Johnson & Johnson set to test its Covid-19 vaccine on 60,000 adult volunteers

The third phase follows positive results from its first and second phase trials, which demonstrated that the safety profile and immunogenicity after a single vaccine were supportive of further development.
The results have been submitted to medRxiv and are due to be published online soon.
Up to 60,000 volunteers across three continents will be enrolled to study the safety and efficacy of a single vaccine dose versus placebo in preventing Covid-19. The vaccine is being developed by Johnson & Johnson’s Janssen Pharmaceutica.
Johnson & Johnson said it will scale up its manufacturing capacity to provide one billion doses of the vaccine each year. Its aim is to provide an affordable vaccine for emergency use and expects the first batch to be available for authorisation in early 2021 if tests prove it to be safe and effective.
“As Covid-19 continues to impact the lives of people worldwide, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, chairman and chief executive officer of Johnson & Johnson. “We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
“We remain focused on developing an urgently needed, safe and effective Covid-19 vaccine for people around the world,” said Paul Stoffels, MD, vice chair of the executive committee and chief scientific officer for Johnson & Johnson. “We value the collaboration and support from our scientific partners and global health authorities as our team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorisation in early 2021.”
The vaccine is being developed using the company’s AdVac technology, which was also used to develop and manufacture the European Union-approved Ebola vaccine as well as its Zika, RSV and HIV vaccine candidates. The AdVac platform has been used to vaccinate more than 100,000 people to date.
With the AdVac technology, the vaccine, if successful, should remain stable for two years at -20 degrees Celsius and at least three months at 2 to 8 degrees Celsius. This makes the vaccine compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.

Phase 3 trial
The Phase 3 study is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60,000 adults above the age of 18, including a significant representation of those above 60. The trial will aim to enrol participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
In order to evaluate the effectiveness of the vaccine, countries and clinical trial sites that have a high incidence of Covid-19 infections and the ability to achieve rapid initiation will be activated.
The company will also collaborate with the UK on a separate Phase 3 clinical trial to explore a two-dose regimen of Janssen’s vaccine candidate.
Johnson & Johnson is also in talks with many governments and global organisations to meet its commitment to make the vaccine accessible globally once it proves to be safe and is approved.
Visit www.jnj.com/coronavirus for more information.