New Delhi: The data from the Phase 3 clinical trials of Bharat Biotech’s COVAXIN show that the vaccine against Covid-19 is 77.8% effective, in review by Subject Expert Committee (SEC).
The Subject Expert Committee (SEC) has reviewed Bharat Biotech’s data.
Earlier the Hyderabad-based coronavirus vaccine manufacturing company Bharat Biotech reportedly submitted the data from the Phase III clinical trials of COVAXIN to Drugs Controller General of India (DCGI) over the weekend, as per government sources.
Bharat Biotech’s coronavirus vaccine, COVAXIN, is one of the only three vaccines which are currently being administered in India. The phase III trial data of its vaccine have been questioned numerous times over the past couple of months and that is why this makes the data vital which will ascertain the efficacy of the vaccine.
The Hyderabad-based company has manufactured the COVID-19 vaccine in association with the Indian Council of Medical Research (ICMR).
Meanwhile Bharat Biotech’s pre-submission meeting has been scheduled on June 23 for evaluation of the World Health Organisation (WHO)’s Emergency Use Listing (EUL) of its indigenous COVID-19 vaccine COVAXIN.
Last month, Bharat Biotech had informed that it had submitted 90 per cent of the documentation needed for WHO’s EUL.
The company added that it would submit the rest of the documents by this month.
The External Affairs Ministry is coordinating with Bharat Biotech to secure WHO recognition for the COVID-19 vaccine. COVAXIN is among three vaccines currently being administered in India against the COVID-19 pandemic.
On June 10, the US Food and Drug Administration (FDA) refused an emergency use authorization (EUA) to COVAXIN on the basis of inadequate data from clinical trials. The news was shared by Bharat Biotech’s US partner Ocugen, which stated they have decided to pursue a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN.