Hyderabad: When Telangana State Chief Minister K Chandrashekhar Rao announced in May that a potential vaccine to prevent Coronavirus will come from Hyderabad by September, it was not a mere wish, but had some sound basis too.
He had interacted with three of the biggest vaccine manufacturers in the country based in Hyderabad—Sanofi Shanta Biotech, Bharat Biotech International and the oldest, Biological E.
All three, the Indian Immunologicals Limited (IIL), a large animal & human vaccine maker and Auro Vaccines, a subsidiary of Aurobindo Pharma are in the race to produce the vaccine which has affected 7 million people across the world so far. In the past two decades Hyderabad has emerged as the hub for vaccine production. It has traditionally been the bulk drug capital of the country.
But, let’s be clear here. Hyderabad could emerge as the manufacturer of the potential COVID-19 vaccine, while most likely being a co-developer (joint research projects) in research, being mostly done in international Labs/ Institutes.
According to Anand Kumar Managing Director IIL, “With many top vaccine giants supplying basic and advanced vaccines to nearly 150 countries, India, over the years, has emerged as the global vaccines hub”.
The value of India’s vaccine market was estimated to be Rs 59 billion in 2016, according to the report titled “Indian Vaccine Market Report and Forecast 2017-2022”. According to projections the market is expected to double in the next 5 years.
At present, the Pune-based, Serum Institute of India (SII), is not only India’s, but the world’s biggest manufacturer of vaccines with an annual capacity of over 1.5 billion doses of different vaccines and supplies to nearly 150 countries.
The Hyderabad Advantage
Being, the bulk drug capital of India, Hyderabad has attracted many Pharma, biotech, genetics and research institutes over the decades. The Indian Drugs and Pharmaceutical Limited (IDPL), set up in the 1950’s, spawned many drug makers, even as it went sick at the turn of the century.
Sometime in the early 1990s, the seeds of vaccine development were laid, when 3 startup companies—Transgene Biotek, Shantha Biotechnics and Bharat Biotech got license to make the hepatitis B vaccine. Of these, Shanta, promoted by K I Varaprasad Reddy and incubated by the Centre for Cellular and Molecular Biology and Bharat Biotech, started by Dr Krishna Ella, succeeded by launching the vaccine, made indigenously, set up manufacturing units on the outskirts of Hyderabad.
They quickly grew, producing a wide range of vaccines. Meanwhile, the IIL, which was mainly into animal vaccines diversified into select human ones too.
According to a report by the US based McKinsey Consulting, “Hyderabad contributes to one-third of the total number of vaccines produced across the world.” Substantiating this, Shakti Nagappan, director of Life Sciences and Pharma of Telangana State said, “The presence of reputed institutes, such as the CCMB, IICT has helped in the technical support for vaccine development. This, combined with skilled manpower and vision of extremely entrepreneurial people, has helped develop total, capacity of more than two billion vaccines doses per annum from Hyderabad alone,”.
Today, with many state-of-the-art manufacturing facilities, India is having the largest global capacity for WHO prequalified vaccine manufacturing. India mass manufactures vaccines for the leading international bodies like the World Health Organisation and the Bill and Melinda Gates Foundation.
It can definitely leverage its ability to mass produce a Covid-19 vaccine whenever it is ready. Further, it’s ability to produce it cost effectively will ensure availability at lower price to the global community.
In this effort, Hyderabad can have a leadership role with so many manufacturers and capacity ready, say experts.
One of the first vaccine maker to emerge from the city was Biological E. It is India’s, first private sector company to make vaccines, beginning in 1962. It has 7 WHO pre-qualified vaccines in its kitty and is already geared to manufacture a potential vaccine.
Bharat Biotech has struck the maximum partnerships and positioned itself strongly to take advantage. It has announced a partnership with the University of Wisconsin Madison and US-based firm FluGen to make CoroFlu vaccine for global distribution.
In the past 20 years, Bharat Biotech has commercialised 16 vaccines, including one against the H1N1 flu, which caused a pandemic in 2009, says Dr Krishna Ella, it Managing Director.
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.
In anticipation of high demand, the company has established a new line to produce 300 million doses of Covid-19 vaccines annually.
The company has also got the approval from the Indian Council of Medical Research (ICMR) for a joint vaccine development of a fully indigenous vaccine using the virus strain isolated at ICMR’s National Institute of Virology (NIV), Pune. The strain has been successfully transferred from NIV to Bharat Biotech.
Auro Vaccines, a subsidiary of Pharma giant, Aurobindo Pharma too has a vaccine platform called VesiculoVax that has shown to provide immune response against viruses such as Ebola and Chikungunya. It is pitching to make the COVID19 variant.
The IIL, part of the National Dairy Development Board (NDDB), is working with Griffith University of Australia to develop a lead vaccine candidate for Coronavirus.
They will use the latest codon de-optimization technology, which appears promising for developing a vaccine for prophylactic, active, single dose immunization against coronavirus in humans, with an enhanced safety profile.
Upon completion of the research, the vaccine strain will be transferred to Indian Immunologicals to further conduct clinical trials which will be taken up in a phased manner. IIL intends to use its existing Vero cell platform technology for mass production of the virus, says Anand Kumar.
Overall, post COVID 19, partnerships with vaccine companies globally to access the Indian market will become common. In order to shorten regulatory time lines, companies may explore the possibility of importing the bulk of an approved product for fill/finish in India. Similarly Indian companies will also look at exporting bulk vaccines for fill finish in other markets, say experts. In short, the Indian Vaccine makers, especially those with strengths from Hyderabad can look forward to an exciting phase.
Somasekhar Mulugu, former Associate Editor & Chief of Bureau of The Hindu BusinessLine, is a well-known political, business and science writer and analyst based in Hyderabad.