Few takers for govt offer on H1N1 vaccine trials

The central government’s invitation to global pharmaceutical companies to conduct clinical trials here of their H1N1 (swine flu) vaccine candidates has evoked only a limited response. Only two companies, Novartis and GlaxoSmithKline, have come forward to seek regulatory approval for such trials in India, it is learnt.

Industry sources said this was due to the government’s reluctance to place advance orders with the vaccine makers, to purchase their vaccine as and when it is ready.

Multinational firms Baxter and Sanofi Pasteur are also in various stages of clinical trials to develop the H1N1 vaccine. Several countries have placed advance orders with these drug majors. Incidentally, Sanofi Pasteur, the vaccine division of Sanofi Aventis, said today its H1N1 vaccine had received US regulatory approval.

Health ministry officials said the absence of applications to conduct clinical trials could be considered as lack of interest. “Only two of them have applied. Others might do so in the coming weeks. We are also looking forward to Indian companies to come up with their vaccines,” a senior official said.

He added multinational firms with clinical trial approvals could be ready with their vaccines by December. “Indian companies should be ready by April. We don’t see the need to give advance orders when we have a medicine that is capable of curing the illness. Further, there is no guarantee that the vaccine trials will be successful,” he added.

India has so far registered over 200 deaths due to the H1N1 flu. According to official figures, of the 30,118 samples tested for Influenza A H1N1 in government laboratories and 6,588 in private labs across the country till September 15, as many as 21 per cent were found to be positive.