CAN COVID-19 VACCINE BE AVAILABLE BY AUGUST 15?

The buzz had suddenly made the whole scientific community of India sit up in a semi-trance. Couple of days ago, virologists, scientists and doctors of India were surprised to find ICMR declaring that a COVID-19 vaccine that is undergoing simultaneous animal and human trials in India, an indigenous vaccine, will hit the markets on 15th August. The date itself was an eye-opener for me atleast for I could easily visualize the announcement being made: India wins freedom against COVID -19. But I knew being a student of science that it would be a gimmick, not a hard-kept secret from the world that India has been experimenting with an indigenous COVID 19 vaccine being developed by Bharat Biotech, and in the race to create one, they have beat the world. Trust me, if really that happened, I would have been like many other Indians, the happiest.

But science is science. One cannot deny that any vaccine production, be it COVID or non COVID needs years of trials, both animal and human to establish the efficiency of the vaccine as well as a more important parameter, its safety among a larger population. Though ICMR tried to say that in a pandemic situation as per WHO directive, vaccines can be produced and marketed within months, and that both animal and human trials can go side by side, later under a huge backlash from the scientific community, ICMR had to backtrack. 

So the central question is why cannot we think of a vaccine in few months? Soumya Swaminathan, Chief Scientist at WHO and also an ex-director of ICMR herself was skeptical of such a claim. In an email press report she said: “A realistic, but very optimistic timeline from the start of Phase 1 to completion of Phase 3 could be abut 6-9 months and that too if everything goes well.” Incidentally Bharat Biotech got an approval to conduct only Phase 1 and 2 trials. So without 3rd phase on the scene, how can a vaccine be launched so quick? Because phase 3 trial is the most important as that phase proves the efficacy of the vaccine on a large group of volunteers. Like the Oxford Vaccine has started trial on more than 40k volunteers of different age groups and ethnicity and the results of that too will take a few months to ascertain.

A senior faculty member of AIIMS who did not wish to be named added: “Any vaccine development needs time and has strict rules and regulatory norms. It has to pass pre-clinical animal and lab studies, then dossier preparation and permission for PKPD studies, then testing for human trials for safety and efficacy. It is a long process and any hurry will lead to failure or even risking human lives.” True to what she said, a major example of such a hurry was the Dengue vaccine that was widely used in countries like Philippines leading to child deaths. So much so, that the vaccine had to be finally called off.  

Prof Ena Ray Banerjee, PhD, DSc Immunobiology and Regenerative Medicine Research Lab, Dept of Zoology, University of Calcutta also believes it is quite impossible to bring a vaccine to the market so soon. Rather the idea itself is like El Dorado. She explains why. “Before a vaccine comes to the market we need to look into the following. We need to test if the vaccine is indeed offering protection, if so for how long, short term or long-term protection and if there is antibody dependent enhancement which is worsening of disease condition because of vaccine and toxicity measures. Once human trials begin, sufficient time needs to be given to the volunteer to whom the vaccine is given. Same with the healthy individuals who are volunteers in the 2nd phase to see if any toxicity arises if the vaccine is pushed into healthy persons. Similarly, time has to be given to the immune system of the body to produce sufficient antibodies in response to the virus injected through the vaccine.”

As Dr Banerjee rightly points out that the vaccines can either carry a heat-killed virus, a part of the viral protein, a DNA or RNA virus or whatever, but the body’s immune response takes months to develop the antibodies that can effectively kill the virus and lead to an efficient vaccine preparation. Taking into account the time when COVID 19 started in India, even if we take March, the virus’ presence in a larger community was much later. And calculating that, it is any child’s play to understand that August cannot be a date when the vaccine trials will be over and it will hit the market. A minimum of 9 months is needed to understand if the vaccine plays a role against the different strains of the virus that is prevalent in India. 

So no wonder, even if a COVID-19 vaccine hitting the market seems a great welcome, it is definitely utopia to even claim that it’s as soon as August!