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‘Though we may seem behind, we are going to catch up quickly… Biological E can make a billion doses of the vaccine’

In an interview to The Indian Express, Dr Maria Elena Bottazzi explains how the facility was able to speed up development of this vaccine and how the tie-up with the Hyderabad-headquartered vaccine maker can help scale up production of an affordable Covid-19 vaccine.

Written by Prabha Raghavan | Updated: September 5, 2020 12:26:44 am
Dr Maria Elena Bottazzi

Baylor College of Medicine’s recent agreement with Biological E will soon propel the Houston-based institution’s Covid-19 vaccine candidate to a crucial position in the ongoing vaccine race, feels Dr Maria Elena Bottazzi, associate dean, BCM National School of Tropical Medicine. In an interview to The Indian Express, she explains how the facility was able to speed up development of this vaccine and how the tie-up with the Hyderabad-headquartered vaccine maker can help scale up production of an affordable Covid-19 vaccine. Edited excerpts:

How did you choose the platform you’ve been working on for your Covid-19 vaccine candidate? How long did the process of development take?

Our vaccine centre has been working on developing coronavirus vaccines for at least a decade. We started in 2011, working with a SARS vaccine programme, and then we also added a MERS vaccine programme. So, we already had a pretty long experience … Our niche is to use recombinant protein technologies.

The moment we knew the sequence of the Covid-19 virus was published in January … we were able to pull out the piece of the sequence we were going to be using as our target. We didn’t have to wait very long. We have only been working with this virus from, say, the beginning of February and, in a very quick turnaround, we already knew how to, in our labs, clone and engineer the candidate.

We also already had designed the production process and lucked out because SARS is very similar to this Covid-19 virus. So, we basically just used the same process we had designed before and it worked beautifully … in 2-3 months, we were able to reproduce exactly the same thing that took us four years before (when we were developing a SARS vaccine).

The world is currently looking at newer technologies for Covid-19 vaccines that have been faster to develop, while yours originates from a fairly traditional platform. What is the reasoning behind your choice?

New technologies may modernise, at some point, how you may tackle vaccine development, but, in the context of a pandemic, it’s an additional risk because it’s the first time you’re using it.

It’s not like we haven’t had attempts of developing viral vaccines before. Yes, maybe we cannot make the protein as quick as a piece of an RNA or DNA, but … we don’t necessarily know if (the newer technology) is going to work 100 per cent.

How is your tie-up with Biological E going to benefit populations waiting on a Covid-19 vaccine and where do you see this agreement putting you in the global race?

On the side of recombinant protein technologies, even though they may be a little bit behind (in the vaccine race, they’re not too far) behind. For example, Biological E is going to start a phase I trial probably between September and October. We will not enter into phase III until probably April of next year, but here’s where the difference is — Biological E already knows it can produce a billion doses a year of this vaccine. There’s nowhere around the world that a single manufacturer can adopt that viral vector, RNA (or) DNA technology and rapidly scale the production and even formulation.

With … the protein-based vaccine approach, the fact (is) that it is the same exact backbone and process as the hepatitis B vaccine. There’s already a network of vaccine manufacturers around the world that know how to make the hepatitis B vaccine. They even have pre-qualifications, meaning they have the infrastructure and the quality. We gave our recipe to Biological E and, I can tell you, in a cycle of three weeks, they went from a laboratory scale to a billion doses per year scale. And that’s unprecedented too. I think you’re going to see that, even though you may believe we are behind, we are going to catch up so quickly. We already have precedent testing a recombinant protein vaccine, so regulatory bodies already are aware of what to look for.

How much can a vaccine using this technology cost?

(With) the hepatitis B vaccine, Biological E already said they can produce this for less than a couple of dollars. We’re working with Biological E to bring the product (to market and) to be able to be evaluated globally. They’re going to be working with WHO, with COVAX (and) we’re working with Latin America, Africa (and) Asia. They’re going to make for India but, at the same time, they have enough material … to be able to support the global need.

All the raw materials are open access, generic … it’s not rocket science here. The backbone of the vector, the backbone of the actual yeast (used to produce the vaccine) is something that (Biological E) has in their kitchen cabinet. The reagents used to ferment and purify are … very simple, cheap resins that they already use in their pre-production and purification processes. And probably also … all the excipients that they use are very simple excipients.

In this case, the cost of labour is (also) exactly the same as they’ve already used. So, they have a very good handle of how much it actually costs them, what is their investment, the fact that it’s also going to be for a public good — this is not to necessarily make any major profit out of it.

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