Johnson & Johnson to initiate its first vaccine study for adolescents in fall

Johnson & Johnson to initiate its first vaccine study for adolescents in fall
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Johnson & Johnson plans to initiate its first study of its COVID-19 vaccine involving adolescents ages 12-17 in the fall, an executive said Wednesday during a Johns Hopkins University of Washington event.

The study will be the first of four planned studies on how the Johnson & Johnson vaccine works among children and adolescents, Macaya Douoguih, the head of clinical development and medical affairs for Janssen Vaccines and Prevention B.V., said.

The next three studies will analyze the vaccine’s effectiveness among 2- to 11-year-olds, those younger than 2 years old and immunocompromised and high-risk children ages 1-17. 

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“While we are encouraged by the progress made with vaccinations, we recognize that a great deal more work is needed as this pandemic continues to affect the world and as the unvaccinated continue to be at risk,” Douoguih said. 

“We're focused on the critical work needed to make our single dose COVID-19 vaccine equitably accessible for all age groups,” she added. 

The vaccine manufacturer intends to enroll a minimum of 4,500 participants across all four studies. Douoguih said the studies were planned using data from an earlier clinical trial among adolescents ages 16-17.

Johnson & Johnson’s progression to studying the vaccine among children and adolescents comes as the manufacturers of the other two vaccines authorized in the U.S. have moved to expand eligibility to the younger populations. 

The Food and Drug Administration (FDA) currently grants the Johnson & Johnson and Moderna vaccines to only be given to adults in the U.S. 

Meanwhile, the Pfizer-BioNTech vaccine has been given emergency authorization for those ages 12 and older, allowing adolescents to get their COVID-19 shots. Overall, 63.6 percent of all Americans ages 12 and older have gotten at least one dose, according to CDC data. 

Last month, Moderna filed a request with the FDA to authorize its vaccine for those ages 12-17 after declaring it was 100 percent effective in a recent study.