For the first in the country, the monkeypox virus strain has been isolated by Indian Council of Medical Research-National Institute of Virology, Pune.
The institution has invited an Expression of Interest (EOI), proposing to handover the strain to industry partners for development of indigenous vaccine and diagnostic kits for the disease, said senior Health Ministry officials on Wednesday.
Isolation of virus strains is the first step towards expediting the development of drugs, vaccines and rapid diagnostic kits in the country.
“ICMR-NIV Pune has successfully isolated and cultured the Monkeypox virus strain from the samples of infected Indian patients. Genomic sequence of the Indian strains has 99.85% match with the West African strain circulating globally,’’ said the official.
There are two known types (clades) of monkeypox virus — one that originated in Central Africa and one that originated in West Africa. The current world outbreak (2022) is caused by the less severe West African clade.
ICMR’s EOI document states that it reserves all the Intellectual Property Rights and Commercialisation Rights on the Monkeypox virus isolates and its method/protocols for purification, propagation and characterisation. ICMR is lawfully entitled to enter into any form of non-exclusive agreements with experienced Drug/Pharma/Vaccine/IVD manufacturers through defined agreement for undertaking R&D as well as manufacturing activities using characterised monkeypox virus isolates of ICMR for development of vaccine against monkeypox disease or diagnostic kit for diagnosis of monkeypox virus, hereinafter referred to as the ‘Product(s)’.
It further stated that ICMR is willing to collaborate with experienced vaccine manufacturers as well as the in-vitro diagnostics (IVD) manufacturers on Royalty basis on fixed term contract condition for undertaking R&D and manufacturing activities for joint development and validation of five potential vaccine candidates against monkeypox disease, development of diagnostic kit (IVD), for detection of the monkeypox virus leading to product development.
Also the firm(s)/organisation(s) would be granted rights to undertake further R&D, manufacture, sell, and commercialise the end product(s) ‘vaccine candidate/IVD’ against the monkeypox disease under defined Agreement.
“Agreement following EoI will be executed on “Non-Exclusive” basis with single/multiple firms, due to the extensive demand of monkeypox virus isolates, which is being envisaged to develop vaccine candidates/IVD kits,’’ said the EOI.
According to the World Health Organisation, monkeypox is usually a self-limited disease with the symptoms lasting from two to four weeks; severe cases can occur. In recent times, the case fatality ratio has been around 3–6%. It is transmitted to humans through close contact with an infected person or animal, or with material contaminated with the virus. Monkeypox is a viral zoonotic disease.
