Mar, 2021 - By WMR
In a collaboration with a medical research team of the Indian government, Bharat Biotech has reported the results of its Phase 3 clinical trials on March 03, 2021.
The Indian bio-tech company, Bharat Biotech, which has been developing the country’s first COVID-19 vaccine, Covaxin, has announced the outcome of its Phase 3 trials in partnership with Indian Council of Medical Research (ICMR) to propel the national inoculation drive in India. The Hyderabad-based company has claimed that the Covaxin has an interim efficacy of 81% against the new variants of COVID-19 virus.
The first interim analysis was conducted on reported 43 COVID-19 patients out of the total 25,000 participants with the age-group of 18 to 98 years. Around 36 patients from the 43 reported cases were given a fake shots of vaccine dosage while the remaining 7 patients were inoculated with Bharat Biotech’s Covaxin. Initial guidelines of the safety measures were included in this interim analysis which displayed the health status of the patients from severe to mild condition of the participants. The trial was executed securely as per the guidelines of Good Clinical Practice. The measured results showed the efficacy rate of over 80% against the new mutations of COVID-19 virus. The company said that more trials will be conducted on 130 infected participants to get further information on the effectiveness of Covaxin.
The Indian government had approved the vaccine maker’s Covaxin in January without disclosing vaccine’s efficacy rate of its final-stage trials, thus raising the concerns over the vaccine’s functionality. The inoculation plan of India is mainly initiated by the home-grown Bharat Biotech and a foreign aid from British pharmaceutical company, AstraZeneca and the Oxford University. The Prime Minister of India, Narendra Modi had received the first Covaxin dosage earlier this week.