The benefits of a WHO approval for Bharat Biotech’s Covid-19 vaccine, dubbed Covaxin, include easier international travel for Indians and vaccine export. The international health body is expected to approve the vaccine this week, according to reports.
Covaxin and Covishield – the AstraZeneca Covid-19 vaccine manufactured by the Serum Institute of India – were the two vaccines with which India began its vaccination campaign on January 16. While Covishield has received WHO approval, Covaxin has not, making international travel difficult for those who have received the homegrown vaccine.
In May, Bharat Biotech submitted an application to the World Health Organization (WHO) in Geneva for an emergency use listing (EUL). Bharat Biotech and WHO met for a pre-submission meeting on June 23. The dossier will be complete and taken up for review by the health body once Bharat Biotech submits the entire Covaxin Phase-3 clinical trials data, according to a senior official at the Hyderabad-based pharma company quoted by Times of India. The company expects to start the review process for Covaxin’s EUL application in July, after the efficacy study data is submitted, according to the official.
Business Today in a report on September 1 had said a WHO panel would convene in the week to assess Covaxin’s application for emergency use listing, which will allow persons immunised with Bharat Biotech’s vaccine to travel freely. The WHO panel will evaluate Covaxin’s immunogenicity, vaccine safety, and vaccine effectiveness, the report had said. The homegrown company had submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO).
“All documents required for emergency use listing (EUL) of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from the WHO at the earliest,” Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech had earlier said.
‘Insufficient Information’: The US Food and Drug Administration had also earlier declined to approve Covaxin. The FDA has stated that there is “insufficient information” on Covaxin to issue its emergency use authorization request for this vaccine.