India to buy 1.5 million doses of H1N1 swine flu vaccine from Sanofi Pasteur: Reports

Sanofi Pastuer recalled 800,000 pre-filled syringes of Influenza A (H1N1) 2009 Monovalent Vaccine for kids from US market on potency problems

India has placed an order with the French drug maker Sanofi Pasteur for supplying 1.5 million doses of H1N1 swine flu vaccine, reports said.

Sanofi Pasteur’s 2009 H1N1 swineflu vaccine batches will be available in India in January.

Sanofi Pasteur, for whom an order of 15 lakh vaccine dosages worth Rs 50 crore has been given, will soon start pre-market vaccine trials in India soon, reports said quoting India’s health ministry sources.

“Of four international vaccine manufacturers, it has been decided that Sanofi Pasteur’s vaccine will be used here,” an official in the Ministry of Health and Family Welfare was quoted as saying

GlaxoSmithKline, which supplies Pandemrix, Baxter (Celvapan) and Novartis (Focetria) are the other multinational vaccine suppliers who have been competing to supply H1N1 swine flu vaccines in India.

India’s health ministry has given approval to French drug maker Sanofi Pasteur for conducting pre-market trials of swine flu vaccine in the country, which is a mandatory condition for selling the vaccine in India.

(Recently, Sanofi Pasteur, the vaccine division of the French drug maker sanofi-aventis, has recalled 800,000 pre-filled syringes of Influenza A (H1N1) 2009 Monovalent Vaccine after finding that vaccine doses meant for kids lost their potency.)

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.

Drug Control General of India has given approval to Zydus Cadila of Ahmedabad to carry out human studies of its H1N1 vaccine in India.

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.

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

Serum Institute of India has started preclinical animal studies for its indigenous H1N1 swineflu vaccines in India.

Pune, Maharashtra based Serum Institute has begun studies to test the toxicity and safety of its experimental vaccine currently being developed before attempting to study in humans, reports said quoting Serum officials.

Serum also plans to make H1N1 vaccine available to the Indian government by March 2010.

New Delhi-based Panacea’s  egg based H1N1 vaccine is currently going through pre-clinical testing in animals. The animal studies are expected to be complted by December. Panacea is  planning to begin the clinical trials in January 2010 and launche the vaccine April 2010, sources said.

Bharat Biotech, Hyderabad, which is currently working on a cell-based vaccine, also expects its animal studies to be over by the end of  December.

Probably Bharat Biotech would start the human studies of its H1N1 vaccine as early as  January, 2010. The clinical studies are expected to be complted by March, 2010, subject to regulatory approval and  Bharat Bio would launch its own vaccine by April 2010, if everything goes as planned.

Cadila Pharmaceuticals and Biological E Ltd, Hyderabad are also working on H1N1 vaccines.

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.

GlaxoSmithKline (GSK), Novartis, Baxter International and Sanofi-Aventis are the multinational companies applied for test license to the DCGI for carrying out clinical trials in India for their version of swine flu vaccines.

India reported 25,572 confirmed cases of swine flu, of which 898 resulted in death, till 29 December. Delhi reported 8,306 cases, the highest among the states.

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.