The subject expert committee recommended Covaxin for emergency use approval (EUA) on Saturday, a day after it advised EUA to the Serum Institute of India which is manufacturing the Oxford-based vaccine – Covishield.
Although the Drugs Controller General will take the final call, the recommendation of Covaxin comes despite lack of efficacy data and with Phase III trials only half over.
Hyderabad-based Bharat Biotech has already announced successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the Phase-3 clinical trial of its COVID-19 vaccine candidate Covaxin across multiple sites in India.
It is to be noted that COVAXIN has been recommended for “restricted use in the emergency in the public interest” by a government-appointed panel, which submitted its findings to the Drugs Controller General of India on Saturday evening.
Interim findings of Phase I trials showed Covaxin induces an immune response and registers no serious side effects. Phase II trial data showed “tolerable safety outcomes” and suggested antibodies may persist for six to 12 months.
Restricted use approval is normally only granted if there is sufficient evidence to suggest the drug is both safe and effective.
Earlier Union minister Prakash Javadekar on Saturday said India is perhaps the only country that is getting ready with four vaccines against Covid-19.
The United Kingdom has given the nod to Pfizer and AstraZeneca vaccine. The United States has approved the emergency use of Pfizer. But India, as it already has three applications, is likely to get more than one vaccine for emergency use, the minister said.