NEW BRUNSWICK, N.J. - Johnson & Johnson said Friday it has started testing its COVID-19 vaccine in older children and teenagers, ages 12 to 17.
The company said in a statement that it has expanded the Phase 2a clinical trial, which first began in September. The study was initially designed to evaluate the safety, reactions and immune response of single-dose and two-dose regimens of the shot in "healthy adults aged 18 to 55 years, as well as adults aged 65 years and older." It now includes adolescents.
The vaccine will initially be tested in a small number of 16- and 17-year-old participants. Following the review of initial data from the Phase 2a trial, the study will be expanded to a larger group of younger kids, the company said.
J&J is currently enrolling participants for the trial in Spain and the U.K., and will later expand to the U.S., the Netherlands, Canada, Brazil and Argentina.
FILE: Johnson & Johnson COVID-19 vaccine given to seniors at coronavirus vaccination clinic established by L.A. County Department of Public Health at Whispering Fountains Senior Living Community on March 31, 2021 in Lakewood, California. (Irfan K
"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," Dr. Paul Stoffels, J&J’s vice chairman of the executive committee and chief scientific officer, said in the 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 company said the trial’s goals are to study two-dose levels of the vaccine and to evaluate potential vaccination schedules at one, two and three-month intervals in two-dose vaccine regimens. The shot is currently being administered as a single shot after receiving an emergency use authorization in February from U.S. health regulators.
In a massive study of adults that spanned three continents, the U.S. Food and Drug Administration said J&J’s vaccine offered strong protection against serious illness, hospitalizations and death. One dose was 85% protective against the most severe COVID-19 illness and protection remained strong even in countries such as South Africa amid the spread of more concerning variants.
Both Moderna and Pfizer-BioNTech, the other two COVID-19 vaccines being used in the U.S., have completed enrollment for studies of children ages 12 and older and are expected to release the data in the months ahead. Both are also now studying their shots in children under 12 — including babies as young as 6 months.
In its statement, J&J said it’s also hoping to expand trials to other groups not included in its massive study.
"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," Dr. Mathai Mammen, Janssen’s global head of research and development, said in the statement. Janssen is Johnson & Johnson’s vaccine division.
This story was reported from Cincinnati.