Centre, private pharma take baby steps to develop monkeypox vaccine
Centre invites EOI to develop vaccines against the virus, with ICMR providing the strain; SII looking at imports, tie-up with Novavax
While the confirmed number of monkeypox cases in India remains in single digit, both the Union government and private pharmaceutical companies are gearing up on the vaccinatin front.
The Centre on Wednesday invited Expression of Interest (EOI) for developing vaccines against the monkeypox. The EOI documents states that the Indian Council of Medical Research (ICMR) is willing to make available monkeypox virus strain/isolates for undertaking research and development validation.
The ICMR also invited EOI from experienced vaccine manufacturers, pharma companies, research and development institutions and in-vitro diagnostic (IVD) kit manufacturers for joint collaboration in development of vaccine candidate against Monkeypox and diagnostic kits for the infection
ICMR, SII take initiatives
The National Institute of Virology (NIV) in Pune under the ICMR has isolated the monkeypox virus from the clinical specimen of a patient which can pave the way for development of diagnostic kits and vaccines against the disease, officials said on Wednesday.
Meanwhile, Serum Institute of India (SII) is exploring the possibility of developing an mRNA vaccine for the virus along with its global partner Novavax. Adar Poonawalla, CEO of SII, the world’s largest vaccine maker, has divulged that the company is considering importing the smallpox vaccine manufactured by Bavarian Nordic, a Danish pharmaceutical company.
Earlier, Union Health Ministry officials had said the Centre would consider procurement of vaccines only if the cases go up in the country. India currently has just four confirmed cases of monkeypox and is not actively considering vaccination. But, it is at the same time not completely rejecting that possibility.
What health experts say
Gagandeep Kang, virologist and professor at Christian Medical College, Vellore, has been quoted as saying the number of cases in India does not justify an immediate need for ring vaccination (a strategy to control the spread of disease by vaccinating contacts of confirmed patients and people who are in close contact with those contacts) but it might be a good idea to get in line for the available drugs and vaccines soon.
Calling monkeypox a “public health concern” since there is human-to-human spread now, she said if the government is aware of symptoms and travel history and contacts are tracked, India does not need to worry too much.
Priority is recommended for contacts of cases, said other health experts, ruling out the need for mass vaccination or global vaccination. Only high risk groups require the vaccination and that number currently is limited.
SII’s plans to import and manufacture
Pune-based SII, which manufacturers Covishield, the Indian version of Oxford AstraZeneca’s COVID vaccine, is poised to import a few million doses of the Danish smallpox vaccine in the eventuality of a larger breakout of the infection in India, said news reports.
The contract with the Danish company Bavarian Nordic is yet to be signed and the consignment is expected to reach India only after a few months. SII is currently in talks with the company, Poonawalla told NDTV.
Further, he said that it is up to the Centre if it wants to start stockpiling a small quantity, like a few million doses. There have not been any formal talks with the Centre yet on the large-scale supply of the smallpox vaccine since only a handful of monkeypox cases have been reported in India so far, he added.
However, SII is all set to import the smallpox vaccine at its own cost, initially, in small volumes, even as the government will have to decide on a health policy.
Poonawalla said that it is “not a mystery” that monkeypox cases are emerging since it has been around for decades. The only difference is that the global health system is more trained and equipped to detect and tackle infectious diseases.
Manufacturing vaccines in India
In terms of manufacturing vaccines to counter monkeypox, SII is also exploring the possibility of developing a new Messenger RNA (mRNA) vaccine for the infection along with Novavax, who is one of its global partners.
Poonawalla said the move would depend on the demand since monkeypox could very well fizzle out in three to four months as well.
Meanwhile, India has no domestic manufacturers of smallpox vaccines, which can protect against monkeypox. However, public health experts claimed that smallpox vaccines can be manufactured by private firms if the government takes a policy decision for a mass vaccination programme.
The World Health Organisation, which had on July 23 termed monkeypox as a “public health emergency of international concern”, has declared that while the smallpox vaccine has 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.
However, the organisation maintained that currently only people who are at risk should be considered for vaccination such as close contact with confirmed monkeypox cases and mass vaccination is not recommended at this time
Drugs for monkeypox
When it comes to drugs to cure monkeypox, an antiviral called Tecovirimat that was developed to treat smallpox was approved in January 2022 by the European Medicines Agency and the USA’s FDA. However, the WHO said that experience with these therapeutics in the context of an outbreak of monkeypox is limited.
Meanwhile, the Danish Bavarian Nordic JYNNEOS smallpox (Monkeypox) vaccine is also FDA approved and is meant to give 85 per cent protection.
Monkeypox testing thrives
As the threat of monkeypox looms around the world, and the need for testing for this infection is increasing, diagnostic companies are coming up with various test kits. Genes2Me Pvt. Ltd, an In vitro diagnostics (IVD) player in India announced they have developed the Real-Time PCR-based kit for quick detection of monkeypox virus with a fast turnaround time for a result in 50 minutes. 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 even distinguish between smallpox and monkeypox using four different colours of fluorescence.
Monkeypox cases around the world
According to the epidemiological update issued by the WHO, from January 1 through July 22, 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 multi-country outbreak of monkeypox situation report published on July 26, 022, 9,989 new cases, which is a 166 per cent increase and two new deaths have been reported. 16 new countries/territories/areas have reported cases, while in the past seven days, 37 countries reported an increase in the weekly number of cases.