Zydus Cadila Healthcare Ltd has received WHO prequalification accreditation for its Rabies vaccine, Lyssavac.
With this, Zydus Cadila becomes the first Indian pharma company and the second pharma company in the world to receive the WHO prequalification accreditation for rabies vaccine.
''WHO has approved Lyssavac N, purified duck embryo rabies vaccine (PDEV), manufactured by Zydus Cadila, for purchase by various United Nations Agencies,'' the company said in a filing with the Bombay Stock Exchange.
Zydus Cadila,the flagship firm of the Zydus Group, had entered into an agreement with WHO in August this year to explore a possible collaboration for the development of a cocktail for the treatment of rabies, through the use of monoclonal antibodies (MAbs), the next-generation biologicals.
The broad-based agreement signed with WHO included evaluation and a possible stepping-stone for the development and commercialisation of the cocktail, to be used as an adjuvant therapy. The World Health Organization would provide monoclonal antibodies capable of neutralising the rabies virus and its genetic sequences for evaluation at the Zydus Research Centre, the Ahmedabad-based company's research arm.
Zydus Cadila, one of the largest manufacturers of rabies vaccine in India, produces 3 million doses of the vaccine per annum. The vaccine facility, set up in technical collaboration with Bema Biotech of Switzerland, is located at Moraiya near Ahmedabad in Gujarat.
The purified duck embryo rabies vaccine is said to be very well tolerated with the best sero conversion for protection against rabies. In India, the vaccine is marketed under the brand name 'Vaxirab' and Lyssavac N. The vaccine is currently exported to countries in South East Asia and Africa.
This MAbs therapy heralds a new approach in the fight against this fatal disease. Currently, there is no treatment for rabies once the symptoms of the disease have appeared. Post exposure prophylaxis for severe bites requires both active immunisation using vaccines and passive immunisation in the form of rabies immunoglobulins (RIG). These immunoglobulins are derived from the blood serum and pose a problem in the treatment as they are often in short supply.
Rabies monoclonal antibodies (MAbs) are an innovative therapy and can emerge as a potent alternative. While the rabies vaccine induces active immunity, the Rabies monoclonal antibodies can be safely administered with the vaccine to provide immediate passive neutralizing activity.
Zydus group is also developing a new cell culture vaccine, which it says will be used for both intramuscular and intradermal vaccination.
Rabies is a zoonotic viral disease, which infects domestic and wild animals. It is transmitted to other animals and humans through close contact with saliva from infected animals through bites, scratches, licks on broken skin and mucous membranes. Once symptoms of the disease develop, rabies is fatal to both animals and humans. The virus infects the central nervous system, causing encephalopathy or disease of the brain and ultimately death, if medical treatment is not sought before the symptoms appear.
Rabies is prevalent across Europe, Asia, America and Africa with approximately 10 million people being treated globally each year after exposure to rabies. Some 40,000 to 70,000 people die of the disease each year, mainly in Africa, China and India.