By Gunjan Bagla
While most Americans are focused on the incredible success of the COVID-19 vaccines developed and produced by Pfizer and Moderna under the $24 billion Operation Warp Speed, there is under-reported news from India that bears a closer look. The country plans to vaccinate its billion plus population using a combination of vaccines manufactured locally and its government donated millions of doses across 10 countries in parallel with a national domestic rollout. Indian companies will soon sign deals to sell their COVID vaccines globally.
High Volume Rollout
The largest vaccine maker in the world by volume, Serum Institute of India, in Pune, just began shipping the adenovirus-based Oxford-AstraZeneca Covishield DNA vaccine after successful Phase 3 clinical trials conducted in several countries and emergency approval in India. India's government also began vaccinating with a second product whose Phase 3 results are expected in March – the Indian developed Covaxin, a whole-virion, inactivated SARS-CoV-2 vaccine with two adjuvants. Both products can be stored and transported at 38 to 46 degrees Farenheit, which is much more manageable than the frigid requirements of the Pfizer product. Covaxin is produced by the privately held Bharat Biotech Ltd., in Hyderabad, India. The 24-year-old company owns 160 patents, including the first one for the Zika virus, and has shipped billions of doses of its various vaccines to over 60 countries.
India trained more than 200,000 vaccinators and 370,000 team members. Large-scale trials were conducted in at least four states and authorities readied 29,000 cold storage units to transport and hold the vaccines safely. Serum Institute had produced 40 million doses in advance of the regulatory approval. India's government began a massive drive on January 16 and vaccinated 1 million healthcare workers in the first week using the vaccines from Serum Institute and Bharat Biotech. India plans to rapidly vaccinate 30 million of its healthcare and frontline workers, followed by 270 million older citizens and others with co-morbidities through the early summer. Subsequently, vaccines will be made available to all its citizens. Frequent updates of progress and adverse reactions are being provided and, so far, less than a dozen people have been hospitalized.
The Indian COVID-19 Vaccine Pipeline
Several other coronavirus vaccines are in development in India. Three of them are credible enough for discussion here:
- Zydus Cadila started enrolling 30,000 volunteers for Phase 3 trials of its three-dose DNA-based COVID-19 vaccine across the Indian cities of Surat, Nashik, Jaipur, and Ahmedabad. Part of Cadila Healthcare, it is one of the top drug makers in India and produces Remdesivir, the COVID treatment drug under license from Gilead Sciences. The company, listed on the Bombay Stock Exchange, with $2 billion in sales, claims that a DNA platform can cope with mutated forms of the COVID virus more effectively than mRNA-based products.
- Another company based in Hyderabad, Biological E Limited, has been producing vaccines for 58 years. Its candidate for the COVID-19 pandemic is based on classical vaccine technology: a protein antigen, SARS-CoV-2 Spike RBD, adsorbed to the adjuvant Alhydrogel (Alum), in combination with a second adjuvant, CpG 101. The company expects to complete Phase 2 trials by the end of Q1 2021. It also has technology partnerships with Ohio State University College of Veterinary Medicine and the Baylor College of Medicine and is evaluating additional technology platforms.
- In collaboration with HDT Biotech of Seattle, Gennova Biopharmaceuticals has developed an mRNA vaccine. Unlike the similar vaccines from Pfizer and Moderna, Gennova claims that its candidate can be stable at temperatures as high 38 to 46 degrees Fahrenheit for two months. The Pune-based company gained approval to begin Phase 1 and Phase 2 trials last December.
India In The Global Supply Chain
Less than 10 days after starting its own vaccination drive, the Indian government sent 3.2 million free doses to Bangladesh, Nepal, Bhutan, and Maldives. Donations to Afghanistan, Mauritius, Myanmar, Seychelles, and Sri Lanka will follow. In a separate deal, Brazil, which has the second highest number of COVID-19 cases in the world, just received 2 million doses of Serum Institute's Covishield from India.
Given that the Indian-made COVID vaccines will cost a fraction of the Moderna and Pfizer products, it is almost certain that India will be the largest supplier of COVID-19 vaccines to most of the planet's population. In fact, commercial shipments from Indian companies to Saudi Arabia and Morocco are in the pipeline and many other deals are under discussion.
But will some of these products become available in the United States? India is already home to the largest number of U.S. FDA approved manufacturing facilities outside the United States. In fact, some of the factories of Serum Institute and Bharat Biotech already have U.S. FDA approval. Bharat Biotech has signed an agreement with a small Pennsylvania company, Ocugen, to help obtain American approval for its COVID-19 vaccine. Ocugen's stock price spiked 800% following the news. AstraZeneca's vaccine was approved by the United Kingdom, and the European Union has already been notified by AstraZeneca that production in the West is falling short of targets. So it is possible that Serum Institute may be asked to scale production in India for these markets.
As of this writing, American authorities are still overwhelmed by domestic issues relating to vaccine logistics and to the changes being implemented by the incoming Biden-Harris administration. So, it could be months before products produced or developed in India gain serious consideration for use in the United States.
Large, diverse democracies such as India, the United States, and Brazil have had a hard time controlling the spread of this current pandemic. Fortunately, the U.S. and India also have the technical manpower and the prowess for rapid innovation and manufacturing scale-up. Pandemics don't respect national boundaries, and to conquer COVID-19, the world needs solutions from both countries. COVID-19 is not the last pandemic we will encounter. Indian and American companies and governments working closely together can beat the next one a bit faster.
About The Author:
Gunjan Bagla is CEO of Amritt Inc., a California consultancy that helps Western companies do business in India. Companies that have benefited from Amritt's expertise include Becton Dickinson (BD), Combe, Clorox Healthcare, Johnson & Johnson, iHealth, Reckitt Benckiser, and Roche. He writes about India for the Harvard Business Review and for Medical Device Online. He holds a mechanical engineering degree from the Indian Institute of Technology Kanpur and an MBA with honors from Southern Illinois University, Edwardsville. Contact him via amritt.com or at https://www.linkedin.com/in/gunjan/.