Lumpy skin disease: Worry over vaccine duopoly

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    New Delhi, September 30, 2022: EVEN AS lumpy skin disease has already killed nearly 1 lakh cattle and infected over 20 lakh animals across 15 states, governments are having to depend on just two companies for the vaccine whose use has been authorised against the virus.

    At present, Ahmedabad-based Hester Biosciences Ltd and the National Dairy Development Board’s Hyderabad-based subsidiary Indian Immunologicals Ltd (IIL) manufacture goatpox vaccine.

    Goatpox, sheeppox and lumpy skin disease viruses belong to the same capripoxvirus genus. The vaccines developed for the first two, and already being commercially produced in the country, offer up to 60-70 per cent cross-protection against lumpy skin disease in cattle.

    But as of now, only goatpox vaccine has been authorised for administering against lumpy skin disease. In an advisory issued to states on September 2, 2021, the Department of Animal Husbandry and Dairying (DAHD) said that “cattle and buffaloes should be vaccinated with available Goat pox vaccine”. At the time of authorisation, Hester Biosciences was the sole manufacturer of goatpox vaccine in the country; IIL launched its goatpox vaccine in December 2021.

    On the other hand, there are a dozen or so manufacturers of sheeppox vaccine, including six state-owned manufacturers. They include, apart from Hester Biosciences and IIL, the Hyderabad-based Brilliant Bio Pharma Pvt Ltd, Bio-Med Pvt Ltd in Ghaziabad (Uttar Pradesh) and state-owned producers such as the Veterinary Biological & Research Institute (Hyderabad), the Institutes of Animal Health & Veterinary Biologicals in Bengaluru and Mhow (Madhya Pradesh), Indian Veterinary Research Institute or IVRI at Izatnagar near Bareilly (UP), Haryana Veterinary Vaccine Institute (Hisar), and the Institute of Animal Health & Biological Products (Zakura, Srinagar).

    Asked why only use of goatpox vaccine has been authorised for control of lumpy skin disease, Praveen Malik, Animal Husbandry Commissioner at DAHD, said the decision was taken based on IVRI’s recommendations. “Scientists there recommended that the goatpox vaccine (Uttarkashi strain) is effective against lumpy skin disease. It is for scientists at IVRI or NIHSAD to recommend whether or not sheeppox vaccine can also be used,” Malik told The Indian Express.

    In a reply to an RTI query filed by one Sandeep Kumar Gupta from Hisar, the Centre for Animal Disease Research and Diagnosis at IVRI-Izatnagar stated that “none of [the centre’s] scientists was involved in advising use of goat pox vaccine in cattle and buffaloes to control lumpy skin disease”.

    IVRI and the National Institute of High Security Animal Disease, Bhopal (NIHSAD) are both under the Indian Council of Agricultural Research (ICAR).

    Two of ICAR’s own institutes — the National Research Centre on Equines in Hisar (Haryana) and IVRI –have jointly developed Lumpi-ProVacInd, a live attenuated lumpy skin disease vaccine. It is homologous and it is claimed to provide 100 per cent protection against lumpy skin disease virus in cattle. These are unlike goatpox and sheeppox vaccines that are heterologous and offer only partial cross-protection of 60-70 per cent against lumpy skin disease according to the reports published in indianexpress.com.

    On September 12, Prime Minister Narendra Modi had expressed concern over the loss of livestock on account of lumpy skin disease in several states. Speaking at the IDF World Dairy Summit in Delhi, he mentioned that “our scientists have developed an indigenous vaccine for lumpy skin disease”.

    ICAR transferred the technology for manufacture of Lumpi-ProVacInd to Biovet Private Limited (BPL) through an MoU signed on September 15. The Bengaluru-headquartered BPL, an associate of Bharat Biotech (developer of ‘Covaxin’), has sought the Drug Controller General of India’s (DCGI)approval for veterinary use of Lumpi-ProVacInd. It has already obtained a licence from the Central Drugs Standard Control Organisation, a regulatory body under the Union Ministry of Health and Family Welfare, to manufacture test batches of this vaccine contingent upon DAHD issuing an NOC.

    BPL has approached DAHD, seeking NOC for testing the vaccine on cattle.

    DGCI has, in turn, written to DAHD seeking data on vaccine trials.

    “Things are moving very fast at our end and we are trying to expedite the process of commercialisation,” Malik said.

    However, a senior ICAR scientist questioned the need for further trials at this stage. “We conducted experimental trials of Lumpi-ProVacInd on 15 male cattle at IVRI’s Mukteshwar campus as per the World Organisation for Animal Health’s guidelines,” the scientist said. “Subsequently, the vaccine has been administered in field trials to 12,000 animals in five states where lumpy skin disease has been widespread. The vaccine has been found 100 per cent effective. Why can’t emergency use authorisation be granted similar to that for Covid-19 vaccines?”

    The scientists, who did not wish to be identified, also alleged that goatpox vaccine was “not used on a single cattle head before being authorised for use as protection against lumpy skin disease”. Nor was any data submitted to DGCI, he claimed. “Its use was recommended based on existing literature, which could also have applied for sheeppox vaccine,” he added.