2 foreign firms ready to try H1N1 vaccine

2 foreign firms ready to try H1N1 vaccine

Preventive medicines are under various stages of research

In India, the plan is to test the vaccine’s safety and efficacy on 400-600 volunteers. AP

However, the government has to commit a minimum, but reasonable purchase order to the company before the firm starts the trial. A government decision is likely this week. A few major global pharmaceutical companies are in the race to develop the H1N1 vaccine including Glaxo Smithklime (GSK), Novartis, Sanofi-Aventis and Baxter.

India has approached all four and received response from GSK and Novartis, director- general of Indian Council of Medical Research (ICMR) Dr V M Katoch told Deccan Herald.

Legal requirement

On Tuesday, the ICMR wrote  once again to all companies spelling out details of the Indian legal requirement of carrying out a bridging study on several hundred people before their vaccines are given commercial approval by the Drugs Controller General of India.

None of the vaccines are available in the market. All are under various stages of research and development.  But several countries have signed advanced purchase agreements with these companies to ensure priority supply.

The advanced agreement is required because their production capacity is limited, which can meet the global demand. The Indian trial—as and when it happens—will be a ‘bridge study’ in which the H1N1 vaccine’s safety and efficacy will be observed on 400-600 volunteers following an ICMR technical guideline. If trials are successful, an imported H1N1 vaccine may be available in limited quantity between December 2009 and February 2010. It will be given primarily to doctors, healthcare workers and security personnel.

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