The Drug Controller General of India (DCGI) on Tuesday accepted the 77.8% efficacy of Bharat Biotech’s Covaxin in the Phase-3 trials, reports fe Bureau in Pune. BB had submitted the data to the DCGI over the weekend and the Subject Expert Committee (SEC) reviewed the data at a meeting held on Tuesday.
With the SEC making its recommendation, the final approval from DCGI is awaited. However, BB has not confirmed the developments. BB is slated to hold its pre-submission meeting with the WHO on Wednesday, as part of the process to get an approval for the emergency use listing of the vaccine.
The vaccine maker has demonstrated clinical efficacy of 78-100% against severe Covid-19 disease, in the interim results, from the Phase-3 trials. The Phase-3 study enrolled 25,800 participants between 18-98 years, including 10% over the age of 60, with the analysis conducted 14 days after the second dose.
Covaxin was developed with seed strains received from the National Institute of Virology and the Phase-3 clinical trials have been co-funded by the Indian Council of Medical Research (ICMR).
