Hope to get nasal vaccine against Covid-19 into market in 12-18 months: Hyderabad-based Bharat Biotech

The most durable protection against the novel coronavirus is a vaccine. World Health Organisation said recently that over 30 vaccines to treat the virus were under development. Hyderabad-based vaccine maker Bharat Biotech International Ltd (BBIL) is one of the many companies on the job. Krishna M Ella, a molecular biologist and chairman and managing director of the Bharat Biotech, spoke to TOI's Surendra Singh in an exclusive interview on the progress made on the vaccine so far. Excerpts:


Q When did you start work on a new vaccine and what is the status of the research?
A. We began work on the new vaccine, CoroFlu, in February this year. CoroFlu builds on cutting-edge technology from an influenza vaccine already being developed by US company FluGen, and based on research at the University of Wisconsin, Madison (UWM). Because CoroFlu is based on a flu vaccine, our team hopes to protect patients from both the flu virus and the novel coronavirus at the same time.

Q. Who are you collaborating with?
A. BBIL is working in collaboration with an international team of virologists and vaccine manufacturers from UWM and FluGen for the development of CoroFlu. The vaccine will build on the backbone of FluGen’s flu vaccine candidate known as M2SR. Based on an invention by UWM virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu. Kawaoka’s lab will insert gene sequences from SARS-CoV-2, the novel coronavirus that causes Covid-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus.


Q. When will human trials start?
A. While the flu vaccine is in clinical trials, the safety and efficacy of CoroFlu must still be assessed in animal models at UWM’s Influenza Research Institute before it can be produced and clinically tested by BBIL. Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at UWM is expected to take three to six months. BBIL will then start safety and efficacy testing in humans. CoroFlu could be in human clinical trials by the fall of 2020.

Q. When will the vaccine be available for people?
A. We are hopeful to get the vaccine into the market in the next 12-18 months. Our immediate goal is to begin human trials in the next three to six months. Once we establish the safety and efficacy of the vaccine, we will reach out for regulatory approvals. The vaccine rollout will depend on how soon we can get the regulatory nod.

Q. The US, China, Australia and Germany are also working on vaccines. Will CoroFlu be more effective than other vaccines under development?
A. What makes our vaccine stand apart from other candidates is that it’s built on a flu vaccine backbone that has already been shown to be safe and well-tolerated in humans in phase I and phase II clinical trials. CoroFlu, like M2SR, will be delivered intranasally. This route of administration mimics the natural route of infection by coronavirus and influenza and activates several modes of the immune system. Intranasal delivery (delivered by nose) is more effective at inducing multiple types of immune responses than the intramuscular shots that deliver most flu vaccines.

Q. Do you seek any government help in research and commercial production of the vaccine?
A. We want the government to give us access to animal testing facilities, which is a big hindrance to speedy vaccine development. We also urge our government to support us with the reagent, which is not available here and has to be imported. The government can also extend support to fund clinical development.

Q. If your vaccine will be ready much before others, will you also export them to the worst affected countries?
A. BBIL will produce the vaccine for global distribution as it has the capability to produce almost 300 million doses per year.

Q. What are the other vaccines you make?
A. Apart from 16 routine vaccines manufactured by BBIL, the company had developed and licensed a vaccine for H1N1 [or swine flu] in 2009 within 14 months of its outbreak in India. This is primarily due to BBIL’s large viral vaccine facility located in Genome Valley in Hyderabad. Our company has successfully developed 10 viral vaccines and delivered over 5 billion doses of viral vaccines, including anti-rabies vaccines. At least 80% of polio vaccine supply for the government’s national immunisation programme is supplied by BBIL and thus it serves as a major player in eradicating polio from the country. Besides being the world’s largest rotavirus vaccine manufacturer, BBIL is also the first company to identify, purify and sequence chikungunya during the 2006 epidemic in Kerala and Tamil Nadu. The chikungunya vaccine is in final clinical trials.