J&J to Include Adolescents in Phase 2a of COVID-19 Vaccine Trial
Johnson & Johnson has started vaccinating teens aged 12 to 17 in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate to reflect dedication in protecting individuals of all ages who are affected by the pandemic.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson 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 wellbeing. 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.”
Since September 2020, researchers have been running a randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to assess the efficacy, reactogenicity (expected reactions to vaccination, such as swelling or soreness), and immunogenicity (ability to trigger 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 those aged 65 and older. The study is now also including teenagers 12 to 17 years of age.
The trials’ objectives include assessing the reactogenicity and immunogenicity of two dose levels of the vaccine candidate and evaluating possible vaccination patterns of two-dose vaccine regimens at one, two, and three-month intervals.
Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson stated:
“Our COVID-19 vaccine candidate development program is designed to deliver on our commitment to protect people of all ages from this pandemic. 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 studied 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. Participants are currently being enrolled in this trial in Spain and the United Kingdom. Recruitment in the United States, the Netherlands, and Canada will begin soon, with Brazil and Argentina to follow.
Janssen’s COVID-19 Vaccine Candidate
Janssen’s COVID-19 Vaccine is based on the AdVac® patented vaccine technology, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen, as well as its investigational Zika, RSV, and HIV vaccines. The Company’s COVID-19 vaccine R&D programs, including the supply of doses to the United States, have been partially financed with federal funding from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA) 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). Since 2015, Johnson & Johnson has collaborated with BARDA on cutting-edge technologies for influenza, chemical, medical, radiological, and nuclear risks, as well as emerging infectious diseases like Ebola.
Regulatory Filings
The J&J 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 one-shot COVID-19 vaccine has also been granted Interim Order authorization in Canada, and additional rolling submissions have been initiated in several countries worldwide.
For more information on the Company’s multi-pronged approach to helping combat the COVID-19 pandemic, please visit www.jnj.com/coronavirus.
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