Ready to roll out

Trials done, Serum Institute looks to apply for licence, hit market in June

Expected next month is one of the most significant developments since swine flu arrived on the country's shores and threatened to reach epidemic proportions in the city.

City-based Serum Institute of India (SII) says the hunt for the H1N1 vaccine is over and it is likely to hit the market in June.

SII is done with the clinical trials for the preventive H1N1 vaccine and is now applying to the Drug Controller General of India for a licence for mass production.
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"The vaccine developed by SII will be in the form of a nasal spray," said Dr Rajeev Dhere, senior director (vaccine production), SII.

"We are extremely excited and are now tabulating the results for Phase-III of the trials. It will be a live attenuated vaccine, that is, it will contain weakened forms of the H1N1 virus sent us by the WHO."

Minimal side effects

To be priced about Rs 150 per unit, the nasal spray is believed to have negligible side effects, like sneezing and a runny nose.

The vaccine will be available in a syringe and delivered by way of a pump-like mechanism atop the syringe.

The vaccine is said to be safe for almost everybody; the exceptions are pregnant women and children below three years of age.

"We will be applying for the licence this week and are trying to get everything processed very soon," said Dhere. "We are hoping to start mass production and get the vaccine in the market by June."

The clinical trials of H1N1 vaccine involved 330 volunteers, who were divided into three age groups of three to 17 years, 18 to 49 years and those above 50 years.
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The trials took place in five hospitals across the city, Ahmedabad and Indore. The participating hospitals included KEM, D Y Patil Medical College and Bharatiya Vidyapeeth in the city.

Rs 150
Approximate price per unit of the nasal spray vaccine on launch