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Indian pharma cos to develop monkeypox vaccines, drugs and testing kits

Indian pharma cos to develop monkeypox vaccines, drugs and testing kits

With India already having reported four cases of Monkeypox, Adar Poonawalla, CEO of Serum Institute of India (SII), said that he is planning to develop an mRNA vaccine against monkeypox in association with its global partner Novavax.

Indian pharma cos to develop monkeypox vaccines, drugs and testing kits Indian pharma cos to develop monkeypox vaccines, drugs and testing kits

While few antiviral drugs and smallpox vaccines are the current management options for Monkeypox disease, the Indian pharmaceutical industry is considering developing new drugs, vaccines and diagnostics after the entry of the viral disease into the country.

With India already having reported four cases of Monkeypox, Adar Poonawalla, CEO of Serum Institute of India (SII), maker of India’s largest used covid-19 vaccine Covishield, on Tuesday, said that he is planning to develop an mRNA vaccine against monkeypox in association with its global partner Novavax. Poonawalla also said that he is also considering importing the smallpox vaccine manufactured by Bavarian Nordic, a Danish pharmaceutical company.

According to the World Health Organization (WHO), smallpox vaccines may also be useful for monkeypox. However, only people who are at risk should be considered for vaccination such as close contact with confirmed monkeypox cases.

While the smallpox vaccine was shown to be protective against monkeypox in the past, current data on the effectiveness of newer smallpox/monkeypox vaccines in the prevention of monkeypox in clinical practice and in field settings are limited,” the WHO said adding that mass vaccination is not recommended at this time.

As India has eradicated smallpox, there are no domestic manufacturers of smallpox vaccines. However, public health experts claim that the smallpox vaccine manufacturing opportunity in India may not emerge strongly until a mass vaccination is required and the government takes such a policy decision.

“Smallpox vaccines do protect against monkeypox but no Indian manufacturers make smallpox vaccines. Global vaccination is also not needed. Only high-risk groups require it, and those are limited,” said Dr Gagandeep Kang, noted microbiologist and virologist, who is a professor in the Department of Gastrointestinal Sciences at the Christian Medical College, Vellore.

When it comes to drugs for Monkeypox, an antiviral that was developed to treat smallpox (tecovirimat) was approved in January 2022 by the European Medicines Agency for the treatment of monkeypox. However, the WHO said that experience with these therapeutics in the context of an outbreak of monkeypox is limited.

“Tecovirimat is an antiviral medication that is approved by the US FDA. Bavarian Nordic JYNNEOS smallpox (Monkeypox) vaccine is also FDA approved and gives 85 % protection. Also, Vaccinia Immune Globulin Intravenous (VIGIV) can be considered for prophylactic use in an exposed person with severe immunodeficiency in T-cell function for which smallpox vaccination following exposure to monkeypox virus is contraindicated,” recommended Dr Satish Koul, Director, Internal Medicine, Fortis Memorial Research Institute.

“Brincidofovir is another antiviral medication that was approved by the FDA for the treatment of human smallpox disease in adult and pediatric patients, including neonates. Data is not available on the effectiveness of Brincidofovir in treating cases of monkeypox in humans,” he said.

According to the epidemiological update issued by the WHO, from 1 January through 22 July 2022, 16,016 laboratory-confirmed cases of monkeypox and five deaths have been reported to WHO from 75 countries in all six WHO Regions. Since the Multicountry outbreak of monkeypox situation report published on 6 July 2022, 9989 new cases, (166% increase) and two new deaths have been reported; 16 new countries/territories/areas have reported cases. In the past seven days, 37 countries reported an increase in the weekly number of cases.

With cases rising, the testing requirement for monkeypox is increasing. Considering this as an opportunity, the diagnostic companies are coming up with various test kits. Genes2Me Pvt. Ltd, an In vitro diagnostics (IVD) player in India on Tuesday announced to have developed the Real-Time PCR-based kit for quick detection of Monkeypox virus with a fast turnaround result time of fewer than 50 minutes.

This kit is available in both the standard version for any commonly available Real-Time PCR instruments as well as Point-of-Care format on Genes2Me Rapi-Q HT Rapid RT-PCR device. The Point-of-Care solution can be used for screening at multiple sites including Hospitals, Airports, Diagnostic Labs, Health Camps, etc, the company said.

“We have the current capacity to manufacture 5 million test kits in a week, however, it can be scaled up to 2 million tests in a day with the added demand,” said Neeraj Gupta, CEO and Founder of Genes2Me.

Similarly, a monkeypox viral detection kit based on RT-PCR has been created by Trivitron Healthcare. With a one-tube single reaction format and a one-hour turnaround time, Trivitron's Monkeypox Real-Time PCR Kit can distinguish between Smallpox and Monkeypox using four different colours of fluorescence. “In this four-gene RT-PCR kit, the first target detects the viruses in the larger orthopox group, the second and third targets detect and differentiate the monkeypox and smallpox viruses, respectively, and the fourth target detects the internal control corresponding to human cell to address the assay performance and aid in following its epidemic spread,” said Chandra Ganjoo, Group Chief Executive Officer, Trivitron Healthcare.

The International Health Regulations Emergency Committee on the multi-country outbreak of monkeypox held its second meeting on 21 July 2022. Having considered the views of Committee Members and Advisors as well as other factors in line with the International Health Regulations (2005), the WHO Director-General on 23 July 2022 declared this outbreak a public health emergency of international concern and issued Temporary Recommendations in relation to the outbreak.