The World Health Organization (WHO) has announced the prequalification of a Chinese-made vaccine for seasonal influenza vaccine. The new WHO pre-qualified vaccine is produced by Hualan Biological Bacterin Corporation, and for use in individuals older than 9 years of age.
“WHO prequalification of the Hualan vaccine is another feather in the cap of China’s growing vaccine manufacturing industry,” said Dr Bernhard Schwartländer, WHO Representative in China.
“This is also very good news for the millions of people in low and middle income countries which cannot afford to manufacture or purchase their own seasonal flu vaccines. WHO prequalification of Hualan’s vaccine will add to the global supply of flu vaccine, helping to stop many people around the world getting sick with flu. In doing so, it will help to save lives,” Dr Schwartländer said.
Influenza can be a serious illness, and it affects millions of people every year. Worldwide, annual epidemics of influenza result in approximately 3 to 5 million cases of severe illness and up to 500 000 deaths. Most people who get the flu recover within a couple of weeks. However, the very young, the elderly, and those with other serious medical conditions are vulnerable to severe complications such as pneumonia.
Hualan’s influenza vaccine is the second vaccine made in China to achieve WHO prequalification, following prequalification of a Japanese encephalitis vaccine in 2013.
WHO’s prequalification program assures that vaccines procured by UNICEF and GAVI are safe and effective. To obtain prequalified vaccines, the vaccine must pass stringent laboratory tests and the manufacturing facility must pass a physical site inspection by WHO.
“China’s vaccine regulatory authorities provide assurance that vaccines made in China are vaccines which meet the highest international quality standards. The news of more WHO pre-qualified vaccines coming out of China shows that the country is set to become one of the preeminent vaccine manufacturers globally,” added Dr. Schwartländer.
Only vaccines from countries with a National Regulatory Authority that has passed WHO assessment are allowed to be prequalified. China’s National Regulatory Authority for vaccines passed WHO assessment in 2010 and reassessment in 2014.
About the World Health Organization
WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.
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