Xiamen, China – The International Vaccine Institute (IVI) and Xiamen Innovax Biotech Co., Ltd. (Innovax) have entered a collaboration to make Hecolin?, the world’s first Hepatitis E vaccine, globally available. As the first step, IVI and the Innovations for Global Health LLC, a consulting firm with experts from pharmaceutical and vaccine industries, health sector is working with Innovax to assess the possible suitability of Hecolin? for prequalification by the World Health Organization (WHO), an evaluation that determines if a vaccine meets international standards for safety, efficacy, and quality, and, if so, makes them eligible for possible purchase by? United Nations procurement agencies such as UNICEF. The current assessment of the vaccine’s possible suitability for submission to WHO prequalification is supported by the Bill & Melinda Gates Foundation.
The Innovax vaccine, Hecolin?, was first launched in China in October 2012. The vaccine demonstrated almost 100% efficacy in the subjects who received all three doses on schedule in a phase III clinical trial with more than 110,000 human subjects and sustained efficacy (93.3%) 4.5 years after vaccination. The vaccine was considered to be safe by the Global Advisory Committee on Vaccine Safety (GACVS) in 2014.
Hecolin? is currently licensed only in China mainly for use in the private market and is not used outside of the country. Considering the significant burden of Hepatitis E globally, particularly in low-income countries, IVI and Innovax will collaborate to make the vaccine available outside of China.
“It has always been the goal of Innovax to be an international supplier of safe, high-quality and effective vaccines. We launched our Hepatitis E vaccine in China in 2012, but it is not yet available for people in resource-limited areas of Africa and South Asia,” said Mr. Steven Gao, General Manager of Innovax, “We are thankful to the Gates Foundation and IVI for their support, and we are pleased to collaborate with IVI. We will work together to bring this product to people in need.”
Hepatitis E is a waterborne viral disease that causes mild illness and in extreme cases, acute liver failure. Large seasonal outbreaks are frequent in low-income countries that have poor sanitation and hygiene. The WHO estimates about 3.4 million symptomatic cases, 70,000 deaths and 3,000 still births annually worldwide. Hepatitis E, in particular, has a high mortality rate in pregnant women (20% of infected pregnant women in their third trimester die) and is associated with higher risks of abortion, stillbirth, death and other complications in newborns. In South Asia, Hepatitis E is estimated to be associated with 10,500 deaths per year in pregnant women.
IVI has been working on Hepatitis E since 2010. The Institute conducts disease burden studies, organized an international Hepatitis E symposium in 2010 and supported a symposium in Nepal in 2015. Talks between IVI and Innovax to register Hecolin? with WHO’s prequalification program began in late 2012 after Hecolin? was launched in China.
“The Hepatitis E vaccine is a successful example of China’s burgeoning biotechnology sector,” said Dr. Jerome Kim, IVI’s Director General, “IVI is committed to helping companies like Innovax develop and deliver vaccines for diseases overlooked in the West, and we look forward to working with Innovax to bring this vaccine outside of China to help those in need.”
The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries including People’s Republic of China and the World Health Organization. The Institute conducts research in more than 20 countries of Asia, Africa and Latin America on vaccines against enteric and diarrheal infections, Japanese encephalitis, and dengue fever, and develops new and improved vaccines at its headquarters in Seoul, Republic of Korea. For more information, please visit http://www.ivi.int
Xiamen Innovax Biotech CO., LTD. (INNOVAX) is a leading company in the field of developing, manufacturing and marketing innovative vaccines with its headquarter and manufacture base in Xiamen, China.
In collaboration with the National Institute of Diagnostics and Vaccine Development in Infectious Diseases (NIDVD), Innovax has established a core-platform using DNA recombinant technology to express protein in E. coli for vaccine production. Based on this platform, the world’s first Hepatitis E Vaccine, Hecolin? has launched in China in October 2012. In addition, its cervical cancer vaccine–Cecolin? (phase III clinical trial under way) and a Genital Warts Vaccine (phase I clinical trial under way) have been developed. Further, a 9-valent HPV vaccine is now in application of clinical approval.