Serum Institute, other firms eye tie-ups to develop monkeypox vaccine

Indian Immunologicals, and Haffkine Research Institute also in the fray

Serum Institute of India (SII) and some other firms have started evaluating options to tie up with international players to develop a monkeypox vaccine. Some of them have shown interest in partnering with the Indian Council of Medical Research (ICMR) to develop the vaccine candidate.

SII CEO Adar Poonawalla had told Business Standard that it was collaborating with Greenlight Biosciences, a US-based company with technology, to make mRNA vaccines, for a handful of vaccines, including one for shingles. “We are even looking at doing something on monkeypox with them. It is a technology that still needs some time,” Poonawalla said.

Over 38,000 people have been infected by monkeypox globally in more than 90 countries. The matter of concern is that more than 85 countries never reported laboratory confirmed cases of monkeypox prior to the 2022 outbreak, and the disease was endemic mostly in parts of Africa.

SII has submitted an expression of interest (EoI) to collaborate with the ICMR to make the monkeypox vaccine. The company did not wish to comment on the matter.

ICMR’s National Institute of Virology, Pune, has already succeeded in isolating the monkeypox virus strain, something it had done at the time of Sars-CoV-2 pandemic.

Public sector companies such as Hyderabad-based Indian Immunologicals, and Mumbai-based Haffkine Research Institute, too, have entered the race to make the vaccine. Sources indicated that Dr Reddy’s Laboratories, which is the Indian partner for Russian Sputnik V Covid-19 vaccine is also in the fray. DRL did not wish to comment on the matter.

Firms are awaiting a communication from the Centre on how to take things forward, multiple industry sources indicated.

ICMR is yet to take the final call on which firm it would partner with, and is scrutinising the EoIs. It would take a 5 per cent royalty from the partner firm, while the vaccine developer will be responsible for conducting clinical trials, producing and commercialising the vaccine.

Sources in the Maharashtra government indicated that Haffkine is likely to opt for an inactivated virus platform monkeypox vaccine. It has the resources to conduct clinical trials, but does not yet have a BSL-III level manufacturing facility. Haffkine was developing a BSL-III level manufacturing facility to make Bharat Biotech’s Covaxin, which could now be put to use for making monkeypox vaccine.

Despite several attempts, Indian Immunologicals could not be reached for comment. At the moment, Danish firm Bavarian Nordic is the only company to have an approved monkeypox vaccine named Jynneos. However, the company has indicated that it was talking to multiple production partners to manufacture its vaccine, as it is unsure of meeting the global demand. It can make about 30 million annual doses at its Copenhagen site, and has supplied vaccines to the US. It is working on expanding its installed capacity and also outsourcing manufacturing.

India can play a key role in manufacturing the Jynneos vaccine as it has huge installed capacity.

Monkeypox was declared a public health emergency by the World Health Organisation last month. This week, it indicated that there is limited human data on monkeypox vaccine Jynneos prior to this outbreak, and some breakthrough cases among those vaccinated have been reported already.

Shot in the arm

• SII has tied up with Greenlight in March this year to design three mRNA products
• ICMR invites EoIs for collaborating to make monkeypox vaccine 
• ICMR to take 5% royalty; NIV, Pune has isolated the virus strain
• Danish firm Bavarian Nordic looking for partners to expand production capacity of Jynneos – monkeypox vaccine