Intranasal vaccine can be more efficient in terms of ease of formation, manufacturing and distribution. Bharat Biotech is soon going to start Phase-3 trials for ‘COVAXIN’ with an investment of Rs 150 crore that will include 26,000 participants. Talking exclusively to Medically Speaking .Sai Prasad, the Executive Director of Bharat Biotech International Ltd, spoke at length about COVAXIN results, preparation for supply chain and planning to start trials in other countries also. Excerpts:
Q. What would be the age group? How many sites will be involved? On how many people are you going to start phase 3 trials?
A. The phase 3 trial for COVAXIN includes approximately 26,000 participants in around 25 sites, pan India. The age group will be 18 years and above.
Q. When it’s expected to launch COVAXIN?
A. . If the trial progresses with the data being permissible and appropriate regulatory approvals in place, we look forward to launching the vaccine in Q2 of 2021.Our phase 1 and 2 immunogenicity data showed excellent results and we are optimistic as we move on to the phase 3 clinical trials.
Q. What would be the route intramuscular or intradermal for giving a vaccine?
A. The current phase III trial will be through the intramuscular route. We are simultaneously conducting phase I/II trials for an intradermal formulation, which is ongoing.
Q. What would be the procurement strategy you are going to follow? Any discussion with Government of India?
A. We don’t have the full details of this right now. Talks are ongoing with the Government of India in regards to volumes and manufacturing timelines.
Q. Do you think we have enough cold storage? What is your cold chain and manufacturing strategy?
A. The Cold storage is in place and the government is taking the necessary steps to augment. Bharat Biotech is ready for both manufacturing and cold chain requirements.The immunisation and vaccine distribution in India is a very good one with extensive distribution to the furthest corners of India.
Q. Are you going to start clinical trials in other countries also?
A. We are in preliminary talks with a few countries. A phase 3 efficacy trial of such a size, 26,000 participants, will hopefully be enough to get robust data in understanding the vaccine.
Q. How much a single dose of nasal vaccine is efficient?
A. An intranasal vaccine may be more efficient in terms of ease of formulation, manufacturing and distribution but we are still in the early stages. Intranasal vaccines will be in the second wave of Covid vaccines.
Q. How much investment you have already made on Covaxin? How much capacity you are planning to scale up?
A. The company is spending around Rs 150 crore on phase 3 trial and additionally Rs 200 crore in setting up a new facility that will be operational by December to increase the capacity. We have access to large-scale facilities outside Hyderabad too, and we are looking to scale up our capacity to approximately 500 million doses per annum.
Q. Any discussion with government on nasal vaccine? How and when you are going to start clinical trials?
A. We have a licensing agreement with Washington University School of Medicine in St Louis for a novel chimp-adenovirus, single-dose intranasal vaccine for Covid-19. Bharat Biotech owns the right to distribute the vaccine in all markets except the US, Japan, and Europe. While the phase I trials will take place in Saint Louis University’s Vaccine & Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and will undertake large-scale manufacture of the vaccine at our GMP facility located in Genome Valley, Hyderabad.