Rohtak: When the entire country was under lockdown in April, Ranbir Hooda (name changed) decided to leave his native village and joined a social organisation based in Rohtak to serve food to hungry and hapless people. "For about two months, I, along with other volunteers, went to every nook and corner to distribute food for the needy who could not afford it," said 26-year-old Ranbir.
An engineer by education, Ranbir was among the first three persons on whom human trial was initiated by Post Graduate Institute of Medical Sciences (PGIMS Rohtak) for anti-corona vaccine - COVAXIN, made by Bharat Biotech Company based in Hyderabad. After blood urine test was done on him and he was found to be physically fit, 5mg of COVAXIN was injected into his shoulder.
"I was asked to come with empty stomach to the hospital on July 17. After administering the vaccine, doctors kept me under observation and asked me whether I felt any change in my body," he said.
When he responded that he did not find any change in his body, he was asked to go home. "Till now, doctors call me twice a day to enquire about my health," he informs. Today, I eat, sleep and do my routine work like any other normal person without making any alteration in the schedule. On being asked about his motivation, Ranbir said that his father is a well-known face for organising mass blood donation in the area and and Ranbir himself has also donated blood nearly three dozen times. "I wanted to join the army but could not qualify in that so I joined social service and when I read that PGIMS Rohtak needed volunteers for conducting human trials, I immediately contacted the doctors and made myself readily available," he added.
On being asked about what he thinks of side-effects, anti-corona vaccine may lay on his body, he said that he had signed a three-page document in which it was mentioned that he would be given best available treatment if any harm comes to him. "But the reality is that I am doing it for my country. Like soldiers fight on frontiers without caring for themselves, I see human trial opportunities like that only," he added. Ranbir would be getting his second dose of COVAXIN on July 31.
Dr. Savita Verma, professor at PGIMS' pharmacology department who is the principal investigator of human trials, said that right now they are in phase-1 and trying to find out the effective doses for human use of vaccine on trial. "We are giving it in two dosages--3 micro grams and 6 micrograms which are suitable for human use. For conducting this trial, the age was defined between 18 to 55 years, subject to volunteers' health. The person should not have chronic illness or blood sugar or blood pressure-related issues to be part of this human trial. We are receiving responses from all spectrums of people - urban and rural areas, from all professions and age groups. Even many females have turned up to be part of this trial study on them," she added. PGIMS Rohtak has conducted phase-1 of the human trial on 50 persons successfully till date. "Despite the psychological fear related to COVID-19, people are coming forward to contribute for this trial with the sheer will to be part of good cause for the society and country," she further said.
Explaining the process, Dr. Verma said that the trial is in two phases--in phase 1, the institutes are to complete human trials on 350 persons and in the second phase it is to be done on 750 individuals across the country.
"Bharat Biotech is an Indian company that made this vaccine for human trial. They already have many vaccines available in the market like Japanese encephalitis vaccine, Rotavirus vaccine, Rabies virus, Typhoid vaccine and they are coming up with Chikungunya vaccine. They have been into the vaccine business for a long time," Dr. Verma added. There are no remuneration benefits for volunteers participating in the vaccine trial process which is against the laws but doctors will be following their health for next six months and they are being given transportation allowance. "In case of any mishap during the trial, they are fully covered by an insurance policy," she added.
What after the Trial?
Dr. Dhruva Chaudhry who is presently Senior Professor & Head, Department of Pulmonary & Critical Care, said that the human trial would be conducted on 1175 individuals of all ages across the country. "After the success of phase-1 and 2, the process of mass vaccination would be started. The number during public vaccination would be huge," Dhruva Chaudhry said who is also Haryana's nodal officer for COVID-19.
He further said that phase-1 has shown encouraging results as none of the individuals who have been administered vaccination showed any adverse impact on them. The second phase would test the amount of antibodies it produces in the body of a healthy individual, he added. He added that new vaccine making and trials is a long process and requires patience and proper investigation before making it available for the public.
Response is overwhelming
Prof Savita Verma said that they were receiving overwhelming response for the COVID-19 vaccine clinical trials. "From house-wives to government servants to students, many are enquiring about it and coming to give their samples. Their key motivation is to serve for the cause of humanity," she added.