H1N1 swine flu vaccines Pandemrix and Celvapan may be launched in India soon

GlaxoSmithKline and Baxter International have started human trials for their H1N1 wine flu vaccines in India.

Both GlaxoSmithKline and Baxter have been granted approval to start clinical studies for their versions of vaccine to fight swine flu causing H1N1 virus India, reports said.

GlaxoSmithKline, which has alredy launched its H1N1 swine flu vaccine Pandemrix in Europe and many other parts of the world, has recently obtained marketing approval from US FDA.

Baxter International Inc completed its first commercial batches of H1N1 vaccine Celvapan in late July and is discussing distribution plans with national health authorities.

Baxter’s Celvapan is made using Baxter’s cell culture process. Cell culture process, where virus samples must be put into specially raised chicken eggs to grow, is considered to be faster than traditional vaccine production methods.

Baxter has supply contracts with five countries, including the U.K., Ireland and New Zealand.

Apart from GlaxoSmithKline (GSK) and Baxter International, Novartis and Sanofi-Aventis are the other multinational companies applied for test license to the DCGI for carrying out clinical trials in India for their version of swine flu vaccines.

Meanwhile, domestic companies including Serum institute of India, Panacea Biotech & Bharat Bio have already lined up their versions of H1N1 swine flu vaccines for launch in India in before the first half of next year.

Serum Institute, Panacea Biotech and Bharat Biotech are expected to launch human studies of their H1N1 swine flu vaccine candidates in India by early next year.

Serum Institute of India of Pune  plans to administer around 500 doses of the H1N1 vaccine to animals over a period of 40 to 50 days.

Serum institute will submit the toxicity and immunogenicity data generated from the studies to the Drug Controller General of India (DCGI) for obtain permission permission to undertake first in man – Phase I – human clinical trials.

Serum Institute expects to complete animal trials by November end or December first week. Serum Institute will begin human trials as soon as the company receives permission from DCGI. Serum Institute is  developing two types of vaccine – one is injectable (inactivated) and other is intranasal route (live attenuated).

New Delhi-based Panacea’s  egg based H1N1 vaccine is currently going through pre-clinical testing in animals. The animal studies are expected to be complted by December. Panacea is  planning to begin the clinical trials in January 2010 and launche the vaccine April 2010, sources said.

Bharat Biotech, Hyderabad, which is currently working on a cell-based vaccine, also expects its animal studies to be over by the end of  December.

Most probably Bharat Biotech would start the human studies of its H1N1 vaccine as early as  January, 2010. The clinical studies are expected to be completed by March, 2010, subject to regulatory approval and  Bharat Bio would launch its own vaccine by April 2010.

Apart from this Zydus Cadila, Cadila Pharmaceuticals and Biological E Ltd, Hyderabad are also working on H1N1 vaccines.

Zydus Cadila of Ahmedabad could be the first pharmaceutical firm to launch H1N1 swine flu vaccine in India, even as several others including Cadila Pharma and Serum Institute of India are speeding up their plans to bring in the vaccine.

Zydus Cadila has already sought permission to conduct human studies of the H1N1 candidate vaccine with the Drug Controller General of India (DCGI), the approving authority for permitting to undertake clinical studies in the country.

Zydus Cadila is the first Indian company to file the clinical trial protocol with the DCGI pushing back other domestic rivals who are also in race to launch H1N1 swine flu vaccine in India.

“Zydus is the first and the only Indian company to file for swine flu vaccine’s trial,”  Dr Surinder Singh, DCGI was quoted as saying.

Zydus Cadila is working with BioCryst Pharmaceuticals on the potential H1N1 vaccine candidate, unconfirmed reports said.

Cadila Pharmaceutical India Ltd is in the process of completing a vaccine manufacturing facility to produce H1N1 vaccine using the virus like particles (VLP) technology in collaboration with  US based company Novavax, CPL Biologicals Pvt. Ltd, the newly formed joint venture between Cadila Pharmaceuticals in India, expects to start producing H1N1 swin flu vaccine in next four months, Novavax Inc announced in a press release.

The CPL Biologicals facility is expected to be be capable of producing over 60 million doses of flu vaccine annually at full capacity.

CPL Biologicals has already begun construction of a state-of-the-art 25,000 sq. ft manufacturing facility that will be used to produce pandemic and seasonal influenza vaccines.

CPL Biologicals will utilize Novavax’s virus-like particle (VLP) vaccine technology to produce commercial-scale quantities of VLP-based influenza vaccines using Novavax’s innovative disposable manufacturing solution.

CPL Biologicals facility will also be used to produce other novel vaccines being developed by CPL Biologicals, based on Novavax’s VLP vaccine technology.

CPL Biologicals facility is being 100% supported financially by Cadila Pharmaceuticals Ltd.

Biological E Ltd,’s  H1N1 vaccine uses toll like receptors (TLR) technology in collaboration with Vaccinate , a US based biotech company.  The technology is being transferred to Biological E and the vaccine would be manufactured at Hyderabad.
Since India reported its first swine flu case in May, more than 20,000 people have been affected by the virus and 627 deaths have been reported so far.