Adar Poonawalla’s Serum Institute of India (SII) is part of the Oxford University-AstraZeneca initiative to develop a Covid-19 vaccine. SII is also working with the US-based firm Codagenix whose vaccine is still in the pre-trial phase. Poonawalla spoke to THE WEEK about the developmental progress of the vaccine candidates and the challenges in administering it.
What is the status of your Covid-19 vaccine projects?
The Oxford University-AstraZeneca vaccine (COVISHIELD) is showing promising results based on the ongoing trials and has been cleared for the final phase. We are hopeful that it will be an efficacious and immunogenic vaccine that is viable for mass use.
We seek to apply for licensure trials within a week. With the government fast-tracking everything, we are hoping to get approvals for this soon. Post this, we will begin the phase-III of human trials in India with around 4,000 to 5,000 people.
Once we get necessary regulatory approvals, we will start manufacturing it in large volumes. As per our arrangement with AstraZeneca, we will be making one billion doses over the next one year for India and other low- and middle-income [Gavi, the Vaccine Alliance] countries. We will manufacture about 60-70 million doses per month (which might stretch to 100 million doses later). With this, we are looking to manufacture around 300 to 400 million doses by the end of this year. Based on the success of the trials, we are expecting to launch this vaccine by the end of this year. I believe by the first quarter of the next year, the vaccine will start reaching the masses. Meanwhile, the Codagenix vaccine candidate is in its pre-trial phase, and it is expected to progress to the human trial phase towards the end of this year.
What makes COVISHIELD unique?
We will have to wait for all the trials and test results for a clearer understanding of its efficacy. So far, based on the trials conducted, we believe it would be an immunogenic vaccine. As per the data from the results, we have found that it has given only mild reactions such as fever, and headache, which is expected out of vaccines. This vaccine candidate has not caused any severe side-effects. In addition, the T-cell response is much better in COVISHIELD, which is an indicator of providing long-term protection to people.
How much time will it take to vaccinate India?
Holistically, it will take around two years or so to administer the vaccine countrywide. In the initial phase, it will be part of a government-administered vaccine programme. It is very important to ensure that the vaccine reaches the most vulnerable and the remotest corner of the country.
In an earlier interview with THE WEEK (April 28), you said that the vaccine may be available by September-October. Is it possible for you to fast track the work for the vaccine?
Usually it takes a minimum of five to seven years for a vaccine to be approved and made available for mass use. However, owing to the current situation and circumstances, the approval processes are being fast-tracked. But none of the tests, trials or similar requisites are being fast-tracked for this. Our aim is to provide an effective and safe vaccine for all. Based on the positive results of phase II and III, we hope to provide the vaccines across markets by the end of this year.
Will you provide the vaccine at a subsidised rate to the government?
It is too early to comment on the vaccine’s price. However, we will keep it under 01,000....We are certain that it will be procured and distributed by governments free of charge.
SII has invested heavily in Covid-19 vaccine research.
We have invested close to $200 million in the current phase of producing the COVISHIELD vaccine. Once the vaccine goes into the developmental phase, we will be able to elaborate more.
We are also working on two of our own vaccines. We seek to release them by the end of 2021. In addition, we are conducting phase-III trials of the recombinant BCG vaccine shots to improve the innate ability to fight the virus and reduce the severity of Covid-19 in India. This is an extremely safe vaccine since it is given to newborn babies, and we have been selling this in more than 100 countries for many decades. Based on our trials, we will be certain on the efficacy and viability of the vaccine, post which we will initiate mass production.
We are working with Mylab Discovery Solutions and are producing two lakh Covid-19 test kits per day. As per our associations, we are to manufacture and distribute the Novavax candidate (which is just a month or two behind AstraZeneca-Oxford vaccine) across GAVI countries. Codagenix vaccine is in pre-clinical trials and we have worldwide rights for it. We have also tied up with a company for a mRNA [vaccine] candidate and hope to announce it soon.
Closest to success
COVISHIELD is one among the five Covid-19 vaccine candidates (as on July 27) in phase III, the most advanced stage of clinical trials
University of Oxford, AstraZeneca Work started in: January 2020
A weakened version of a common cold virus that affects chimpanzees; contains genetic material of SARS-CoV-2 virus spike protein Interim results (phase I/II)
With a single dose of vaccine
•Four-fold increase in antibodies to the coronavirus spike protein in 95 per cent of participants one month after injection
•In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection
Participants (phase I/II)
1,077 healthy individuals aged 18-55 in five UK hospitals
Less than Rs1,000 per dose
SII’s production plan
In a year: 1 billion doses
In a month: gradual increase from 60 million to 100 million doses
SOURCE WHO, AstraZeneca, Oxford University