CDSCO grants approval to Biovet’s BIOLUMPIVAXIN, first Indian & global DIVA marker vaccine for lumpy skin disease

New Delhi: Bharat Biotech group company Biovet has announced that its Lumpy Skin Disease (LSD) vaccine for dairy cattle and buffaloes, BIOLUMPIVAXIN^®, the world’s safest and first-ever Differentiating Infected from Vaccinated Animals (DIVA) marker vaccine, has received a license from the Central Drug Standards Control Organization (CDSCO).

The soon-to-be-launched BIOLUMPIVAXIN^® is the world’s only marker vaccine for LSD. It offers a high safety and efficacy profile while enabling serological differentiation between naturally infected and vaccinated animals with the DIVA concept in it.

The quality, safety, and efficacy of the vaccine have been extensively tested at ICAR-NRCE and at the Indian Veterinary Research Institute (IVRI), ensuring it meets the highest global standards.

Biovet is an animal health vaccine producer based in Mallur, Karnataka.

This novel Indigenous live-attenuated marker vaccine was developed using the LSD virus/Ranchi/2019 vaccine strain from Indian Council of Agriculture Research-National Research Centre on Equines (ICAR-NRCE), Hisar, in collaboration with Bharat Biotech’s Biovet.

The vaccine is the result of three years of dedicated research by scientists at NRCE, led by Dr. Naveen Kumar (now Director, NIV-Pune) under the leadership of Dr. B. N. Tripathi (former DDG, Animal Sciences, ICAR, now Vice Chancellor, SKUAST, Jammu).

ICAR and its scientists made significant contributions and played a crucial role in the development of this collaborative, world-class vaccine for animal health.

Dr. Krishna Ella, Founder of Biovet, said “This DIVA marker vaccine is a game-changer for veterinary medicine for disease surveillance and eradication programs. Epidemiologists and Field workers can now distinguish if an animal received BIOLUMPIVAXIN^® or was previously infected with LSD.”

Dr. Ella adds “The CDSCO licensure for this vaccine is a significant step toward India’s self-reliance (Atmanirbhar Bharat) in veterinary healthcare, which avoids dependency on imported vaccines. As India moves towards a disease-free livestock population, this path-breaking vaccine will play a crucial role in ensuring the dairy industry’s sustainability.”

Over the past two years, approximately 200,000 cattle have died, and millions more have lost their milk production capabilities due to Lumpy Skin Disease (LSD) nationwide. The LSD vaccine BIOLUMPIVAXIN® will very soon be commercially available. The Biovet Mallur facility can produce 500 million doses of BIOLUMPIVAXIN® annually.

The dairy industry plays a crucial role in India’s GDP and its future economic growth. Dairy cattle provide a consistent daily source of income for hundreds of millions of farmers and women across the country. The impact of preventive vaccines against Lumpy Skin Disease (LSD) will positively affect every village and district in India, supporting the sustainability and growth of the dairy sector.

Key attributes of BIOLUMPIVAXIN^®:

BIOLUMPIVAXIN^®, is provided in freeze-dried form with stabilizing agents for long-term stability. Diluent for the reconstitution of freeze-dried vaccine is provided separately. Each vaccine dose contains NLT log₁₀ ^3.5 /mL. It is a single vaccination regimen given once in a year to cattle and buffaloes above 3 months of age.

DIVA marker concept: Post-vaccination seromonitoring helps to differentiate infected animals from that of the vaccinated animals for implementing effective LSD control programs.

Lumpy skin disease (LSD) is a transboundary animal disease that has gained significant attention in India due to its severe impact on cattle health and the dairy industry. The disease is characterized by the development of skin nodules across the body, fever, swollen lymph nodes, decreased milk yield and difficulty in movement. LSD virus transmission is largely attributed to vector bites, with mosquitoes, ticks, and other biting insects playing an essential role.