The All India Institute of Medical Sciences (AIIMS) in Delhi administered its first dose of Bharat Biotech's vaccine candidate against the coronavirus disease (Covid-19) – Covaxin, as part of its combined phase 1 and 2 trials for the drug, to a 30-year-old healthy man on Friday.
Two other of the 12 trial centres for the vaccine, in Patna and Rohtak, have already administered the vaccine in humans.
"The vaccine candidate was administered to the first trial participant — a healthy 30-year-old man — around noon on Friday. He was monitored for two hours to check for any adverse reactions. All trial participants will be monitored every day for the first seven days. They will then be followed-up on day 14 and day 28. They will be tracked for up to a year to observe any long-term impacts," said Dr Puneet Misra, one of the investigators of the trial and a professor of community medicine at AIIMS.
The centre has received nearly 3,500 applications for the trials so far, and 100 healthy participants will be enrolled from among them. Participants have to be between the ages of 18 and 55 years, and have no comorbidities like diabetes, hypertension, heart or kidney disease.
The centres are conducting simultaneous phase 1 and phase 2 clinical trials to study the safety and immunogenicity of different doses and adjuvant combinations of the vaccine developed by the biotechnology company, in collaboration with the Indian Council of Medical Research's National Institute of Virology. An adjuvant is a compound that helps increase the effectiveness of a vaccine.
"Our priority is safety and hence we need healthy participants. Those who are called in for the trial have to undergo a battery of tests to determine their general health. They are tested for a current infection using RT-PCR test and for past infections using an antibody test. Participants are given the vaccine only if they are free of Covid-19. For now, we are also selecting participants only from Delhi and the National Capital Region for the ease of follow-ups," said Dr Misra.
The vaccine is currently being administered in two doses — 0.3 and 0.5 microgram. In the 0.5 microgram dosage, the vaccine is being given with two different adjuvants. Of the 100 who will be enrolled, 80 will get different dosages and combination of the vaccine, and 20 participants will receive placebos.
Dr Randeep Guleria, director of AIIMS Delhi had earlier this week said, "Normally, a vaccine takes about 10 years to develop. That is because the different phases of the trial are conducted one after the other, after evaluation of the results. It is a financial risk if everything is done simultaneously as all vaccine candidates do not work and scientists might have to go back to the drawing board. But, in this case, everything is happening simultaneously. Even as the effectiveness of the vaccine is being studied, manufacturing capacity is also being built."
Dr Jugal Kishore from the department of community medicine at Safdarjung said, "We have to look at who gets these vaccines. It should be given to those at a higher risk of developing a severe disease like the old, those with comorbidities or the immunocompromised."