Bharat Biotech’s Arm Biovet Gets CDSCO Nod for Biolumpivaxin
"Bharat Biotech group company Biovet, an innovative animal health vaccine producer based in Mallur, Karnataka, 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, said the company. .
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.
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, Biovet, said “This DIVA marker vaccine is a game-changer for veterinary medicine for disease surveillance and eradication programmes. Epidemiologists and field workers can now distinguish if an animal received Biolumpivaxin or was previously infected with LSD.”
“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,” he added.
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 nationwide. The LSD vaccine Biolumpivaxin will very soon be commercially available. The Biovet Malur facility in Karnataka can produce 500 million doses of Biolumpivaxin annually.
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. The presentation is in multi dose vials from 25 doses up to a maximum of 100 doses per vial and the vaccine is stable at 2-80 C storage temperature.
During the 2022 LSD outbreak in India, morbidity rates reached up to 80% with case fatality rates as high as 67%, across states such as Gujarat, Rajasthan, Maharashtra, Uttar Pradesh, Punjab, and Jammu & Kashmir. Historically, LSD was first reported in Zambia, Africa, in 1929. For several decades, the disease remained confined to Africa before spreading transcontinental to Egypt in 1988 and Israel in 1989. Over the years, the LSD virus has expanded its geographic range across the Middle East, Europe, and most recently, numerous Asian countries, including India. The first confirmed outbreak in India occurred in 2019, and since then, LSD virus has rapidly spread across multiple states, leading to substantial economic losses and a decline in milk production.