‘No one can speed up vaccine trials, and their evaluation’

INTERVIEW

13.12.2020

‘No one can speed up vaccine trials, and their evaluation’

As the founder of Shantha Biotechnics, one of the first Indian companies to develop vaccines indigenously and the only one to develop a vaccine independently, K I Varaprasad Reddy has a unique insight into the ongoing global race to launch a Covid-19 vaccine. In an interview with Swati Bharadwaj, the Padma Bhushan awardee talks about the challenges ahead

It takes years to develop a vaccine but now the process is being fast-tracked. Are you worried that safety is being compromised?

Everyone knows that no vaccine was ever developed this fast. TB vaccine took 28 years, Ebola took 5.5 years. AIDS, though known for 40 years, does not have a vaccine as yet. Yes, technological advancement in virology and experiments with repurposed vaccines speeded up the development of this vaccine but no one can speed up clinical trials and their evaluation. A car can be designed to go at 300 km/hr speed. Still we fix a 100/120 speed limit on Indian roads because our road tests say so. Similarly, tests alone can testify to the safety of this vaccine. Also, risks involved will be different for each vaccine and will be known once mass vaccination starts.

Vaccine makers are facing tremendous public and political pressure to deliver a vaccine. Are basic aspects of vaccine development being ignored in this haste?

Pressure from governments is obvious. A scientist does not compromise on quality or ignore basic aspects of development of vaccine but he cannot be sure of the efficacy and immunogenicity of his invention unless it is analysed and observed on a reasonable time basis and peer-reviewed. But governments are eager to put the stamp of approval under the head ‘Emergency Authorisation of Use’, even without this essential process. I am afraid vaccine makers are running the risk in these circumstances as their image is at stake.

Do you think there is enough scientific data on Covid-19 vaccine candidates?

We get only press reports. Data is revealed only to a committee of experts in the regulatory authority’s office. They are neither crosschecked nor peer-reviewed nor published in international scientific journals as much as they should be.

The world is looking to India and vaccine capital Hyderabad to churn out Covid vaccines. What challenges do Indian vaccine makers face?

Let us be clear on one point. India has not produced any original vaccine so far, except for cholera by Shantha Biotechnics. What we have here is robust infrastructure to manufacture vaccines in bulk. If someone hands us over a good vaccine, we can produce them in large quantities at an affordable cost so that even third world countries can buy it. The challenge Indian vaccine makers face is how to keep producing other ongoing vaccines with the same infrastructure, while trying to produce billions of doses of Covid vaccines in a short span of time.

Once Covid-19 vaccines are approved for use, what is the way forward?

As of now, we are far from having a viable vaccine, whatever it means. Normally, after a vaccine has been approved, we manufacture five consistent batches of vaccine and send them for testing to the National Testing Laboratory for sterility, potency tests, etc and start mass production only after getting clearance. In the case of the Covid vaccine, large-scale manufacturing started even before third-stage clinical trials were concluded. In these circumstances, every step poses a challenge, right from determining shelf-life to the period it takes for developing immunogenicity in the body. The biggest challenge is to see that the public does not lose faith in the whole process of vaccination, in case there are any adverse effects.

How prepared are we for the mammoth task of vaccinating 1.3 billion Indians?

Delivery system poses a number of problems especially since our primary health centres (PHCs) are in poor condition. Government should use this as an opportunity to develop logistics to strengthen the healthcare system.

Many developed nations have already cornered a chunk of Covid-19 vaccines? What are its implications for developing nations?

Here production capacity does not matter. What matters is who funded the research and had modern technology. Successive Indian governments did not encourage R&D in the country and, now, we are depending upon others’ innovations. Developed nations paid huge amounts to block the production for them. India did no such thing and we cannot grumble. Indian government allowed 100% FDI in the healthcare industry. So even socially conscious entrepreneurs like me are hand-tied to do our bit in this matter.