Chinese bio firm Sinovac makes single shot vaccine against H1N1 swine flu virus

Chinese firm Sinovac Biotech Co has claimed to have developed a single shot vaccine against the swine-flu causing H1N1 Influenza A strain virus.

Sinovac has tested the vaccine shots in 1,614 volunteers and found that the vaccine is safe and protects people against the pandemic virus after a single shot, the company claimed.

The Beijing-based Sinovac is currently in the process of compiling the clinical data on the one-shot flu vaccine Panflu for seeking regulatory approval in different markets.

Sinovac’s seasonal influenza vaccine Panflu was released by China SFDA and commercially launched at the end of July 2009.

In June 2009, the Beijing municipal government made its first purchase of its H1N5 vaccine Panflu from Sinovac, with an initial order of four million doses that are expected to be delivered by the end of September 2009.
Sinovac expects more orders in October, taking the total to 10 million doses, reports said.

Sinovac began the clinical trials of its one-shot H1N1 vaccine on July 22, 2009. The volunteers included 101 elders, 706 adults, 404 juvenile and 403 children. All 1614 volunteers had received the first shot of the vaccine through July 25.

None of the volunteers participating in Sinovac’s clinical tests exhibited any sign of severe adverse reactions, during the three-day observation period. Total adverse event rate is 11.8%, which is similar to that of seasonal influenza vaccine. The adverse events were all mild and transient. The most severe symptom was pain at the site of injection, Sinovac said in a companyrelease.

Panflu’s clinical trial was organized by China’s Center for Disease Control (CDC), and undertaken by Beijing CDC. The Ministry of Health (MOH) and State Food and Drug Administration (SFDA) were paying close attention to this clinical trial. Deputy Director General of MOH Disease Control Department, Director of SFDA Registration Section, and other relevant experts visited the clinical trial site to observe the clinical trial.

Sinovac Biotech Ltd is focusing on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac’s commercialized vaccines include Healive (hepatitis A), Bilive (combined hepatitis A and B), Anflu (influenza) and Panflu (H5N1). Sinovac is currently developing Universal Pandemic Influenza vaccine and Japanese encephalitis vaccine Sinovac is the first and currently the only company in the world to have been granted permission to begin clinical trials for a vaccine to prevent SARS.

Australian firm CSL Ltd, Sanofi-Aventis SA, GlaxoSmithKline Plc and other vaccine makers are currently in race to prepare vaccine against the pandemic H1N1 virus.

CSL Ltd expects preliminary results on the first dose of its vaccine next week, according to a company spokesperson. No severe adverse reactions have been observed so far, and the Melbourne-based company plans to submit the data to the Australian government on Sept. 4, she said.

In india, three desi biotech firms — Serum Institute, Bharat Biotech and Panacea Biotech — are working on the H1N1 vaccine. The companies have already started the preliminary research and they have submitted a detailed timeline for developing the vaccine to the drug regulator.

The country’s top drug regulator Drug Controller General of India (DCGI) had allowed the three biotechnology companies to procure seed strains from labs in the US and the UK in July 2009.

Serum institute is planning to start immunogenicity tests on the vaccine in August itself and the animal toxicity tests will commence from November 2009. Panacea Biotech and Bharat Biotech have also submitted their plans to the ministry.

The Pune-based Serum Institute is developing an “egg-based” vaccine, while the other two are developing “cell line vaccines”.

India-made H1N1 vaccines are expected to hit the market by 2010, sources said.