India is emerging as a leading player in the world’s search for a “variant-proof” coronavirus vaccine that would work against all emerging variants of coronaviruses and future epidemics. If things go to plan, the pharma industry thinks an India-developed pan-coronavirus vaccine may be available in the next two to three years.
Out of the nine projects awarded by the Coalition for Epidemic Preparedness Innovations (CEPI), a partnership between public, private and philanthropic organisations to develop vaccines against future epidemics, two are from India. The Bharat Biotech, University of Sydney and ExcellGene consortium is the latest to be awarded $19.3 million by CEPI under its $200-million programme launched in March 2021 to advance the development of vaccines that would provide broad protection against the Sars-CoV-2 variants and also other betacoronaviruses. In February, Panacea Biotec, along with public sector institute Translational Health Science and Technology Institute (THSTI), had won funding support of $12.5 million for a broad-protection vaccine.
Richard Hatchett, chief executive officer, CEPI, had acknowledged then that Indian scientists and industry have played a central role in the global fight against Covid-19.
Hatchett had warned that the Sars-CoV-2 that causes Covid-19 will not be the last coronavirus to infect humans, and there is nothing to stop the next one being even more deadly or contagious. “It’s, therefore, vital for global health security that we invest now in research to develop vaccines that are broadly protective against variants of SARS-CoV-2 and other coronaviruses before they emerge,” he had said.
At least one of the vaccines being developed in India could start human trials soon. “Pre-clinical studies on animals have begun, and if things go as expected, by next year we should see at least one of these candidates going into human trials. It should ideally be a matter of two to three years before such a multi-variant vaccine is available for use,” said a senior official at a vaccine firm.
These projects are working on diverse vaccine technology platforms — ranging from mRNA tech to protein-subunit platforms and nano-particle-based candidates, among others.
The Bharat Biotech consortium, for example, is working on a protein subunit adjuvanted vaccine platform. Adjuvants are chemicals that are added into the vaccine construct to enhance its efficacy and ability to generate long-term immunity.
The University of Sydney will provide a framework for pre-clinical assessment of vaccine candidates, together with access to Australia’s early phase clinical trial community. Meanwhile, ExcellGene, a privately-owned company offering research, development and manufacturing services to academia and industry partners, will provide the tech platform. ExcellGene’s technology was used in the past to identify and manufacture an antigen for an Ebola vaccine candidate.
The vaccine candidate from Panacea and THSTI is a multi-epitope (which are small pieces of antigens or pathogens), nano particle-based candidate, which is expressed on an E-coli platform. An E-coli-based expression platform for vaccines is easily scalable and affordable. THSTI has developed the nano particle-based antigen platform, and Panacea has developed the proprietary EmulsiPan adjuvant.
Syed Khalid, chief scientific officer of Panacea Biotec, said a few pre-clinical studies have been conducted, and toxicology studies would be done on animals before phase 1 trials on humans can begin in 15 to 18 months.
Khalid added that THSTI will test the candidate in animal challenge trials across the various betacoronaviruses, including SARS, MERS and Sars-CoV-2. Challenge trials are those in which the subject is intentionally exposed to a pathogen to see if the vaccine works.
Several independent projects across the world are also trying to come up with a multi-variant coronavirus vaccine. Globally, human trials have begun recently with multi-variant Covid-19 vaccines. OSE Immunotherapeutics of France has developed a next generation multi-variant vaccine called CoVepiT.
Indian firms are also pitching in. For instance, Ahmedabad-based Zydus Lifesciences is testing a multi-variant Covid-19 vaccine on animals, a senior company official said. Earlier, Sharvil Patel, MD, Zydus Lifesciences, had told Business Standard that the company has developed almost eight strains of the Sars-CoV-2 virus, and was testing to see which of these works best to neutralise the maximum number of mutations of Sars-CoV-2.
Zydus is using its DNA platform to develop the vaccine. “It is like plug-and-play technology; all you have to do is to change the strain. We don’t need to change anything that is part of the vaccine platform,” Patel explained.
Experts such as Gagandeep Kang, microbiologist and professor at Christian Medical College, Vellore, have pointed out that the scientific community feels that one needs to prepare for the future waves of the coronavirus pandemic. “A big positive is that no vaccine is completely failing against any particular strain. However, nowhere in the world do we have the original strain in circulation now,” Kang had said at a recent event.
She added that as for future preparedness against evolving strains of the Sars-CoV-2 virus, it is possible to vaccinate a person with one dose of a vaccine based on the original strain (current vaccines in use are based on the original Wuhan strain of Sars-CoV-2), and a second dose of a vaccine based on one of the newer versions of the virus. Such a “multivalent approach” would give people a reasonable level of immunity against different strains of the virus. These are called Wave 2 vaccines, and these are already in the works, she said.
The scientific community is also thinking about Wave 3 vaccines — where a single dose would give long-term immunity and broader coverage against various strains. The challenge, of course, is to stay ahead of the next wave of the pandemic.