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Tuesday, August 04, 2020

Renu Swarup: ‘Confident that we will have a safe and effective indigenous vaccine’

Globally, the non-replicating viral vector-based vaccine from Oxford-AstraZeneca and one inactivated alum platform from SinoVac are the leads being in Phase III.

Written by Prabha Raghavan | New Delhi | Updated: July 29, 2020 5:55:36 am
Renu Swarup. (File)

The Department of Biotechnology (DBT) has been at the helm of the government’s efforts to boost vaccine development and testing in India during the COVID-19 pandemic. In an interview, DBT Secretary Dr RENU SWARUP tells PRABHA RAGHAVAN about how this background work may speed up access to a safe, effective and indigenous vaccine here. Edited excerpts:

When do you think we can realistically see a vaccine for COVID-19 becoming available?

Globally, the non-replicating viral vector-based vaccine from Oxford-AstraZeneca and one inactivated alum platform from SinoVac are the leads being in Phase III. From our current indigenous portfolio, the plasmid DNA candidate from Zydus supported by DBT has become the first Indian vaccine for COVID to enter Adaptive Phase I/II human clinical trials, the other being the whole virus platform from Bharat Biotech supported by ICMR.

We have started working on the preparedness for the phase III clinical trials of the Oxford candidate in India and, irrespective of the candidate, our aim remains to strengthen the manufacturing capacities so as to have equitable distribution of the vaccine to all our citizens. We are on track and I am hopeful we will have a safe and effective vaccine soon.

Vaccines using newer technologies like DNA and m-RNA have seldom been successful in addressing other outbreaks. What is the significance of experimentation with these platforms during this pandemic?

The pathogen is new, so our approach has to be novel and multi-directional. Besides supporting conventional platforms, we have several novel platforms in the pipeline.

These platforms offer several advantages. The DNA vaccines have better cellular responses, are more stable and offer ease of large-scale manufacturing. Similarly, the m-RNA candidates offer rapid, inexpensive and scalable manufacturing besides being safe due to their non-integrating platform. (They) have shown significant merit in preclinical studies and have moved forward in a leads-based manner driving them into clinical trials. Globally also, the vaccine candidates which have advanced are based on the newer platforms.

How is India trying to balance the need for sufficient data to ensure a vaccine’s safety and effectiveness with the need to bring one to market at the earliest in this pandemic?

One of our early efforts has been the development of a rapid response regulatory framework to fast-track vaccine development. We have made a special provision for expediting the review process of COVID-19 related biomedical solutions. This is one of the reasons for the speed at which our vaccines could move ahead.

The novel platforms also have shorter manufacturing cycles, so there are multiple factors which will allow a vaccine to be launched in an unprecedented time frame in comparison to previous vaccines.

However, I would like to assure that all data is rigorously reviewed by the regulators before any approvals are given, so the safety would never be compromised. It’s not important to be the first but to have a candidate which fulfills the desired risk benefit ratio. Our efforts are directed towards having a safe, immunogenic, effective and well tolerated vaccine for our population.

What is India’s biggest challenge in vaccine development, testing and supply right now and how do you plan to overcome them?

Well, there are many challenges. But, the capacity building we invested in over the last decade, the far-sighted policy decisions we took in building the infrastructure and the support we offered to the industry helped us respond in the way we have.

Our vaccine story is there for all to see, and I am confident that even for COVID, we will have a safe and effective indigenous vaccine. DBT’s Autonomous Institutes are engaged in expediting development of reagents, assays and animal models to support vaccine development.

Testing the effectiveness and safety of a vaccine is essential and, therefore, evaluating the immunogenicity of a vaccine is necessary…THSTI, Faridabad has been majorly involved in these immunogenicity studies.

Two major programmes that have played a pivotal role in giving a fillip to vaccine development efforts nationally are the DBT’s National Biopharma Mission and the Ind-CEPI Mission.

Last, but not the least, ensuring Good Clinical Practices-compliant clinical trials, working on methodologies to ensure augmented manufacturing capacities and equitable distribution of vaccines remains (our) top-most priority. We are working in all these aspects. The Department has, under the National Biopharma Mission, supported the immunoassay lab and five phase-III clinical trial sites.

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