Indigenous Covid-19 vaccines effective against mutated virus strains

The Niti Aayog has recently outlined the central government's plan, which involved a total of eight Covid-19 vaccines that will help India inoculate all its citizens by the end of 2021. The Narendra Modi government has also decided to speed up the vaccine manufacturing and has issued emergency use authorisation to Biological E, Zydus Cadila, Serum Institute of India for Novavax, Bharat Biotech's nasal vaccine, Gennova and Sputnik V. But for the time being, there will be three options available for the Indian citizens: Russia's Sputnik V, Oxford-AstraZeneca vaccine - Covishield and Bharat Biotech's Covaxin. Speaking to Bizz Buzz exclusively, Dr Subhrojyoti Bhowmick, a leading clinical trial specialist and clinical pharmacologist and Director, Clinical Research & Academics, Peerless Hospitex Hospital and Research Center Ltd, who is also the Principal Investigator, clinical trials for new vaccines, decodes these vaccines and status of their clinical trials. The youngest Chairman of the Indian Society for Clinical Research (Eastern Chapter), the largest clinical research body in India, also shares his thoughts on the vaccination initiatives

When Sputnik V vaccine began its Phase-III trial in India, Peerless Hospitex Hospital and Research Center Ltd was chosen as the only study site from Eastern India. Could you please throw some light on this trial and its current status?

Sputnik V is a viral vector vaccine for Covid-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology, Russia. Dr Reddy's from India was responsible for conducting the trial procedures in the country.

After receiving the approval from the Institutional Ethics Committee on the December 18, 2020, the trial began at our site. This phase-III trial was a randomized double blind placebo controlled trial in which 75 per cent of the participants were supposed to receive the vaccine. Within less than a month, 54 subjects were screened after the extensive procedure of informed consenting. As Covid was already prevalent, 33 per cent of the total screened participants were found eligible (a negative SARS-COV 2 antibody test) to get randomized for the study. 18 subjects who were randomized were very enthusiastic and cooperated with the study team regarding their scheduled visits. At our site no subject faced any SAEs or Serious Adverse Events till date apart from the regular side effects like fever, nausea and mild malaise. We can proudly say that none of the participants contracted Covid-19 infection, even after the ongoing increase in Covid-19 cases in India and are still going through their follow up visits as per schedule.

Mind you that the first consignment of Sputnik had landed in India on May 1. However, the regulatory clearance from the Central Drugs Laboratory-Kasauli was given only on May 13. The second consignment of Covid vaccine Sputnik V also arrived in India on May 16.

What about COVIDVAC?

We will also conduct the clinical trial and Peerless Hospitex Hospital and Research Center Ltd will be the trial venue for the latest vaccine COVIDVAC by Hetero Healthcare. It will be unique with one jab of COVIDVAC on one arm and the other arm shall receive SPUTNIK V vaccine simultaneously.

The trial to be conducted on 100 volunteers has been cleared by the Hospital's Ethics Committee and these trials shall be conducted across 10 venues in India with Peerless Hospital, Kolkata being the only venue in the Eastern part of India.

And Johnson & Johnson vaccine…..?

Peerless Hospital has also been selected as the only trial venue in the East for Johnson & Johnson for their single dose vaccine which is currently being used under emergency authorization. We will be recruiting 100 participants at this site, six such sites have been selected for this trial of this unique single dose vaccine.

How do you see the approval of Sputnik V in the current situation?

The Indian Council of Medical Research (ICMR) has found a total of 192 Covid-19 cases of the new variants of mutated SARS-CoV-2 in the last 3-4 months and counting, including four from the variant emerging in South Africa and one from the Brazilian variant, which in no time may increase to a massive number. In these circumstances the approval of Russia's Covid-19 vaccine Sputnik V comes amid a surge in cases across several states and Union Territories. India now has three approved Covid-19 vaccines - Covaxin, Covishield and Sputnik-V. Johnson & Johnson has also been given a go-ahead by the Drugs Controller General of India (DCGI).

How hopeful are you about these new vaccines, in fact multiple choice of vaccines for the people?

I am very hopeful about the new vaccines and I am confident that it would go a long way in minimising the vaccine scarcity once approved for vaccination.

What would be your take on the current situation?

It would be next to impossible to predict the situation looming on us and people must take utmost precautions, as in the past year, to face the threat of the pandemic getting worse.

Would indigenous Covid-19 vaccines be effective against the mutated virus strains?

The virus has mutated to a worse form and announced its re-emergence bringing in the second wave of covid-19. Even though vaccine roll out in India has started and is about to pick up its pace, Interim results of the ongoing clinical trial indicate that the indigenous Covid-19 vaccines would be effective against the mutated virus strains reported from the United Kingdom, South Africa and Brazil. The Indian Council of Medical Research (ICMR) had said that back in February.

What are the distinctive features of new variant of SARS-CoV-2? And what would be your take on vaccine Vs herd immunity?

The distinctive features of new variant of SARS-CoV-2 are that it spreads more easily and quickly than other variants. Health experts have cited that those who test positive for the variant are more likely to report persistent cough, tiredness, muscle aches, sore throat and fever compared to those who have the original strain. India is counted as the fifth country in the world to isolate the Covid-19 virus as part of the efforts to develop a vaccine for the pandemic, rather than India had from the outset resisted the temptation of going for herd immunity unlike many European countries, including the UK and Italy, and its decision had been vindicated from what happened in the western nations that allowed the pandemic to spread.