Panacea Biotec develops Swine flu vaccine
03 March 2010
Panacea Biotec Ltd has developed `Pandyflu', the first indigenous vaccine against the H1N1 virus (Swine flu). Panacea said it has used the egg-based technology to develop the conventional inactivated split virion vaccine and that the vaccine would be available by April.
The company said Phase I trials in healthy adult volunteers indicated excellent safety and encouraging immunogenicity after two doses. Phase I studies would be completed by March 2010, to be followed by Phase II/III studies in adult and pediatric population, it said.
Panacea Biotec hopes to make availble the Pandyflu vaccine by April 2010 for emergency use authorisation, subject to EUA clearance by DCGI on completion of Phase I trials, the company said in a filing with the Bombay Stock Exchange (BSE).
Panacea Biotec said it has been working very closely with the ministry of health and family welfare, the Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) to develop this vaccine in an accelerated manner. Panacea expects the process of licensing with Government of India to be over by July 2010.
The ministry of health has been actively encouraging indigenous development of influenza A (H1N1) and other pandemic flu vaccines ever since the onset of the influenza A (H1N1) pandemic.
The ministry also held a series of meetings with indigenous vaccine manufacturers to assess their capacity and willingness to develop, manufacture and supply the product. The ministry recently entered into an advance market commitment (AMC) with Panacea Biotec and other two manufacturers.