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Vietnam-produced seasonal influenza vaccine licensed for production and use

January 15, 2019 by PATH

Milestone represents more than 10 years of partnership between Vietnamese manufacturers, PATH, the United States and Vietnam governments, and the World Health Organization.

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Representatives of BARDA, IVAC, and PATH attend a press conference for the licensed seasonal influenza vaccine. Photo: Nguyen Phu Cuong/PATH.

Media contact: Kate Davidson | media@path.org

On January 15, 2019 the Institute of Vaccines and Medical Biologicals (IVAC) in Vietnam announced the successful licensure of a seasonal influenza vaccine that protects against three influenza strains: A/H1N1, A/H3N2, and B. This vaccine can now be produced and used to protect against influenza in Vietnam, and can potentially be exported within the region. The development of this vaccine is the result of almost a decade of partnership between IVAC, PATH, Vietnam’s Ministry of Health, the World Health Organization (WHO), and the Biomedical Advanced Research and Development Authority (BARDA) within the United States Department of Health and Human Services.

The availability of a high quality, domestically produced seasonal influenza vaccine in Vietnam helps to strengthen the country and the region against future influenza pandemics.

“Until now, Vietnam has been reliant on imported influenza vaccines, which cannot be mobilized quickly in the event of an emergency,” said Dr. Duong Huu Thai, IVAC Director. “Now, not only can we start to encourage more people to get vaccinated against seasonal flu in order to prevent the spread of disease, but we can maintain vaccine production capacity that can be quickly switched to pandemic flu vaccines if and when needed. This is important to ensure not only Vietnam’s own health security, but that of the whole region and even the world.”

PATH, with support from BARDA and in collaboration with WHO, has been working with IVAC and Vietnam’s Ministry of Health on influenza vaccine production since early 2010. This technical assistance has included the transfer of knowledge, expertise, and equipment for high quality vaccine clinical trials and production; collaboration on a long-term plan for influenza vaccine production and use; and the development of guidelines for influenza vaccine clinical trials and licensure. The final clinical evaluation (Phase 2/3 clinical trial) of IVAC’s egg-based seasonal influenza vaccine was completed in September 2018. The clinical study found that the vaccine was safe and capable of prompting an immune response in healthy adults. From there, licensing was the next and final step in making the vaccine available on the domestic market.

“On behalf of PATH, I am very proud and pleased to be able to celebrate this achievement with IVAC,” said Dr. Nguyen Tuyet Nga, PATH’s Vietnam Deputy Country Director. “Pandemic preparedness is a major focus for PATH in Vietnam. In recent years, Vietnam saw several outbreaks of influenza that resulted in several deaths and cost families and communities a great deal. Now that Vietnam has its own domestically produced seasonal flu vaccine, more people may be able to be protected against flu in the future, and Vietnam becomes more prepared to respond to potential pandemics.”

Dr. Rick Bright, BARDA Director and Deputy Assistant for Preparedness and Response, has been engaged with this vaccine production since the beginning. In 2008, Dr. Bright served as PATH’s project director on the Vietnam Influenza Vaccine Capacity Building project. During his time at BARDA, he has continued to champion vaccine development around the world, including in Vietnam. PATH and IVAC were honored to welcome Dr. Bright to Vietnam to witness the final outcome of the work he started over ten years ago.

“More than 100 years after the largest influenza pandemic the world has ever seen, influenza remains a very present and real threat to global health security,” said Dr. Bright. “From experience, we know that a threat of influenza anywhere is a threat to health security everywhere, which means the availability and production of vaccines in every region of the globe is essential to prevent the spread of disease at home and across our interconnected world. The approval of this vaccine marks a great milestone for IVAC, and for Vietnam and shows the incredible work that can be achieved through collaboration and partnerships.”

Seasonal influenza causes up to 650,000 deaths and 3-5 million cases of severe disease worldwide each year, including more than one million cases of influenza-like illnesses in Vietnam. The last major influenza pandemic to hit Vietnam was the A/H1N1 pandemic in 2009, which caused more than 284,000 deaths worldwide—78,000 in South East Asia alone—in 12 months.

Supporting influenza vaccine suppliers in low and middle-income countries, like IVAC, is critical to ensuring that global vaccine production is able to meet need and ensure equitable access to vaccines, especially in the face of a pandemic. The licensure of IVAC’s seasonal influenza vaccine ensures that Vietnam is leading the way in vaccine development regionally.