COVID-19 vaccine tracking: Phase III clinical trials commence for Bharat Biotech’s COVAXIN
Phase III clinical trials: Hyderabad based pharma giant, Bharat Biotech has announced of beginning phase III clinical trials of India’s first indigenous Covid-19 vaccine, COVAXIN. This phase will include 26,000 volunteers across 25 centres in India and is to be conducted in collaboration with the ICMR (Indian Council of Medical Research). This will make COVAXIN phase 3 trial the largest to be done in India for Covid-19 vaccine and also the first for Indian vaccine for coronavirus.
COVAXIN is an inactivated virus and highly purified vaccine which is being developed by Bharat Biotech in collaboration with ICMR.
The trial will include volunteers being inoculated with two intramuscular shots 28 days apart. The participants will be given random shots of a placebo or COVAXIN in a 1:1 ratio. The COVAXIN dose will be titrated to 6 mcg in each injection. The trial is double blinded, which means neither the investigators nor the participants will be aware of who has been administered with which shot. Participants are required to be over 18 years of age. COVAXIN was evaluated in around 1000 participants in phase I and II trials, and showed promising safe and efficient results of immunogenicity data.
The volunteers will be monitored over next year to detect occurrence of Covid-19 infection, company sources reveal.
Suchitra Ella, Bharat Biotech’s joint managing director said, “The development and clinical evaluation of COVAXIN marks a significant milestone for vaccinology in India for a novel vaccine. COVAXIN has garnered interest from several countries worldwide for supplies and introduction.”
The vaccine is being manufactured at a BSL-3 (Biosafety level 3) high containment facility in Bharat Biotech’s vero cell manufacturing platform.
The next big challenge that lays for government, pharma companies and healthcare professionals is making the vaccine available across India to all people and also make them willing to take the vaccine.