The Indian Council of Medical Research – National Institute of Virology, Pune, isolated the monkeypox virus strain for the first time.

The agency has invited expressions of interest (EOIs) to propose handing over the strains to industry partners to develop homegrown vaccines and diagnostic kits for the disease, a senior health ministry official said on Wednesday.

The isolation of the virus strain is the first step in the country’s accelerated development of drugs, vaccines and rapid diagnostics.

“ICMR-NIV Pune has successfully isolated and cultured monkeypox virus strains from infected Indian patient samples. The genome sequence of the Indian strains matches 99.85% of the globally prevalent West African strains,” the official said.

There are two known types (clades) of monkeypox viruses – one originating in Central Africa and one in West Africa. The less severe West African branch causes the current world outbreak (2022).

ICMR’s EOI document states that it retains all intellectual property and commercialisation rights to monkeypox virus isolates and methods/protocols for their purification, propagation, and characterisation. ICMR has the right to enter into any form of non-exclusive agreement with an experienced drug/drug/vaccine/IVD manufacturer to conduct R&D and manufacturing activities using ICMR’s characterised monkeypox virus isolates to develop monkeypox-specific vaccines for diagnostic monkeypox virus disease or diagnostic kits, hereinafter referred to as “products”.

It further stated that ICMR is willing to cooperate with experienced vaccine manufacturers and in vitro diagnostic (IVD) manufacturers on a royalty basis on a fixed-term contract basis to jointly develop and validate R&D and manufacturing activities for five potential monkeypox vaccines. Candidate, developing a diagnostic kit (IVD) to detect monkeypox virus, leading to product development.

In addition, under the above agreement, the company/organisation will be granted the right to develop, manufacture, market and commercialise the final product “Vaccine Candidate/IVD” against monkeypox disease.

“Due to the widespread demand for monkeypox virus isolates, post-EOI agreements are expected to be executed on a ‘non-exclusive’ basis with single/multiple companies to develop vaccine candidates/IVD kits,” EOI said.

According to the World Health Organization, monkeypox is usually a self-limiting disease, with symptoms lasting two to four weeks; severe cases can occur. Recently, the case fatality rate has been around 3-6%. It is transmitted to humans through close contact with an infected person or animal or virus-contaminated material. Monkeypox is a viral zoonotic disease.