No pressure on the drug regulator on the COVID-19 vaccine approval: Dr VK Paul

There will be no pressure on the drug regulator on the COVID-19 vaccine approval and the final call on allowing its emergency use approval will be made on scientific principles,” Dr VK Paul, Member, NITI Aayog said while addressing the session on Vaccine Magic and reimagining healthcare in a post COVID world, organized during FICCI’s 93rd Annual Convention.

Dr Paul said that India is fully prepared for a vaccination initiative and at the threshold of receiving a vaccine. He stated that globally, 33 vaccines are in clinical trial phase out of which 10 vaccines are in the advanced trial phase. “3 Indian vaccines are part of the top 10 global players. It is a proud moment to say that the key 3 indigenous players- Bharat Biotech-ICMR, Zydus Cadila and Serum Institute-Astra Zeneca are in clearance phase-2, which has created an Apollo 11 moment for India,” said Dr Paul. This gives us hope for manufacturing the vaccines not just for India but also for the world, he said.

He further shared that the key consideration while prioritizing the population for vaccine inoculation has been accessing to the population with risk to mortality and protection of our healthcare system as well as the COVID-19 response system.

He urged FICCI to work with the state government to increase healthcare spending, enhance the human resources in healthcare by optimizing the training in the private sector, bridge the huge healthcare infrastructure gap and build institutions for optimal disease control system as well as data management system. He also urged the industry to work towards building mental health capacities in the country. He further called for higher private sector participation in ramping up health infrastructure.

Lord David Prior, Chair, NHS England said the pandemic has shown mankind its worst and its best. We must win public confidence in the efficacy and safety of the vaccine. He further said that one of the silver linings of this pandemic could be to open up a whole new branch of pharmaceutical research and development and there needs to be a fundamental change as to how we deliver healthcare. He further mentioned that addressing the cost of the vaccine is crucial along with fair distribution of vaccine to all countries and not just to the poor.

“Healthcare will become more preventive and more personalized and functional genomics is a powerful tool as we go forward,” he said.

Dr Prathap C Reddy, Chairman, Apollo Hospitals Group said that COVID-19 has been an unparalleled medical crisis and toughest test of leadership. Preventive healthcare has been the most important aspect of this decade and our focus must be on non-communicable diseases.

Dr Sangita Reddy, President, FICCI said that at no time has everyone been so focussed on healthcare as we are now. She said we all need to educate the community about the need, safety, efficacy as well as positive impact of vaccines and why we should not resist getting vaccinated. The COVID-19 vaccine is the first vaccine that has been developed in less than a year’s research. Hence, there are hidden fears and questions, which we need to allay together, she added.

Speaking further Dr Reddy said that during the COVID-19 pandemic we were told to test, trace and treat and the medical system was upgraded and currently it is a matter of trust that the vaccine is safe and will be received by all. She also mentioned that while India has been a powerhouse for vaccine production and distribution with its 42-year-old immunisation programme, vaccinating over a billion people is a first, and appears to be a daunting task which requires current capacities to be scaled up fast.

Speaking on the efficacy of the trials and its impact during trial stages, Dr Krishna Ella, CMD, Bharat Biotech International Ltd, said that it has been crucial for the companies to protect the volunteers. He further said that the trials are completely transparent, and all data are enclosed. All Indian manufacturers are 100% sensitive and completely are to be trusted, he said.

Pankaj Patel, Past President, FICCI & Chairman, Cadila Healthcare Ltd, said, The phase two trial of the vaccines have begun and we have seen a promising and encouraging result. The vaccine may not require very cold temperature as it is a stable vaccine. He further said India can create the vaccine with continuous support from the government.