In a positive development for India's fight against COVID-19 pandemic, the Hyderabad based Bharat Biotech International Limited (BBIL) has begun the third phase of clinical trials for its COVID-19 vaccine candidate COVAXIN, reports Livemint.
The third phase of the trials will witness enrolment of as many as 26,000 participants for the assessment of the vaccine candidate's efficacy and will also mark the largest such efficacy trial ever conducted in the nation.
The trials will take place at 25 sites across the country, and the participants will be receiving two intramuscular injections of COVAXIN about 28 days apart. Eight of these sites have already received the approval from concerned ethics committees for conducting the trials. The ethics committees monitor whether the trial conducted at a site is meeting the ethics and the study protocols.
The primary objective of the trial will be to see if the two-dose shot can prevent a patient from developing symptoms of COVID-19. The secondary objective will be to measure how effective the vaccine is in avoiding severe symptoms of the disease and death in a patient.
It should be noted that under the first and second phase trials, COVAXIN has been evaluated in 1,000 participants and, according to the company, the results have shown promising safety and immunogenicity data.
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