Rohtak (Haryana) [India], November 19 (ANI): Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, hopes to get 1,000 healthy volunteers by Thursday for the third-phase trial of Bharat Biotech‘s COVID-19 vaccine candidate, Covaxin, that will begin from Friday, Vice-Chancellor OP Kalra said on Wednesday.
“We are hoping to get 1,000 healthy volunteers by Thursday. Of them, 200 volunteers will be administered the Covaxin initially so that we get to know about their antibody response earlier. There are three centers in the country where antibody response are studied. If the response is good in 600 volunteers, then ICMR will take permission for market authentication so that mass production can be done,” Kalra said.
He added the lower age limit for volunteers is 18 years, while there is no upper age limit in this phase. “In the third phase, even diabetes, high blood pressure or kidney disease patients can register as volunteers.”
He further said, “Two doses will be injected to each volunteer. The second dose will be administered after 28 days of giving the first dose, and the response of antibodies will be studied after 42 days. If it is found to be satisfactory, then by February and March we can have mass production of the vaccine. Its efficacy should be more than 90 per cent.”
About the first two phases, he said that there were either no side effects or minimum side effects like pain in the area where the injection was applied or a slight fever.
He suggested following COVID-appropriate behaviors like using masks, sanitisers and maintaining social distancing till a vaccine is available.
Meanwhile, Haryana Health Minister Anil Vij has offered to become the “first volunteer” for the Phase-III clinical trial of Bharat Biotech‘s COVID-19 vaccine.
“Trial for the third phase of Covaxin a coronavirus vaccine product of Bharat Biotech to start in Haryana on 20th November. I have offered myself as first volunteer to get vaccinated,” Vij tweeted.
Apart from PGIMS, ESIC hospital in Faridabad has also been identified in Haryana where the trials will be conducted, as per Bharat Biotech‘s statement.
In October, the Drugs Controller General of India gave permission to Bharat Biotech for conducting the Phase-III clinical trial for Covaxin.
Anil Vij offers to be ‘first volunteer’ for Phase-III trial of Covaxin in Haryana
New Delhi [India], November 18 (ANI): Haryana Health Minister Anil Vij has offered to become the “first volunteer” for Phase-III clinical trial of Bharat Biotech‘s COVID-19 vaccine ‘Covaxin’, which will begin in Haryana from November 20.
“Trial for third phase of Covaxin a coronavirus vaccine product of Bharat Biotech to start in Haryana on 20th November. I have offered myself as first volunteer to get vaccinated,” Vij tweeted.
Volunteers who wish to participate in this trial should be adults over 18 years of age.
In Haryana, Pandit Bhagwat Dayal Sharma University of Health Sciences in Rohtak and ESIC hospital in Faridabad have been identified among those sites across India where trials will be conducted, as per Bharat Biotech‘s statement.
In October, the Drugs Controller General of India (DCGI) gave permission to Bharat Biotech for conducting Phase-III clinical trial for Covaxin.
“The DCGI thoroughly analyzed recommendation of the Subject Expert Committee for Bharat Biotech COVID-19 vaccine. On Friday, the top drug regulator granted approval to the pharma giant to conduct phase III clinical trial in India for Covaxin,” a government official had said.
According to the Subject Expert Committee (SEC), on October 5, the firm presented their data from the phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven phase III clinical trial to assess the efficacy of the vaccine.
Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for a country-made COVID-19 vaccine using the virus strain isolated by ICMR’s National Institute of Virology (NIV) based in Pune.
The Phase III trials will involve 26,000 volunteers across India, the company said.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive COVAXINâ„¢ or placebo. The trial is double-blinded, such that the investigators, the participants, and the company will not be aware of who is assigned to which group.
COVAXIN has been evaluated in 1000 subjects in Phase I and Phase II clinical trials, with “promising safety and immunogencity data”. (ANI)
