India readies for H1N1 mass vaccination against swine flu as Sanofi Pasteur completes safety trials

India may start H1N1 vaccination drive against swine flu in the coming weeks as the bridge clinical trials to ascertain safety of the imported vaccine samples from Sanofi Pasteur is completed and the data submitted for regulatory review.

Indian Government has imported 1.5 million doses of vaccines from Sanofi Pasteur, the vaccines division of Sanofi Aventis Group

The safety study of Sanofi Pasteur’s H1N1 vaccine doses have been conducted 100 people at two sites –Kalavati Saran Hospital in Delhi and Bharatiya Vidyapith in Pune, reports said.

Drug Controller General of India will review the trial data and will allow the Sanofi Pasteur vaccine for immunization purpose in the country.

The imported H1N1 vaccines from Sanofi-Pasteur will be mainly used for the high-risk group of medical practitioners.

Sanofi-Pasteur’s H1N1 vaccine will cost around Rs.300 per dose in India.

The India-made H1N1 swine flu vaccines will not be available before April.

Initially, India was planning to import four million doses of the vaccine. Indian manufacturers will now supply the remaining doses.

However, the health ministry cut it down to 1.5 million doses, in view of the possibility indigenously produced H1N1 swine flu vaccine to be made available by March.

The health ministry has been trying to make the vaccine available in India for the last three months and had sped up regulatory approvals for studies to be conducted on the safety of the vaccine.

India’s ministry of health and family welfare was holding discussions with indigenous vaccine manufacturers to assess their capacity to develop, manufacture and supply H1N1 swineflu vaccine for national programme.

Panacea Biotec has entered into an advance marketing agreement with Ministry of Health and Family Welfare (MoHWF) for supplying its H1N1 swine flu vaccine Pandyflu.

Panacea Biotec, which is based in New Delhi, northern India, is currently doing clinical studies on Pandyflu vaccine. Pandyflu is an inactivated split version vaccine using egg- based technology.

Zydus Cadila was the first Indian company to file the clinical trial protocol with the DCGI pushing back other domestic rivals who are also in race to launch H1N1 swine flu vaccine in India.

Zydus Cadila would have the vaccine ready by March, so the government would not need to import batches, according to government sources.

Serum Institute of India has  also been granted approval by the Drug Controller General of India (DCGI) to carry out clinical studies for the intra-nasal spray vaccine.

And most recently, Bharat Biotech, one of India’s leading vaccine makers, has launched first-in-man studies for cell culture vaccine HN-Vac against H1N1 influenza swine flu in India.

Bharat Biotech, Panacea Biotec and Serum Institute of India are the three biotech companies assigned by the Indian government to develop H1N1 swine flu vaccine.

Recently, India’s Biological E Limited has entered into an agreement with USA’s VaxInnate Corporation to license its recombinant H1N1 pandemic swine flu vaccine.

Cadila Pharmaceuticals, another pharma major from Ahmedabad, is also developing an H1N1 Swine flu vaccine in callaboration with Novavax.
CPL Biologicals Pvt. Ltd, the newly formed joint venture between Cadila Pharmaceuticals in India, expects to start producing H1N1 swine flu vaccine in next four months, Novavax Inc announced in a press release.

The H1N1 vaccine could get cheaper in India as more such indigenous vaccines come to the market late this year.

Similarly, Drug Controller General of India has given approval for Panacea Biotec to conduct clinical trials for its swine flu vaccines in the country, recently.

India has reported 1376 deaths from H1N1 swine flu infection in the country as of 2nd March 2010, according to an official communique from the ministry of health and family welfare issued by Press Information Bureau.

India has tested samples from 128944 persons for Influenza A H1N1 in government laboratories and a few private laboratories across the country till date and 29710 or 23.04% of them have been reported positive.

The western state of Maharashtra comes first with 369 deaths among the total 5577 lab confirmed cases of H1N1 swine flu deaths.

Maharashtra is followed by other states – Gujarat and Rajasthan -in the western region with 289 and 194 deaths respectively.

Gujarat and Rajathan have 1214 and 2192 each.

Delhi has the highest number of lab confirmed cases of H1n1 infection: 9687. However, India’s capital city registered only 95 cumulative number of deaths from swine flu.

Among the southern states, Karnataka accounted for the highest casualties with 148  deaths and 2138 cases of lab confirmed infections.

Andhra Pradesh reported 52 deaths and 782 infections while the states of Tamil Nadu and Kerala registered 7 deaths 2084 confirmed infections and 37 deaths and 1468 infections respectively.

The north-eastern states of West Bengal, Manipur, Meghalaya, Nagaland and nothern states of Bihar, Jharkhand as well as union territories Daman Diu, Andaman Nicobar reported zero deaths from swine flu.

It was reported earlier that H1N1 influenza or swine flu infections could continue in India for one more year.

Even though the trend in H1N1 swine flu infection is on the decline globally, it has now started showing up in places which are new. So, naturally India may have to face another year of swine flu infection, according to V M Katoch, Director General, Indian Council of Medical Research (ICMR).

“In places where swine flu cases were already reported, it has been contained. But we found that it is spreading to new pockets and hence we face the challenge for one more year. It is like a flood and will take some time to recede,” V M Katoch stated.

World Health Organisation recently reported that there is still intensive virus activity in some countries including India, even though H1N1 swine flu started waning in other parts of the world including US and Europe.