- COVAXIN has been evaluated in 1,000 subjects in Phase I and Phase II
- The Phase III trials will involve 26,000 volunteers across India: Company
- Anil Vij offered to be the first volunteer for the phase-3 trial of Covaxin
Ambala: Haryana Health Minister Anil Vij was administered a trial dose of Bharat Biotech’s COVID-19 vaccine ‘Covaxin’ at a hospital in Ambala on Friday. “It is a matter of pride for India that a company of India has developed a vaccine for coronavirus. Two successful trials have been done and the third phase has begun today. I offer to be the first volunteer so that people without any fear can come forward for vaccination trials. If everything goes well, this vaccine will be in the market soon,” Mr. Vij told ANI.
He had offered to be the first volunteer for the third phase trial of Covaxin, which started in the state today.
I will be administered trial dose of Coronavirus vaccine #Covaxin a Bharat Biotech product tomorrow at 11 am at Civil Hospital, Ambala Cantt under the expert supervision of a team of Doctors from PGI Rohtak and Health Department. I have volunteered to take the trial dose, Mr. Vij tweeted on Thursday.
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 COVAXIN(tm) 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 1,000 subjects in Phase I and Phase II clinical trials, with “promising safety and immunogencity data”.
Also Read: Where Are We In The COVID-19 Vaccine Race?
(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.[corona_data_new]