Johnson and Johnson expands COVID-19 vaccine trial to include adolescents

"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. "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 randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) has been ongoing since September 2020, and was initially designed to evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness) and immunogenicity (ability to induce an immune response) 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 study is now including adolescents 12 to 17 years of age.

Among the study's goals are 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.

"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."

The Johnson & Johnson COVID-19 vaccine candidate will initially be tested in a small number of adolescents aged 16-17 years. Following the review of initial data in this Phase 2a trial, the study will be expanded to a larger group of younger adolescents in a stepwise approach.

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.

The Company's Janssen COVID-19 Vaccine leverages the AdVac vaccine platform, a proprietary technology that was also used to develop and manufacture Janssen's European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

Research and development activities for the Company's COVID-19 vaccine, including the delivery of doses to the U.S., have been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).

Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza; chemical, biological, radiation and nuclear threats; and emerging infectious diseases such as Ebola.

The Johnson & Johnson single-shot COVID-19 vaccine was granted Emergency Use Listing from the World Health Organization (WHO) on March 12, Conditional Marketing Authorization from the European Commission on March 11 and Emergency Use Authorization by the U.S. Food and Drug Administration on February 27, 2021. The single-shot COVID-19 vaccine has also been granted Interim Order authorization in Canada, and additional rolling submissions have been initiated in several countries worldwide.

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