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Johnson & Johnson commences Phase 3 trial of COVID-19 vaccine candidate

29 September 2020 12:46

NEW BRUNSWICK - Johnson & Johnson launched its large-scale Phase 3 clinical trial for its coronavirus (COVID-19) vaccine candidate JNJ-78436735, which is being developed by Janssen Pharmaceutical Companies, on 23 September 2020.

The Phase 3 trial followed positive interim results from the company’s Phase 1/2a clinical study, which have been submitted to medRxiv and will be published online immediately. Based on these results and recommendations from the US Food and Drug Administration (FDA), the Phase 3 trial will involve up to 60,000 volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States, and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic,” Johnson & Johnson CEO Alex Gorsky said in an official statement received by IDNFinancials.com.

“This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”

The Phase 3 clinical trial is carried out in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) of the US Department of Health and Human Services.

The COVID-19 vaccine candidate uses Johnson & Johnson’s AdVac technology platform, which was previously used to develop Janssen’s Ebola vaccine and construct its Zika, RSV (respiratory syncytial virus), and HIV (human immunodeficiency virus) vaccine candidates. (MS)

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