10 June 2020 | News
Collaboration will enable global development, manufacturing and distribution of the candidate vaccine
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New Delhi based Panacea Biotec is advancing its response to address the unprecedented challenges of COVID-19 by collaborating with Refana Inc. USA to make candidate Covid-19 vaccine widely accessible around the world in an equitable manner through a Joint Venture company based in Ireland.
The collaboration aims to bring to patients a whole inactivated virus-based vaccine for Covid-19. Under the collaboration, Panacea Biotec will be responsible for product development and commercial manufacturing, with the Joint Venture undertaking clinical development and regulatory submissions across the World. Both Panacea and Refana will undertake sales and distribution of the vaccine in their respective territories.
Dr. Rajesh Jain, Managing Director, Panacea Biotec, said, “The world needs a vaccine that is safe, effective, and scalable in a cGMP compliant manufacturing facility that has sizeable capacity and capability to cater to global demand. Our collaboration with Refana aims to manufacture over 500 million doses of our Covid-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year. Our candidate vaccine is based on tried and tested technologies that have been proven over decades with existing vaccines. Whole inactivated viral vaccines have a higher probability of being safe and efficacious, given their long history and better understanding of their mechanism of action, which has been elucidated over many decades. Our vaccine leverages a dose-sparing Adjuvant to maximise the number of immunisations available for distribution. Additionally, intramuscular/sub-cutaneous mode of administration with pre-existing, compatible infrastructure ensures adequate supply chain availability until the last mile. This vaccine has the potential to become the Vaccine of Choice for the global fight against Covid-19. We believe and hope that our vaccine candidate will enable the world to get back to work fearlessly as soon as possible.”
Dr Phillip Schwartz stated "Refana and its international network of scientific researchers and practitioners are dedicated to finding practical solutions to complex and urgent global medical problems. We are grateful for the input we have obtained from dozens of medical scientists and epidemiologists in more than a dozen countries in this unprecedented worldwide collaboration to end Covid-19. Our partnership with Panacea Biotec brings this dream to a practical realization with the ability to manufacture 500 million Covid-19 vaccines over 12 months. Utilizing proven models of viral pathogenesis and parallel conduct of multiple pre-clinical and clinical studies, Refana believes it can significantly accelerate the vaccine development and approval process for its tried and true whole inactivated viral vaccine approach. We are very excited to combine this approach with Panacea Biotec’s world class technology, development and production capabilities."
This collaboration brings together the Panacea Biotec’s expertise in vaccinology, R&D, manufacturing and distribution capabilities with Refana’s Scientific team’s strong ability to work on complex challenges through innovative technologies. We believe that by joining forces, we can accelerate the globalisation of a vaccine to combat the virus and protect people from most contagious virus in more than a century.