View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
February 1, 2021

J&J’s Covid-19 vaccine shows efficacy in Phase III trial

Johnson & Johnson (J&J) has reported that the Phase III ENSEMBLE clinical trial of its single-dose Covid-19 vaccine candidate met all primary and key secondary endpoints.

Johnson & Johnson (J&J) has reported that the Phase III ENSEMBLE clinical trial of its single-dose Covid-19 vaccine candidate met all primary and key secondary endpoints.

Free Report
img

Build resilience in the face of COVID-19 disruption

COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
by GlobalData
Enter your details here to receive your free Report.

The investigational vaccine is being developed by J&J’s subsidiary Janssen Pharmaceutical .

Dubbed ENSEMBLE, the Phase III trial was launched last September, and involved subjects aged 18 years and above, with and without comorbidities, in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the US.

The safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of Covid-19.

According to J&J, the single-shot candidate has been found to be 72% effective in the US and 66% effective overall at preventing ‘moderate to severe’ coronavirus.

Furthermore, it is 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults aged 18 years and above.

Once cleared for emergency use, the vaccine will be the first single-dose regimen introduced for commercial use.

Johnson & Johnson board of directors chairman and CEO Alex Gorsky said: “Johnson & Johnson embarked on the global effort to combat the Covid-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine.

“Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic.

“We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

The latest results in the vaccine’s Phase III trials enabled J&J to become the fifth company supported by the US Government to develop an effective Covid-19 vaccine in less than a year.

J&J intends to file for EUA in the US early this month and expects to have ready-to-ship product immediately after authorisation.

Related Companies

Free Report
img

Build resilience in the face of COVID-19 disruption

COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena