COVAXIN phase 3 trials will start soon: Bharat Biotech Executive Director

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. These trials will be conducted in 25 sites across India. Talking exclusively to The Daily Guardian, 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. When is Bharat Biotech planning to launch COVAXIN?

A. Our phase 1 and 2 immunogenicity data showed excellent results and we are optimistic as we move on to the phase 3 clinical trials. 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.

Q. On how many people are you going to start phase 3 trials and what would be the age group? How many sites will be involved?

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. What would be the route of giving vaccines intramuscular or intradermal?

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?

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. What is your cold chain and manufacturing strategy? Do you think we have enough cold storage?

A. The immunisation and vaccine distribution in India is a very good one with extensive distribution to the furthest corners of India. 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.

Q. Are you planning to start clinical trials in other countries also? If yes, then when?

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. Do you think a single dose of nasal vaccine will be more 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 have you made on Covaxin? How much capacity are you expecting?

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. Have you discussed the nasal vaccine with the government? 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.