Mornings begin early on the 200-acre campus of the All India Institute of Medical Sciences (AIIMS), located in the heart of the national capital of Delhi. Even as the rest of the city shakes off its slumber, there’s visible hustle at the hospital’s Department of Pulmonology. Phase II of clinical trials for a Covid-19 vaccine candidate is underway.
With no separate waiting area, the fifty-odd healthy volunteers—ranging from 18-65 years—sit outside in the open. The benches they occupy abut the hospital’s tuberculosis department, with a constant stream of infected patients flitting past them.
The volunteers are called in batches to receive the second dose of Bharat Biotech’s Covaxin. Each assigned a serial number, they enter a designated 10×10 sq ft room to receive their injection from a doctor. The initial results of the Covaxin trials have been promising, indicating it is safe.
The volunteers constitute a small sliver of the thousands of applications AIIMS received after it advertised the ongoing trial in a leading daily. “We needed close to a hundred volunteers, whereas we received up to 4,500 emails in three to four days,” says Sanjay Rai, a professor at the department of Community Medicine, and the principal investigator for the trials.
Rai has had to turn down most of the applications. “I have been a co-investigator earlier in global influenza and rotavirus trials, but the interest in this Covid-19 vaccine trial is unprecedented,” he says. However, for the next stage—Phase III—even this level of volunteer enthusiasm may not suffice.
Phase III clinical trials require tens of thousands of volunteers. The final hurdle before the vaccine enters the market, they are conducted in diverse populations to be doubly sure that the vaccine is safe and effective.
S P Kalantri, director of Mahatma Gandhi Institute of Medical Sciences (MGIMS) in rural Maharashtra, is understandably concerned. The pandemic has made inroads into even remote villages now, with Maharashtra the worst-affected state.
“Over the past few weeks, we have had close to a thousand Covid-19 patients admitted with us, of which over a hundred have died. That is a mortality of 10%. It’s higher in this hospital because this is the only tertiary care centre in the district,” says Kalantri. MGIMS is also one of the 17 sites for the Phase II and III trials spearheaded by Pune-based Serum Institute of India—the world’s largest vaccine manufacturer—for the Oxford University-AstraZeneca vaccine candidate vaccine candidate The Lancet Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine Read more ChAdOx1 nCoV-19.
