5,000 Indians to enrol for Oxford vaccine trials: Adar Poonawalla
3 min read . Updated: 21 Jul 2020, 11:12 PM ISTIt’s too early to comment on the price of the covid-19 vaccine. However, we will keep it affordable... under ₹1,000 per dose
Serum Institute of India is now preparing for the phase 3 clinical trials of the covid-19 vaccine candidate developed by the University of Oxford, after interim data from a clinical study published in The Lancet journal on Monday showed that it was safe and provided dual immunity against the fatal respiratory disease. The world’s largest vaccine manufacturer by number of doses produced and sold, globally, had last month signed an agreement with British-Swedish multinational pharmaceutical company AstraZeneca, the co-developer of the vaccine, to supply an additional 1 billion doses, principally for low- and middle-income countries. In an interview with Mint, Serum Institute of India chief executive officer Adar Poonawalla said it plans to start phase 3 trials in India with 4,000-5,000 participants. Edited excerpts:
When will the Serum Institute conduct phase 3 clinical trials in India? How many participants are you looking at?
The phase 3 clinical trials are expected to commence in India in August, and we plan to look at 4,000-5,000 participants.
Do you expect an expedited approval from the Drug Controller General of India (DCGI) for the vaccine based on interim data, considering the evolving covid-19 situation?
We seek to apply for licensure trials within a week to DCGI. We would not want to rush the approvals on the vaccine as it is important to ensure its viability and efficacy. With the government fast-tracking everything, we are hoping to get approvals in about two weeks. After that, we will begin phase 3 human trials here in India.
AstraZeneca said it will offer the vaccine at no profit. What will be the cost of the vaccine considering that you are targeting low- and middle-income countries, including India?
It is too early to comment on the vaccine’s price. However, we will keep it under ₹1,000 per dose.
Having said that, our aim is to provide an efficacious and affordable vaccine. We are certain that it will be procured and distributed by governments without charge.
Do you have enough capacity to manufacture the covid-19 vaccine, more so, as you manufacture more than 1 billion doses of other vaccines such as BCG, DPT, IPV and H1N1?
Our facility is well-equipped with state-of-the-art technology to manufacture Covidshield. Keeping in mind the pandemic situation, we have two dedicated facilities to produce millions of doses of the covid-19 vaccine, while withholding vast production of other products.
Is the Serum Institute planning to go for a fund-raising to scale up its capacity? Recent reports claimed that you could be looking to raise $1 billion to fund the covid-19 vaccine project. Can you please clarify?
It will only happen if we get the right offers and valuations, in a subsidiary, which has five covid-19 vaccine candidates, and other vaccines, including the 1 billion dose facility as an asset. If it works, we may look at diluting about 15-20% equity and raise capital. We won’t be raising capital at the Serum Institute level, as it will have other implications for all other vaccines and commitments.
Is the Serum Institute in talks with other covid-19 vaccine developers, such as Moderna, Johnson & Johnson, and China’s CanSino Biologics?
No, we are not in talks for partnership with the above-mentioned companies. We are working on five different candidates at this point.
Is the Serum Institute continuing the development of its own vaccine candidate in collaboration with Codagenix? When will the human trials begin?
Yes, we are. The Codagenix vaccine candidate is in the pre-trial phase and we are expecting it to progress soon. It may enter human trials towards the end of the year.
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