A vaccine will be key to controlling India's coronavirus outbreak.Credit: Satish Bate/Hindustan Times/Getty
As scientists edge closer to creating a vaccine against the SARS-CoV-2 coronavirus, Indian pharmaceutical companies are front and centre in the race to supply the world with an effective product. But researchers worry that, even with India’s experience as a vaccine manufacturer, its companies will struggle to produce enough doses sufficiently fast to bring its own huge outbreak under control. On top of that, it will be an immense logistical challenge to distribute the doses to people in rural and remote regions.
Indian drug companies are major manufacturers of vaccines distributed worldwide, particularly those for low-income countries, supplying more than 60% of vaccines supplied to the developing world. Because of this, they are likely to gain early access to any COVID-19 vaccine that works, says Sahil Deo, co-founder of India’s CPC Analytics in Pune, which is studying vaccine distribution in the country.
Several Indian vaccine makers already have agreements to manufacture coronavirus immunizations that are being developed by international drug companies, or are working on their own vaccines. The government has said that these manufacturers can export some of their supplies as long as a proportion remain in the country.
Without India, there won’t be enough vaccines to save the world, said Peter Piot, director of the London School of Hygiene and Tropical Medicine, during an online vaccine symposium organized by the Indian government in July.
Local need
A vaccine will be essential to combat India’s huge coronavirus outbreak. On 30 August, the country reported almost 79,000 new cases — the highest single-day increase recorded in any country. By next year, the outbreak is predicted to be the world’s largest.
To reduce the number of people dying from COVID-19, researchers say, those most at risk of exposure or severe infection will need to be immunized first. This includes first responders, people with other illnesses and older adults, who make up roughly 30% of the population — around 400 million people, says Gagandeep Kang, a vaccinologist at the Christian Medical College in Vellore, India. But that is a huge number of vaccine doses that need to be made and distributed, researchers say.
The government has assembled a task force to determine how best to distribute the vaccines. It is headed by Vinod Paul, a member of the National Institution for Transforming India, a government think tank, and has representatives from state and central government agencies. The government is also working with vaccine makers to speed up clinical trials and regulatory approvals.
World’s supplier
The world’s largest vaccine maker, the Serum Institute of India in Pune, has an agreement to manufacture one billion doses of a coronavirus vaccine being developed by scientists at the University of Oxford, UK, and UK pharmaceutical company AstraZeneca if it is approved for use. The vaccine is currently undergoing phase III clinical trials in Brazil, the United Kingdom and the United States to test its effectiveness.
If the vaccine works, the Serum Institute and the Indian government have committed to reserve half the company’s stock of it for India, and to supply half to low-income nations through GAVI, a funder of immunizations for low-income nations, says Adar Poonawalla, Serum’s chief executive.
So far, the company has invested 11 billion rupees (US$200 million) to manufacture the vaccine, and has produced about 2 million doses for use in regulatory clearances and testing, even before the trials have ended, Poonawalla says. Two factories that were producing other vaccines have been redirected to this effect, and the company can make 60 million to 70 million doses a month at full capacity, says Poonawalla.
“The decision [to stockpile the Oxford vaccine] has been solely taken to have a jump-start on manufacturing, to have enough doses available if the clinical trials prove successful,” says Poonawalla. If the vaccine doesn’t work, Serum will shift its attention to other candidates, he says. The company is also developing and testing four other COVID-19 vaccines — including two developed through in-house initiatives and two being developed in collaboration with biotechnology companies Novovax in Gaithersburg, Maryland, and Codagenix in Farmingdale, New York.
Drug firm Biologicals E, headquartered in Hyderabad, India, has also entered into a partnership to manufacture a vaccine candidate. This one is being developed by Janssen Pharmaceutica, based in Beerse, Belgium, and is currently going through phase early-stage safety trials. Biologicals E might also manufacture a candidate being developed by Baylor College of Medicine in Houston, Texas, it says. And Indian Immunologicals, also in Hyderabad, is working with Australia’s Griffith University in Brisbane to test and manufacture the university’s vaccine. Two other Indian companies — Hyderabad-based Bharat Biotech and Zydus Cadila in Ahmedabad — are working on vaccines that are in phase I and II trials.
Scientists have applauded the Indian government for allowing the country’s pharmaceutical companies to export some of their vaccine stocks to other nations. The decision to share supplies contrasts with the stance of nations such as the United States and the United Kingdom, which have each pre-ordered hundreds of millions of doses of coronavirus vaccines under development, enough to supply their respective populations many times over.
But even with manufacturer's commitment to supply a portion of their vaccines locally, scientists say that making the required 400 million doses for people who are most at risk of contracting severe COVID-19 will still take time. And by that point, the brunt of the epidemic, which is currently in major cities, will probably have shifted to rural areas, where health services are weaker, says Deo.
Distribution challenges
This means that the biggest hurdle will be getting vaccines to people across India. “It is a huge challenge,” says Randeep Guleria, director of the All India Institute of Medical Sciences in New Delhi and a member of the government’s vaccine task force. “India is a huge country, we have a very large population and we have remote areas, like the Northeast and Ladakh [in the Himalayas].”
The immunization programme will probably take years, says Kang. One of the country’s largest vaccination campaigns so far — delivery of the measles–rubella vaccine to 405 million children, starting in 2017 — has taken 3 years.
Guleria says that innovative approaches will be needed to distribute vaccines in rural and remote regions. He says national election campaigns could offer lessons. In 2019, 11 million poll workers journeyed across India to set up polling stations, so that people didn’t need to travel more than 2 kilometres to vote. The network reached 900 million voters, including those in the most remote areas, in just over 6 weeks. A similar network of health officials to give vaccines could cover much of the country, says Guleria.
But it’s not as simple as getting the vaccine to people, says Kang. “The vaccine has to be kept cold, people have to be trained.” It will also be expensive to buy syringes and needles, to train people to vaccinate, and to purchase the vaccine.
The Serum Institute has priced the Oxford vaccine at 225 rupees (US$3) a dose. That means the cost of vaccinating 400 million people will be at least $1.2 billion. Typically, the government buys vaccines for less than the price of bottled water — 60 rupees. “We have never paid $3 for a vaccine,” Kang says.
It’s unlikely that the Indian government will bear the entire cost of immunizing its people, Deo notes. It will probably pay for vaccinations for the poorest citizens, and ask everyone else to buy their own vaccines, he says.
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