NORTH TEXAS (CBSDFW.COM) - Pharmaceutical company Johnson & Johnson says it's expanding the clinical trial of its coronavirus vaccine to include adolescents from age 12 to 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 well-being," Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, Dr. Paul Stoffels said. "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 drugmaker said its double-blind, Phase 2a study, ongoing since September, initially focused on evaluating the safety and efficacy "of single-dose and two-dose regimens of the Johnson & Johnson COVID-19 vaccine candidate in healthy adults aged 18 to 55 years, as well as adults aged 65 years and older."
The company plans to test "a small number" of 16 and 17-year-olds at first, then enroll "a larger group of younger adolescents in a stepwise approach," the news release said.
Johnson & Johnson's vaccine, which currently requires just one dose, was the third to gain approval for emergency use in adults by the U.S. Food and Drug Administration. A clinical trial found that one dose of the vaccine was 66% effective at preventing COVID-19 in adults, compared with 95% efficacy for two-dose vaccines by competitors Pfizer and Moderna, the news agency reported.
So far, Pfizer's vaccine is the only one authorized for emergency use in 16 and 17-year-olds.
"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."
This trial is currently enrolling participants in Spain and the United Kingdom; enrollment will commence shortly in the United States, the Netherlands and Canada, with Brazil and Argentina to follow.
for more features.