The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2019 and subsequent COVID-19 pandemic, and ongoing Ebola and Lassa fever epidemics in western and southern Africa demonstrate the urgent need for vaccines and therapeutics against emerging and re-emerging infectious diseases. IAVI has a robust vaccine and antibody pipeline to address such challenges.
IAVI’s emerging infectious diseases (EID) vaccine platform includes four vaccine candidates to prevent diseases of global importance:
- Coronavirus disease 2019 (COVID-19)
- Lassa fever
- Marburg virus disease
- Ebola Sudan virus disease
The urgency for a COVID-19 vaccine is clear, and the U.S. Centers for Disease Control and Prevention has classified viruses that cause the other diseases such as hemmorhagic fever viruses listed above as high-priority agents that pose a risk to national security. They have high case fatality rates, and in addition to being epidemic threats, have potential to be used for bioweapons.
IAVI’s EID vaccine candidates are based on a live, replication-competent recombinant vesicular stomatitis virus (rVSV) vector similar to the technology used to develop Merck’s highly effective Ebola Zaire virus vaccine, ERVEBO®, that was recently approved in 2019 by the European Commission, the U.S. Food & Drug Administration, and, in 2020, regulators in several African countries. See graphic, below.
IAVI and Merck, known as MSD outside the United States and Canada, are collaborating to develop an rVSV-based investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. Use of an established vaccine technology could speed development, clinical testing, and approval of the vaccine candidate in the midst of the continuing global public health threat of the COVID-19 pandemic.
IAVI and Merck are working together to advance the development and global clinical evaluation of the SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists at the Design and Development Lab in Brooklyn, New York. Clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved.
The Coalition for Epidemic Preparedness Innovations (CEPI) is the main funder of IAVI’s Lassa fever vaccine program. The U.S. Department of Defense/Defense Threat Reduction Agency is the main funder of IAVI’s Marburg vaccine program and is supporting IAVI's COVID-19 vaccine program. The Government of Japan in collaboration with the World Bank has committed to contribute to IAVI’s COVID-19 vaccine program.
IAVI, Serum Institute of India Pvt. Ltd. and Merck KGaA, Darmstadt, Germany are partnering to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) as innovative interventions to address the COVID-19 pandemic, with global access as a primary goal.
Scientists at IAVI’s Neutralizing Antibody Center at Scripps Research and immunologists at Scripps Research were part of a team that identified antibodies from the blood of recovered COVID-19 patients that are capable of neutralizing SARS-CoV-2, the virus that causes COVID-19. Animals that received the potent neutralizing antibodies were protected against disease after challenge with SARS-CoV-2. The results were published in Science in June 2020.
Under IAVI’s agreement with Merck KGaA, Darmstadt, Germany and Serum Institute, the partners will conduct an accelerated, integrated program of preclinical and clinical research to evaluate the specific highly potent mAbs that broadly neutralize commonly circulating variants of SARS-CoV-2 singly and potentially in combination for treatment of COVID-19. A Phase I clinical trial is expected to start in early 2021.
Once the mAb candidate is shown to be efficacious, Merck KGaA, Darmstadt, Germany will lead commercialization in developed countries Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India. In low- and middle-income countries, Serum Institute’s experience with global procurement mechanisms will be a key factor in ensuring that the therapy is rapidly and widely available and accessible.
The portfolio of mAbs identified by IAVI and Scripps Research scientists and their partners provide the foundation for a comprehensive program with potential application to COVID-19 treatment and prevention as well as to other coronaviruses that may arise or re-emerge in the future.
IAVI is committed to ensuring that the mAbs we develop are affordable and globally accessible to the people who need them. Our 2020 global call to action, commissioned by Wellcome, highlights the lack of equitable access to mAbs in LMICs. We proposed a set of actions that could solve the access problem, including a call for global health players to form innovative partnerships to address the need for affordable mAbs worldwide. The collaboration among IAVI, Serum Institute of India, and Merck KGaA, Darmstadt, Germany is the kind of innovative partnership identified in the call to action that could set an important precedent for enabling affordable access to SARS-CoV-2 mAbs in LMICs and potentially be applied more widely to mAbs for a range of infectious and non-communicable diseases.