Hyderabad-based Bharat Biotech today said it had launched the country's first indigenously developed cell culture H1N1 swine flu vaccine, HNVAC, which it said had tested safe in Phase I, II and III clinical trials for flu vaccines in India.
It said the product was the only flu vaccine from the developing world to be manufactured using the cell culture route, a highly sterile and controlled manufacturing process, instead of eggs.
The company saidd in a statement HNVAC was developed with approved strains from WHO and centre for Disease Control (CDC) Atlanta.
"This single dose vaccine has been developed by Bharat Biotech's scientists at the Genome Valley facility in Hyderabad," the statement said. "HNVAC places Bharat Biotech's superior, clean, safe and controlled mammalian cell culture technology ahead of several multinational and Indian vaccine companies, which still use eggs for manufacturing. USFDA has discouraged the use of egg based vaccines due to adverse reactions from egg based proteins, especially in children," the statement added.
Making the announcement Bharat Biotech's chairman and managing director, Dr Krishna Ella, said we "Our goal right now is get the flu vaccine easily accessible and at affordable cost to high risk groups."
He said, ''The key benefit of our cell culture vaccine is its potential to scale up and produce large quantities quickly as required, it also has a much more sterile and faster production cycle, without the external dependence on eggs and thus enabling quicker response times in the event of a pandemic.''