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As cases of lumpy skin disease (LSD) surge among India’s cattle population, an indigenous vaccine launched a month ago is still awaiting approval for emergency use.
Union Minister of Agriculture & Farmers Welfare Narendra Singh Tomar launched the shot developed by the Indian Council of Agricultural Research (ICAR) August 10, 2022. The vaccine needs the nod for emergency use from the Department of Animal Husbandry and Dairying (DAHD).
The delay is mainly due to confusion over the vaccine’s efficacy and questions about who will be responsible for producing it.
There have been several meetings between the officials of the ICAR and the animal husbandry department, the most recent September 5, over granting emergency approval for the Lumpi-ProVacInd vaccine.
Lumpi-ProVacInd has been developed by ICAR-National Research Centre on Equines (ICAR-NRCE), Hisar, Haryana, in collaboration with ICAR-Indian Veterinary Research Institute (IVRI), Izatnagar, Uttar Pradesh.
Currently, India is administering the goat pox vaccine for LSD, which has killed about 50,000 bovines and infected around 12 lakh cattle. It’s a heterologous vaccine that offers cross-protection (up to 60-70 per cent) for cattle against the disease.
Goat pox, sheep pox and LSD belong to the same capripoxvirus genus. Lumpi-ProVacInd is a homologous vaccine made with the same virus as the disease.
Homologous live-attenuated vaccines provide better and longer immunity compared to heterologous ones, according to experts.
However, there are concerns about the safety of the shot in the animal husbandry department. There were reports of unusual new virus strains discovered in Russia, Kazakhstan and China between 2017-2019 after using the homologous lumpy skin disease virus (LSDV) vaccine, officials said.
However, the LSDV strain used in Lumpi-ProVacInd is not a recombinant strain, like the one used in Russia. “The LSDV strain used in Lumpi-ProVacInd is not a recombinant strain, it’s a Neethling strain closely related to the one from Kenya,” said Naveen Kumar, principal scientist, NRCE.
“It’s not related to the strains from China and Russia. The recombinant virus in China and Russia were accidentally generated in the lab during amplification of the virus in cell culture, then injected in the animals through vaccine,” Kumar added.
This was realised later when the vaccine vials were tested positive for multiple viral strains, the scientist said.
There have been meetings between ICAR officials and the department specifically over this issue.
“There are a few concerns, but recent research has found that the vaccine batches in Russia were contaminated in the lab that caused the new strains. It wasn’t because of the type of the vaccine,” BN Tripathi told Down To Earth. He is the deputy director general for Animal Science.
Tripathi was referring to a research paper published June 29, 2022, by scientists from Belgium and Kazakhstan in MDPI journal. The research revealed three strains were mixed in the vaccine at the production stage in the laboratory.
“LSDV vaccines are being successfully used in European countries to prevent the outbreak and are more effective than the goat pox vaccine. There are reports from some farms in India that the goat pox vaccine is not very effective,” he said.
The government has set a target to vaccinate the entire 30 crore cattle population. In August, around 1.53 crore cattle were vaccinated with the goat pox vaccine, which is currently being manufactured by two companies — Hester Biosciences Ltd and Indian Immunologicals Ltd.
The demand for the vaccine is increasing as the disease spreads from one state to another.
Several states have asked for the vaccine doses at the same time, said Praveen Malik, animal husbandry commissioner, DAHD. “The demand for the shots was low before 2019, so the manufacturing capacity was also less. Now it is being amped up to meet it,” he said.
However, veterinarians believe that a dedicated LSD vaccine is required to control the spread of the disease.
“The vaccine for LSD is under development and also undergoing trials, but goat pox is the closest that can offer about 70-80 per cent immunity. But considering the severity, a dedicated vaccine is needed,” said Anil Bhikane, director of extension education at Maharashtra Animal and Fishery Sciences University, Nagpur.
ICAR’s LSD vaccine was considered a breakthrough in this regard.
Several scientists are confident that the indigenous vaccine is safe and will provide better protection against the LSD virus than the goat pox vaccine. The scientists at NRCE isolated the virus in 2019 when the disease was first reported in India.
The first experimental trial of the vaccine was done at ICAR-IVRI Mukteshwar campus in April 2022 and 10 animals were given a dose. After a month, the animals, along with five control animals that weren’t given the vaccine, were injected with the virulent virus.
The control animals showed LSD symptoms, while the vaccinated animals developed immunity.
Following this, field trials were done at 36 farms in Rajasthan, Uttar Pradesh and Haryana in July with 7,000 animals, out of which cases were reported in four farms after the vaccine.
“The immunity takes one month to develop and a clean period wherein the animal doesn’t come into contact with the disease is required. But given that the disease is widespread now, the animals would have contracted it before full immunity kicked in,” said Kumar.
“The technology is ready and we have everything required for emergency-use approval, but we are just waiting for a go-ahead from the ministry,” he said.
Meanwhile, the vaccine is being given to the organised sector — government and private farms and gaushalas on an undertaking basis. The undertaking said that it’s an experimental vaccine and the institute will not be responsible for any adverse impact. “This is a formality for an emergency use approval,” said Kumar.
More than 80,000 doses have been distributed to different state government and private farms. The institute says it can produce up to 500,000 to 1 million doses per month.
Who will produce of vaccine is another bone of contention between the two units. Animal Husbandry Commissioner Malik said that NRCE had asked permission to produce the vaccine in its labs for supply across the country, but the permission could not be granted since the laboratories are not good manufacturing practice compliant.
However, Tripathi said that ICAR’s commercialisation arm Agrinnovate India had issued an expression of interest document for the vaccine along with four companies. “Our job is to develop the vaccine. We will hand over the technology to the companies once approval is given,” he said.
However, even this will take at least six months before the companies manufacture it, test it, and seek the approval of the Drug Controller General of India.