutical company allowing minors to join coronavirus vaccine trials at the moment. The company initially lowered the age to 16, and this week, Cincinnati Children's Hospital Medical Center vaccinated the first 12-year-old.
Vaccine experts and pediatricians have voiced mixed reactions, USA Today reported. Some say drug manufacturers should wait until the vaccines have been approved in adults, but others say it's necessary to proceed vaccine testing among specific groups, including minors.
"If I were part of the FDA, I would certainly want to be very convinced about the safety of a vaccine before I approved its use in children," Cody Meissner, MD, a pediatric infectious disease specialist at Tufts Children's Hospital, said Thursday during an FDA advisory panel meeting.
The disease characteristics can be different in children, he said, which raises questions about testing both minors and adults at the same time. However, others argued that this year's devastating pandemic calls for different protocols that would get teens and pre-teens into clinical trials "as soon as possible."
"We should not allow children to die. That's our job as pediatricians to make noise and make sure people are noticing," Barbara Pahud, MD, an infectious disease researcher at Children's Mercy Hospital, told USA Today.
More than half a million children in the U.S. have contracted COVID-19 this year, the newspaper reported, and it's possible that even more have been infected but not tested. Most children recover without major symptoms, but some have died, and many have likely transmitted the coronavirus to their parents, grandparents, and teachers.
"With something that's turned our world upside down, it gives you even a stronger reason of why you want to test now," Robert Frenck Jr., MD, director of vaccine research at Cincinnati Children's, told USA Today.
Frenck gave the first Pfizer vaccines to minors last week and administered the vaccine on Thursday to the 12-year-old, who is the youngest volunteer so far. Frenck said he's seen few side effects. The most common include fatigue, muscle pain at the injection site and joint aches for a few days.
Pfizer hasn't released details about the program for teens, according to USA Today, but the company said it will study the vaccine in one age group before moving to younger ages.
Sources:
USA Today, "Pfizer has expanded its COVID-19 vaccine trial to include teens. Some say it's risky. Others argue it's necessary."
FDA," Vaccines and Related Biological Products Advisory Committee, October 22, 2020."
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Cite this: Pfizer Begins COVID-19 Vaccine Trial in Teens - Medscape - Oct 26, 2020.
