The World Health Organization (WHO) activated its incident management support team as part of its emergency response framework on the emergence of a cluster of atypical pneumonia cases emerging from Wuhan, China, on January 1, 2020. On January 30, WHO declared the novel coronavirus-caused disease outbreak a public health emergency of international concern. The pandemic was not unexpected. The world had been witnessing a series of epidemics in the last two decades, triggering warning alarms from experts. Despite these warnings, there was almost no global preparedness to combat the pandemic. Health experts realised almost immediately that the Covid-19 pandemic was in for a long haul and there was an immediate need for a vaccine.
The global race for a vaccine began immediately and what followed was unprecedented. The vaccine against Covid-19 was developed in less than a year: The first emergency use authorisation (EUA) was given to Pfizer BioNTech Covid-19 vaccine on December 11, 2020. India, the dark horse in the vaccine race, did the unexpected and against all odds, approving EUA to two vaccines — “made in India” Covishield and Covaxin. India began administering the vaccine on January 16, 2021, and has since administered 2.2 billion doses.
Several indigenous vaccines were developed and “made” in India. Zydus Cadila’s ZyCov-D, the first DNA-based Covid 19 vaccine to get national EUA; GEMCOVAC, the indigenous mRNA-based vaccine by Gennova, Pune, in collaboration with HDT Biotech Corporation, US; and Corbevax, India’s first indigenously developed protein subunit based vaccine by Biological E, Hyderabad in partnership with Texas Children’s Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas. This, along with the emergence of vaccine startups such as Mynvax, has exponentially expanded the vaccine ecosystem. As of May 2022, India has exported about 140.2 million Covid-19 doses to the world, accounting for about 2.3% of global exports.
The latest emergency use listing by WHO to Corbevax is a testament to the Indian industry’s growing prowess in vaccine development. Biological E continues to innovate vaccine development for emerging variants of coronavirus with its US partners. This model is being cited as the way forward for pandemic preparedness, against emerging diseases, and as a mechanism to bypass big pharma and provide affordable vaccines to the world.
These strengths need to be capitalised on. The dynamism of the Indian vaccine industry needs to be supported by an efficient and unambiguous governance structure. India must take the lead in providing a policy framework for ongoing and emerging epidemics, and align its regulatory processes with international regulatory bodies. The industry needs a regulatory authority that is independent, transparent and effective. The Indian pharmaceutical industry is hamstrung with an understaffed and under-financed regulatory body. That the Indian industry prefers to conduct its preclinical research with partners outside India, is not without reason. Partnership abroad is preferred due to the regulatory ease in carrying out preclinical research there. (Preclinical research is the safety and efficacy research carried out before the vaccine is administered to humans in clinical trials) Agencies must also hasten to ease the conduct of clinical trials. They must categorise infectious diseases, such that human challenge model trials/studies can be initiated in India on some of the diseases.
Collection, curation, and flow of data is one of the biggest gaps in our health management. Smooth data flow is essential to track, treat and prevent emerging diseases. The government needs to put in place a rigorous systematic structure, allowing access to data and not controlling it. Accessible data systems would be invaluable in developing predictive “warning” systems for new and chronic diseases.
The unprecedented speed at which the world developed the Covid-19 vaccine was primarily due to the seamless and unprecedented collaborations for research, clinical trials and manufacturing. Collaborations must not be viewed with suspicion and overregulation of foreign collaboration, even at conference and workshop levels, needs to ease. Collaborative partnerships within the country, outside the country — of industry, academia and government — are vital for sustainable and economically viable use of resources.
India is the largest supplier of vaccines worldwide, producing 62% of the global demand, housing 740 FDA-approved manufacturing units. If collaborative research is facilitated and a smooth and easy regulatory process is put in place, India will become the established leader in vaccine research, development, innovation and manufacturing.
Shailja Vaidya Gupta is a former adviser with the department of biotechnology (DBT), GoI. The views expressed are personal
