The US Food and Drug Administration Wednesday approved the H1N1 influenza vaccine from four different manufacturers, clearing the way for the vaccine to be administered as soon as enough of it is available in that country. But authorities in India said there is still some time before a vaccine is available here.

“We have to wait for the results of our own trials before we give approval here. The USFDA approval doesn’t change anything in India. The companies have to do bridging studies here,” said Dr V M Katoach, DG ICMR and Secretary, Health Research.

The vaccines approved in the US are made by Australia’s CSL Ltd., Switzerland’s Novartis, France’s Sanofi-Pasteur and Maryland’s MedImmune, which makes an inhalable vaccine that might be available by the end of the month.

Licensing in the US means the authorities there consider the vaccine meets specific manufacturing and quality standards. The Indian officials insist that vaccine manufacturers will have to conduct limited trials in the country.

The officials are insisting on trials to assess how Indians react to vaccines. “The import of vaccines will also depend on the trial results,” said Dr Katoach.

The Health Ministry, through the ICMR, has written to four international vaccine manufacturers to conduct trials in India. Out of the four, Glaxo SmithKline and Novartis have agreed to conduct the trials provided the government gives them some guarantee of purchase. A third company also agreed to conduct the studies on Wednesday, but officials are not willing to give out the name yet.

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