Bharat Biotech joins race of Indian H1N1 swine flu vaccine makers by developing cell culture HN-VAC

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.

HN-Vac Phase I clinical evaluation studied have begun following the approval from Drugs Controller General of India (DCGI), Bharat Biotech announced in a press release.

HN-Vac is expected to boost immunity against the new H1N1 influenza strains, and help protect public health as the pandemic evolves.

Bharat Biotech is the first company in India to develop, a cell culture based vaccine candidate for influenza, which can serve as a platform technology for both pandemic and seasonal flu vaccines, the release said.

“In preclinical evaluation HN-Vac vaccine candidate triggered a beneficial immune response,” Dr. Krishna Ella, chairman and managing director of Bharat Biotech International stated.

The phase I clinical trial has started in Bangalore with more than 150 subjects under evaluation for safety and immunogenicity and is slated for completion within 6 weeks, he added.

Bharat Biotech has an outlay of Rs 70 crores towards HN-Vac development,manufacturing facilities and R&D facilities for this cell culture based H1N1 vaccine.

Cell culture based flu vaccines represent a new generation vaccine technology that removes the need for traditional egg based vaccines.

Egg based vaccines are limited by the availability of high quality eggs in millions to manufacture the vaccine and require a cumbersome manufacturing process.

Cell culture based vaccines would enable Bharat Biotech to respond quickly to pandemics and rapidly increase the manufacturing capacity as required.

Bharat Biotech has received the H1N1 vaccine strains from WHO/CDC centers.

Through launching the Phase I clinical trials of HN-Vac, Bharat Biotech joined the growing ralley of Indian vaccine makers who are in currently in race for developing indigenous vaccines to fight H1N1 influenza swine flu virus.

Already, several Indian companies including Zydus Cadila, Serum Institute of India, Panacea Biotec have started clinical trials of their own versions of H1N1 swine flu vaccines 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.

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.

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.

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 is a privately-held biotechnology company based in USA and is focused on developing proprietary vaccines, including those for both pandemic and seasonal influenza.

Biological E plans to manufacture H1N1 pandemic swine flu vaccine under a technology licence from VaxInnate.

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.

Biological E., Ltd is a biopharmaceutical company based in Based in Hyderabad, India.

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.

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

Sanofi Pasteur’s 2009 H1N1 swine flu vaccine batches will be available in India by February.
Last year, four companies had approached the government to provide assistance in locally developing the vaccines for HINI.

Currently, the imported H1N1 swine flu is priced around Rs 300-400. But H1N1 swine flu vaccines produced by Indian companies may have a price of only Rs 50-100, reports said.

Initially, the India made H1N1 swine flu vaccines were expected to be launched in India only by April this year. However, Indian companies have advanced their their schedule to launch the vaccine as early by March, reports said quoting V M Katoch, director-general, Indian Council of Medical Research (ICMR) and secretary to the Government of India, department of health research.

India has reported 1010 deaths confirmed by lab due to H1N1 as on January 6, 2010, as per the data available with the Union Health Ministry,.

Maharashtra on top of the list with 282 lab confirmed death cases. After Maharashtra, the maximum number of people who have lost their lives due to this pandemic disease is in Rajasthan which has registered 152 cases till January 6, and is followed by its neighbour Gujarat with 134 lab confirmed death cases so far. Gujarat is closely followed by the southern state of Karnataka with 133 death cases.

Delhi reported 73 deaths, Andhra Pradesh 52 , Kerala 34, Punjab 35 and Haryana 33.

The states which were registered comparatively less number of deaths included Uttar Pradesh (16), Uttarakhand (13), Madhya Pradesh (11), Chandigarh (8), Tamil Nadu (7), Himachal Pradesh (7), Puducherry (6), Goa (5), Orissa (3) Chhattisgarh (2), Jammu & Kashmir (2), Mizoram (1) and Assam (1).

However, no deaths were registered in some states like Bihar, Jharkhand, West Bengal, Nagaland, Manipur, Meghalaya, Andaman & Nicobar and Daman & Diu.

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.

Pandemic H1N1 influenza was reported in more than 208 countries and with more than 12,500 deaths. India has reported approximately 26,000 cases with more than 1000 deaths.

Bharat Biotech International Limited, Hyderabad, India, s one of the largest manufacturer of anti-rabies vaccines in India. Indirab is a market leader in India and several countries globally.

Bharat Biotech is one of the first bio-pharma facilities in India to be audited and approved by Korean Food & Drugs Administration (KFDA).

Bharat Biotech is also a WHO prequalified manufacturer of Hepatitis-B vaccines for supply to UNICEF and global procurement agencies.