Sanofi Pasteur, Fiocruz, and WRAIR to collaborate on Zika vaccine research
The three research organizations have a history of flavivirus vaccine collaboration.
Sanofi and its vaccines global business unit Sanofi Pasteur, has agreed to Principles of Collaboration with the Oswaldo Cruz Foundation - by means of its Immuno-Biological Technology Institute known as Bio-Manguinhos/Fiocruz-and the Walter Reed Army Institute of Research (WRAIR) - a US Department of Defense Laboratory-regarding Zika vaccine development. This collaboration follows the signing this past summer of a Cooperative Research and Development Agreement (CRADA) between WRAIR and Sanofi Pasteur to conduct research and development of a Zika vaccine using WRAIR's inactivated-virus vaccine (ZPIV) technology.
Under the Principles of Collaboration, Fiocruz, WRAIR and Sanofi Pasteur intend to combine their expertise in the fight against Zika. Fiocruz's activities will complement WRAIR and Sanofi Pasteur's activities, provide additional expertise, and increase the likelihood of successfully developing and licensing a safe and effective Zika vaccine as quickly as possible.
According to the CRADA signed by WRAIR and Sanofi Pasteur, WRAIR is providing its Zika purified, inactivated-virus vaccine (ZPIV) candidate to Sanofi Pasteur to produce clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimize the upstream process to improve production yields, and characterize the vaccine product. WRAIR-along with the U.S. National Institute for Allergy and Infectious Diseases (NIAID)--will sponsor and support a series of Phase I trials.
Last month the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services agreed to a proposal to fund Sanofi's manufacture of the inactivated Zika vaccine for Phase II development. Sanofi Pasteur is in the process of creating a clinical development and regulatory strategy while WRAIR and NIAID are conducting the Phase I ZPIV trials. Beyond the funding provided by BARDA for the two Phase I/II clinical trials, there is an option in the contract that BARDA can exercise for continuing support through Phase III industrial and clinical development.
Building on the WRAIR partnership, areas of collaboration with Fiocruz could include process development, vaccine characterization, epidemiological studies, pre-clinical and clinical evaluation of a vaccine, as well as clinical assay optimization.
"Fiocruz, WRAIR, and Sanofi Pasteur have a history of collaborating," explained John Shiver, Sr. VP for R&D at Sanofi Pasteur. "It only makes sense for the pursuit of public health that we combine our expertise and resources on Zika with Fiocruz, which is ideally based in Brazil where the heart of the current Zika experience lies. We have a common goal of developing a vaccine to prevent this emerging disease threat imposed by the Zika virus."
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance