Gennova Biopharmaceuticals’ Covid-19 mRNA vaccine is expected not only to achieve similar efficacy to the candidates developed by Pfizer and Moderna, but also to be more affordable for a country like India, according to CEO Dr. Sanjay Singh.
How does your mRNA vaccine, which uses a self-amplification model, compare to the candidates from Pfizer and Moderna?
Our vaccine will work similarly to the Pfizer and Moderna candidates. Regardless of whether it is based on the self-amplifying mRNA platform, it allows the message to be transmitted to the cells, which converts it into an antigen, generating a neutralizing immune response against the Covid-19 virus. Unlike ours, Moderna and Pfizer vaccines use non-replicable mRNA.
A self-amplified type mRNA is much more beneficial in a pandemic situation, where vaccine deployment is not in the millions, but in the billions. For the population of the country, this will be the most suitable candidate vaccine. The advantage is that you can perhaps administer a smaller dose of the vaccine.
Moderna’s vaccine is reported to work at 100 micrograms in two doses, while Pfizer’s vaccine works at 30 micrograms in two doses. Our goal is 5, 10, and 25 micrograms and we expect any of these doses to be effective.
In a self-amplification module, an mRNA molecule enters the cell and produces multiple copies, which will then produce higher amounts of protein antigen compared to a similar dose of non-replicating mRNA. Therefore, the effective dose can be quite lower, providing similar protection against disease. Another advantage of mRNA in general is that it never enters the nucleus and therefore there is no possibility of integration into the organism’s genome, where the DNA resides. It does its work in the cytoplasm and, due to this chemical structure, it is a molecule that naturally self-degrades and disappears in a limited time.
We did extensive preclinical animal testing, beginning in March for nine months. This is important because it will reduce our risk, improve safety, and help us understand the possible effective doses of our vaccine.
What deadlines are you looking for for testing your candidate vaccine in India? What is the scope of global testing for this vaccine?
For phase 1, we have two sites where we will soon start signing up. These are the KEM Hospital in Pune and a government hospital in Kolhapur. The first phase will have 120 participants. We are looking to enroll 500 participants for phase 2 trials and this will be included in many sites. I hope there are 6-10 sites.
We hope to start phase 1 soon. We will present our data from phase 1 to the DCGI (Controller General of Drugs of India), before starting the second phase, so the timeline for completing the trials will depend on these factors. I expect this to take about two and a half months, but this can vary.
Our goal is to begin phase 1 testing in the US with our partners as well. The NIH has funded us, about $ 8.2 million, and we will expand it globally.
We are currently in discussions with the US FDA, but we hope that by mid-February we can begin phase 1 trials. The number of participants (in the US) will be decided by the FDA there, the same way as the participants in India has been decided by CDSCO (Central Medicines Standards Control Organization).
There is a possibility that we will conduct larger global trials, and I assume that 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 capable of developing the required immune response) will you look at to ensure that your vaccine is effective?
We will examine correlates similar to those that Pfizer has studied in its trials and some additional correlates. For example, (we would be looking at) the humoral response in terms of antibodies and neutralizing titers. Another correlate is how good the cellular response is (T cell). If a vaccine that has been approved uses the same platform, we know what the correlates of protection are. During our phase 1 and 2 tests, we will have to see if we are getting a similar type of response. We will also look at additional correlates of protection, but these are the most important.
Pfizer and Moderna vaccines appear to be expensive for developing countries. How do you expect your vaccine to be priced?
The price of the vaccine is directly related to its mass production. It has to be affordable and competitive, but right now the priority is safety and efficiency. The price of our vaccine 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 a result of scale.
How are you overcoming potential supply chain problems with your vaccine? What capacity are you targeting?
We have already installed a production capacity of 30 million doses per month, but we can increase it quite quickly with our parent group, Emcure. In terms of raw materials, we are already doing backwards 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 surely emerge as a problem. But for the level we are at today, we have sourced the raw materials in such a way that we can produce a few hundred million doses a year 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 are going to target.
Realistically, when do you expect a Covid-19 vaccine to be available in India?
I think we can have some bright prospects around March to April. This means a vaccine in visibility with established safety and efficacy data.
How has funding and support from CEPI and BIRAC helped in the development of your vaccine?
Aside from the seed funding and support from DBT, the most important thing we received is that we have gone through a multi-level review process, and these expert feedback was an added bonus for us.
Every two months, we present ourselves to the committee and they are evaluating our data. Therefore, Gennova has the unique advantage of having a group of experts available for the development of its vaccine, in addition to the initial funding.
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