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 Institue 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.
Mot probably Bharat Biotech would start the human studies of its H1N1 vaccine as early as January, 2010. The clinical studies are expected to be complted by March, 2010, subject to regulatory approval and Bharat Bio would launch its own vaccine by April 2010, if everything goes goes as planned.
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.
GlaxoSmithKline (GSK), Novartis, Baxter International and Sanofi-Aventis are the multinational companies applied for test license to the DCGI for carrying out clinical trials in India for their version of swine flu vaccines.
Glaxo has a vaccine against H1N1 swine flu branded Pandemerix.
Filing for test licence to conduct clinical trials is normally long process. After Zydus Cadila, GlaxoSmthKline is “comparatively ahead” in the filing process, DCGI said.
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.