Tell us how you developed Covaxin.
Undoubtedly, COVID-19 was the biggest humanitarian crisis in the world. It affected nations, their population and economy. I felt that if India has to fight Covid-19, it will have to develop and manufacture its own vaccine. We needed to be independent. In the past, we had developed more than 11 viral vaccines and we worked on an inactivated virus platform. So, I knew we had the resources to develop a safe and effective vaccine. When we approached the Indian Council of Medical Research (ICMR) for the strain, they voluntarily gave it to us.
During the initial phase of vaccine development, we were dealing with a total lockdown and it was a big challenge as we were dealing with an unknown virus. However, when I told my scientists about developing Covaxin, they didn’t hesitate for a moment and were willing to take the risk for a greater humanitarian cause. Our team went to the National Institute of Virology (NIV), Pune to bring a live, highly contagious virus to our Genome Valley plant. With the help of ICMR and NIV, Pune, we introduced Covaxin in less than 11 months.
We achieved several milestones during the preclinical and clinical phases of Covaxin. The largest vaccine efficacy phase 3 trials to date involved 25,600 volunteers from more than 22 clinical sites and capturing even more extensive data that was published in more than 23 peer-reviewed international journal articles on Covaxin. This led to difficult emergency-use authorization in India and emergency-use listing from WHO.
We were also faced with the question of whether an inactivated vaccine platform would work against the new platform. However, we knew that our platform had an established history of efficacy and safety. Furthermore, capacity building for production was equally overwhelming for a company like ours. Yet we went ahead and built manufacturing facilities and reused facilities to achieve an annual capacity of 1 billion doses. Our vaccine Covaxin also ensured that India has a vaccine to protect its people, which is not only world class but also affordable.
When are we expecting the much-anticipated nasal vaccine?
Our intranasal COVID-19 vaccine is a game-changer as it will prevent infection and disease transmission. We have collaborated with Washington University School of Medicine in St. Louis on an intranasal vaccine for COVID-19, a novel chimp-adenovirus. Intranasal vaccine stimulates a broad immune response, neutralizing IgG, mucosal IgA and T cell responses. At the site of infection, immune responses in the nasal mucosa are necessary to block both infection and transmission of COVID-19. The nasal passage has excellent potential for vaccination due to the organized immune system of the nasal mucosa. It is also a non-invasive and needle-free vaccine.
Our Phase III clinical trials are underway in the country. We have already conducted clinical trials on 5,000 participants. The preliminary results are promising and once we complete the trial, we will capture the data and submit it to the drug regulator for approval.
What about your plans, collaborations and vaccines in the pipeline?
In addition to our intranasal vaccine for COVID-19, we are working on the Chikungunya vaccine. We are also working with rabies vector-based vaccines for long-term immunity against COVID-19. It is a highly immunogenic protein. We have completed the Phase I trial and will start Phase 2 and 3 very soon.
In March, we partnered with Biofabri, a Spanish firm, to develop, manufacture and market a tuberculosis (TB) vaccine. This partnership will guarantee the supply of TB vaccines to more than 70 countries, especially in Southeast Asia and Sub-Saharan Africa, where TB cases are high. Other vaccines that are in the research and development pipeline are malaria, Zika, cholera, NTS conjugate, and Salmonella paratyphi.
What are the future threats to India?
We see zoonotic hazards, which means diseases borne by animals. There are about 40,000 unknown viruses and 1,000 zoonotic viruses. To prevent this, we need ideal vaccines that have long-term immunity.
Who do you see as a competitor?
Our competitors are infectious diseases, not countries or companies. I predicted in 2000 that all neglected diseases would become epidemics. Mostly, Africa and Asia contribute to neglected diseases. Our fundamental philosophy was to continuously build on this niche area and we have been successful in this for over 25 years. Our strategy is to be prepared to thwart neglected diseases.
Where do you think India should improve in terms of innovation?
Innovation is the key to the future. But who makes it? Individuals, not companies or countries, are responsible for the invention. This is a scientist trying to invent something new. To innovate, you will need knowledge, a good degree and a set of skills. For example, many Chinese people do not speak English but are successful in science and technology because of their skill set. Imagination is also a component of invention. Suppose you hire an architect to build a house. To build a house, he uses his imagination. When you combine all three, to a degree, skill set and imagination, you get innovation. This is a simple definition of innovation.
We also need to build a successful public-private-partnership (PPP) to tackle major public health problems.
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