Phase 1 trial of India’s COVID-19 vaccine, Covaxin starts on 375 people
The trials of the first Indian vaccine for COVID-19 has started Bharat Biotech International Limited said. BBIL which developed India's first potential indigenous COVID-19 vaccine said that testing has begun on 375 people. BBIL said that the human trials of Covaxin started on July 15. The company has jointly developed the vaccine along with the Indian Council of Medical Research (ICMR).
Earlier this month, it was reported that the Belagavi Jeevan Sakhi Multi Speciality hospital would be among the units where the multi city clinical trial of the vaccine would be conducted. Trials would also be conducted at the AIIMS, Delhi and Hyderabad. The trial would also be conducted at the Nizam's Institute of Medical Sciences, Hyderabad.
The drug has been developed by the Hyderabad based Bharat Biotech and is known as Covaxin.
The Drug Controller General of India had granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. During the trial researchers would examine the vaccine's efficacy with a single dose as well a double dose on the 1st and 14th day.
Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune. Bharat Biotech developed an “inactivated" vaccine at its high-containment facility at Genome Valley in Hyderabad.
“Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus," said the company.
Covaxin underwent pre-clinical testing on animals to see if it is safe. "Results from these studies have been promising and show extensive safety and effective immune responses," the company earlier said.
The human trials of Covaxin has begun at the All India Institute of Medical Sciences, Patna. AIIMS-Patna chose 10 volunteers to start the human trial of Covaxin.
According to several reports, the first dose of the vaccine has been administered to the study participants. They will be given he second dose after an interval of 14 days. Once their schedule is complete, the volunteers will be examined thoroughly for any after-effects of the vaccine.
The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. Hyderabad’s Nizam’s Institute of Medical Sciences was one of the trial sites that received ICMR’s letter. Only institutes with clinical pharmacology departments were selected for the trials of Covaxin.
Covaxin will be tested on over 1,100 people in two phases. Bharat Biotech has planned to enroll 375 people in the first phase of clinical trials. Depending on the results of the first trial, the company has a plan to enroll 750 people in the second phase of trial.
The human trial of India's first vaccine candidate has initiated in Rohtak’s Post-Graduate Institute of Medical Sciences today. "Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse efforts," said Anil Vij, health minister of Haryana.