We are researching two candidates for Covid vaccines: Serum Institute CEO

Pune-headquartered Serum Institute of India (SII), the world’s largest vaccine maker by quantity, has been in the spotlight, having committed itself to supplying 3.2 billion doses of the Covid-19 vaccine. This is more than double the company’s FY20 production of 1.5 billion doses. Apart from global agencies like Geneva-based Gavi (earlier called Global Alliance for Vaccines and Immunisation) procuring from SII, the Indian vaccination programme too will bank on it. In an e-mail interview with Sohini Das, Adar Poonawalla, chief executive officer, Serum Institute of India, says the firm is not raising additional capital through private equity. SII is researching two new coronavirus vaccines on its own, he adds.

What is your assessment of demand for vaccines, Covid and non-Covid, over five-ten years?

The pandemic has been an experience for us. It has brought out the significance of vaccine manufacturers. It has also been an enlightening lesson on how critical it is to focus on our public health systems. In my opinion, the new decade will be the golden one for the vaccine industry worldwide.

Currently, owing to logistical issues, demand for vaccines (non-Covid) has been hit. In some countries, it is due to the shortage of health care workers and in some, customs and cargo are not available. That said, we at SII have been working on optimising our facilities, technologies, and resources to quicken and smoothen the development as well as distribution processes.

How have you planned your production for 2021 to meet the demand for Covid and non-Covid vaccines?

We are working to ensure all vaccines are supplied in required quantities while keeping the one for Covid-19 as priority. We have dedicated two facilities in India to produce the Covid vaccine. Adding to the enormity of our Hadapsar plant, which produces over 1.5 billion doses annually, our new state-of-the-art multi-functional production facility will further boost our annual capacity to around 2.5 billion doses.

How much have you invested so far and how much has been the funding? You were in talks to raise $1 billion from private equity firms.

We have invested $270 million in the Covid vaccine candidates. Add to that, Serum, Gavi, and the Bill & Melinda Gates Foundation have collaborated to ensure fair and equitable access to future Covid vaccines. Through the association, we have received an additional $300 million from the Bill & Melinda Gates Foundation. For now, we are not raising additional capital through private equity.

You have deferred producing some pipeline vaccines. When these come on stream, how do you plan to expand?

We have deferred producing some of our other vaccines. That said, we were quick to adapt and were able to navigate these unprecedented situations owing to our capacity planning. We re-assessed our operations to ensure that we meet our commitment to our other vaccines as well.

How long do you think the demand for Covid-19 vaccines would last?

While full-coverage immunisation will certainly aid in containing the spread of the virus, it is impossible to say when the disease will go. It will be take two-three years to get the world’s population vaccinated. 

Being a two-dose vaccine, how do you plan the logistics to ensure one gets the right dosages?

This vaccine will be given with a gap of 28 days. Distribution lies with government bodies and the health ministry. 

Do you expect any supply crunch for vials in 2021?

Considering the demand initially there could be some crunch. However, I am certain most vial makers must be readying their capacities.

One has also seen adverse events.

Your comments on the vaccine development process and the incident concerning the Chennai volunteer. 

The vaccine developed by Oxford University is a viral-vector type that uses a harmless virus to deliver the genetic material of a pathogen into cells, which is then supposed to create an immune response against the original pathogen. A chimpanzee adenovirus (a common cold virus) has been used.

While the Chennai case was unfortunate and SII is sympathetic with the volunteer’s medical condition, there is no correlation with the vaccine trial and the medical condition of the volunteer. Such adverse events take place during trials, and companies follow all the mandated regulatory processes.

Can you elaborate on your vaccine tie-ups and in-house development plans for Covid-19?

We have tied up with five vaccine candidates for Covid-19. Apart from the Covishield (AstraZeneca-Oxford candidate) phase – II and III clinical trials, we have a manufacturing and trial partnership for Novavax candidate (which is just a couple of months behind the Oxford vaccine) across Gavi nations. We have also partnered USA-based Codagenix, which is in its pre-clinical trials phase and will move to the human trial phase by the end of 2020. We have a global manufacturing and supply association with them. We are also researching two candidates for the Coronavirus vaccine and will be able to share more information on this later.

What is the update on the BCG vaccine that you were refurbishing for use to boost immunity?

We are conducting Phase-III trials of the recombinant BCG vaccine shots to improve the ability to fight the virus and reduce the severity of Covid-19.

This is a safe vaccine since it is given to the new-born and we have been selling this in more than 100 countries worldwide for many decades. Based on our trials, we will be certain on the efficacy and viability of the vaccine, after which we will initiate mass production.