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Biological-E developing Omicron specific vaccine, contemplating it to be used as bivalent jab: Mahima Datla, CEO

The managing director of vaccine manufacturing company says regulatory framework along with financing and market predictability are important bottlenecks in developing variant specific vaccines against evolving coronavirus

September 12, 2022 / 04:06 PM IST
Mahima Datla, Managing Director and CEO, Biological-E

Mahima Datla, Managing Director and CEO, Biological-E

The homegrown Covid-19 vaccine, Corbevax, manufactured by Hyderabad-based Biological E, has been allowed by the Union government to be used as a heterologous booster on Indian population.

The company says it has produced 30 crore doses of Corbevax and has supplied 10 crore doses to Centre for administration in the eligible age-group.

Mahima Datla, Managing Director and CEO, Biological-E, spoke to Moneycontrol on her company developing the second generation of variant specific vaccine of Covid-19 and the bottlenecks related to it.

Datla said her company has submitted clinical data to World Health Organisation for getting the Emergency Use Listing (EUL) by the global health body.

Edited excerpts:

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Corbevax, the vaccine manufactured by your company, is the first to be allowed as heterologous booster, what is the status of the vaccine manufacturing and supply to government of India?

We were contracted by the government to produce 30 crore doses last year and we have produced 30 crore doses. From a manufacturing stand point, we have worked very hard last year, to provide the government what they needed.

Our first supply to the government was close to 10 crore doses, majority of which was used in the adolescent above 12 years.

We have produced the 30 crore doses and we will be ready to respond to government’s requirement immediately. The corbevax has been approved as heterologous booster dose has been approved. It is starting to be integrated with the booster strategy of the government.

Despite the sub technical committee of NTAGI giving a green signal, the government has not given the approval for Covid-19 vaccination in children below 12 years? What is the bottleneck?

We are still not clear if there will be an expansion (of vaccination) to lower than 12 years of age group. Other countries have lowered down the age of vaccination but we are waiting for the government decision in this matter.

The government is having internal deliberation on this. We are in touch with the government on this issue on a daily basis. This is largely to work with them to make sure we are doing the inventory management appropriately.

We have 20 crore doses with us. The working group of the government is looked into this matter positively.

You said there are 20 crore doses available with the company, is expiry of the vaccine doses threat to the stock pile?

The corbevax, due to the formulation and platform on which it has been developed, has an approved shelf life of 18 months, so for us the shelf life is not the consideration. Obviously, 20 crore stock pile is very huge volume of product to consume. It really depends on people because government has been vocal for uptake of booster dose.

The government has said that it is in contact with the vaccine manufacturers for developing the second generation of vaccine, what has been the message from Centre?

The government has taken update from companies on lifecycle management and our plans on Covid vaccines. Not only us, I think other companies have also shared their developing plans for Omicron variant, for a bivalent vaccine, some companies are also looking at the possibility of developing a universal vaccine.

There are couple of key considerations when we talk about variant specific vaccine. There are two key bottlenecks; one is we need to have a very clear and abbreviated regulatory pathway. We need efforts from our regulators as well as WHO to give clear pathways on what it is going to take to come out quickly with variant specific vaccine. The second bottleneck is the market certainty and financing. The good news is many of us are developing the variant specific vaccine.

It’s not the technology or infrastructure that are bottle necks, because we have already invested in the infrastructure.

What is your company, Biological E doing on developing a second generation vaccine?

We are developing an Omicron specific vaccine but we are also contemplating that to be used as a bivalent vaccine. We believe that it is too soon to rule out that your vaccines don’t need any component of the original strain. I am not sure if we can come to that conclusion. Obviously the great solution would be to have a vaccine that stops the transmission but the scientific community hasn’t found a solution on that.

How viable are second generation vaccines in India from a manufacturer’s point of view, given that boosters haven’t received a great response?

The United States has now adopted the variant vaccine as fourth dose. The companies in America get a lot of funding from the government. Here, the risk factor is something that we are all very sensitive to.

What is the status of Emergency Use Listing for corbevax from World Health Organization?

We applied for Emergency Use Listing and gave the data to WHO in January or February. The bottleneck for WHO is that they didn’t have the guidelines for vaccines which didn’t go through the path of efficacy.

The WHO has a very long process to formalize this process. We have presented our clinical data very recently. I am hoping that in next couple of months we can get the necessary approval. Unfortunately, there is no sense of urgency.
Ayushman Kumar Covers health and pharma for MoneyControl.
first published: Sep 12, 2022 04:06 pm