India plans H1N1 vaccine launch by Dec, fresh wave of swine flu sweeps across the country

Fresh H1N1 outbreaks and deaths reported in Bangalore, Maharashtra, Delhi and Haryana

Swine flu vaccines will be introduced in India by mid December, according to the top drug regulator Drug Controller General of India (DCGI), even as the country witness a fresh outbreak of H1N1 infections.

India is planning to bring swine flu vaccines in India by mid December as December and January are the two months when the flu-related cases are traditionally been reported mostly in the country, DCGI Surinder Singh is quoted as saying.

Indian government, however, is yet to to order international to influenza A HINI vaccine suppliers.

Health ministry is expected to take a decision on importing vaccine soon.

The government has written informed four multi-national H1N1 influenza vaccine makers to include India as well in their global clinical trials programme to test experimental vaccines in humans.

Foreign companies should first have to complete safety protocol study in India before introducing H1N1 influenza vaccine in the country, DCGI said.

India’s insistence to conduct separate clinical studies in India to ensure safety of H1N1 influenza vaccines could further delay the availability of the preventive vaccine in the country, experts said.

among the H1N1 vaccine makers in India only CPL Biologicals is expected to supply the vaccine atleast by next year.

CPL Biologicals, a joint venture between Ahmedabad based Cadila Pharmaceuticals and US based vaccine maker Novavax is planning to supply 10 million doses of swine flu vaccine (H1N1) in the first phase from January-February next year.

CPL Biologicals is setting up a manufacturing facility at Dholka for about Rs 100 crore with a capacity to produce up to 250 million doses H1N1 vaccines.

CPL, which makes H1N1 vaccines on new virus-like particle-based (VLP-based) platform technology, is expected get DCGI approval to start human studies for their candidate vaccine soon.
The new development is said to have potential to expand vaccine supplies while reducing development time for a vaccine from six months to just one.

Cadila Pharma owns 80 per cent stake CPL Biologicals and the remaining 20 per cent is held by Novavax. Cadila also holds 5.75% equity stake in Novavax of USA and has a position on the board of directors of Novavax.

Serum Institute of India, Bharat Biotech, Panacea Biotec are among the other Indian vaccine makers conducting early stage studies for H1N1 influenza vaccine. These companies also plan to conduct human studies this year so that they can roll out the vaccines as early as next year.

Meanwhile, a fresh wave of H1N1 influenza (swine flu) has broken out in various parts of the country.

Atleast three new swine flu deaths were reported in Karnataka, on Thursday.

Out of 106 swine flu death reports in Karnataka, 71 were in Bangalore and rest from other parts of the state.

11 fresh cases tested positive for H1N1 influenza in Bangalore, the previous day.The total number of positive cases has touched 1,124 in the state, officials said.

Over 100 fresh cases of swine flu. Of these, 46 were from Maharashtra, 29 from Delhi and 14 from Haryana.

Maharashtra is number one with a total of 3,152 cases, followed by Delhi, which has nearly 3,000 cases of swine flu.

According to recent union health ministry data, the number of H1N1 cased in India has crossed the 11,000 mark. The flu has so far claimed over 370 lives in the country.

Global H1N1 vaccine makers including Novartis, GSK and Baxter may also start safety studies in Indian population.

GlaxoSmithKline, which makes H1N1 vaccine Pandemirix has contracts to supply more than 400 million doses of vaccine for the H1N1 swine flu.

Baxter International Inc. received European Commission approval for its swine flu vaccine Celvapan.

Baxter is trying to determine through its trials if a single dose of the swine flu vaccine Celvapan is possible as well as if a lower dosage will be enough to prompt the necessary immune response.

H1N1 vaccine vaccine has been percolating into various parts of the United States over the last several days, where the pandemic H1N1 flu has killed about 600 people in this country.