Thailand today became one of the first countries in the world to test an H5N1 avian, or bird, influenza vaccine in a needle-free, nasal spray formulation. This Phase I clinical trial of a live attenuated influenza vaccine, known as LAIV, to protect people from the H5N1 virus, resulted from international collaboration with health agencies around the world, including 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.
“Influenza vaccines remain a critical component of public health preparedness worldwide,” explained BARDA Director Robin Robinson, Ph.D. “By enhancing the capacity of developing countries to develop, manufacture and test their own influenza vaccines, we are improving pandemic preparedness globally.”
Robinson noted that conducting this clinical trial demonstrates a milestone in international efforts to accelerate development of locally produced influenza vaccines around the world. At the same time, BARDA supports public-private partnerships with manufacturers in the United States to continue to build influenza vaccine manufacturing capacity domestically, and to develop new, faster technologies for producing a greater quantity of effective vaccines in the United States.
On behalf of the Thai government, the World Health Organization (WHO) negotiated rights to the license for LAIV for avian influenza from Biodiem Ltd., headquartered in Melbourne, Australia. The vaccine was developed initially at the Institute for Experimental Medicine (IEM) in St. Petersburg, Russia; IEM sold the vaccine license to Biodiem. Russian scientists have provided technical assistance to Thailand’s Government Pharmaceutical Organization (GPO) to develop the vaccine in Thailand under this license.
Through a grant to the WHO, BARDA has provided funding and technical assistance to support Thailand’s GPO as well as other developing countries. The grant supported building pilot scale manufacturing facilities to produce the vaccine, devising a clinical trial process to study the vaccine’s effectiveness in protecting people against avian influenza and a regulatory process to evaluate the vaccine, as well as conducting clinical trials in humans.
Thailand’s GPO sent a dozen scientists to the United States for training in advanced biomanufacturing skills and good manufacturing practices. BARDA established the training program and continues to sponsor the program at the North Carolina State University and Utah State University.
The new vaccine developed and being tested in Thailand is part of the National Strategy Plan for Pandemic Preparedness that the Thai government released in 2005 in response to highly pathogenic H5N1 avian influenza outbreaks in Thailand. Avian influenza viruses such as H5N1 can be passed from infected birds to humans and hold potential to become a pandemic if the virus changes in a way that makes it spread easily among humans. The study and data analysis for this clinical trial are expected to be completed by May 2013.
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 public health emergency preparedness visit www.phe.gov