Pune-based Serum Institute of India (SII), founded by Cyrus Poonawalla in 1966, is the world's largest vaccine manufacturer, which produces over 1.5 billion doses and immunises over 65 per cent of the children worldwide. Serum Institute made headlines globally after it launched three critical initiatives for defeating COVID-19 virus - one with UK's Oxford University, one with US-based biotech company Codagenix, and its own recombinant BCG vaccine.
In an exclusive interview with PB Jayakumar of Business Today, Adar Poonawala, son of Cyrus Poonawala and CEO of Serum Institute of India, says he is taking the risk of initiating production even before the vaccine has reached advanced clinical trials and will sell the vaccine, if developed, for just Rs 1,000 per dose.
Business Today: When do you expect trials for the Oxford vaccine to be over? What prompted Serum to take up manufacturing even before the Phase 1 result is out?
Adar Poonawalla: While the clinical trials have already commenced in the UK, we are simultaneously initiating production as well, in the hope that when the trials are successful, we will have the first batch of doses ready for use by September or October. The decision has been solely taken to have a jump-start on manufacturing, to have enough doses available and the distribution of the doses will commence only once the trials are successful and the vaccine is efficacious as well as safe for use. We are also working on conducting human trials in India in May 2020.
BT: Why do you think this vaccine can be a game changer?
Poonawalla: At present, all the health institutions are working tirelessly to achieve a viable and efficient treatment to the pandemic. We have worked with the Oxford team earlier on a malaria vaccine; they were also the first ones to develop a vaccine for the Ebola virus. A vaccine usually takes 12-18 months to be in the market. The very fact that we have a potential vaccine candidate in such a short period of time is a definitely something to cheer about.
BT: When do you plan to start manufacturing and what will be the timelines? For that, what changes Serum will adopt in the manufacturing lines? How much are you investing? At what price are you looking to commercialise it?
Poonawalla: Our facility is already equipped to make this COVID-19 vaccine and we have dedicated the same towards developing the vaccine. Our Pune's manufacturing facility has an investment of about Rs 500-600 crore that we have already done for one of the other vaccines in the past. In addition, building a brand-new facility for COVID-19 vaccine will take approximately 2-3 years.
As mentioned, one of our existing units will commence production in approximately three weeks. We aim to manufacture 4-5 million doses per month, following which, we hope to scale up production to 10 million doses per month, based on the success of the trials. We are looking forward to produce around 20-40 million doses by September-October. If successful, we will make the product available in as many countries as possible, including India. It is too early to give the exact price of the vaccine at this point, however we will surely make it affordable, maybe around Rs 1,000.
BT: You have also partnered with Codagenix for a corona vaccine. Will there be a clash of interest? US doesn't support the idea of making a vaccine available for other nations to manufacture. In this scenario, will you pursue this tie-up?
Poonawalla: At this stage we need multiple companies across the world to try various vaccine trials. Through our association with US-based biotechnology firm Codagenix, we have developed a vaccine-virus strain that is identical to the novel coronavirus. We have commenced our pre-clinical trials and hope to progress to the human trial phase by September or October. The aim is to make the vaccine available by early 2021 to help combat the novel coronavirus. With the combined efforts of our partner Codagenix, we are optimistic that we will be able to provide a viable and effective vaccine for mass use soon.
BT: What is the progress related to the recombinant BCG vaccine for COVID-19 and what are your plans related to this?
Poonawalla: We are developing the recombinant BCG vaccine shots to improve the innate ability to fight the virus and reduce the severity of COVID-19 in India. We have got the backing of DBT (Department of Biotechnology) and will be starting the trials in India within two weeks from now. This is an extremely safe vaccine since it is given to newborn babies and we have been selling this in more than 100 countries worldwide for more than 2 decades.
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