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Biovet receives CDSCO licence DIVA marker vaccine for lumpy skin disease – DairyDimension

Biovet, a Bharat Biotech group company specialising in animal health vaccines, has announced that its Lumpy Skin Disease (LSD) vaccine for dairy cattle and buffaloes, BIOLUMPIVAXIN, has received a licence from the Central Drug Standards Control Organization (CDSCO). The vaccine is the world’s first Differentiating Infected from Vaccinated Animals (DIVA) marker vaccine for LSD.

Developed in collaboration with the Indian Council of Agricultural Research (ICAR), BIOLUMPIVAXIN is an indigenous live-attenuated marker vaccine. It was created using the LSD virus/Ranchi/2019 vaccine strain from ICAR-National Research Centre on Equines (ICAR-NRCE), Hisar. The vaccine underwent quality, safety, and efficacy testing at ICAR-NRCE and the Indian Veterinary Research Institute (IVRI).
The development of BIOLUMPIVAXIN was led by ICAR scientists over three years, with contributions from Dr Naveen Kumar, now Director at the National Institute of Virology (NIV), Pune, under the leadership of Dr B. N. Tripathi, former Deputy Director General, Animal Sciences, ICAR, and currently Vice Chancellor of SKUAST, Jammu.
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 added, “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.”
Lumpy Skin Disease has significantly impacted the Indian dairy industry, with approximately 200,000 cattle deaths and widespread losses in milk production over the past two years. The Biovet Mallur facility has an annual production capacity of 500 million doses of BIOLUMPIVAXIN.
BIOLUMPIVAXIN is provided in a freeze-dried form with stabilising agents for long-term stability. The vaccine is administered as a single annual dose to cattle and buffaloes over three months old. It is available in multi-dose vials ranging from 25 to 100 doses and remains stable at storage temperatures between 2°C and 8°C.
Preclinical studies confirmed that the vaccine is free from extraneous agents and demonstrated safety, immunogenicity, and protective efficacy in a controlled BSL-3 animal facility. No reversion to virulence was observed, and the vaccine virus was not detected in milk, semen, or bodily excretions from vaccinated animals.
Clinical trials conducted by ICAR-NRCE, Hisar, and Biovet involved thousands of cattle and buffaloes under field conditions. The vaccine was found to be safe across all animal groups, including pregnant and lactating cattle and buffaloes, as well as breeding bulls.
Unlike globally available LSD vaccines based on the Neethling LSDV strain, which have been associated with local reactions, micronodules, fever, and temporary reductions in milk yield, BIOLUMPIVAXIN did not cause such effects.
The DIVA marker in the vaccine allows for post-vaccination seromonitoring, enabling the differentiation of naturally infected animals from vaccinated ones. This supports the implementation of effective LSD control programmes.
Lumpy Skin Disease (LSD) is a transboundary animal disease affecting cattle. It is characterised by the development of skin nodules, fever, swollen lymph nodes, decreased milk yield, and movement difficulties. The disease is primarily transmitted by biting insects such as mosquitoes and ticks.
India experienced a major LSD outbreak in 2022, with morbidity rates reaching 80 per cent and case fatality rates as high as 67 per cent across multiple states, including Gujarat, Rajasthan, Maharashtra, Uttar Pradesh, Punjab, and Jammu & Kashmir. Economic losses were estimated at ₹18,337.76 crore, with a 26 per cent decline in milk production.
LSD was first reported in Zambia, Africa, in 1929 and remained confined to the continent for decades before spreading to Egypt in 1988 and Israel in 1989. The virus has since expanded across the Middle East, Europe, and Asia, with India’s first confirmed outbreak occurring in 2019.
Vaccination is the most effective strategy for LSD control. Homologous vaccines instruct the immune system to mount a defence against LSD virus infection. Immunity development takes three to four weeks post-vaccination, making advance immunisation crucial for preventing outbreaks and protecting dairy cattle and buffaloes.

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