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Institute of Vaccines and Medical Biologicals
Vietnam-made COVID-19 vaccine moves to Phase 2 following positive Phase 1 results
Nha Trang, Vietnam, August 25, 2021 – State-owned vaccine developer, The Institute of Vaccines and Medical Biologicals (IVAC) of Vietnam and the National Institute of Hygiene and Epidemiology (NIHE), today announced having started the Phase 2 portion of a Phase 1/2 clinical study for a new COVID-19 vaccine candidate (COVIVAC) with the potential to be manufactured and scaled up affordably in Vietnam. The announcement follows positive results from the Phase 1 part of the study recently approved by the Ministry of Health of Vietnam, which show the vaccine candidate to be acceptably safe and able to elicit an immune response sufficient to move to Phase 2. Phase 2 will evaluate which COVIVAC formulation and dose are optimal for advanced clinical development. Safety and immune response will also continue to be evaluated.
The Phase 1/2 study sponsored by IVAC is part of a larger strategy to examine COVIVAC’s potential as an option for addressing COVID-19 and, ultimately, to strengthen long-term domestic COVID-19 vaccine supply and access. The Phase 1 study was conducted at the Hanoi Medical University by NIHE investigators and implemented according to the highest international standards for safety and conduct. Phase 2 is being conducted in Thai Binh province. One hundred twenty adult volunteers participated in the Phase 1 study and 375 are targeted to participate in the Phase 2 study.
“The results of the Phase 1 study show all doses tested are acceptably safe and we are able to select 2 doses for advancing to the Phase 2,” stated Prof. Dr. Dang Duc Anh, Director of the National Institute for Hygiene and Epidemiology. “The Phase 2 will be very crucial for us to select the most appropriate dose with an acceptably safe and confirmed strongly immune response for testing in Phase 3.”
“We are pleased to announce the Phase 1 results, which confirm the readiness of COVIVAC to progress in development,” stated Dr. Duong Huu Thai, Director of IVAC. “Studying this vaccine is important because, if we learn that it can safely protect people from COVID-19, it could help improve affordable and equitable vaccine access needed to control the virus long term.”
Vaccine supply scarcity, unaffordability, and delivery unsuitability are among the challenges leading to COVID-19 vaccine access inequities worldwide. An advantage of the COVIVAC vaccine is that it is made in chicken eggs in much the same way as influenza vaccines in widespread use, meaning that affordable manufacturing capacity already exists in Vietnam for large-scale, pandemic production. Adding an egg-based COVID-19 vaccine to the disease prevention arsenal could help close the access gap due to its affordability deliverability, high-volume production capacity, standard cold chain storage, and potential to enable greater vaccine supply control for Vietnam and potentially other countries.
As IVAC drives development in Vietnam, international collaboration has been central to this vaccine candidate’s advancement—bringing together classic egg-based technology with cutting edge science. The Icahn School of Medicine at Mount Sinai in New York developed the recombinant Newcastle disease virus (NDV) technology that forms the building block of the vaccine. The NDV is inactivated so it cannot cause disease and is modified so that its surface presents a stabilized spike protein from the SARS-CoV-2 virus that causes COVID-19. That stabilized spike protein (Hexapro), developed at the University of Texas at Austin (UT Austin), is what trains the immune system to recognize and fight COVID-19 infection.  
Under license agreements with Icahn Mount Sinai and UT Austin, the nonprofit global organization PATH is helping to provide IVAC and other manufacturers access to the vaccine technologies. PATH further serves as a connector and facilitator for this consortium of collaborators, as well as a technical advisor to the manufacturers—aligning with PATH’s commitment to advancing immunization equity. 
Although Vietnam has obtained COVID-19 vaccine doses via bilateral deals and the COVAX Facility, the country currently has no indigenous supply of COVID-19 vaccine—underscoring the importance of developing such capacity to ensure that affordable, safe, and effective vaccines can be within reach in Vietnam beyond the acute phase of the pandemic. An egg-based COVID-19 vaccine like COVIVAC, if successful, could be an important strategy for meeting that need. 
About IVAC
IVAC, established in 1978 by Vietnam’s Ministry of Health, plans and carries out the production of vaccines and serum for the Expanded Program on Immunization in Vietnam and the overall prevention and treatment of diseases. IVAC conducts research and applies technological advances in vaccine development and production in cooperation with organizations in country and abroad. IVAC’s main facility is located in Nha Trang, Vietnam, with other facilities in Suoi Dau.