Hualan is the First Influenza Vaccine Manufacturer in China Getting WHO Prequalification Approval
In June 10th, the influenza vaccine (split virion, inactivated) of Hualan Bio passes the world health organization (WHO) pre-qualification and is taken into UN purchase plan. This is the first time when China’s influenza vaccine passes WHO pre-qualification. Influenza vaccine produced by China enters in UN vaccine purchase plan for the first time, supplying the global market and serving the world.
Flu is one of the most severe epidemic diseases human encountered, as well as the infectious disease causing the maximal death toll. Flu vaccination is the most valid method to prevent flu. In 1918, the Spanish flu pandemic led to 20 million people’s death and far exceeded World War I; subsequently, both the Asian flu pandemic in 1957 and the Hong Kong flu pandemic in 1968, brought about millions of people to die. According to the forecast of WHO, 1/3 children and 1/10 adults on average will be infected with flu each year. Due to the fast spread speed of flu and its great impact on global public health, it has been monitored intensively by all countries.
WHO Pre-qualification is one UN action plan, launched in 2001 and aimed at expanding the acquisition of selected prior drug and ensuring the quality, efficacy and safety of purchasing drug in international fund (such as the global fund GFTAM and UN aid international drug purchase mechanism UNITAID). It serves the patients in developing countries. Vaccine pre-qualification is a very important part of WHO pre-qualification as well as a kind of assessment and qualification work, conducted by WHO to guarantee vaccine products quality, safety and validity can reach international standards. It also provides “passport” for vaccine purchase of UN purchase institution. In order to promote vaccine internationalization in our country, in March 2011, China FDA makes unremitting efforts to facilitate the vaccine supervision system passing WHO assessment for the first time. This shows our government implements high-quality supervision to domestic vaccine products and the vaccine supervision system of our country has reached international standards.
At present, Hualan Bio is the largest influenza vaccine manufacturer in China. It can produce influenza vaccine of three dosage forms for more than 50 million human doses and single dosage form for 300 million human doses annually. Hualan Bio is the fifth in the world and the first in our country to pass the influenza vaccine WHO pre-qualification. It is the milestone of enterprise products globalization and facilitates other vaccines’ pre-qualification applied for subsequently. Meanwhile, it also promotes China’s vaccine to “step out” and serves global disease prevention career with effetive and qualified products.
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