IVI and Vietnam
Vietnam’s Support for IVI
On October 28, 1996, His Excellence Mr. Gô Quang Xuân, Permanent Representative of Vietnam to the United Nations, signed the Agreement on the Establishment of the International Vaccine Institute.
On May 3, 1997, the government of Vietnam passed Decision No. 289-TTg, ratifying the IVI Establishment Agreement. One month later, On June 3, Vietnam deposited an instrument of approval with the United Nations.
From 2004 to 2012, Dr. Ngyuen Tran Hien of Hanoi Medical University served as Vietnam’s representative on the IVI Board of Trustees.
Between 2002 and 2010, Vice Ministers of Health Dr. Trinh Quan Huan and Dr. Nguyen Thi Kim Tiem respectively served on the Board of Counselors and Asia-Pacific Dengue Prevention Board of the Pediatric Dengue Vaccine Initiative (PDVI), an IVI consortium established to lead the accelerated development, evaluation, and introduction of dengue vaccines.
Cholera Vaccine Development
IVI and VaBiotech formed a product development partnership to produce the world’s first safe, efficacious, and affordable oral cholera vaccine (OCV) for global health. VaBiotech’s ORC-VaxTM vaccine was proven safe and effective in the Vietnamese population but was not formally certified by the WHO for global distribution. To ensure the vaccine met international Good Manufacturing Practice (GMP) standards and WHO global production guidelines, IVI and VaBiotech developed a reformulated vaccine with a higher yield, lower production costs, and a more affordable price. The reformulated low-cost vaccine was tested in clinical trials in both Vietnam and India and was demonstrated to be safe and more effective than the earlier version of ORC-Vax. To ensure the reformulated vaccine could be made available internationally, IVI facilitated a technology transfer between VaBiotech and Shantha Biotechnics Ltd. of India. In 2009, the vaccine was licensed in both Vietnam (mORCVAXTM) and India (Shanchol), and in 2011, Shanchol was approved by the WHO Prequalification Program, making it the first affordable OCV ($1.85 per dose) available for the global public market.
In November 2017, IVI’s Epidemiology unit initiated its TUNDRA program. TUNDRA, or the Real-time tracking of Neglected Bacterial Diseases and Resistance Patterns in Asia, establishes and conducts real-time disease surveillance of pathogens in the febrile and respiratory infections from hospitalized children. These hospital-based surveillance operations characterize pathogen resistance patterns phenotypically and genotypically. In Vietnam, the TUNDRA program operates at the Hospital for Tropical Diseases, Children’s Hospital 1, and Children’s Hospital in Ho Chi Minh City.
From 2007 to 2013, IVI worked in the Democratic People’s Republic of Korea (DPRK) to improve its capacity for preventing and controlling infectious diseases. Vietnam played a critical role in this program, with the NIHE hosting 11 North Korean scientists in Hanoi in 2009 and 2010 for laboratory training and a training workshop. The training equipped these scientists with the knowledge and skills necessary to train their peers in the DPRK.
From 2000 to 2010, IVI worked with the National Institute of Hygiene and Epidemiology (NIHE) to combat Japanese Encephalitis in Vietnam. A primary component of this work was conducting disease burden, cost-of-illness, and cost of vaccination studies. In addition, IVI conducted a mass vaccination campaign from 2004 to 2006 in Ha Tay province using VaBiotech’s locally produced JE vaccine. IVI trained 800 public-health workers in preparation for the vaccination campaign, and over 62,000 children aged 1-10 received the vaccine. The vaccination campaign proved the feasibility, acceptability, and cost-effectiveness of JE vaccination with the locally produced JE vaccine.
From 2001-2006, IVI carried out a typhoid vaccination campaign in Hue as part of its Diseases of the Most Impoverished (DOMI) program. Working with local investigators, over 32,000 school-aged children in Hue received the Vi-PS typhoid vaccine. As part of the vaccination effort, IVI conducted a nationwide disease burden surveillance study. Analyses of the study concluded that typhoid vaccination of school-age children in high-risk provinces in Vietnam can substantially reduce the burden of typhoid fever with no extra costs to the government if cross-subsidization schemes are used. These analyses were presented at an international meeting on DOMI in Hanoi in 2005. As a result, in 2006 the government of Vietnam decided to support a pilot project of a financially sustainable Vi PS immunization program in Dien Bien province, which had the country’s highest typhoid incidence rates.
From 2002-2005, IVI investigated shigella in Hue as part of its DOMI program. IVI’s disease burden studies, cost of illness studies, and public surveys showed that shigellosis imposes a heavy economic burden on both public-sector institutions and private households, which considered shigella as a high-risk threat to their children. The studies found that there would be a uniformly high demand for a vaccine against shigella for children. While a vaccine does not yet exist, IVI is developing an affordable shigella vaccine.
Between 2000 and 2009, IVI conducted a number of activities combating the diarrhea-causing rotavirus across Vietnam. IVI conducted hospital-based studies in Vietnam to determine the incidence rates of intussusception, a side-effect of the first rotavirus vaccine, RotaShield. IVI discovered 114 cases of intussusception in Vietnamese children, adding impetus to the need for a safe rotavirus vaccine. To that end, in 2006 and 2007 IVI assisted the NIHE with clinical trials for two new rotavirus vaccines- RotaRix and Rotateq, in Khan Hoa and Nha Trang. In 2009, IVI and the NIHE completed a one-year surveillance study in Khanh Hoa, Vinh Phuc, and Hai Phong to determine the rotavirus diarrhea incidence rate in children under 5. Results indicated 1 out of 5 children seeking treatment for gastroenteritis had rotavirus. Economic data were used to estimate the cost-of-illness from both rotavirus and other diarrheas incurred by the public sector and by families. The results were used alongside RotaTeq vaccine efficacy data to calculate the vaccine’s cost effectiveness in Vietnam.
Technical Assistance and Training
In Nha Trang, the NIHE hosted one of IVI’s first training programs, the 2001 First International Course on Vaccine Evaluation in Developing Countries. This program later evolved into IVI’s annual Vaccinology Course, in which Over 60 Vietnamese health professionals have received training.
In 2002, IVI helped Vietnam establish a large, linked database for recording, tracking, and evaluating potential vaccine adverse events. Headquartered in Nha Trang, the database allows Vietnamese health professionals to share and review medical records describing vaccinations and medical events and identify potential adverse effects. The successful creation of this database in Vietnam led IVI to develop the Vaccine Adverse Events Information Management System (VAIEMS) as part of the WHO’s Global Vaccine Safety Initiative (GVSI). The VAIEMS database system is now used in health programs around the world.
From 2010 to 2011, IVI worked with the government of Vietnam to strengthen its existing National Immunization Technical Advisory Groups (NITAGs) by providing training and technical assistance. Capacity-building initiatives included sending delegates from Vietnam’s NITAGs to Australia where they received training and consultations from the Australian Technical Advisory Group on Immunization.
Respiratory Bacterial Disease Research
From 1999 to 2011, IVI worked with the NIHE to conduct a number of disease burden studies on Haemophilus influenza (Hib), Streptococcus pneumoniae and Neisseria meningitides in Hanoi and Nha Trang. The results of these studies were provided to Vietnamese policymakers to inform their decision on introducing Hib conjugate vaccine in the national immunization schedule, helped the NIHE understand the spread of seasonal and pandemic influenza viruses, and led to the development of enhanced public health control measures in Vietnam.
From 2008 to 2015, PDVI and the subsequent Dengue Vaccine Initiative (DVI) carried out a number of projects to determine the impact of dengue fever in Vietnam, from funding a dengue fever surveillance study among children in My Tho, to cost of illness and willingness to pay for vaccines studies in Nha Trang.
DVI also provided technical support to Vabiotech with the development of their dengue vaccine candidate, specifically in process development, regulatory guidance, and capacity-building in clinical trials.