Hyderabad-based Bharat Biotech announced last week that it is working on the development of a nasal vaccine for Kovid-19. In the United States, animal testing has been initiated in collaboration with virologists from the University of Wisconsin-Madison and vaccine developer FluGen. Kishna Ella, president and CEO of Bharat Biotech, spoke with Ritmah Kaul about the new vaccine trial, the crucial phase it represents for animal testing, the delivery mechanism and the challenges facing India’s vaccine manufacturers.
Which vaccine are you developing against Covid-19?
We have full control of the pandemic vaccines; whether it was H1N1, Chikungunya or Zika, we opened them when they were needed. Our CoroFlu vaccine will be based on the M2SR skeleton candidate for the FluGen flu vaccine. Based on an invention of the virologists at the University of Wisconsin-Madison and co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR is a self-contained version of the influenza virus that causes an immune response to the flu.
The gene sequences of Sars-CoV-2, the pathogen of Covid-19, will be introduced into the M2SR in the Kawaoka laboratory, so that the new vaccine will also induce immunity against the coronavirus. It is expected that the clarification of the concept of the CoroFlu vaccine and its testing in animal models at UW-Madison will take at least three months. Bharat Biotech in Hyderabad will then start expanding production to test safety and efficacy on humans. CoroFlu could be in human clinical trials in July.
Why did you move to the United States for testing?
For Covid-19 we thought we had to have the best specialists in the world. Kawaoka is the best flu shot in the world. There’s no second or third flu in the world, if you ask me. The importance of the flu area lies in the fact that the flu and Covid-19 follow the same infection pattern: you cough, the infection goes via the nose and oral path to the lungs. In this type of respiratory pathogen, the lungs are the target, so mucous immunity is very important for this type of pathogen.
Testing of the animal model has begun. Our animal studies will be delayed because we need to determine safety and effectiveness, but human studies will be carried out very quickly. Animal testing will take at least three months to establish safety. Then Phase 1 is just one dose of vaccine with a 30-day test. Phase 2 does not need to be performed because the same platform (arcade) has already set the required concentration in one person – so it can be minimized. For phase 3, we then need 1,000 people, which equates to 45 extra days of testing in India. The duration of experiments on humans will be very short; only experiments on animals are important because we want to establish safety and effectiveness, which is crucial.
Why the nasal vaccine?
We want to take the same route as this pathogen – nasal. The ideal pandemic vaccine should have a simple delivery mechanism that can easily reach the villages; even a staff member in Anganwadi should be able to administer it to the villagers. Look at the polio vaccine, it is a great success because it fell in the mouth; it reached the last mile because it was easy to administer. Just like that, a nose drop will work better. Moreover, the safety of the people on the platform has already been established. In the United States, the second phase (humane studies) of the influenza vaccination study (FluGen) has already been completed. The safety of the platform is proven, so we can rely on the platform for human use. So if it turns out to be safe in three months’ time, we will continue, but if there is a problem with the animals, we may not even proceed with the product, because the safety of humans is the most important thing.
If you reach the level of human experimentation, which category will you take into account when recruiting staff in India?
In the subsequent recruitment of candidates for human trials, we will focus on doctors and medical professionals as well as police personnel, as they are at the forefront of the fight in India. It has to be in India because the country of origin has to approve the results. They will be tested in the first and third phases.
What are the challenges for vaccine manufacturers in India?
In a pandemic situation, everyone wonders when the vaccine will be ready, why it is too late, what options there are, when it will be marketed, what the price will be, etc. In fact, we need to talk about long-term fundamentals, such as innovation in India, start-ups in India; what we need for all these life science companies to be self-sufficient are reagents that are available within 24 hours, because speed is of the utmost importance for any start-up.
We are very dependent on foreign countries for our raw materials, and in India there are sometimes no small things. The right animal model (specific type of mouse) needed for testing does not exist in India. It is available in the United States and priority will be given to your country or neighboring Europe. What kind of research can you do on vaccines? It’s very difficult. In this case, we funded animal testing at the University of Wisconsin. We need to build small infrastructure islands in this country, as China has done. You created the infrastructure first, here we create the settings first.