A trial will enroll up to 60,000 participants to assess the safety and efficacy of a COVID-19 vaccine candidate that only requires a single dose.
Johnson & Johnson’s single-dose coronavirus disease 2019 (COVID-19) vaccine, JNJ-78436735, has entered into phase 3 clinical trials, according to the company.
COVID-19 has caused more than 966,000 deaths and there has been over 31.3 million confirmed cases worldwide according to the World Health Organization. Numerous companies have COVID-19 vaccines in development, with Johnson & Johnson’s vaccine being developed and produced by its pharmaceutical arm, Janssen Pharmaceutical Companies.
Johnson & Johnson’s phase 3 trial, known as ENSEMBLE, will enroll up to 60,000 volunteers aged 18 years and older, across 3 continents. It will evaluate the safety and efficacy of a single-dose vaccine versus placebo in preventing COVID-19 and will focus on individuals over 60 years of age.
The phase 3 trial was initiated after positive interim results from the company’s phase 1/2a clinical study. The earlier trial demonstrated the safety profile and immunogenicity after a single vaccination of the candidate, which supported further development. Johnson & Johnson have continued to scale up its manufacturing capacity and remains on track to provide 1 billion doses of a vaccine each year, which will be offered on a not-for-profit basis for emergency pandemic use, according to a company press release.
“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same—leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” chairman and chief executive officer at Johnson & Johnson, Alex Gorsky, said in a press release. “As the world’s largest health care 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. 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.”
If proven safe and effective, the vaccine is anticipated to be made available for emergency use in early 2021, according to the press release.
Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate [News Release] September 23, 2020; New Brunswick, NJ. https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate. Accessed September 23, 2020.