‘Minor side effects are good signs… mean one’s body is responding well’: Covid Vaccine Principal Investigator


Some journeys are about faith and fire, when the mind and the heart work together to seek answers that go beyond one’s own self, and encompass hope for the larger good. There are apprehensions, setbacks, roadblocks, but in the end, it’s about the determination to go on, against the odds, reflects Professor Madhu Gupta of Department of Community Medicine and School of Public Health, PGIMER, Chandigarh, speaking about her and the entire PGIMER staff’s journey since the advent of the coronavirus infections.

As PGIMER was approved by the ICMR and Serum Institute of India as a site for conducting the concurrent Phase 2 and Phase 3 clinical trials of the Oxford Covid-19 vaccine and Professor Gupta was appointed as the Principal Investigator for the trials here. “It is very prestigious that the vaccine underwent trials at the PGIMER, one of the 17 approved sites in India. I am very proud of my institute and all the support,” she says.

On January 16, as Professor Gupta received the first dose of Covishield at the APC, life had come full circle for the doctor, whose areas of expertise include vaccinology, maternal and child health, and health inequalities. She has been deeply involved in both developing and conducting vaccine trials of pentavalent vaccine and rotavirus vaccine, to help increase the availability of these vaccines at an affordable rate for Indian children, besides the vaccines for measles, Hepatitis A, BCG, and for prevention of diarrhoea.

Professor Gupta looks back at the past months as a time of great dilemmas, with the people and medical fraternity facing the unknown in the form of Covid-19– with many lives tragically lost to the infection, with no definite treatment to prevent mortalities in sight.

“In this scenario, the news of vaccine trials, that too from a very reputed source was a ray of light and my first thought was that I should be participating in this trial and as they say, the rest is history. The trials here at PGIMER were a team effort, with the doctors and staff of the departments of Pharmacology, Internal Medicine, Virology…working hand-in-hand with me to make it a success, along with the Director supporting us at every step. As a principal investigator, I was nervous, if people would participate in this trial of an investigational product, as there were many apprehensions, and I prayed for the trust of the people in science, like we had trust and faith in science. We decided to put up advertisements for volunteers online and while we needed about 150 participants who were Covid free, by the end we had about 600 applications and the response was overwhelming. We went slow and steady, conducting the trials on just 2-4 participants in a day, and following up on their health regularly. What was more heartening and satisfying was that all those involved in the trials, reported very minor side-effects,” recalls Professor Gupta.

While the normal time period for the development of a vaccine is about 10 years, the Covid-19 vaccine trials across the world has been happening at an accelerated speed, with the intent to prevent more infections and save lives. “We now have vaccines during the pandemic and for a public health specialist, it is a dream come true. This was the need of the hour. For me, the historic moment came when the vaccine was approved. All our efforts has been worth it, and it is a fulfilling feeling for all of us who have been a part of this,” smiles Professor Gupta.

Happy to have received her first dose of the vaccine, Professor Gupta encourages everyone to get the two doses, especially the elderly and those at a higher risk of Covid-19, adding that the vaccine is safe as per the preliminary data of the Phase 3 trials. “There are just minor side-effects like pain, fever and body aches, which are good signs, for it means our body is responding well to the vaccine. Except for minor pain, I have experienced nothing and am now back to work and a normal routine. As for how long will the immunity last, at present we do not have much evidence, but our experience says the immunity will last for six to twelve months. What the vaccine will do is, prevent the spread of infection and build herd immunity. Then the incidence of new infections will hopefully be prevented,” sums up the doctor.

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