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‘Vaccine price to be outcome of scale; have output capacity of 30 mn doses per month’

In an interview to PRABHA RAGHAVAN, Singh details how the Pune firm’s vaccine works and delves into plans to test and scale up production for a vast population. Edited excerpts:

Written by Prabha Raghavan | Updated: December 26, 2020 4:05:35 pm
covid-19 in india, Covid-19 vaccine in india, Gennova Biopharmaceuticals, Gennova Biopharmaceuticals covid vaccine, Pfizer, indian express newsDr Sanjay Singh.

The mRNA Covid-19 vaccine by Gennova Biopharmaceuticals will hopefully not only achieve a similar efficacy to the candidates developed by Pfizer and Moderna, but will also be more affordably priced for a country like India, according to CEO Dr Sanjay Singh.

How does your mRNA vaccine, which uses a self-amplifying model, compare with Pfizer and Moderna’s candidates?

Our vaccine will work in a similar fashion to Pfizer’s and Moderna’s candidates. Regardless of the fact that this is based on the self-amplifying mRNA platform, it allows you to give the message to the cells, which converts it into the antigen, generating a neutralising immune response against the Covid-19 virus. Unlike ours, Moderna’s and Pfizer’s vaccines use non-replicating mRNA.

A self-amplifying type mRNA is much more beneficial in such a pandemic situation, where the vaccine deployment is not in millions, but billions. For the country’s population, this will be the most appropriate vaccine candidate. The advantage is that you can give maybe a lower dose of the vaccine.

Moderna’s vaccine is reported to work at 100 micrograms in two doses, while Pfizer’s works at 30 micrograms in two doses. We are targeting 5, 10 and 25 micrograms and we hope that any one of these doses will prove to be efficacious.

In a self-amplifying module, one mRNA molecule enters the cell and produces multiple copies, which will then make higher quantities of protein antigen compared to a similar dose of the non-replicating mRNA. Therefore, the effective dose can be quite less, providing a similar protection to disease. Another advantage of mRNA in general is that it never enters the nucleus and, thereby, there is no possibility of integration in the organism’s genome, where the DNA resides. It does its work in the cytoplasm, and because of this chemical structure, it is a naturally self-degrading molecule — it goes away within a limited time.

We did extensive preclinical animal testing, starting somewhere in March for nine months. This is important because it will reduce our risk, improve safety and help us understand the possible efficacious doses of our vaccine.

What timelines are you looking at for the testing of your vaccine candidate in India? What is the scope for global testing of this vaccine?

For phase 1, we have got two sites where we will be starting enrolment soon. These are KEM Hospital in Pune and a government hospital in Kolhapur. The first phase will include 120 participants. We are looking at enrolling 500 participants for phase 2 trials and this will go into many sites. I hope it will be 6-10 sites.

We hope to start phase 1 soon. We will present our phase 1 data to the DCGI (Drug Controller General of India), before starting the second phase, and so the timeline for the trials to be completed will depend on these factors. I hope this will take around two and a half months, but this can vary.

We are aiming to start phase 1 trials in the US also with our partners. The NIH has funded us — around $8.2 million — and we will expand this globally.

At present, we are in discussions with the US FDA, but we expect somewhere in the middle of February to be able to start phase 1 trials. The number of participants (in the US) will be decided by the FDA there, the way the participants in India have been decided by the CDSCO (Central Drugs Standard Control Organisation).

There is a possibility that we might go in for larger global trials, and I presume the target countries for these trials will include Brazil and South Africa.

What correlates of protection (correlates of protection are signs that the vaccine is able to develop the immune response required) will you be looking at to ensure that your vaccine is efficacious?

We will be looking at correlates similar to what Pfizer has studied in its trials, and some additional correlates. For instance, (we would be looking at) the humoral response in terms of antibody and neutralisation titers. Another correlate is how good the cellular (T-cell) response is. If a vaccine which has been approved uses the same platform, we know what the correlates of protection are. During our phase 1 and 2 trials, we will have to see whether we are getting a similar kind of response. We will also look at additional correlates of protection, but these are the most important.

Pfizer and Moderna’s vaccines seem to be expensive for developing countries. How do you expect your vaccine to be priced?

The price of the vaccine is directly correlated with its mass production. It has to be affordable and competitive, but right now the priority is safety and efficacy. Our vaccine’s pricing will certainly be in the affordable range — we are committed to that — but it will also depend on how many doses we are asked to manufacture. The price will be an outcome of scale.

How are you overcoming potential supply chain issues with your vaccine? What capacity are you aiming for?

We already have installed a production capacity of 30 million doses per month, but we can ramp it up fairly quickly with our parent group, Emcure. In terms of raw materials, we are already doing backward integration to make sure we are self-sufficient in this crucial part of the supply chain. If we have to produce billions of doses, the raw material will certainly crop up as an issue. But, for the level we are at, currently, we have sourced the raw materials in such a fashion that we can produce a few hundred million doses annually in a very short time.

Once we complete phase 2, we will be in a much better position to understand what kind of production capacity we’re going to aim for.

Realistically, when do you expect a Covid-19 vaccine becoming available in India?

I feel we can have some bright prospects close to March to April. This means a vaccine in visibility with established safety and efficacy data.

How has financing and support from CEPI and BIRAC help in the development of your vaccine?

Other than the initial seed funding and support from DBT, the most important thing that came to us is that we have gone through a multi-layer review process, and these expert comments were an added advantage for us.

Every second month, we are presenting to the committee, and they are evaluating our data. So, Gennova has a unique advantage of having such an expert group available for their vaccine development apart from just seed funding.

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