Pharmaceutical company Johnson & Johnson says it is expanding the clinical trial of its coronavirus vaccine to include adolescents from age 12 to 17.
In a news release early Friday, the drugmaker said its double-blind, Phase 2a study, which has been 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.
“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,” Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in a statement. “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 announcement came just two days after Pfizer and BioNTech said their coronavirus vaccine has been 100% effective in a clinical trial of children ages 12 to 15, according to preliminary results. A news release said the vaccine “demonstrated 100% efficacy and robust antibody responses” in a Phase 3 trial of 2,260 participants in that age group. The companies already included 16- and 17-year-olds in their trial of adults, unlike Moderna and Johnson & Johnson, whose youngest trial participants were 18.
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Johnson & Johnson’s vaccine, which currently requires just one dose, was the third to be approved for emergency use in adults by the U.S. Food and Drug Administration, according to The Associated Press. 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.
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Cox Media Group
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