NEW DELHI: The research ethics committee of the All India Institute of Medical Sciences, Delhi gave a go-ahead to the human trials for Covaxin, an indigenous vaccine candidate for COVID-19, only after ensuring that enough safeguards are in place for volunteers who take the shot to help examine its safety and efficacy.
The committee approved the phase 1 clinical trial protocol on Saturday after reviewing it twice and on both occasions, some changes were made in the original protocol submitted.
Covaxin is a vaccine candidate developed by Bharat Biotech and the Indian Council of Medical Research (ICMR) and it had hit the limelight after the ICMR director-general, earlier this month, urged 12 hospitals chosen for its trial to fast track the project saying the government plans to launch it by August 15.
Covaxin, along with another potential vaccine by Zydus Cadilla are the only two candidates granted permission for human trials by the Drug Controller General of India as of now.
“The safety profile and measures for subjects were not explicitly mentioned and therefore we had raised the concerns which were later addressed,” Dr T P Singh, chairman of the committee told this newspaper.
The changes that have been incorporated include graphic details of medical plans ensured for patients in case of any adverse events, something which was missing in the protocol submitted in the beginning.
The changes being made also mean that other trial sites where the research is being conducted will also need to modify their trial designs. At many of these hospitals including AIIMS, Patna, trials on healthy volunteers have already started.
“We are now assessing the volunteers through different tests and hope to start administering the vaccine by Thursday,” said Dr Sanjay Rai, principal investigator of the trial at AIIMS, Delhi who will also lead the multi-centric exercise.
AIIMS director Dr Randeep Guleria said that the trial will be conducted in three phases.
“It will depend on recruitment and then follow up that has to be done. The study is a combination of phases I and II. We expect it to be completed within the next two-three months, but that is subject to good recruitment, while also keeping in mind the vaccine’s safety and efficacy. If it doesn’t work out then we will have to adjust the dosage. It is science, you have to see how things evolve,” Guleria said.
Phase I of the trial will be done on healthy people, aged between 18 and 55 years, having no co-morbid conditions. Women with no pregnancy will also be part of the trial in phase I. In phase II, 750 people will be recruited between the ages of 12 and 65, he said.
1,175 volunteers for 3-phase trials
In phase I and II, the vaccine will be tried on 1,175 volunteers after which it will move to phase 3 where even more subjects will be needed.