Bharat Biotech has received the clearance from the Drugs Controller General of India (DCGI) to conduct the phase I clinical trials for the H1N1 vaccine. The company is now gearing up to commence the phase I clinical evaluation of the HN-VAC, its cell culture based H1N1 vaccine candidate.
This vaccine will boost immunity against the new H1N1 influenza strains and help protect public health as the pandemic evolves. Bharat Biotech is the first company in India to develop, a cell culture based vaccine candidate for influenza, which can serve as a platform technology for both pandemic and seasonal flu vaccines, according to the company. “For the company, this is yet another important milestone in our endeavour to develop vaccines and provide human healthcare solution”, stated Dr Krishna Ella, chairman and managing director of Bharat Biotech International.
“In preclinical evaluation, the vaccine candidate triggered a beneficial immune response. The phase I clinical trial has started in Bangalore with more than 150 subjects under evaluation for safety and immunogenicity and is slated for completion within 6 weeks” he added. .
Vaccines are one of the most effective ways to protect people from contracting illness during influenza epidemics and pandemics. H1N1 pandemic influenza is caused by a new virus and virtually everyone is susceptible.
Bharat Biotech allocated Rs 70 crore for product development, manufacturing facilities and R&D for this project of developing cell culture based H1N1 vaccine. It received the H1N1 vaccine strains from WHO/CDC centres.
Pandemic H1N1 influenza was reported in more than 208 countries and with more than 12,500 deaths. India has reported approximately 26,000 cases with more than 1000 deaths.
Cell culture based flu vaccines represent a new generation vaccine technology that removes the need for traditional egg based vaccines. Egg based vaccines are limited by the availability of high quality eggs in millions to manufacture the vaccine and require a cumbersome manufacturing process. Cell culture based vaccines would enable Bharat Biotech to respond quickly to pandemics and rapidly increase the manufacturing capacity as required, said Dr. Ella.