A medical scientist for 30 years, Gagandeep Kang is a “career scientist” who knows her vaccines. That’s something the scientific universe does not dispute. The first Indian woman to be elected a Royal Society Fellow, Kang is professor with The Wellcome Trust Research Laboratory, Christian Medical College (Vellore). She is also Vice-Chair of the board of CEPI – the Coalition for Epidemic Preparedness Innovations – a global partnership launched in 2017 to develop vaccines to stop future epidemics. Recently, when India approved two Covid-19 vaccines for “restricted emergency use”, from the Serum Institute of India and Bharat Biotech, Kang raised certain serious concerns on the approval process, concerns that triggered an emotional and political debate in the country. In an interview with BusinessLine , Kang provides the much-needed sane explanation on why it is important to build trust in the product, its development, and the approval process to prevent anti-vaxxers from running away with the agenda. Excerpts:

Do you feel the process has been cut short on the approvals for both Serum (AstraZeneca-OxfordUniversity vaccine) and Bharat Biotech vaccines?

The DCGI (Drug Controller General of India) is the regulator and has the authority to waive all clinical trials in an emergency situation, this is for products developed elsewhere, at least in my understanding. As far as I am aware, the CDSCO (Central Drugs Standard Control Organisation) had issued draft guidance in September, stating what would be considered a sufficient data package for review of vaccines developed in the country, and based on what is available, the authorisation was based on less than previously stated as required data.

Covishield did conduct bridging studies in India. But would 1,600-odd people be enough to give an idea on safety and efficacy?

And would you have an idea if details were given to the Subject Expert Committee /DCGI?

One thousand six hundred people are enough for a safety and immunogenicity study, but safety would be expected from a larger efficacy study as well, and I understand that the AstraZeneca UK and Brazil data was what was submitted since no clinical efficacy was planned for India.

The 1,600 participants could certainly be followed up for efficacy, but it would be too small a trial size to yield sufficiently robust efficacy data. I do not know what data were submitted to the SEC/DCGI.

There are concerns on the ‘clinical trial mode’ approval and whether people would understand they were not taking a finally-approved vaccine. But government representatives indicate they are being pre-emptive and keeping a back-up against the UK strain

of the virus. Your thoughts.

The DCGI has approved the products with stipulations, and it will be up to the implementers to ensure that the stipulations are complied with. I actually do not know what a ‘clinical trial mode’ is – is it like an open label trial without a control group? Then why not just give permission for a single arm, open label study?

Is Bharat Biotech’s vaccine being seen as a back-up? And since it is known technology, would its general profile be safe? Would government

not be cognisant of the

risk if this backfires?

Bharat Biotech is a great company. I have worked with them, and they really focus on making quality products and they have a lot of experience with inactivated vaccines. But included with the inactivated vaccine is an adjuvant that has not been widely tested in humans. I believe that Covaxin will be very safe and very efficacious. But the data for that must be generated and are not available at this time. The data should be available in a few months, and I do not see why with all the careful planning the government has done, why we could not get a fully approved vaccine out quickly, instead of what will presumably be a slower process in ‘clinical trial mode’. The additional idea of the back-up – yes, of course – it is better to have two vaccines on different platforms rather than one. But as far as efficacy against the UK variant is concerned, I would like to see the data before stating that as the reason for this vaccine over any other.

Do you think that Indian pharma is at risk of having its reputation dented

if the regulatory procedures are not followed?

Regulations are there to protect us. Regulators assure us that products are safe, efficacious and of high quality so that people trust the products that are made with regulatory approval. In an emergency, while speed is very important, the regulator’s responsibilities do not change.

In this pandemic, the regulator has set up rapid response systems and issued guidance that was useful for vaccine manufacturers.

Countries are taking the Russian and Chinese vaccines as well, despite

the shortened regulatory process. Does this

worry you as a

CEPI representative?

Many countries have no access to the products of multi-national companies in the doses they need and, have, therefore, gone to the Russian and Chinese manufacturers. In India, we are lucky to have a fantastic vaccine manufacturing industry that has delivered on quality products for decades, so we have not had the need to rely widely on vaccines from other countries.

I think we do not realise how much influence anti-vaxxers are exerting around the world, and from the point of view of CEPI and as a public health researcher, this really worries me. Trust in the product and trust in the process of development and approval are critical – and trust is hard to build.

Related Topics
comment COMMENT NOW