After international pharmaceutical companies announced they are ready to roll out the H1N1 vaccine, the Health Ministry has written to them saying they can conduct “limited drug trials” in the country so that their vaccines can be evaluated for the Indian population.

Letters went out to Aventis-Sanofi, Glaxo SmithKline (GSK) and Baxter. GSK has agreed to conduct the trials provided the government gives it some “guarantee of purchase.”

These companies are said to be ready to launch their vaccines between December and February while Indian companies have a March deadline. ‘Talks are on with the companies and we are working out how many units of vaccines we are likely to need,” said V M Katoch, DG ICMR and Secretary, Health Research. “We have identified eight testing sites where the trials (for both international and domestic companies) are likely to happen,” he said. “We will surely give the companies a purchase guarantee,” Katoch said.

If the trials are successful, sources said, the plan is to order the vaccines first for health workers directly exposed to the virus and wait for development of the indigenous vaccine for the general public.

“There have been negative experiences associated with vaccines in the past. Although the vaccines have been found to be safe abroad, the Indian population can react differently. We don’t give influenza vaccines here, our immunity levels are different,” said Katoch.

There was no tearing hurry, he said. “We have been able to keep the death rates really low by giving Tamiflu, so we can wait a little more.”

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