Phase 3 Trial Of Bharat Biotech's COVID Vaccine Covaxin Likely To Start In AIIMS Soon
As the race for a COVID-19 vaccine continues around the world, India's coronavirus vaccine candidate 'Covaxin', is set to advance in the trials.
According to reports, the All India Institute of Medical Sciences (AIIMS) in New Delhi is likely to submit a proposal to the Institute of Ethics Committee to start Phase 3 clinical trials.
Hyderabad-based Bharat Biotech had received approval for Phase 3 trials on October 22.?
"The proposal is being prepared for the Phase 3 trials and within a couple of days we will be submitting it to the institute of ethics committee for approval," Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi told Hindustan Times.
AIIMS Delhi is one of the 21 hospitals selected for the final-stage trials to be conducted across India.
Earlier this week, it was reported that a hospital in Bhubaneswar is also set to start the third phase of the human trial of the indigenous vaccine against COVID-19.
The search for a suitable vaccine for COVID-19 has almost come to the final stage, Dr. E Venkata Rao, Principal Investigator in the Covaxin human trial and Professor in the Department of Community Medicine at the Institute of Medical Sciences and SUM Hospital Bhubaneswar, said on Sunday.
IMS and SUM Hospital is among the 21 medical institutes selected across the country by the Indian Council for Medical Research (ICMR) where the third phase trial would be conducted.
The indigenous vaccine, being developed by ICMR and Bharat Biotech has received the approval of the Central Drugs Standard Control Organisation (CDSCO) for initiating the third phase trial. 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, Dr Rao said.
Like the previous phases, half of the volunteers would receive placebo and the remaining half would be administered Covaxin in this phase. Even health care 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 disease.
This comes as Bharat Biotech is eyeing the vaccine which is developed by ICMR to be ready for public use by the second quarter of 2021. The launch of 'Covaxin' can be expedited in case the government advances it through emergency use authorisation.
Dr Balram Bhargava, Director General (DG ) of the Indian Council of Medical Research (ICMR) had on Tuesday said that currently, three vaccines are in different stages of trial in India.
"There are three vaccine candidates in different stages of clinical testing- Covaxin has got approval for phase III trials, Cadila also progressing with phase-II trials & Serum is completing phase 2b trial and has an ongoing trial in Brazil, South Africa, and the US," said Dr Bhargava.?
