Covaxin's preliminary Phase I results show it is safe: Report

The preliminary results of Phase I clinical trials of indigenously developed Covaxin suggest that it safe, Economic Times reported, quoting principal investigators conducting the trials.

The human trial of BBV152 Covid-19 vaccine or Covaxin is being tested on 375 volunteers enrolled at 12 different sites across the country. Two doses of the vaccine are being administered to each volunteer, according to the report.

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Principal investigator, Savita Verma, who is leading the trial at PGI, Rohtak, told the publication, “The vaccine is safe. We have not observed any adverse events in any of the volunteers at our site.”

Verma added, “The second step is to know how effective the vaccine is for which we have started collecting the samples. We are in the process of giving a second dose to the healthy volunteers and so far, we have not seen anything unusual event in patients.”

Last month, Verma had said that Covaxin trials showed "encouraging" results.

Read: Indigenous Covid-19 vaccine Covaxin shows 'encouraging' results in trials

According to the ET report, investigators are collecting blood samples to test the immunogenicity of the vaccine and expect to complete the Phase I trial by August end.

Read: How you can volunteer for Covid-19 vaccine trials

Covaxin is the first indigenous vaccine developed by India against Covid-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.

ICMR and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received the approval for Phase I and II by the Drugs Controller General of India (DCGI).

Telangana-based Bharat Biotech's Covaxin, along with ZyCoV-D, are the only two vaccine candidates to have got a nod from the DCGI to conduct human trials.

(With agency inputs)