Phase III trials will start on Saturday, say serum scientists.
Large-Scale COVID-19 Vaccine Set for Human Trials in India Within Days
India is gearing up for large-scale human trials of a vaccine as the Covid-19 pandemic continues to claim lives across the globe.
Russia claimed this month that it has made strides, and pharmaceutical makers in the United States and Europe are also working feverishly to find a cure. Governments and private foundations are devoting huge sums to financing research and prepare for the distribution of medications that pass trials.
A vaccine being tested in India was produced by a partnership of the pharmaceutical giant AstraZeneca and Oxford University. The Serum Institute of India has begun phase 2 and 3 clinical trials of the experimental serum at seventeen sites across the country. Recruitment of volunteers is likely to begin this week.
Vaccines that the institute produces are now used in 170 countries. It announced Aug. 7 that it has entered into a partnership with Gavi, the vaccine alliance, and the Bill & Melinda Gates Foundation to manufacture and deliver up to 100 million doses of an approved Covid-19 vaccines in India and other low- and middle-income countries.
The partnership is also providing billions of dollars to accelerate the manufacturing process for the Oxford-AstraZeneca vaccine and another under development by the U.S.-based drug maker Novavax.
Their goal is to cap the price of a mass-produced vaccine at $3 per dose, making it among the cheapest in the world.
Of 17 approved vaccine testing sites, eight trial sites are in Maharashtra, the state in western India that has recorded more than 600,000 cases and more than 20,000 deaths—the highest in India. Those Maharashtra sites include two in Mumbai, four in Pune and one each in Wardha and Nagpur. The other trial sites include two in Chennai and one each in Visakhapatnam, Mysore, Jodhpur, Patna, Chandigarh, Delhi and Gorakhpur.
India has recorded more than 2.6 million confirmed cases of Covid-19, and more than 500,000 deaths. That’s the world’s third-highest tally, after the United States and Brazil.
The vaccine trials will cover 1,600 healthy Indians over seven months.
In Mumbai they will be conducted at the BYL Nair Hospital and the King Edward Memorial Hospital.
“Each hospital will recruit 160 volunteers,” said Mumbai additional municipal commissioner Suresh Kakani. “Both hospitals will start recruiting volunteers as soon as the ethics committees give a go-ahead this week.”
He said they will be screened for pre-existing conditions like HIV and hepatitis. They must be 18 or older.
Dr. Ramesh Bharmal, dean of Mumbai’s BYL Nair Hospital, said participants “will be screened for the presence of antibodies to ascertain if they have already had the Covid-19 infection.” Women “will have to be on contraception for at least 28 days before and 57 days after the inoculation,” he said.
In the north, the Post Graduate Institute of Medical Education and Research, Chandigarh, another one of the 17 trial sites, volunteer recruitment is likely to begin in the next two days.
“The initial round will have a sample size of 250. Once the staff is trained, advertisements calling for volunteers to participate in the study will be put out. The institute plans to screen at least 350 volunteers to reach the target sample size of 250,” said Dr. Madhu Gupta, principal investigator of the trial.
Gupta described a two-part process involving a second dose four weeks after the first.
A World Health Organization draft assessment lists 29 potential vaccines in the clinical trial stage and 138 pre-clinical candidates. Two of those are made in India.
The assessment, last updated on Aug. 13, includes a Russian vaccine named Sputnik V, saying it’s in phase 1 clinical trials. A Russian government website, however, claims phase 1 and 2 trials were completed Aug. 1, and that the Russian Ministry of Health announced on August 11 that “under emergency rules adopted during the COVID-19 pandemic,” the vaccine “can be used to vaccinate the population in Russia..”
“[A]ll the volunteers are feeling well,” Moscow reports, and “no unforeseen or unwanted side effects were observed.”
(Edited by Matthew Cooper and David Martosko.)