The company said in a statement that the Phase 2a study, which has been ongoing since September, was initially designed to evaluate the safety of the vaccine candidate in "healthy adults aged 18 to 55 years, as well as adults aged 65 years and older."
Now, the study is being expanded to include "a small number" of older children and teens. It will first test the COVID-19 vaccine on 16- and 17-year-olds before expanding to a larger group of kids.
“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.
White House Chief Medical Adviser Dr. Anthony Fauci recently told lawmakers he believes vaccines will be available for older children beginning in the fall, but elementary school aged kids may need to wait until next year. Moderna and Pfizer recently announced pediatric trials for children under 12 years old.
Johnson & Johnson said in a statement that the goal of the study is to "evaluate reactogenicity and immunogenicity of two dose levels of the vaccine candidate, and to evaluate potential vaccination schedules at one, two and three-month intervals in two-dose vaccine regimens."
The study is currently working to enroll participants in Spain and the United Kingdom. The company said it will soon begin to enroll participants from the United States, the Netherlands and Canada, with Brazil and Argentina to follow.
“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,” Dr. Stoffels added.
Johnson & Johnson received Emergency Use Authorization for its one-dose vaccine from the U.S. Food and Drug Administration on February 27, 2021. However, it was only approved for individuals 18 years of age or older.
The news of the expanded study comes a few days after a large batch of Johnson & Johnson coronavirus vaccines failed to reach quality standards at an Emergent BioSolutions factory.
The drugmaker didn’t say how many doses were lost, and it wasn’t clear how the problem would impact future deliveries.
A vaccine ingredient made by Emergent BioSolutions — one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, J&J said.
J&J had pledged to provide 20 million doses of its vaccine to the U.S. government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.”
The Associated Press contributed to this report.