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‘No one can speed up vaccine trials and their evaluation’ | India News

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As founder of Shantha Biotechnology, one of the first Indian companies to develop vaccinations KI Varaprasad Reddy has a unique insight into the ongoing global race to launch a Covid-19 vaccine and is the only one to have independently developed a vaccine. In an interview with Swati Bharadwaj, the Padma Bhushan Awardee talks about future challenges
It takes years to develop a vaccine, but now the process is accelerating. Are you concerned that security will be compromised?
Everyone knows that a vaccine was never developed so quickly. The tuberculosis vaccine took 28 years, Ebola took 5.5 years. AIDS, although known for 40 years, still does not have a vaccine. Yes, technological advancement in virology and experiments with repurposed vaccines accelerated the development of this vaccine, but no one can speed up clinical trials and their evaluation. A car can be designed to go at a speed of 300 km / h. Still, we set a 100/120 speed limit on Indian roads because our road tests say so. Likewise, tests alone can attest to the safety of this vaccine. Also, the risks involved will be different for each vaccine and will be known once the mass vaccination begins.
Vaccine manufacturers face tremendous public and political pressure to deliver a vaccine. Are the basics of vaccine development being ignored in this rush?
The pressure from governments is obvious. A scientist does not compromise on quality or ignore the basics of vaccine development, but cannot be sure of the efficacy and immunogenicity of his invention unless it is analyzed and observed in a reasonable amount of time and peer reviewed. But governments are eager to put the stamp of approval under the heading “Emergency Use Authorization”, even without this essential process. I fear that vaccine manufacturers are at risk in these circumstances, as their image is at stake.
Do you think there is enough scientific data on the candidates for the Covid-19 vaccine?
We only receive press reports. The data is disclosed only to a committee of experts in the office of the regulatory authority. They are not collated, peer-reviewed, or published in international scientific journals as much as they should.
The world is looking to India and the vaccine capital, Hyderabad, to produce COVID-19 vaccinations What challenges are Indian vaccine manufacturers facing?
Let’s be clear on one point. India has not produced any original vaccine so far, with the exception of Shantha Biotechnics cholera. What we have here is a strong infrastructure to manufacture bulk vaccines. If someone gives us a good vaccine, we can produce it in large quantities at an affordable cost so that even third world countries can buy it. The challenge facing Indian vaccine manufacturers 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 period of time.
Once the use of Covid-19 vaccines is approved, what is the way forward?
As of now, we are far from having a viable vaccine, whatever that is. Typically, after a vaccine has been approved, we manufacture five consistent batches of vaccine and send them for analysis to the National Testing Laboratory for testing of sterility, potency, etc. And we start mass production only after getting authorization. In the case of the Covid vaccine, large-scale manufacturing began even before the third-stage clinical trials were completed. In these circumstances, each step poses a challenge, from determining the lifespan to the period required to develop immunogenicity in the body. The biggest challenge is that the public does not lose faith in the entire vaccination process, in case there are any adverse effects.
How prepared are we for the gigantic task of vaccinating 1.3 billion Indians?
The service delivery system raises a number of problems, especially since our primary health centers (PHCs) are in poor condition. The government should seize this as an opportunity to develop logistics to strengthen the health system.
Have many developed nations already cornered a portion of Covid-19 vaccines? What are its implications for developing nations?
Production capacity does not matter here. 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 depend on the innovations of others. Developed nations paid huge amounts to block its production. India did no such thing and we cannot complain. The Indian government allowed 100% FDI in the healthcare industry. So even socially conscious entrepreneurs like myself are tied to doing our bit on this matter.

Times of India

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