Bharat Biotech inactivated vaccine Covaxin is the outcome of complicated scientific approach that is required to obtain ideal efficacy and immunogenicity, mentioned Dr. Krishna Ella Chairman & Managing Director, Bharat Biotech International Limited, on the occasion of panel discussion on India’s Massive COVID-19 Vaccine Program: The Accessibility Strategy as element of Virtual FE Healthcare Summit which started from August 18 and will conclude on August, 2021.
Bharat Biotech has submitted its security information to the Drugs Controller General of India (DCGI) based on the phase 2/3 clinical trials for manufacturing vaccine for children aged in between 2 to 18.
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 10billion 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 areonly10 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 not too long ago scaled up manufacturing capacity across facilities in Hyderabad and Bengaluru to create 700 million doses of the Covaxin vaccine a year.
Bharat Biotech is the only enterprise in the world which has carried out efficacy trial for delta variant when the epidemic was there. It accomplished 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 mentioned.
Talking about production of vaccine, adaptation in the public wellness program, revolutionary clinical analysis, 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 has 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 technique.
Talking about distinct methods on vaccine development and clinical analysis, Dr Ella mentioned that there are distinct methods that require to be adopted like the nasal vaccine. We are also searching at the Thomas Jefferson Rabies Vaccine platform which has entered phase 1 trial. It is becoming applied for immuno-compromised and old patients who do not respond to any vaccine. We are also searching at working on vaccines for each Covid and Rabies place collectively for each India and Africa Countries.”
He additional added that we also do see some synergistic impact of heterologous mixture like Covaxin followed by nasal vaccine. All injectable vaccines can avoid symptoms of the illness and hospitalization of the illness. Despite this, illness is bound to come back for the vaccinated men and women 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 infact doing innovative clinical research which is not being done in the world,” he explained.
Talking about time span on development of vaccines, Dr Ella mentioned, “We have Drugs Controller General of India (DCGI) approval for phase 2/3 trial which we are trying for heterologous changeover. Nasal 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. 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 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 so we landed exactly in the Covid second wave when 80% of the infections in the country was delta,” Dr Ella concluded.