Bharat Biotech has submitted its safety data to the Drugs Controller General of India (DCGI) based on the phase 2/3 clinical trials for manufacturing vaccine for children aged between 2 and 18.Bharat Biotech inactivated vaccine Covaxin is the outcome of complex scientific process that is needed to achieve best efficacy and immunogenicity, said Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech International Limited, Hyderabad, on the occasion of panel discussion on “India’s Massive COVID-19 Vaccine Program: The Accessibility Strategy” as part of Virtual FE Healthcare Summit which began from August 18 and will conclude on August 20, 2021.
Bharat Biotech has submitted its safety data to the Drugs Controller General of India (DCGI) based on the phase 2/3 clinical trials for manufacturing vaccine for children aged between 2 and 18. The vaccine is expected to be rolled out in the month of October 2021.
To substantiate his point, Dr Ella stated that “Making inactivated vaccine like Covaxin is complex and not as easy as making vaccine through mRNA technology or live adenovirus vector platform. If Pfizer can make 1 million doses of mRNA vaccine then we can make 10 billion doses of equivalent capacity of inactivated vaccine. In the case of 2 billion doses of making vaccines in a live adenovirus vector platform, we can make 20 billion doses of equivalent capacity. We are only10 to 15 % of the capacity that can produce mRNA and adenovirus vaccines.”
Bharat Biotech reached 28 million doses capacity in August, 2021. The Company which had previously pegged the capacity at 200 million doses a year has recently scaled up manufacturing capacity across facilities in Hyderabad and Bengaluru to produce 700 million doses of the Covaxin vaccine a year.
Bharat Biotech is the only company in the world which has conducted efficacy trial for delta variant when the epidemic was there. It achieved 71% efficacy against the delta variant.
“We were shown UK Variant, Brazilian Variant and South African Variant. In addition to the in-vitro studies of protection we finally got real efficacy data through the trials. One is delta efficacy and the other is asymptomatic population which does not control the viral load. We captured both data points for better efficacy. Though it was late, it has helped us in capturing relevant and latest data on the delta variant,” Dr Ella said.
Talking about production of vaccine, adaptation in the public health system, innovative clinical research, Dr Ella added, “India is today providing the cheapest vaccine in the world at Rs 225 per dose. The Indian Government has done a good job in negotiating prices with the manufacturers at bulk quantity to provide vaccine to the entire population on a sustainable, accessible and affordable manner. All manufacturers, policy makers and government systems of delivery have done extremely well.”
The US has excess vaccine production but only 16 crore population has been vaccinated. On the other hand, in India 55 crore population is vaccinated of the 1.1 billion adult population out of the 1.3 billion total population which speaks volumes of India’s vaccine strategy.
Talking about different strategies on vaccine development and clinical research, Dr Ella said that there are different strategies that need to be adopted like the nasal vaccine. We are also looking at the Thomas Jefferson Rabies Vaccine platform which has entered phase 1 trial. It is being used for immuno-compromised and old patients who do not respond to any vaccine. We are also looking at working on vaccines for both Covid and Rabies put together for both India and Africa Countries.”
He further added that we also do see some synergistic effect of heterologous combination like Covaxin followed by nasal vaccine. All injectable vaccines can prevent symptoms of the disease and hospitalization of the disease. Despite this, disease is bound to come back for the vaccinated people also.
“Only nasal vaccine will stop the transmission. There are three ways to prevent transmission like masks, isolating oneself and third being nasal vaccine. It has not yet confirmed whether nasal vaccine will work alone or in combination with other vaccines the data of which will come in the next two to three months. No body has done that type of clinical research in the world. They have only done nasal and some has failed. Nasal in combination with inactivated vaccine is a new way of thinking in priming innate activity in the body and the challenge it with the live vaccines later seems to be a new concept building in the next two to three months. We are in fact doing innovative clinical research which is not being done in the world,” he explained.
Talking about time span on development of vaccines, Dr Ella said, “We have Drugs Controller General of India (DCGI) approval for phase 2/3 trial which we are trying for heterologous changeover. Nasal vaccine trial also alone has been given approval for phase 2 trial. So there are parallel two routes of clinical trials going on. Let us see which one picks up better in clinical research. It is being assumed that nasal vaccine followed by inactivated vaccine is the best but we are seeing opposite in the Covid scenario. So we are going to see a different science. We will see in the next two to three months a lot of data coming in on the same.”
“Bharat Biotech is the only company in the world which captured the second wave of Covid. All other companies globally captured the first wave including Astrageneca, Pfizer and Moderna when there was no delta variant and everybody got the highest efficacy. In Covid second wave, when we were late in phase -3 efficacy, we landed exactly in the Covid second wave when 80% of the infections in the country was of delta variant,” Dr Ella concluded.
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