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H5N1 Vaccine Approved for Humans in China, Vietnam Begins Human Vaccine Trials

By Michelle Cantu, April 4, 2008

On April 2, 2008, Sinovac, a China-based biopharmaceutical company, announced the approval by the China State Food and Drug Administration (SFDA) of a production license for its human vaccine Panflu. According to a Sinovac press release, Panflu is Sinovac’s H5N1 whole viron inactivated vaccine and is the “first and only approved vaccine available in China against the H5N1 influenza virus.” The vaccine will not be made available for sale to the public, but will be used solely for China’s national vaccine stockpiling program. Additionally, the press release quoted Weidong Yin, the company’s Chairman, President, and CEO: “the government of China has indicated publicly their intention to stockpile the vaccine in advance of the Olympic Games in Beijing this summer.”1

In June 2006, Phase I clinical trials were completed for Panflu and showed “good immunogenicity and safety.” Phase I trials were followed by randomized, double-blind Phase II trials which were completed in 2007. These, too, yielded positive results, and Sinovac submitted to SFDA for licensing of the vaccine in February 2008.1 In a Reuters article on April 3, 2008, Liu Peicheng, Sinovac’s publicity supervisor, said that the company’s next steps would be to conduct tests, “to see if the vaccine may offer cross protection against other strains of the virus found in Indonesia, Turkey, and Anhui province in China.”2

In other vaccine news, on April 3, 2008, Reuters reported that the National Institute of Hygiene and Epidemiology in Hanoi, Vietnam, has begun clinical trials on a human vaccine for the H5N1 virus, VN1194. So far, eleven research volunteers have received a second dosage of the vaccine. Dr. Nguyen Tuyet Nga, the epidemiologist and lead virologist for the clinical trial reported that cross-protection will be tested in later clinical trials, but for now researchers are looking to “see how long protection lasts.”3 Last month, the Biosecurity Briefing reported on Vietnam’s plan to test an H5N1 vaccine in humans at the Military Medical Academy in Ha Tay province near Hanoi.4 According to Reuters, Vabiotech expects up to 30 military personnel to participate once the Ministry of Defense approves the trial.3

References

1. Sinovac receives China State Food and Drug Administration (SFDA) approval for pandemic influenza H5N1 vaccine [news release]. Beijing, China: Sinovac Biotech, LTD.; April 2, 2008. http://www.sinovac.com/Investors/2008/4/c7r8015ko7.htm. Accessed April 3, 2008.
2. Lyn TE. China approves bird flu vaccine for humans. Reuters. April 3, 2008. http://www.reuters.com/article/healthNews/idUSHKG9313420080403. Accessed April 3, 2008.
3. Vietnam starts human trials for bird flu vaccine. Reuters. April 3, 2008. http://www.msnbc.msn.com/id/23937163. Accessed April 3, 2008.
4. Nuzzo J. Vietnam to test H5N1 vaccine in humans, new warnings of H5N1’s pandemic potential in Indonesia. Biosecurity Briefing. March 21, 2008.  http://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-03-21-vieth5n1vactestindonesia.html. Accessed April 3, 2008.