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Institute of Vaccines and Medical Biologicals
IVAC launches first clinical studyof affordable, new COVID-19 vaccine produced in Vietnam
    Nha Trang, Vietnam (March 15, 2021) – A clinical study in Vietnam began today to evaluate COVIVAC, a new COVID-19 vaccinecandidate with the potential to be manufactured and scaled up affordably in Vietnam. The Phase 1/2 study is part of a larger strategy to strengthen long-term domestic COVID-19 vaccine supply and access. Sponsored by Vietnam’s Institute of Vaccines and Medical Biologicals (IVAC) and conducted by investigators from the National Institute for Hygiene and Epidemiology and Hanoi Medical University, the study is evaluating the vaccine’s safety and ability to induce an immune response in healthy adults. Phase 1 is occurring at the Hanoi Medical University.If Phase 1 results warrant moving ahead in clinical evaluation, Phase 2 will take place at Vu Thu District Health Center in Thai Binh province. 
   An advantage of the vaccine is that it is made in eggs in much the same way as traditional influenza vaccines in widespread use, meaning that affordablemanufacturing capacity already exists in Vietnam for large-scale, pandemic production. This first-in-human study is an important step toward understanding if it could be a potential option for addressing COVID-19. It is designed according to the highest international standards for safety and conduct. Results will help determine if the vaccine isacceptably safe and able to elicit an immune response sufficient to progress in clinical studies and which formulation and dose are optimal for moving forward. 
   “To address COVID-19, the call for vaccine scale up is unmatched in history. Vaccine demand continues to outpace supply, leaving communities in harm’s way,” say Dr. Huong Huu Thai, director of IVAC. “We’re thrilled toadvance into clinical studies because a locally produced vaccine like this could enhance Vietnam’s ability to sustainably and affordably protect our population, reduce dependency on imported vaccines, and potentially supply vaccine to other countries.”
   The vaccine was developed in the United States by Drs. Peter Palese, Adolfo Garcia-Sastre, and Florian Krammer at the Icahn School of Medicine at Mount Sinai in New York.The innovative design works by using another virus, inactivated Newcastle disease virus (NDV), to induce the body to build protective defenses against COVID-19. 
   ”We are happy to have developed a safe, effective, low-cost and most stable COVID-19 vaccine which should protect a majority of the population in Vietnam against the virus”, says Dr. Peter Palese, Chair of the Department of Microbiology at the Icahn School of Medicine at Mount Sinai.
   The vaccine being studied in Vietnam also includes a key component, HexaPro, a stabilized spike protein developed by the University of Texas at Austin (UT Austin). Jason McLellan, associate professor of molecular biosciences and Welch Chair at UT Austin, along with his team of researchers, also contributed to the design of an earlier version of the spike protein, which forms the basis of at least three COVID-19 vaccines currently being administered to global populations. 
   “My team and I are thrilled that our second-generation stabilized spike protein is part of this vaccine. Our hope is that the vaccine will be safe, efficacious, and affordable, allowing more people around the world to have protection against the spread of COVID-19,” McLellan said.
   Via license agreements with Mount Sinai and the University of Texas, the global organization PATH is helping to provideIVAC and other manufacturers around the world access to the vaccine.In an effort to advance the supply of affordable and accessible vaccines, PATH has also played a limited technical advisory support roleover the course of the vaccine’s development.
   To meet the urgent pandemic need, Vietnam has bilateral deals in place or negotiation with several international COVID-19 vaccine suppliers and is eligible to participate in the COVAX Facility—a global risk-sharing mechanism managed by Gavi, the Vaccine Alliance for pooling procurement and equitably distributing COVID-19 vaccines. The country, however, currently has no indigenous supply of COVID-19 vaccine—underscoringthe 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. By advancing this COVID-19 vaccine development, IVAC is now one of severalVietnamese vaccine companies working to address that need. 
   About IVAC
   The Institute of Vaccines and Medical Biologicals (IVAC), founded in 1978 by Vietnam’s Ministry of Health, is a state-owned company that plans and carries out the production of vaccines and serum for the overall prevention and treatment of disease in Vietnam. IVAC has been involved in the production of vaccines for a number of ailments including diphtheria, tetanus, pertussis, influenza and tuberculosis.