Vietnam has begun a Phase I clinical trial for the first H1N1 influenza vaccine developed entirely in that country. The vaccine was developed and is being tested with support from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). A Phase I clinical trial is the first step in testing new vaccines in humans.

 

Since 2005 BARDA has supported developing countries, including Vietnam, in building their own vaccine manufacturing capacity to maximize the amount of vaccine available worldwide during a pandemic. This trial marks a major milestone in that endeavor. 

 

“Vaccines remain the cornerstone of pandemic preparedness, and adequate manufacturing capability to address global demand for pandemic vaccine is a critical challenge,” explained BARDA Director Robin Robinson, Ph.D. “Conducting this clinical trial demonstrates success in international efforts to accelerate development of locally produced influenza vaccines across the globe.”

 

He noted that infectious diseases do not respect country borders, so increasing the ability of any country to make flu vaccine helps every country reduce the spread of influenza. “We know that in a pandemic, everyone in the world would need a vaccine to be protected. Today, the capability to make vaccine in every country does not exist,” he said.

 

This clinical trial represents a milestone in international collaboration. To conduct the Phase I clinical trials, the state-owned vaccine manufacturer in Vietnam, called the Institute of Vaccines and Medical Biologicals (IVAC) is partnering with Pasteur Institute - Ho Chi Minh City and PATH, a nonprofit global organization headquartered in Seattle and formerly known as the Program for Appropriate Technology in Health. This innovative new partnership is funded by BARDA and reflects BARDA’s public-private partnership model.

 

The Phase I clinical trial began April 27; the study and data analysis are expected to be complete by the end of 2012. This study is the culmination of work that began five years ago as part of a World Health Organization (WHO) program to expand capacity for the production of pandemic influenza vaccines in developing countries, including Vietnam. The United States, through HHS/BARDA, has been a significant partner in the WHO program.

 

To build on influenza vaccine production capacity in Vietnam, BARDA contracted in 2009 with PATH. Through this cooperative agreement, IVAC established a local, steady supply of eggs for use in vaccine manufacturing, trained the staff in good manufacturing practices for influenza vaccine, built the quality manufacturing facilities needed to produce vaccine, and developed the vaccine itself.

Robinson noted that, at the same time, BARDA and other U.S. agencies and manufacturers continue to build vaccine manufacturing capacity and support the development of new, faster technologies for producing a greater quantity of effective vaccines in the United States.

 

BARDA, an agency within the HHS Office of the Assistant Secretary for Preparedness and Response, provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats including chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.

For more information about pandemic preparedness visit www.phe.gov and www.flu.gov.

 

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