Coronavirus: Serum Institute CEO explains key challenge behind developing a vaccine 

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Published: February 21, 2020 3:15:40 AM

Codagenix at the moment is experimenting with mice. Serum’s role will be to establish the product on a suitable cell line, followed by a scale-up process.

Adar Poonawalla, CEO of Serum InstituteAdar Poonawalla, CEO of Serum Institute

Coronavirus has claimed 2,129 lives and infected 75,762 persons till date. Serum Institute of India and Codagenix of the US have announced a collaboration to rapidly co-develop a live-attenuated vaccine against coronavirus. Serum Institute is the world’s largest vaccine manufacturer by the number of doses, while Codagenix is a clinical-stage synthetic biology company that uses software to recode genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumors. Adar Poonawalla, CEO of Serum Institute, tells Geeta Nair that Serum and Codagenix hope to soon push a coronavirus vaccine in the clinic.

How did this collaboration happen and why did you choose to work with Codagenix?

This collaboration happened because Codagenix has an algorithm to produce any virus at a rapid speed. For example, we already have potential candidates to go into animal studies for the coronavirus outbreak.

Big companies have not shown interest in developing vaccine for COVID-19. What made you respond to this public health crisis?

Most companies, including us, generally won’t be interested in ebola, coronavirus, etc. But I have taken the view of experimenting with this technology to see if it will work. Something serious may happen and we need to be able to rapidly manufacture vaccines. I wanted to test this technology platform of Codagenix keeping in mind that eventuality. Having said that, I do believe that there will be some commercial value to this. I have already got enquiries from China to buy the rights and technology if this vaccine becomes successful.

How will you be working together? What will be your contribution? What would be investments required?

Codagenix at the moment is experimenting with mice. Serum’s role will be to establish the product on a suitable cell line, followed by a scale-up process. The next step is funding and conducting human clinical trials and taking it to licensure. Serum will then manufacture this worldwide, except the US.

How challenging is vaccine development and manufacturing in the current context?

The real challenge is whether it really works and is efficacious in humans. It will also be a challenge to prove its efficacy and design a trial in a country where there are outbreaks – most probably China.

Why is it taking time to develop the vaccine?

It typically takes 7-8 years to develop a vaccine. It takes that much of time because of animal studies, human studies and also establishing when you make a strain, it does not revert back to the wild type, and is safe to use in humans.

By what time can we expect your partner to reach clinical trials and when will you scale up production?

Hopefully, in six months, we should be able to enter human trials. We expect the licensure one year after that, depending on how regulatory bodies in China, India or other countries look at it, granting us fast-track permission for this vaccine as a special case.

Previously, you had created vaccines, but it had no taker and the crisis ended. What if that happens again?

The last time we had developed a flu vaccine during the H1N1 crisis. And yes, after two years, nobody wanted to take the vaccine. This is because in India, unlike in Europe and the US, adults generally do not take flu vaccine or any other kind of vaccine. This awareness is lacking. We, in India, rush to take the cure when we get the disease. I am working on creating the awareness that ‘prevention is better than cure’ and vaccines should be taken to prevent hospitalisation and treatment.

What are the regulatory challenges you could face in manufacturing and selling the vaccine globally.

It is too early to comment as the situation is evolving. It can go either way.

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