Bharat Biotech's Covid-19 vaccine 'Covaxin' to begin phase 3 trials in Odisha

Bharat Biotech and ICMR's COVID-19 vaccine Covaxin's third phase human trials are set to commence at the Institute of Medical Sciences (IMS) and SUM Hospital in Odisha soon. IMS and SUM Hospital is the only institute in Odisha out of the list of 21 medical institutes which have been selected by Indian Council for Medical Research (ICMR) for the phase III trials of the COVID-19 vaccine. Earlier on Friday, the Drugs Controller General of India (DCGI) gave permission to Bharat Biotech to conduct the phase III trials for the indigenous COVID-19 vaccine Covaxin, after receiving a thoroughly analysed recommendation from the Subject Expert Committee (SEC).

'Large-scale efficiency trial'

The Principal investigator in the Covaxin human trials and Professor in IMS and SUM Hospital's Department of Community Medicine, Dr E Venkata Rao spoke about the phase III human trials of the Bharat Biotech COVID-19 vaccine. He informed that Covaxin received approval from the Central Drugs Standard Control Organisation (CDSCO) as well for the third phase trials. Dr Rao further added the during the trial the efficacy of the vaccine will be evaluated by following up with the volunteers over a considerable period of time. 

Read | Covaxin, Bharat Biotech's COVID Vaccine, Gets DCGI Approval For Phase 3 Of Clinical Trials

Read | COVID-19: Bharat Biotech's Covaxin Phase-3 Trials To Take Place In Lucknow And Gorakhpur

"After completion of the first and second phase of the trial with demonstrable safety profile and immunogenicity, the large scale efficacy trial involving thousands of volunteers has been planned now," informed Dr E Venkata Rao. 

Read | 'Submit Covaxin's Phase II Data Before Proceeding For Phase III': CDSCO To Bharat Biotech

"The age limit and eligibility/screening criteria would be relaxed and several volunteers who are otherwise apparently healthy would be recruited for the trial. Like the previous phases, half of the volunteers would receive placebo and the remaining half would be administered Covaxin in this phase. Even healthcare workers would be recruited for the trial. The volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing the development of the coronavirus disease," added Dr Rao.

Read | Covaxin To Use ViroVax's Adjuvant Alhydroxiquim-II To Boost Immune Response

Read | Arvind Kejriwal Jumps Into COVID Vaccine Debate, Says 'should Be Free For Entire Country'

While speaking about the response and enthusiasm among people to volunteer for the trial, Dr Rao said, "The interested volunteers for the project could enrol themselves for the trial by registering online at www.ptctu.soa.ac under the section register for clinical trials."

Read | Israel To Start Human Trials Of COVID Vaccine On Nov 1

Read | AstraZeneca Resuming US Testing Of COVID-19 Vaccine

(With inputs from ANI)