COVID-19 vaccine in market by Sep-Oct 2020 if trials succeed: Poonawalla

Interview with Adar Poonawalla, Serum Institute CEO

64-Adar-C-Poonawalla Adar C. Poonawalla

Adar Poonawalla, CEO of the Serum Institute of India (SII), had said in an interview with THE WEEK in March 2020 that the SII had tied up with two companies in the US to develop the COVID-19 vaccine and that work was progressing well. Through a tie-up with Codagenix in New York, the company had plans to scale up the manufacturing of a COVID-19 vaccine in India.

However, before doing that, the SII had to prove this vaccine in human trials, which Poonawalla felt were still far away. Simultaneously, the SII has partnered with the Oxford University vaccine project—which began human trials last week—as one of the seven global institutions manufacturing the vaccine. SII's team has been working closely with Dr. Adrian Hill from Oxford University. Now, Poonawalla talks to THE WEEK about the company's tie-up with Oxford University and how the simultaneous tie-up with Codagenix in New York is progressing. He talks about the ever-growing need to develop the COVID-19 vaccine at the earliest.

In an earlier interview with THE WEEK in March 2020, you had mentioned your tie-up with the New York-based company Codagenix to develop the COVID-19 vaccine. How is the work progressing on that front?

Through our association with US-based American 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 this year. All this is aimed at making the COVID-19 vaccine available by early 2021 to help combat the growing menace of 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 the masses soon.

Regarding your plans to develop the recombinant BCG vaccine shots, how is the work progressing on that front currently?

Our aim has been to make the vaccine available at the earliest. 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 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.

We have been selling this vaccine in more than 100 countries worldwide for more than two decades. We are likely to start the trials in Maharashtra, particularly in Pune. These trials are expected to involve at least 2,000 to 3,000 people.

What about your partnership with the Oxford University vaccine project? How is it progressing?

We have partnered with the Oxford University vaccine project as one of the seven global institutions manufacturing the COVID-19 vaccine. Our team has been working closely with Dr. Hill from Oxford University. While we are commencing its production in 2 to 3 weeks at our own risk, its distribution will only commence once trials are proven successful and the vaccine is efficacious and safe for use. The decision has been solely taken to have a jump start on manufacturing so that enough doses available, if the clinical trials prove successful.

How many doses you plan to manufacture during the initial stages? How you plan to scale up the production as you go forward regarding the COVID-19 vaccine that you are developing with Oxford University?

We seek to produce 4 to 5 million doses of COVID-19 [vaccine] per month, following which, we hope to scale up production to 10 million doses per month to meet the requirement. This will be possible only if the trials are successful with requisite safety and assured efficacy. We expect this COVID-19 vaccine in collaboration with Oxford University to be out in the market by September or October 2020. We will be starting trials in India for this vaccine hopefully in the next 2 to 3 weeks’ time.

Is it possible to come up with a vaccine in such a short time span? You had mentioned earlier that it might take a year-and-a-half or close to two years to come up with the COVID-19 vaccine?

Usually it takes around 6 to 7 years to develop a vaccine. However the Indian regulatory authorities have aided us and are working with us to ensure a smooth procedural functioning. This will help us in speeding up the overall development process.