InterviewJune 21

Appropriately Designed COVID19 Vaccine Trials are the need of the Hour

Kolkata-based Peerless Hospital has been a part of the pan-India trials of two versions of the Sputnik V vaccine, one manufactured in India and the other in Russia. Dr Subhrojyoti Bhowmick, Director Clinical Research & Academics, Peerless Hospital, under whose guidance the trials are being undertaken, gives an idea about the trials being undertaken, the challenges being faced during the lockdown etc, in interaction with IndiaMed Today. Excerpts from the interview.

Two versions of the Sputnik V vaccine — one made in Russia and the other manufactured in India are undergoing trials at Peerless Hospital. Why has Peerless Hospital undertaken the trials?

Apart from Dr Reddy’s Laboratories, the Drug Control General of India has allowed other companies to market the Sputnik V vaccine in India. These companies have to do a head-on comparative therapeutic equivalence trial to prove that Dr Reddy’s vaccine (Sputnik V vaccine from Russia) and the Indian version of the vaccine has the same efficacy rate as the Russian vaccine.For doing that they need to do a phase III clinical trial. I was approached by the Hyderabad based pharmaceutical company because I had worked as the principal investigator for the initial Sputnik V vaccine trial in Eastern India. I readily agreed as I believe that single-handedly Dr Reddy’s Laboratory cannot cope with the huge demand of 130 crore Indians and we need many more suppliers of Sputnik V vaccine to be based within the country so that the Sputnik vaccine demand can be fulfilled.

With lockdowns what challenges did you face conducting the trials especially when it comes to looking out for volunteers?

There is a challenge to lockdown as people cannot move out and people cannot travel for trials. We have issued them letters from our hospital. We have counselled the volunteers that they can inform the police that they can be allowed to travel. They are doing this for vaccine development in the country.Sponsors are playing a great role in clinical trials. Apart from paying for the travel cost of the volunteers, sponsors are supporting the hospital in bringing in volunteers for the screening process. I expect the government to put in place an efficient courier system where blood samples of the volunteers can reach the central laboratory without any hurdles when lockdown restrictions are in place.

What type of patient safety protocols are followed while conducting the trials?

Patient safety protocols start from the ethics committee review. The ethics review the trials on their utility and the simple dictum is that what is not scientifically valid can never be ethically valid. Scientifically valid protocols ensure that patient safety is kept in place. There are experts within the ethics committee like say, clinicians, medical pharmacologists to ensure that the study design is proper and the right check mechanism is in place.

Once the study starts then active monitoring of the treatment-emergent adverse events gets captured and appropriate —analysis is performed to identify the side effects which are related to the drugs in the clinical trials.

Appropriate serious adverse event (SAE) capturing and serious adverse event management also needs to be looked into. A serious adverse event may lead to the death of a volunteer, permanent injury, disability, hospitalisation or prolonged hospitalisation and congenital anomaly in pregnant ladies. Even if one of the above events takes place it is reported as a serious adverse event

Govt of India has come up with strict guidelines where in case of any adverse events, appropriate compensation should be provided to the volunteers or their nominees in case of death. The ethics committee plays a vital role in monitoring the serious adverse event and as well as deciding on the compensation amount.

Even during the trials, if the patients or volunteers suffer from any adverse events they are free to approach principal investigators like me or any of the ethics committee members so that their voice about a concern can be addressed.

India is currently facing a vaccine shortage. Will this trial somehow bring an end to the shortage?

Yes. Vaccine trials are the only hope to end the pandemic. If we bring in new vaccines from different manufacturers, a single manufacturer can’t satisfy the needs of 130 crore Indians. The infrastructure is not in place and not feasible within the supply chain management. Clinical trials are appropriately designed and conducted to bring an end to the shortage of vaccines in the country.

What do you have to say about the third wave which is looming large?

COVID-19 have been characterised by different waves where a large number of patients get affected at a time. The third wave is expected in this country as a large number of Indians will be infected at a single point in time. A larger population consisting of children below 18 years of age is likely to get infected in the third wave. I fear that the third wave will affect the unvaccinated children population.

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