- The Phase 3 trials for COVAXIN will involve 26,000 volunteers across India
- Volunteers will receive two intramuscular injections about 28 days apart
- COVAXIN(tm) is a highly purified and inactivated vaccine
Hyderabad: Bharat Biotech announced the commencement of Phase III trials of COVAXIN on Monday (November 16). The Phase III trials will involve 26,000 volunteers across India and will be conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India. This is India’s first phase 3 efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India. The trial has been registered at www.ctri.nic.in (CTRI/2020/11/028976) and approved by the Drugs Controller General of India.
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Trial volunteers will receive two intramuscular injections about 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 about 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be adults over 18 years of age.
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COVAXIN(tm), India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility. COVAXIN(tm) is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.
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Suchitra Ella, joint managing director of Bharat Biotech said,
The development and clinical evaluation of COVAXIN(tm) marks a significant milestone for vaccinology in India. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. COVAXIN(tm) has garnered interest from several countries worldwide for supplies and introduction.
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(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.