ICMR isolates monkeypox virus; could pave the way for diagnostic kits, vaccines

The National Institute of Virology (NIV) in Pune, under the aegis of ICMR, has isolated the monkeypox virus from a patient’s clinical specimen, which may pave the way for the development of test kits. diagnostics and vaccines for the disease, officials said Wednesday.

As India isolates the virus, the Indian Council of Medical Research has also invited experienced vaccine manufacturers, pharmaceutical companies, research and development institutes and manufacturers of in vitro diagnostic (IVD) kits to protest. their interest in joint collaboration in the development of a candidate vaccine. against monkeypox and diagnostic kits for the infection.

Isolation of the virus boosts India’s ability to do research and development in many other directions, said NIV senior scientist Dr Pragya Yadav.

The development comes amid India reporting four cases of monkeypox – three from Kerala and one from Delhi – so far.

“The National Institute of Virology has successfully isolated monkeypox virus from a patient’s clinical specimen, which may aid in the development of diagnostic kits and also vaccines in the future. For smallpox, the live attenuated vaccine has been successful for mass vaccination in the past, new platforms can be tried to manufacture vaccines.

“Isolating the virus is enhancing India’s ability to do research and development in many other directions,” Dr Yadav said.

Currently, the fluid inside the skin lesions is used for virus isolation because it has the highest viral titer.

Dr Yadav said the monkeypox virus is an enveloped double-stranded DNA virus with two distinct genetic clades – the Central African (Congo Basin) clade and the West African clade.

“The recent outbreak which has affected several countries resulting in a worrying situation is caused by the West African strain which is less severe than the previously reported Congolese lineage. The cases reported in India also belong to the less severe lineage from Africa of the West,” she told PTI. .

The EOI documents indicate that ICMR is willing to make available monkeypox virus strain/isolates to undertake validation of research and development as well as manufacturing activities using characterized monkeypox virus isolates within the scope of a joint collaboration within the framework of a public-private partnership for the development of a vaccine candidate against monkeypox disease and diagnostic kits for the diagnosis of the infection.

“ICMR is in possession of characterized monkeypox virus isolates/strains and thus is willing to collaborate with experienced vaccine manufacturer as well as In Vitro Diagnostics (IVD) manufacturers on a royalty basis on condition of availability. a fixed-term contract to undertake R&D and manufacturing activities for Joint development and validation of 5 potential vaccine candidates against monkeypox disease, development of a diagnostic kit (IVD), for the detection of monkeypox virus leading to product development,” the EOI document states.

The company(ies)/organisation(s) would be granted the right to undertake further R&D, manufacture, sell and market the final product(s) “Vaccine/IVD candidate” against Monkeypox disease under a defined agreement,” the document reads.

ICMR reserves all intellectual property rights and commercialization rights to Monkeypox virus isolates and its method/protocols for purification, propagation and characterization, the EOI document states.

The World Health Organization (WHO) on Saturday declared monkeypox a global public health emergency of international concern. Globally, more than 16,000 cases of monkeypox have been reported in 75 countries and there have been five deaths so far.

According to the WHO, monkeypox is a viral zoonosis, a virus transmitted to humans from animals with symptoms similar to smallpox although clinically less severe.

Monkeypox usually manifests with fever, rashes, and swollen lymph nodes and can lead to various medical complications. It is usually a self-limiting disease with symptoms lasting two to four weeks.

The “Guidelines for the Management of Monkeypox” published by the Center states that human-to-human transmission occurs primarily through large respiratory droplets generally requiring prolonged close contact.

It can also be transmitted through direct contact with bodily fluids or lesions, and through indirect contact with lesion material, such as through contaminated clothing or linens of an infected person. Animal-to-human transmission can occur by biting or scratching infected animals or by preparing bushmeat.

The incubation period is typically six to 13 days, and the case fatality rate of monkeypox has historically reached 11% in the general population and higher in children. Lately, the case fatality rate has been around three to six percent.

Symptoms include lesions that usually begin within one to three days of the onset of fever, last about two to four weeks, and are often described as painful until the healing phase when they become itchy. A noticeable predilection for the palms and soles of the feet is characteristic of monkeypox, according to the guidelines.

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