Highlights
- Phase 3 trials of Covaxin will involve thousands of volunteers
- Volunteers to be observed for a sizeable period to look at vaccine efficacy
- Health workers will be recruited for phase 3 trial of Covaxin: Researcher
Bhubaneswar: The third phase human trial of indigenously developed COVID-19 vaccine ‘Covaxin’ will soon commence at the Institute of Medical Sciences (IMS) and SUM Hospital in Odisha. IMS and SUM Hospital is in the list of 21 medical institutes selected across the country by the Indian Council for Medical Research (ICMR) where the third phase trial would be conducted. It is the only institute in Odisha which has been selected for the trial.
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Speaking about the third phase, Dr E Venkata Rao, Principal Investigator in the Covaxin human trial and Professor in the Department of Community Medicine at IMS and SUM Hospital said that 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 added.
He said the volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine.
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, he said.
Dr Rao added that there had been a huge response and enthusiasm among people who had offered themselves to be volunteers for the trial.
The interested volunteers for the project could enroll themselves for the trial by registering online at www.ptctu.soa.ac under the section register for clinical trials, he said.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene.
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