SII, Zydus Cadila get approval for H1N1 vaccine trials

NEW DELHI — Pune-based Serum Institute of India, the largest vaccine maker in the country, has received approval from India’s drugs controller to conduct clinical trials of its H1N1 vaccine, the company announced Jan. 6.

SII’s vaccine will be the only live-virus vaccine in the country and will be inhaled through the nose, as opposed to being injected.

This is the second indigenous vaccine trial to get the drug controller’s nod for clinical trial. Zydus Cadila Health Care received approval for a trial Jan. 4.

Zydus Cadila’s team at its Vaccine Technology Centre in Ahmedabad developed the egg based, inactivated vaccine based on conventional technology.

With speedy completion of trials and fast track approvals, the indigenous H1N1 vaccine is expected to hit the markets by April 2010. The demand for H1N1 vaccine in India is estimated to touch 50 to 60 million doses in the initial phase.