Bharat Biotech Gets Go-Ahead to Conduct Phase-III Trials of Covaxin

Business Standard Bharat Biotech gets go-ahead to conduct Phase-III trials of Covaxin

The around 28,500 people expected to enrol for the Phase-III trials would be given two doses of the investigational vaccine.

With Hyderabad-based Bharat Biotech receiving an approval to conduct PhaseIII trials for Covaxin, India inches closer to having its own vaccine to fight the coronavirus pandemic. This is crucial as the government plans to start vaccinating the healthcare and essential workers starting January.

The Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) which is reviewing proposals related to Covid-19 drugs and vaccines has granted permission to the vaccine maker to start Phase-III trials after it assessed data from the Phase-I and II trials along with the animal challenge study.

"In continuation of the SEC meeting dated 05.10.2020, the firm presented their data from Phase-I and II along with animal challenge data in two species including NHP on the Inactivated Coronavirus Vaccine (BBV152) along with the proposal to conduct event-driven Phase-III clinical trial to assess the efficacy of the vaccine," the expert panel said.

The SEC, however, has also noted that this approval is conditional, subject to the primary efficacy endpoint for symptomatic cases being amended. It has recommended that once a suspect case was confirmed, it would be evaluated to be classified as a symptomatic case. Either an RT-PCR test confirmation or, if the subject shows symptoms like shortness of breath or difficulty in breathing, it should be present to classify a case as confirmed symptomatic.

According to sources, around 28,500 people are expected to enroll for the Phase-III trials who will be given two doses of the investigational vaccine. The preliminary results of Covaxin trials have shown promising results (including immunogenicity) and not many side effects.