Healthcare workers from hospitals in Delhi may soon be part of Phase III human trials of India’s first indigenously developed Covid-19 vaccine, Covaxin. Developed by Bharat Biotech in collaboration with the National Institute of Virology (NIV) and the Indian Council of Medical Research (ICMR), the vaccine recently received approval from the Drugs Controller General of India (DCGI) to conduct Phase III trials subject to certain conditions.
According to senior health department officials, Bharat Biotech has reached out to the Delhi government. Confirming the development, a statement from Health Minister Satyendar Jain’s office said: “We have received the proposal and sent it to the Secretary, Health, for in-principle approval.”
Senior officials said around 3,000-4,000 healthcare workers from both government and private hospitals will participate in the trials, once the proposal is approved. Senior officials from the health department said the proposal is being examined thoroughly before it gets final approval. “We need to have clarity on the entire proposal. The vaccine makers have sought permission from us before selecting participants for the trials,” said a senior health official.
After completion of the first and second phase of the trial, with demonstrable safety profile and immunogenicity, a large-scale efficacy trial involving thousands of volunteers has been planned now.
On October 2, the vaccine maker had applied to the DCGI seeking permission to conduct the phase III randomised double-blind placebo-controlled multicentre trial of its Covid-19 vaccine.
Like previous phases, in the third phase, half the volunteers would receive a placebo and the remaining half would be administered Covaxin. It will cover around 28,500 subjects, aged 18 years and above, and will be conducted in 21 sites across 10 states, including Delhi, Mumbai, Patna and Lucknow.
IMS & SUM Hospital is among 21 medical institutes selected across the country by ICMR where the third phase trials would be conducted. Recently, Dr E Venkata Rao, Principal Investigator and Professor in the department of Community Medicine at the Institute of Medical Sciences and SUM Hospital, had said healthcare workers would be recruited for the trial.
Volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing development of Covid-19. Anyone above the age of 18 years can participate in the human trials.
DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its Covid-19 vaccine in July. According to experts, the vaccine may be ready by June 2021.
Other vaccine candidates are those of Zydus Cadila, which is close to completing Phase II trials of ZyCov-D, and Russia’s Gamaleya Research Institute, which will soon begin phase II and III trials of Sputnik V in collaboration with Dr Reddy’s.
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