Janssen Research and Development partner with BARDA to accelerate clinical trials and manufacturing of COVID-19 vaccine

BARDA Response

BARDA and long time partner Janssen, part of Johnson & Johnson, are collaborating to speed the development and manufacturing of a vaccine to prevent COVID-19. BARDA will support non-clinical studies and a Phase 1 clinical trial of Janssen’s COVID-19 investigation vaccine, Ad26 SARS-CoV-2. The goal of the clinical trial is to examine the vaccine’s safety in healthy adult volunteers and its ability to induce an immune response in the recipients.  

BARDA’s support for this vaccine candidate started in February 2020 with Janssen using the same vaccine platform to develop an investigational vaccine for Ebola.  The Phase 1 trial for AD26 SARS-CoV-2 will begin no later than fall of 2020 with the goal of making the vaccine available for emergency use in the US in early 2021.  In parallel to the clinical evaluation BARDA also committed to working with Janssen to accelerate advanced clinical trials, regulatory support and large-scale manufacturing to produce up to 300 million doses of the vaccine in the US each year. 

Development work such as this takes decisive action and Janssen and BARDA will work together to streamline the development and regulatory processes to make a safe and effective vaccine available as widely and as quickly as possible.

This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.

About Janssen: 

The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products. 

 Janssen is creating a future where disease is a thing of the past as the Pharmaceutical Companies of Johnson & Johnson. They work tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. Janssen focuses on areas of medicine where it can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.