In Conversation with Prof. E. Venkata Rao

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This article is an interview report taken for publication in the magazine ‘Inventa’. This year the theme is Science, Society and Advancements. 2020 has been everything about the  COVID-19 pandemic. It has created a havoc all over the world with an exceeding rate of morbidity and mortality. In the present situation of ‘community spread’, creating herd immunity seems as the only mode of intervention. Bharat Biotech company has developed a vaccine in collaboration with ICMR trade- named COVAXIN. 12 institutes were chosen for it in the first phase back in July and IMS was the only hospital chosen from the state. Presently in phase 3, if cleared by the Drug Controller General of India, it will be used for mass vaccination across the country. It will not only be a great advancement in the field of medical science but also for the society. The interviewee, Prof Dr E. Venkata Rao, Dept of Community Medicine is the chief investigator and team head for the COVAXIN human trials held in IMS and SUM Hospital. The interviewer Akankshya Arunima, a 3rd year MBBS student from IMS and SUM Hospital, holds keen interest in the advancement in the medical research and this keeps her on her toe, even so during the crisis. The interview aimed at getting a clearer and more insightful picture of the situation of  vaccine for corona in India. 

1. It’s a pure privilege to take the opportunity to interview you, sir. My first question is what are your views on COVID 19 pandemic as an Epidemiologist? What is its impact on the health of the community and society as a whole?

It’s a new virus, had never affected human beings. It has a unprecedented ability to cause a pandemic in the recent times because of its transmissible potential and unique pathophysiologic mechanism of tissue destruction especially among persons with comorbid conditions. It’s impact can be expressed not on the terms of morbidity and mortality but also its impact on shaking the economies of the world.

2. What is the usual course of a pandemic or any infectious disease outbreak? What factors determine its spread or containment? 

A pandemic usually has 6 phases starting from the animal kingdom to persistence in the human population over more than one World Health Organization (WHO) regions. The transmissible potential and the survival of the virus in the infection cycle mainly determines the spread or the containment. 

3. On our knowledge about the previous pandemics in the history, can you please enlighten us the role of a vaccine in such situations?

Developing a vaccine from the scratch for the control of a pandemic has never been in the history of the mankind. Now with the amalgamation of the advancement in the genetics and vaccine manufacturing had been able to bring out a few successful candidates with an unprecedented speed.

4. What are the steps of a vaccine development and approval process?

Ideally a vaccine candidate is developed and tested first for its safety in vitro and then in animal models, up to primates, which is considered as phase 0. Phase 1 starts with healthy volunteers for safety and phase 2 for immunogenecity. Then it enters the phase 3 to check for efficacy, that is the ability to prevent development of the disease in question. Phase 4 refers to post marketing surveillance. 

5. As of now, over 150 experiments are running across the country to come up with an effective vaccine. Where does COVAXIN stand in the race? Is it likely to come earlier than the foreign developed vaccines?

COVAXIN has been developed by a traditional method of vaccine development which in itself a time consuming process. Nevertheless, it is time tested for its safety. On the contrary mRNA or DNA vaccines are manufactured by newer technology for the need of speed and rapidity of development of immunity. Thus they are likely to hit market earlier. About long term safety, only time will determine. 

6. Which strain of the coronavirus is used? If the virus shows antigenic shifts or drifts, will the COVAXIN still be effective?

As of now literature shows that the antigenic shift or drift will not affect the vaccine efficacy, but again it is too early to predict about the same. Time may unfold newer facts.

7. What determines the effectiveness of a vaccine under trial? How effective is our qCOVAXIN as per the results collected till now?

The results of COVAXIN has not yet need made public, as it is awaiting a publication but has been shared the regulatory authorities, which indicates it is highly effective. 

8. During human trials, what side effects can be expected and did you experience any such incidents while conducting your tests?

So far except a few local side effects there has not been any report of serious adverse event in case of COVAXIN even after administering thousands of doses.

9. How was/is the enthusiasm among general public to volunteer in the trials? Was it easy to motivate them to participate?

Contrary to the belief the response from the public to contribute to a noble cause has been exemplary. Hardly any failure was encountered by us while motivating to participate. 

10. What are the eligibility criteria for volunteering? 

Phase 1 had strict eligibility criteria. But in phase 3 it was that the volunteer needs to be  free from corona & apparently stable.

11. How many volunteers were enrolled in the Phase III trial?

A total of 25800 across the country. 

12. What is herd immunity?

When a chunk of the population are already immune either due to vaccination or due to natural infection then they prevent the transmission of infection from any infected person to another, thereby break the chain of transmission. 

In case corona it is estimated that at least 60 to 70% of the population have to be immune to provide a herd immunity to break the chain of transmission.  

13. How long should it take for the vaccine to be available to the general public for mass vaccination after approval? Can you please simply the guidelines issued by the government for the priority of the vaccine drive?

Ideally, after the phase 3 trial, approval from the regulatory authorities should not be an issue. Afterwards, large scale production, community demand and the marketing potential will determine the time taken to come to the market. A wild guess would be that it will be ready in the first quarter of 2021.

14. What according to you is the opportunity in the field of medical and scientific research due to this pandemic? 

Disease surveillance plays a pivotal role in shaping the success of any health system. Eliciting the reliable estimates of the disease burden in terms of cause of death, is the need of the hour. Researchers in the field of science and medicine can avail the opportunity created by the pandemic to learn curbing their mistakes.

15. What according to you has been the effect of the pandemic on the health policy of India? Does this show a new horizons for the health sector in India?

It should. 

16. According to you, how well has India succeeded in combating the pandemic till now? Any particular step that you personally appreciate or would like to criticize?

Definitely, India has fared well with drastic measures in the initial stages like lockdown and preparing for the creation of facilities. Quarantine,  isolation,  social measures etc are worth appreciation. 

17. What is the impact of the vaccine on society as a whole and the field of Medicine in particular?

Vaccines are the best discovery of mankind. They are never 100% preventive but extremely useful in controlling diseases in association with other public health measures.