NEW BRUNSWICK, NJ — The Johnson & Johnson Company has started testing its coronavirus vaccine, developed by the Janssen Pharmaceutical Companies of J&J, in adolescents.
The company says it has expanded its Phase 2a trial, which began last September, to now include teens between the ages of 12 and 17.
“The COVID-19 pandemic has had a profound impact on adolescents, not just with the complications of the disease, but with their education, mental health, and wellbeing,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “It is vital that we develop vaccines for everyone, everywhere, to help combat the spread of the virus with the goal to return to everyday life.”
The company says the study is randomized, double-blind, and placebo-controlled.
The study will evaluated the vaccine's safety at different dose levels in both a single dose and two dose regimens.
It will also evaluate potential vaccination schedules at one, two and three month intervals between doses.
“Our COVID-19 vaccine candidate development program is designed to deliver on our commitment to protect people of all ages from this pandemic,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “In addition to expanding this ongoing study to include adolescents, we are in discussions with health authorities and are hard at work to initiate studies in pregnant women and children in the near future.”
J&J says the vaccine study will first be tested in a small number of teens aged 16 and 17 years old, then expand to a larger group of younger teens.
The trial is currently enrolling participants in the United Kingdom and Spain, but will soon expand to teens in the U.S., the Netherlands, and Canada, with Brazil and Argentina to follow.
The vaccine is currently authorized for emergency use in the U.S. as a single dose in adults ages 18 and older.
You can read more about the vaccine trial by visiting the J&J website here.