China wins WHO backing for encephalitis vaccine

In a first, China has had a vaccine pre-qualified for worldwide use by the World Health Organisation, a move that could help fight a deadly fever threatening millions of people, many of them children in developing countries. The World Health Organisation has pre-qualified vaccine SA 14-14-2 for Japanese encephalitis, the leading cause of viral neurological disease and disability in Asia. "This is a welcome development, both in the fight to protect children in developing countries and in the future availability of vaccines more generally, as China is now producing vaccines up to WHO standards," WHO director general Dr Margaret Chan Fung Fu-chun said. "There is a huge potential for vaccine manufacture in China and we hope to see more and more Chinese vaccines become WHO prequalified. The whole world will benefit." Pre-qualification allows UN procurement agencies to buy the vaccine. More importantly, the decision is an official endorsement of quality for countries that might otherwise suspect its reliability. The vaccine has fewer side effects than other Japanese encephalitis vaccines, making it safe for children, who are particularly vulnerable to the disease. Bill Gates, who supported the project through the Bill and Melinda Gates Foundation, welcomed the WHO decision. "China's emergence as a supplier of high-quality, low-cost vaccines for developing countries is a victory for millions of children in Asia who will no longer be vulnerable to a deadly and disabling disease," he said. Japanese encephalitis is carried by mosquitoes and endemic in many regions in Southeast Asia and the Western Pacific. Between 10,000 and 15,000 deaths are reported each year and many children who survive are left with severe brain damage. The vaccine has been in use in China since 1988 and about 600 million doses have been administered. Since 2008, fewer than 5,000 infections have been reported each year. But the success of the vaccine was little appreciated outside of China due to a widespread lack of confidence in the quality of Chinese-made health products. Yang Lingjiang, international co-operation manager for the Chengdu Institute of Biological Products, a major manufacturer of the vaccine, said the company initially received a cold reception to the vaccine in the mid 1990s. "The international community had no trust in Chinese vaccines. We were struggling for recognition," she said. "The WHO pre-qualification is not only a milestone for our company, but the entire vaccine industry of China. Other Chinese manufacturers will be hugely encouraged and apply for pre-qualification for their vaccines." "It opens a new chapter in the health industry, that China can finally provide the world with high quality and relatively low-cost vaccines. Paul Zhou, an immunologist with the Institute Pasteur of Shanghai, said the vaccine had been used in China for so long its safety and effectiveness was well established. PATH, a global health nonprofit organisation based in Seattle, had given significant help to the vaccine’s global recognition by facilitating overseas clinical trials for more than a decade. “This milestone brings the world within reach of an audacious goal: the elimination of a devastating disease through expanded access to an affordable and lifesaving vaccine,” said Steve Davis, PATH president and CEO. “Our groundbreaking collaboration with leading Chinese partners also helped lay the foundation for reshaping global vaccine supply, pricing, and accessibility through increased competition. This milestone signals China’s rising importance as a global supplier of high-quality vaccines for the most vulnerable children in the world.” Dr. Kathy Neuzil, director of vaccine access and delivery at PATH, said that SA-14-14-2’s safety for use in children had been confirmed by WHO’s prequalification and stamp of approval. “More than one million children have been followed in safety studies of the vaccine, which have shown side effects are rare,” she said. However, like all other vaccines, JE vaccine can result in mild side effects such as transient fever or pain, swelling, or redness at the injection site. “SA-14-14-2 has been used in China for more than 20 years and is now licensed or used in 11 additional countries. Use of the vaccine in these countries has provided excellent safety data. As with all vaccines, safety will continued to be monitored carefully as this vaccine is used more widely,” she said. “PQ removes an important barrier to access of this vaccine, and allows countries to plan large catch-up campaigns among children and incorporate this vaccine into routine immunization programs. We are likely looking at tens of millions of doses of this vaccine used on a yearly basis.”

China wins WHO backing for encephalitis vaccine

Drug to fight deadly Japanese encephalitis that has been used by China since 1988 has finally been cleared for United Nations agencies to use