Bio Saga Headlines

Bio Saga

Tuesday, May 18, 2010

Pune-based Serum Institute of India (SII) has developed a H1N1 vaccine

In a major advancement in influenza science, India is ready with its first indigenous vaccine against H1N1 swine flu.

Pune-based Serum Institute of India (SII) has developed a H1N1 vaccine — not a painful syringe shot but a harmless nasal spray — which can be used by anybody above the age of three except pregnant women.

To cost around Rs 150, SII will apply to the drug controller general for licensure of its product next week.

Scientists, who are presently completing tabulation of results from the vaccine’s phase-III clinical trial, say it is safe and effective with side-effects being runny nose and a bout of sneezing.

Interestingly, the breakthrough comes exactly a year after India reported its first case of swine flu (May 15, 2009).

Confirming this to TOI, SII’s executive director (operations) Adar Poonawala said, “Our nasal mist vaccine is now ready. We will apply for licensure next week. It had no side-effects which are synonymous to injectible vaccines like fever, swelling or convulsions.”

Poonawala added, “India now has the capability to make its very own seasonal influenza vaccines. With the technology now in place, all we have to do is switch the pandemic H1N1 strain with the seasonal flu virus.”

The vaccine will be delivered into your nose through a devise fitted on top of a syringe. A quick spray in each nostril, the major route that the flu virus takes to enter, and the body develops antibodies to protect against H1N1.

“It is a live attenuated vaccine containing weakened forms of the H1N1 virus designed not to cause the flu. The strain was given to by the World Health Organisation once H1N1 was declared a pandemic,” said Serum’s H1N1 vaccine project director Dr Rajeev Dhere.

Explaining the clinical trials of this vaccine, Serum’s additional medical director Dr Prasad Kulkarni said it was a double blind placebo control trial involving 330 people of which 110 were 18-49 years, 110 were above 50 years and the rest children aged 3-17 years.

This means half of them were given the vaccine while half were given placebo. Testing of the samples was jointly done by Serum and the National Institute of Virology (Pune). Trials were conducted in three institutes from Pune — KEM hospital, D Y Patil Medical College and Bharatiya Vidyapith — and one each from Indore and Ahmedabad — Chacha Nehru hospital and Lambda Lab.

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