Chinese Vaccine Leader Sinovac Starts Preparations To Produce H1N1 Vaccine

SHANGHAI - Chinese vaccine maker Sinovac announced June 8 it received the influenza A H1N1 virus strain from the U.S. Centers for Disease Control and has started perparations to turn out a pandemic vaccine.

Sinovac will use the virus strain for its pandemic influenza vaccine Panflu , spokesman Liu Peicheng told PharmAsia News.

"We are not certain now if we need to do extra clinical trials because we have already received approval from China's State FDA for Panflu," Liu said.

Sinovac will replace the H5N1 virus strain with the new H1N1 virus strain, according to Liu. H5N1 and H1N1 both are a subtype of influenza A.

Last April, Panflu, a pandemic influenza H5N1 whole viron inactivated vaccine - the first and only approved vaccine available in China against the H5N1 influenza virus - was granted a production license by China's State FDA (Also see "Sinovac To Launch New Vaccines In China; Chinese Government Biggest Purchaser" - Scrip, 18 Aug, 2008.).

Sinovac will follow SFDA's guidelines if more clinical trials are needed, according to the spokesman.

SFDA issued a notice June 8 that it would grant special approvals for companies to produce A H1N1 vaccines.

Companies that already received production licenses of the prototype vaccine will not need to apply for a new production license, but they will still need to perfect the technology to develop the vaccines and conduct clinical trials to find the optimal dose. Companies will also need to get manufacturing approvals.

Companies that currently do not have production licenses will have to apply for both the production license and manufacturing approval at the same time, according to the notice.

In China, vaccine producers need to apply for manufacturing approval to produce a certain batch of vaccine through local FDAs even if they already have a production license.

"Given that A (H1N1) is a new virus and yet to be well known, we'll deploy staff to oversee the entire process of the vaccine's research and development, production, testing, circulation and final use," SFDA spokeswoman Yan Jiangying told reporters June 8.

First Batch Of H1N1 In China By Fall

"Before the end of September, China can bring the first batch of H1N1 vaccines to market," Yin Hongzhang, division director for biological products in SFDA's drug registration department, said at the press conference.

China now has 11 vaccine producers, out of a total of 32 worldwide, according to Yin. "All of them will get the virus strain by the end of this week," he said.

The notice said the special approval will accelerate the process but will not simplify the approval procedure. Companies need to establish a post-marketing evaluation plan for the vaccine so that SFDA can strengthen its post-marketing surveillance.

Sinovac's annual production capability for pandemic influenza is 20-30 million doses. But the company would not estimate how many doses would be prepared for the A H1N1 virus, Liu said.

Sinovac announced June 2 that China's Vice Premier Li Keqiang; State Councilor and Secretary of State Council Ma Kai; Head of General Administration of Quality Supervision, Inspection and Quarantine Wang Yong; Minister of Health Chen Zhu and other high-level officials inspected Sinovac's manufacturing facility in preparation for the H1N1 vaccine.

"Li also emphasized the importance of having a vaccine for influenza A (H1N1) and encouraged Sinovac to step up vaccine production," the company said.

"We were excited to showcase to China's vice premier our significant progress towards the production of a vaccine against the influenza A (H1N1) virus, Sinovac CEO Yin Weidong said. "The visit by high-ranking national officials gives us confidence that the Chinese government recognizes our capabilities. We believe that we can play a significant role in providing vaccines against influenza A (H1N1) virus."

At the end of May, U.S. CDC began distributing the influenza A H1N1 virus strain to manufacturers. U.S. drug maker Baxter said it was testing a strain of the virus for a potential vaccine, and if a pandemic is declared by WHO, the company could be in the forefront of the worldwide race to turn out an A H1N1 vaccine (Also see "Baxter Expanding Facilities In China To Keep Pace With Exploding Market Growth, Testing A/H1N1 Strain In U.S. For Potential Vaccine" - Scrip, 4 Jun, 2009.).

Yin told investors in April that the company would initiate several vaccine research projects in 2009, including an HIV vaccine, a vaccine for epidemic encephalitis and a pneumonia vaccine in preparation for China's healthcare reform. He said the company plans on bringing one to two vaccines into clinical trials every year from 2009 to 2011 and will launch one new product every year from 2012 to 2014 (Also see "Sinovac Beefs Up R&D To Bring Vaccines Into Clinical Trials To Prepare For Healthcare Reform" - Scrip, 17 Apr, 2009.).

- Dai Jialing ([email protected])