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Vaccine volunteers

Rajiv Nath | Updated on January 10, 2021

Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd, gets his first dose of Covaxin

Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd

Why I signed up for the Covaxin clinical trial

Bharat Biotech launched its Phase 3 clinical trials in late-November and in my town, Faridabad, at the ESI Medical College.

The invitation received from ESI via the Faridabad Industry Association office was circulated at our manufacturing plants. I was surprised to learn from the human resources department that the initial response was lukewarm, especially from our office staff, though some workers were keen to volunteer.

I told the staff that it was an excellent opportunity to get immunised as, after the animal studies, the Phase 1 and Phase 2 trials were known to be safe with no serious adverse event reported.

As the number of volunteers was in the 10s and not 100s, as envisaged, I decided to join the clinical trial the following Sunday.

Leaders need to show the way and not dither, so I was hoping that more employees would gain confidence on knowing that their Managing Director was opting to volunteer.

Surprisingly, I faced stiff resistance from my own family, who were worried about my co-morbidities — since I’m a heart patient and a diabetic. They also felt

it was highly risky for me to visit a government hospital, since it may not be clean or hygienic and possibly crowded with infected visitors and patients and long queues. I countered that the risk of crowds and queues will be more once the actual vaccination drive begins and, in comparison, the trial was with limited numbers and by appointment.

I was also taken aback by the many calls and text messages from close friends and relatives trying to dissuade me. One line of argument went like this: “In a country of 130 crore people, 25,800 vaccinations is a very low percentage; so please wait for six months after the vaccine launch before risking it.”

The following were my counter-arguments: When you set the forging die on your press, the setter checks the initial few samples against some go, no-go gauge or takes measurements? Once he gets the confidence that his product meets the quality norms , he starts mass production — it’s the same for vaccine manufacturers. You do not compare the quality of your output related to the population of India but as a percentage sample of your hourly or daily production.

So I told my wife and kids, “No worries!” In a vaccine trial, Phase 1 tests the vaccine primarily for safety on a few 100s. The secondary objective is to study immunogenicity (antibody response after vaccination). Phase 2 trials, on the other hand, study the immune response primarily and define the appropriate dosages, while also assessing the safety of the vaccine in a larger number of volunteers — approximately 1,000. Phase 3 trials test the vaccines in tens of thousands of volunteers to provide pivotal evidence that a vaccine both works by reducing the rate of infection and is safe. About 11,699 had already been vaccinated by then with no reported serious adverse event.

If manufacturers have the confidence to produce and build inventory for potential sale, investing crores of rupees, we too should trust them. The sooner the clinical trials are over the faster the manufacturers and regulators will have data to seek market authorisation for mass vaccination, so people could go about their lives without fear.

D-Day arrived and I reached the venue, where I was joined by 52 employees of HMD. It was a lovely clean building, modern construction and could compete with any 4-star private hospital facilities.

We were all given an introduction to the clinical trial process by Dr Yadav and our queries and apprehensions were addressed methodically. The staff was well trained and friendly and professional. Very reassuring; and the injection itself was painless.

The first 24 hours passed, then 48, then 96 and now over two weeks — no issues, no pain, no redness, no itching, no swelling and no dizziness for me or my colleagueswho accompanied me on that Sunday. As the second dose comes up shortly, I am glad I participated and contributed in this historic journey of the vaccine.

(The writer is Managing Director, Hindustan Syringes & Medical Devices Ltd. Views are personal.)

Published on January 10, 2021

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