Long-awaited data of Bharat Biotech’s Covid-19 vaccine Covaxin has demonstrated a 77.8% efficacy in Phase III trials.
The Subject Expert Committee (SEC) met on Tuesday to review the data but has not yet approved it.
The SEC will now send the data to the Drugs Controller General of India (DCGI) for review.
According to the data submitted, Covaxin demonstrated an efficacy of 77.8% during the trial, which was conducted on 25,800 subjects.
The data comes just in time for Bharat Biotech’s 23 June meeting with the World Health Organization (WHO), where it is expected to submit its proposal for an Emergency Use Listing (EUL) for Covaxin.
On 18 June, the WHO accepted the Hyderabad-based company’s Expression of Interest for Covaxin to get EUL.
Last month, the firm stated that it expects to receive EUL approval for Covaxin between July and September.
EUL is the procedure to streamline the process so that new or unlicensed products can be used during public health emergencies like the Covid-19 pandemic.
The EUL would make it more straightforward for Covaxin – India’s first homegrown vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – to get approvals in other countries.
The sharing of the Phase III data comes after months of controversy following the vaccine’s restricted-use approval from India’s leading drug regulator, the Central Drugs Standard Control Organization (CDSCO) in January when no such data was available.