India may begin H1N1 swine flu vaccination drive by March; Sanofi-Pasteur vaccine only by Feb

India may begin vaccination against H1N1 swine flu in the country by March this year as the first batches of imported vaccine from Sanofi-Pasteur will arrive India by the end of February.

India’s ministry of health placed an order with the french vaccine maker Sanofi-Pasteur to import 1.5 million doses of H1N1 swine flu vaccines in December last year,

The first H1N1 vaccine lots from Sanofi-Pasteur was expected to be available in India as early as January 2010. However, contrary to the expectation, the availability of the H1N1 vaccine has been delayed as Sanofi-Pasteur is yet to complete the mandatory human trials before launching the vaccine in India, according to Drug Controller General of India Surinder Singh.

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 two months and had sped up regulatory approvals for studies to be conducted on the safety of the vaccine.

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.

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.

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 vacccine.

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.

VaxInnate recombinant H1N1 vaccine is based on the novel Toll-Like Receptor (TLR) technology platform, which dramatically improves vaccine immunogenicity and efficacy.

Biological E would produce vaccine for India and other South Asian countries, including Bangladesh, Bhutan, the Maldives, Nepal, Pakistan and Sri Lanka.

The H1N1 pandemic swine flu vaccine is projected to enter clinical development in India in early 2010. And the vaccine could become available for emergency use in India by mid 2010.

TLR technology enables Biological E to produce more than 300 million vaccine doses every month and is a practical indigenous solution to meet the needs of India’s 1.2 billion population, making the country self sufficient in the event of an emergency, the release said.

Cadila Pharmaceuticals, another pharma major from Ahemedabad, 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 swin 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.

India has reported over 1,100 deaths due to H1N1 swine flu virus and over 28,000 people have been infected with the disease, so far.

So far, India has reported over 1,100 deaths due to the contagious virus and over 28,000 people have been infected with the disease till now.

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.