Cadila Pharmaceuticals of Ahmedabad, western India, has been denied permission to conduct clinical studies for its H1N1 swine flu vaccine on the ground that the vaccine uses a new technology which has not been proven safe, reports said.
Cadila Pharmaceuticals utilises virus-like particle (VLP) technology to develop H1N1 vaccine, which is quite different from traditional vaccine manufacturing technologies.
Cadila Pharmaceutical’s is the only vaccine that uses VLP technology right now. Since no other vaccine maker employs VLP technology Cadila needs to substantiate its credentials of the new technology before conducting clinical trials in India, reports said quoting Drug Controller General of India (DCGI) Surinder Singh.
“We are still looking at the data they gave us and trials are also on in Mexico. It is being seen as new pathway for the vaccine, but on the other hand, we already have traditional vaccines … so we need to be very cautious,” DCGI is quoted as saying
Cadila has a joint venture with Novavax for developing vaccines based on VLP technology.
CPL Biologicals Pvt. Ltd., the newly formed joint venture between Cadila Pharmaceuticals in India, will utilize Novavax’s virus-like particle (VLP) vaccine technology to produce commercial-scale quantities of VLP-based influenza vaccines.
CPL Biologicals was expected to start producing H1N1 swin flu vaccine in next four months, Novavax Inc, announced in a press release.
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 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.
Novavax is currently conducting 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine studies in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries.
Novavax was planning to conduct a major portion of the clinical trials for 2009 H1N1 pandemic flu vaccine in India.
Novavax VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology.
A few Indian companies are already in advanced stages of launching H1N1 swine flu vaccine i India.
Zydus Cadila was 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 Cadila would have the vaccine ready by March, so the government would not need to import batches, according to government sources.
Serum Institute of India has also been granted approval by the Drug Controller General of India (DCGI) to carry out clinical studies for the intra-nasal spray vaccine.
Similarly, Drug Controller General of India has given approval for Panacea Biotec to conduct clinical trials for its swine flu vaccines in the country, recently.
And most recently, Bharat Biotech, one of India’s leading vaccine makers, has launched first-in-man studies for cell culture vaccine HN-Vac against H1N1 influenza swine flu in India.
Bharat Biotech, Panacea Biotec and Serum Institute of India are the three biotech companies assigned by the Indian government to develop H1N1 swine flu vacccine.
Recently, India’s Biological E Limited has entered into an agreement with USA’s VaxInnate Corporation to license its recombinant H1N1 pandemic swine flu vaccine.
VaxInnate recombinant H1N1 vaccine is based on the novel Toll-Like Receptor (TLR) technology platform, which dramatically improves vaccine immunogenicity and efficacy.