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HYDERABAD : Intranasal vaccines will be game-changer in the fight against covid, said Dr Krishna Ella, chairman of Bharat Biotech. In an interview, Ella said phase 3 clinical trials of the non-invasive, needle-free vaccine are on, and the initial results are promising. Once the trials are completed, Hyderabad-based Bharat Biotech will submit the data to the regulator for approval. Ella also spoke about vaccines in the pipeline to be manufactured by Bharat Biotech, including those against Chikungunya and Zika. The firm is upgrading its manufacturing facilities, specifically for Covaxin, after the World Health Organization (WHO) suspended the vaccine supply through UN procurement agencies. Recently, WHO inspected the Bharat Biotech plant and identified good manufacturing practice (GMP) deficiencies. Edited excerpts.

Tell us how you developed Covaxin.

Undoubtedly, covid-19 was the biggest humanitarian crisis across the world. It impacted nations, their populace, and economy. It struck me that if India has to fight covid-19, it must develop and manufacture its own vaccine. We needed to be self-reliant. In the past, we developed more than 11 viral vaccines and we had worked on an inactivated virus platform. So, I knew we had the resources to develop a safe and efficacious vaccine. When we approached the Indian Council of Medical Research (ICMR) for the strain, they willingly gave it to us.

During the initial phase of vaccine development, we were dealing with a total lockdown and it was a huge 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 the live, highly infectious virus to our genome valley plant. With the help of ICMR and NIV, Pune, we introduced Covaxin in less than 11 months.

We achieved many milestones during the preclinical and clinical phases of Covaxin. The largest-ever vaccine efficacy phase 3 trials involved 25,600 volunteers from over 22 clinical sites and even more extensive data capturing that was published in more than 23 peer-reviewed international journal articles on Covaxin. This led to the tough Emergency Use Authorisation in India and emergency-use listing from WHO.

We also faced the dogma of whether an inactivated vaccine platform will work against the new platforms. However, we knew our platform had an established history of efficacy and safety. Furthermore, building capacities for production was equally overwhelming for a company such as ours. Yet we went ahead and created manufacturing facilities and also repurposed facilities to attain the annualised capacity of 1 billion doses. Our vaccine Covaxin also ensured that India had its own vaccine to protect its people, with a vaccine that is not only world-class but also affordable.

When are we expecting the much-awaited nasal vaccine?

Our intranasal covid-19 vaccine is a game-changer as it will prevent infection and the transmission of the disease. We have collaborated with the Washington University School of Medicine in St. Louis on a novel chimp-adenovirus, an intranasal vaccine for covid-19. An intranasal vaccine stimulates a broad immune response, neutralising IgG, mucosal IgA, and T cell responses. Immune responses at the site of infection, in the nasal mucosa, are essential for blocking both infection and transmission of covid-19. The nasal route has excellent potential for vaccination because of the organised immune systems of the nasal mucosa. It is also a non-invasive and needle-free vaccine.

Our phase 3 clinical trials in the country are underway. We have already conducted a clinical trial on 5,000 participants. The initial results are promising and once we complete the trials, we will capture the data and submit it to the drug regulator for approval.

What about your plans, collaboration, 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 one trial and will start phases two and three soon.

In March, we entered a partnership with Biofabri, a Spanish firm, for developing, manufacturing, and marketing a tuberculosis (TB) vaccine. This partnership will guarantee the supply of TB vaccines in more than 70 countries, especially in Southeast Asia and sub-Saharan Africa, which have high TB incidence. The other vaccines that are in the research and development pipeline are those for malaria, Zika, cholera, NTS conjugates, and salmonella paratyphi.

What are the future threats to India?

We see zoonotic threats, which means diseases originating from animals. There are approximately 40,000 unknown viruses and 1,000 zoonotic viruses. To prevent this, we need to have ideal vaccines that have long-term immunity.

Whom do you see as competitors?

Our competitors are infectious diseases, not a country or a company. I predicted in 2000 that all neglected diseases would turn out to be pandemic. Mostly, Africa and Asia contribute to neglected diseases. Our fundamental philosophy was to consistently build on this niche area and we have succeeded in this for more than 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 creates that? Individuals, not companies or countries, are responsible for invention. It is a scientist who is attempting to invent something new. To innovate, you’ll need knowledge, a decent degree, and a set of skills. For example, a lot of Chinese people do not speak English but are successful in science and technology because of their skill sets. Imagination is also a component of the invention. Suppose you hire an architect to construct a home. To build a house, he uses his imagination. When you combine all three, a degree, skill sets, and imagination, you get innovation. That is a simple definition of innovation.

We also need to build a successful public-private-partnership (PPP) to deal with larger public health problems.

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