The preliminary results of phase 1 clinical trials of Bharat Biotech-ICMR developed Covaxin, a COVID-19 vaccine, has shown that the vaccine is safe. The results were informed by the principal investigators who have been conducting the trials of the vaccine.
The vaccine for COVID-19 has already been tested on 375 volunteers who were enrolled at 12 sites in India. As per the investigators, two doses of vaccine are being administered to each volunteer.
As the race to secure the vaccine for COVID-19 begins, the Indian government has been keeping a close eye on the latest developments. Recently, Russia became the first country to officially register the vaccine to cure COVID-19.
Preliminary Results of Covaxin:
Savita Varma, Principal Investigator, who is also leading the trial at PGI, Rohtak mentioned that the vaccine is safe and the team has not observed any adverse events in any of the volunteers at the site.
While volunteers have been administered with the second dose, investigators will be collecting blood samples which will test the immunogenicity of the vaccine.
As per the investigators, as of now, the vaccine is safe. The second step will be to know how effective the vaccine is for which the team has already started collecting the samples. They are expecting to finish phase 1 by the end of August 2020.
Sanjay Rai, Principal Investigator at All India Institute of Medical Sciences (AIIMS), Delhi also commented on the development and informed that the team is in the process of giving a second dose to the healthy volunteers and so far, nothing unusual has been seen in the patients.
AIIMS had earlier recruited 16 volunteers for testing the Bharat Biotech’s Covaxin.
About Covaxin:
Covaxin is India’s first COVID-19 vaccine candidate which has been developed by Bharat-Biotech in collaboration with the Indian Council of Medical Research (ICMR). The vaccine has been developed from a strain of SARS-CoV-2 which was isolated by the ICMR-National Institute of Virology, Pune.
Once the safety data from all the 12 selected sites will show desirable results, Bharat-Biotech will approach the Drug Controller General of India (DGCI) for conducting Phase II trials and if all goes well, the vaccine may be available in the first half of next year.
