Upstate doctor published in New England Journal of Medicine on safety and efficacy of COVID-19 vaccine for adolescents 12 to 15
Upstate Medical University infectious disease physician-scientist Stephen J. Thomas, MD, is a co-author of a new article in the New England Journal of Medicine describing the safety and efficacy of the Pfizer/BioNTech COVID-19 vaccine in adolescents ages 12 to 15. Thomas is the coordinating principal investigator for the late-stage Pfizer/BioNTech global vaccine trial and the principal investigator at Upstate, which enrolled 12- to 15-year-olds in the study.
The article, “Adolescent Safety, Immunogenicity, and Efficacy of BNT162b2 COVID-19 Vaccine,” was published May 27 in the NEJM, which is considered one of the most prestigious peer-reviewed medical journals in the world. Thomas is part of a large team of investigators, trial coordinators, recruiters, and lab and other science support personnel executing the trial.
The U.S. Food and Drug Administration expanded the emergency use authorization of the Pfizer/BioNTech vaccine on May 10 to include adolescents 12 to 15 years of age and follows authorization of the vaccine in those 16 and older in December 2020. The CDC reports more than 2.4 million 12- to 15-year-olds have been vaccinated since the authorization.
Today’s NEJM paper describes results of the trial, which included more than 2,200 participants, half of whom received a placebo while the other half received the Pfizer/BioNTech vaccine in the same dosage as those 16 and older. Of those who received the placebo, 16 contracted COVID-19 while there were zero cases reported among vaccine recipients, translating into a vaccine efficacy of 100%.
“The safety profile was similar to what we have seen in people 16 years and older who have been vaccinated,” Thomas said. Participants reported post-vaccination symptoms similar to what older recipients reported including pain at the injection site, fatigue and headache. Volunteers rated the symptoms as mild to moderate in severity and there were “no vaccine-related serious adverse events,” according to the paper.
“The immune responses in the 12- to 15-year-olds were great,” Thomas said. That data, combined with the increasing burden of COVID in that age group is why the advisory committee to the FDA voted 14 to zero to recommend emergency use authorization, he said.
Thomas, interim chair of microbiology and immunology, and serves as the director for Upstate’s Institute for Global Health, said his own 13-year-old son received the vaccine at the New York State Fairgrounds.
“I said Charlie, do you want to get vaccinated and he said, ‘not really but I don’t want COVID either so I guess I will,’ ” Thomas said. “I also have a 6-year-old and I’m waiting for the vaccine to be available for her age range.
“I firmly believe that one of the most devastating effects of this pandemic has been on our kids, caused, in part, by the lack of in-person learning and cancellation of numerous extracurricular activities. The only way that everybody – the teachers and the teacher’s unions, the parents and the administrators, and the departments of health – the only way that everyone is going to feel comfortable with bringing kids back every day, full-time is to create these bubbles of immunity in our schools. To do this requires wide-scale vaccination among these groups.”
Thomas was a co-author of a paper in the New England Journal of Medicine about the effectiveness of the Pfizer/BioNTech vaccine in December. He reflected on the latest achievement for Upstate.
“I’m the lucky guy here at the right time waving the flag for a team of dozens and dozens of committed professionals who have not had a single break during this pandemic. For me, it’s special to have Upstate and CNY attributed to this work. It shows we did our part. We chipped in and we participated.”
Upstate is involved in additional Pfizer/BioNTech COVID vaccine trials. Joe Domachowske, MD, is a pediatric infectious diseases physician-scientist at Upstate and the principal investigator of a trial testing the vaccine in children as young as 6 months of age.