New Delhi: With the world joining hands to find a vaccine for Covid-19, all eyes are on India, the powerhouse of vaccine manufacturing.
India produces 60 per cent of the world’s vaccines and accounts for 60-80 per cent of the United Nations’ annual vaccine procurement. A number of Indian companies have also helped over the years to produce and distribute vaccines to the world.
“The world is looking at India,” said Dr Krishna Ella, chairman and managing director, Bharat Biotech. “With Covid-19 being a unique challenge, team work and global partnerships will be crucial in bringing forth a safe and effective vaccine available to all.”
Last month, US Secretary of State Mike Pompeo told The Times of India that the US and India are working together on Covid-19 therapies and vaccines.
At present, it is not just top vaccine makers such as Bharat Biotech, Serum Institute of India (SII) and Zydus that are racing to develop a coronavirus vaccine. Even mid-rung companies such as the Gurugram-based Premas Biotech, Ahmedabad-based Hester Biosciences and start-ups Neuberg Supratech and Mynvax have also joined the efforts.
“India mass manufactures vaccines for the leading international bodies like the World Health Organisation and the Bill and Melinda Gates Foundation,” said Anant Bhan, adjunct professor and researcher in bioethics at Mangaluru’s Yenepoya University. “It can definitely leverage its ability to mass produce a Covid-19 vaccine whenever it is ready.”
Bhan added that India will help reduce the price of these vaccines. “India will be the only country to sell at the lowest possible price due to its mass production ability,” he said. “Reasonable price would be the only factor in assuring the Covid-19 vaccine’s access across the globe.”
An established wide global network
What works in India’s favour in the race for a vaccine is that a number of Indian firms are key players in the global vaccine industry.
The Pune-based SII is the world’s largest vaccine maker by number of doses produced and sold globally. The 50-year-old company makes 1.5 billion doses every year, mainly from its two facilities in Pune.
It specialises in a variety of vaccines such as polio, diphtheria, tetanus, pertussis and BCG (Bacillus Calmette–Guérin). According to the company, its vaccines are being used in around 170 countries across the globe for their national immunisation programmes.
Other Indian firms have proven experience in pandemic response.
The Hyderabad-based Bharat Biotech has so far commercialised 16 vaccines, including one against the H1N1 flu, which caused a pandemic in 2009.
“We were the first company in the world to predict, work, and file a patent on Zika Vaccine before the US and WHO recognised the problem,” Ella said. “So, identifying viral threats has been a forte of the Indian Biotech industry, which gives us a position of great strength.”
About 90 per cent of the company’s vaccines are sold in lower- to middle-income countries. It owns 160 global patents and sells products in over 65 countries.
Another pharma giant, the Ahmedabad-based Zydus group, which was the first to develop and indigenously manufacture the vaccine to combat Swine Flu during the outbreak in 2010, is also developing the Covid-19 vaccine through its research arm in Europe, Etna Biotech.
The company is betting on its robust manufacturing facilities that would enable rapid ramping up of the production for vaccine candidates, once the proof-of-concept is established.
Premas Biotech has out-licensed its vaccine candidate to Akers Biosciences Inc, USA. Premas specialises in creating recombinant protein for vaccine development. These proteins target the three proteins on the SARS-CoV-2 virus: the spike protein, envelope protein, and membrane protein.
The ability to target all three offers a strong case for the vaccine.
‘India ahead of the curve, should take lead’
The industry also believes that India is ahead of the Covid-19 curve and should take the lead in the producing the vaccine.
“India is certainly ahead of the curve,” said Ella, praising the government effort for easing regulatory norms and handholding companies that need support in every stage of the development.
“India must take a leadership role and establish itself as a central and significant player in this pandemic,” said Dr Prabuddha Kundu, managing director, Premas Biotech, adding that the most immediate need and role for India to play right now is “to enable large scale manufacturing, to enable rapid approvals, guidelines, and collective wisdom to deliver the appropriate vaccine”.
“The big vaccine makers of the country already have distribution networks in place. They will be able to reach across the globe very quickly,” Adar Poonawalla, CEO of the Serum Institute of India (SII) had told ThePrint earlier. SII is taking the risk of starting production even before the vaccine has reached advanced clinical trials.
Collaborations and partnerships
Vaccines are the best long-term strategy to combat pandemics, although coronavirus vaccines for all strains we’ve known so far, like those of SARS, MERS, and even common cold, have been notoriously hard to develop due to their rapid mutation.
Vaccines are expected to be refined each year to keep up with the mutations.
The strategic approach to vaccine development by Indian biotech companies is to collaborate with academia, universities, research organisations and virologists to develop vaccines in co-support.
Once development is over, Indian companies have mastered the art of accelerating mass-production and distribution across the world.
Sample the collaborations.
A leading candidate for a Covid-19 vaccine is the one being developed by Oxford University, which is collaborating with SII. The vaccine has shown promising results in animal trials on rhesus monkeys, considered the closest to humans for medical trial purposes. The vaccine, called ChAdOx1 nCoV-19, is a weakened version of the ChAdOx1 virus that infects chimpanzees.
Despite no clinical evidence yet that the vaccine works on humans, SII plans to be ready. It plans to produce up to 400 million doses next year if all goes well.
Another vaccine candidate, developed by SII, is in partnership with the US-based biotechnology firm Codagenix. The vaccine was among the earliest candidates in the pandemic to reach the preclinical stage of animal testing, back in mid-February.
The company is jointly developing a live-attenuated vaccine. It means the vaccine will be created using a live virus but by reducing its virulence. “It can be market-ready by 2022,” Poonawalla had earlier told ThePrint.
Similarly, Bharat Biotech has partnered with the University of Wisconsin, Madison, and the US-based company FluGen to develop a vaccine, Coro-Flu.
The company will develop the vaccine candidate invented by UW–Madison virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann. The vaccine is built on an existing flu vaccine called M2SR. It contains the weakened live H3N2 influenza virus.
“Kawaoka’s lab will insert gene sequences from SARS-CoV-2, the novel coronavirus that causes the disease Covid-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus,” the company had said.
In anticipation of high demand, the company has established a new line to produce 300 million doses of Covid-19 vaccines annually.
The price factor
India has been able to achieve price affordability through the economy of scale. A classic example is the case of the Rotavac Vaccine for “rotavirus” infections. India was able to manufacture and sell at almost one-fifteenth of the then-market cost in 2013.
A similar pricing trend is expected now when the world is grappling with a pandemic. For instance, SII has said it will sell a dose for just Rs 1,000.
“We will not consider the pricing of the vaccine as an important issue. Even today, we sell all of our vaccines at very low prices,” Poonawalla said.
(With inputs from Sandhya Ramesh, Bengaluru)
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