Working toward a COVID vaccine

While they aren’t talking exclusively about the novel coronavirus that leads to COVID-19, it is definitely on their radar, and is consistent with IAVI’s trajectory, which began with a focus on HIV/AIDS vaccines and then grew to encompass other unmet or under-met global health challenges that could be addressed via vaccination, such as tuberculosis.

Batavia brings a state-of-the-art manufacturing approach for highly intensified, modular vaccine production. IAVI, with expertise in vesicular stomatitis virus (VSV) vector technology that it has developed through its own VSV HIV vaccine candidate, will use Batavia’s approach to develop an end-to-end platform for flexible, low-cost production of epidemic preparedness vaccines, including vaccines against a group of viruses that cause hemorrhagic fevers and other emerging viral disease threats.

As Batavia and IAVI noted in their announcement about the deal, collaborating on these vaccines and developing the platform will also enable them to accelerate the development of a vaccine candidate to address the COVID-19 outbreak or similar future outbreaks.

The HIV vaccine program has given IAVI more than a decade of experience in the development and production of viral vector vaccines, with a particular recent focus on the VSV vector approach that will be applied to develop the viral hemorrhagic fever candidate.

Currently in development, IAVI's viral hemorrhagic fever candidates are designed to prevent disease caused by Lassa virus, Marburg virus and Ebola Sudan virus, which are high-priority public health threats with high case fatality rates, as well as potential bioterrorism threats.

Licensed from the Public Health Agency of Canada (PHAC), the vaccine candidates are based on a recombinant VSV vector and were developed by scientists at PHAC's National Microbiology Laboratory. The platform was used to produce Merck's Ebola Zaire virus vaccine, Ervebo, recently approved by the European Commission, the U.S. FDA and regulators in several African countries, as well as prequalified by the World Health Organization. Ervebo was originally developed by PHAC scientists and advanced through clinical testing and approval by Merck & Co.

According to Dr. Mark Feinberg, IAVI’s president and CEO, “We need new partnership models and new, more flexible ways to respond to emerging infectious diseases. While the recent approval of the Ebola Zaire vaccine is a great achievement, we must be prepared for future outbreaks. We need to be creative about how we get there. Partnering with Batavia helps us achieve our shared vision of a suite of VSV-based vaccines and a secure and sustainable manufacturing solution to produce vaccines for emerging infectious diseases.”

Added Dr. Menzo Havenga, Batavia’s president and CEO: “We are very excited to partner with IAVI and to provide cost-effective manufacturing solutions to combat disease threats that have plagued humanity far too long, such as those posed by viral hemorrhagic diseases."

The objective is to have a stable, affordable supply of vaccines for outbreak pathogens through flexible manufacturing solutions. While traditional vaccine manufacturing methods are designed for continuous, long-term production of high volumes of individual vaccines, which requires substantial investments in large-scale fixed facilities, this model is not economically practical for producing vaccines needed intermittently in relatively small quantities, such as for stockpiles for outbreak pathogens.

To address this challenge, Batavia Biosciences is developing state-of-the-art, highly intensified vaccine manufacturing processes that can be applied in small footprint, low-cost, modular manufacturing facilities. Such an approach enables a rapid response and delivery of vaccines against new and emerging outbreaks, as well as quickly offering surge capacity as needed to respond to larger outbreaks.

IAVI previously announced an award of $37.5 million from the Defense Threat Reduction Agency of the U.S. Department of Defense to support further development of the Marburg vaccine candidate. Much of the preclinical work on the vaccine candidates is being done by scientists at IAVI’s Vaccine Design and Development Laboratory in Brooklyn, New York, home to IAVI’s VSV vaccine preclinical development.

Critical work to validate the key assays needed to measure immune responses in clinical trials will be done at IAVI’s Human Immunology Laboratory at Imperial College London. Support for IAVI’s VSV HIV vaccine candidate has come from the Bill & Melinda Gates Foundation, the Danish Ministry of Foreign Affairs, the government of Canada, Irish Department of Foreign Affairs and Trade, the Japanese Ministry of Finance, the Louis & Rachel Rudin Foundation, the Netherlands Ministry of Foreign Affairs, the Norwegian Agency for Development Cooperation, the Starr Foundation, the U.K Department for International Development, the U.S. National Institutes of Health, the World Bank and the United States Agency for International Development.