It is a race to save millions of lives and protect not just 1.3 billion Indians, but people from around the world, especially those in low-income countries. As the world scrambles to develop a vaccine against SARS-CoV-2, the virus behind the Covid-19 pandemic, three Indian biotechnology companies have emerged at the forefront of the global response to the pandemic.
On August 5, the Indian Council of Medical Research (ICMR) announced that Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoV-D had successfully completed the first phase of clinical trials, where the vaccines were given to a small group of adults to test their safety and confirm that they stimulate the immune system. These two vaccine candidates now enter Phase II, where they will be tested on several hundred individuals.
The third candidate in the fray is the famous Oxford-AstraZeneca vaccine, which is being manufactured in India by the Serum Institute, under the brand name Covishield. The Drugs Controller General of India (DCGI) has approved it for Phase II and III trials across 17 sites in India, where it will be tested on tens of thousands of individuals. This is just one step away from final approvals and mass production — assuming the vaccine works and has no adverse side effects. Overall, around 30 Indian companies have announced plans for vaccine development, while WHO has given approvals to seven candidates.
The ICMR Director General, Dr Balram Bhargava, has cautioned that it is still too early to celebrate. An Indian vaccine that actually works is still months — probably a year or more — away. “The need for a vaccine is both great and urgent,” he said in a recent press briefing. “But there is a dilemma. The Covid-19 pandemic is growing rapidly and to develop a vaccine takes time.”
Dr Om Srivastav, Director of Infectious Diseases at Jaslok Hospital and Research Centre and a member of the Maharashtra government’s Covid-19 task force, agrees that what these vaccines are promising now is only on paper and in theory. “The real test is going to be on how effective the vaccine is when it’s placed on the table and given to the general population,” he says, noting that these candidates are all first-generation vaccines and not repurposed ones. They need to go through a few stages of refinement before they are declared effective and robust.
A biotech powerhouse
However, given the strength of India’s biotechnology sector and its rapid growth, there is ample confidence that the country’s battle against Covid-19 will eventually yield game-changing results. Data from various government sources reveals that the biotechnology industry in the country was worth a mere $1.1 billion (Dh4.03 billion) in 2003. But by 2019, it had grown exponentially to $64 billion. Currently, it accounts for a 3 per cent share in the global biotechnology market, but by 2025, that is expected to jump to 19 per cent as the sector crosses $100 billion in value.
India is the world’s largest producer of generic drugs and controls 20 per cent of global exports by volume. Moreover, the country currently has 2,700 biotech start-ups, and it is likely to be home to around 10,000 by 2024. Further, with around 2,500 biotech companies, India has emerged as a leading destination for clinical trials and manufacturing.
Change in direction
The Covid-19 pandemic has changed the game for almost every industry, while the biotechnology industry is bang in the middle of massive disruption. Dr V.L. Ramprasad, CEO of MedGenome Labs, describes it as a strategic asset for a nation and the world and believes the pandemic has triggered a major shift in focus. Previously, the biotechnology industry had emphasised innovations in oncology, immunology and other critical conditions. “But Covid-19 has pointed out infectious diseases too as a focus area that needs attention. Beyond the immediate crisis, biopharmas and medtechs are trying to find their footing in a market that has shifted dramatically in recent weeks.”
The pandemic has resulted in many of these companies switching priorities and working overtime to develop and deliver more reliable diagnostic tests, or to meet the need for ventilators, personal protective equipment and related gear. Some are pitching in with Covid-related research. MedGenome is conducting large-scale molecular testing to understand the spread of Covid-19. It has also collaborated with SciGenom Research Foundation to analyse DNA sequence and variation data from over 300,000 individuals to predict susceptibility to Covid-19.
The combined efforts of the industry are already showing results. For example, latest ICMR figures reveal that, within months, the country has ramped up Covid-19 testing and is now running close to 600,000 tests a day — ICMR is targeting one million tests daily — while the cumulative total of samples tested so far exceeds 2.33 million. ICMR reports that on January 23, India had only one testing lab. Now, there are more than 1,000.
The post-Covid future
Dr Ramprasad believes that the experience, new skills and strategies the Indian biotechnology sector has acquired because of the pandemic will help it quickly adapt to and cope with future pandemics. It will also improve the sector’s response to other diseases.
He offers the example of tuberculosis, which is considered to be a public health concern, with India being one of the highest contributors to the global burden.
“With an infrastructure for rigorous Covid-19 testing, contact tracing and addressing the stigma, there is a comparatively smoother way paved for duplicating the efforts in tuberculosis as well,” says Dr Ramprasad.
And since the Indian biotechnology industry offers numerous comparative advantages in terms of R&D facilities, knowledge, skills and cost-effectiveness, it has immense potential to emerge as a key global player. “Rapid innovations have the potential to improve the lives of people around the world, and biotechnology has led to new ways of treating a variety of human diseases,” he adds.
Serum Institute: In the thick of the action
When any of Serum Institute’s vaccine arrives in India, it is likely to cost just Rs225 (Dh11). That is the commitment made by the world’s largest vaccine manufacturer based in Pune. Serum Institute of India (SII) is currently working on five vaccine candidates — three are manufacturing deals with international biotech firms, while two are being developed inhouse.
The low pricing is the result of a collaboration between SII, the global vaccine alliance, Gavi, and the Bill & Melinda Gates Foundation, where SII will benefit from an at-risk funding of $150 million to speed up the production and delivery of 100 million doses of Covid-19 vaccines. These will be distributed in India as well as low- and middle-income countries. Adar Poonawalla, CEO of SII, calls it an “attempt to make the fight against Covid-19 stronger and all-embracing”. He observes that to ensure maximum immunisation coverage and to contain the pandemic, it is important to make sure that the most remote and poorest countries of the world have access to the vaccine. “Through this association, we seek to ramp up our constant efforts to save the lives of millions of people from this dreadful disease.”
Serum Institute certainly has the capacity to deliver at scale — the company already manufactures 1.5 billion doses of other vaccines annually.
For the Covid-19 vaccines, SII has set aside two assembly lines and six machines that can collectively churn out a total of 3,000 doses every minute — or 180,000 every hour. Poonawalla claims the plan is to have 300 million doses ready by the end of 2020.