How does India’s vaccine manufacturing prowess place it in the fight against COVID-19?

With about 15 million infected cases globally within eight months, COVID-19 could be deemed as the fastest and largest blow to life and economy in modern history. The world is waiting with bated breath for the release of an effective vaccine to end this pandemic.

India is one of the largest vaccine manufacturers globally by volume and provides 70 percent of UNICEF’s requirement. The largest supplier is the Serum Institute of India (SII), followed by other companies such as Biological E, Panacea Biotech, Bharat Biotech, and Shantha Biotech.

The high reproductive number of the virus causes experts to estimate that about 60 percent of the world’s population needs to vaccinate for herd immunity. This translates to the gargantuan requirement of about 4.7 billion vaccine doses.

To ensure speedy approval, manufacturing, distribution, and administration, multiple vaccine candidates are being trialed on an unimaginable fast-track globally.

Various Indian players are at the forefront of the COVID-19 vaccine development. Notable examples are: Bharat Biotech, which has partnered with the Indian Council for Medical Research (ICMR); Zydus Cadila which has developed the DNA based and life attenuated vaccines in-house and is currently in Phase I and II; and, the SII which has signed a licensing agreement with Astra Zeneca for the supply of 1 billion doses of the vaccine being developed along with Oxford University to middle- and low-income countries. The other notable progress is Indian Immunologicals Limited which is in partnership with Griffith University, and Panacea Biotech, which is partnering with US-based vaccine developer Refane.

India is also attractive for clinical trials due to the incidence of myriad diseases, cheaper healthcare services, and favorable regulations. This completes India’s bouquet of offerings for vaccine developers and manufacturers.

A question that’s being often asked is whether India is ahead of the world in efforts to end COVID-19? Possibly, but certain nuances are critical to India’s fight to end the pandemic.

Vaccine Nationalism 

During the 2009 Swine Flu outbreak, Australia and Canada restricted access to the locally-developed vaccines by banning exports and stockpiling. The United States promised to donate its stock to developing countries but waited until the stabilization of pandemic to do so. Hence, the ‘nationality’ of the vaccine discovered is significant.

Around the world, about 25 vaccines have entered the clinical trial phase; among this, only two vaccines (Bharat Biotech and Zydus Cadila) are from Indian companies. In absence of an Indian vaccine, it is possible that innovator and affluent countries stockpile, and India gets supplied quite late on the pandemic damage curve.

To avoid this possibility, organizations such as the World Health Organization (WHO) and Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) have been proactive. Notable measures by Gavi is the Covax AMC (Advanced Market Commitment) for countries to pre-book vaccines assuring manufacturers of sufficient volumes as well as ensuring access for developing countries. AstraZeneca, which is a leading player in the vaccine development race, has promised 400 million doses to Covax AMC in partnership with the SII. India is also well-positioned strategically at the WHO with Health Minister Harsh Vardhan as chairman of the executive board, and Soumya Swaminathan as chief scientist.

Priority Population

Even with India possessing the world's largest manufacturing facilities, the facility type would be clear only post a full-fledged approval of the vaccine. With a variety of innovative technologies for vaccine production, the current processes could be rendered unsuitable — and this is a risk preventing Indian players from investing in any current technology. This is exactly the kind of risk Covax AMC seeks to incentivize, through fund flow to Indian manufacturers looks quite limited for now.

Nevertheless, India’s vast capacities would ensure the eventual incoming of manufacturing volumes — if not by Covax AMC, then by trade partnerships.

Vaccine manufacturers make larger revenues from exports, and hence a significant supply volume is expected to be funneled overseas — a practice the Government of India would neither want to nor could disrupt.

With limited vaccine stock at hand, the frontline healthcare workers would be the top priority for vaccination, followed by the geriatric population. India’s large migrant population pool would also need immunization to avoid newer outbreaks.

The logistics could further complicate if recent reports turn out to be validated and multiple doses are required for complete protection against the virus. This could increase the burden on payers, manufacturers, and distributors.

Overall, a global vaccination would not be possible without India playing a key role. To quote Bill Gates: “India's pharmaceutical industry will be able to produce COVID-19 vaccines not just for the country, but also for the entire world”.

Authored by:

Madhur Singhal, Practice Leader, Pharma and Life Sciences 

Ashish Agarwal, Practice Leader, Pharma, and Life Sciences