Covaxin Vaccine Appears Safe In Phase I Preliminary Results
Bharat Biotech-ICMR Covaxin Vaccine
Principal investigators conducting the trials of the Covid-19 vaccine, Covaxin, developed by Bharat Biotech and ICMR said that the preliminary results of phase 1 clinical trials of the vaccine suggest that the vaccine is safe.
At 12 sites in India, around 375 volunteers have enrolled, and the vaccine is being tested on them, with two doses of the vaccine being administered to each volunteer.
Leading the trial at PGI, Rohtak, the principal investigator, Savita Verma said that at their site, they have not observed any adverse events in any of the volunteers, the vaccine has shown to be safe.
Savita Verma added saying that the vaccine appears to be safe as of now, determining how effective the vaccine is is the second step, for which the sample collection has begun. To test the immunogenicity of the vaccine, investigators are collecting blood samples. As there have been no unusual events in patients seen so far, the team is currently in the process of giving a second dose to the healthy volunteers.
At All India Institute of Medical Sciences, Delhi, 16 volunteers have been recruited for testing the Bharat Biotechvaccine, and the principal investigator, Sanjay Rai said the vaccine has shown to be safe in the volunteers.
The government is keeping a close eye on developments as the race to secure vaccines begins. In collaboration with the Indian Council of Medical Research (ICMR), Bharat Biotech has developed India’s first vaccine candidate, Covaxin. The ICMR-National Institute of Virology, Pune, isolated a strain of SARS-CoV-2, from which the vaccine is developed.
For conducting Phase II trials, the company will approach the Drug Controller General of India once the safety data from all 12 sites show desirable results. By August end, the investigators are expecting to finish the Phase I trial. Another investigator added that the vaccine may be available in the first half of next year if everything goes well.
Covaxin Vaccine Appears Safe In Phase I Preliminary Results, Bharat Biotech-ICMR Covaxin Vaccine