Indigenous Covaxin phase-3 trial results in November 2021, says NICED
The results of the phase-III trial of indigenously developed coronavirus vaccine candidate, Covaxin, will be available in November 2021, top officials of the National Institute of Cholera and Enteric Diseases (ICMR-NICED) in Kolkata have said. They added that the interim report may be available by May 2021 at the earliest.
“The analysis will take a year. An interim analysis may be done after six months. If it is found that the vaccine has sufficient protective efficacy, the results would be shared with the policy makers. The government will take the final call thereafter,” Shanta Dutta, director of NICED, told media persons on Wednesday.
The phase-III trial of Covaxin was launched at NICED on Wednesday by governor Jagdeep Dhankhar. Dhankhar and the State urban development minister Firhad Hakim have expressed their interest in volunteering for the phase-III trial.
“In phase-III trial, we would primarily test the protective efficacy of the vaccine. Safety and immunogenicity have already been tested in phase I and II,” Dutta added.
Covaxin – the first indigenously-developed anti-coronavirus vaccine -- is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Around 350 people have applied to become volunteers. NICED is looking for around 1000 volunteers to conduct the phase-III clinical trial.
“The applicants would be invited one by one for interviews and tests. If they are eligible they can become volunteers. The enrolment of 1000 volunteers for trial would have to be completed by February 2021,” said a senior official of NICED.
The ICMR-NICED in Kolkata is one of the institutes selected to conduct the Central Drugs Standard Control Organisation (CDSCO)-approved regulatory trials. It would be conducted in around 25 sites across 10 states. The trial has already started at a few sites.
Prime Minister Narendra Modi on Saturday congratulated the scientists at Bharat Biotech facility at Hyderabad for the progress made by them in manufacturing Covaxin vaccine trials.
On Monday, he held virtual meetings with teams from Gennova Biopharmaceuticals Ltd in Pune, Biological E Ltd, and Dr Reddy’s Laboratories Ltd which are working on vaccines for Covid-19. Currently, all the vaccine candidates are at different stages of trials.