Covaxin inches closer to emergency use listing as WHO accepts Bharat Biotech’s expression of interest

HYDERABAD: Covaxin has inched a step closer to a World Health Organization (WHO) emergency use listing (EUL) with the global body accepting Bharat Biotech’s expression of interest (EoI) for the inactivated vaccine after it provided additional data sought by WHO.
The pre-submission meeting of the vaccine maker with WHO officials is now planned for June 23 as per the latest WHO EUL guidance document dated June 16, uploaded on the WHO site. However, Covaxin’s dossier would be complete and taken up for review by WHO only after the company submits the entire phase-3 clinical trials data, a senior Bharat Biotech official told TOI.
An interim analysis of Covaxin’s Phase-3 trials, conducted on 25,800 volunteers across India, had indicated an overall efficacy of 78%.
An interim analysis of Covaxin’s Phase-3 trials, conducted on 25,800 volunteers across India, had indicated an overall efficacy of 78%. Bharat Biotech is now conducting a phase-3 study on 4,500 volunteers in Brazil and will be conducting a trial in the United States as well as part of its decision to take the Biologics Licence Application (route) for that market.
WHO’s seal of approval would be a major booster for the desi vaccine that has found itself mired in controversy ever since the Drugs Controller General of India (DCGI) granted an emergency use nod on January 3 this year while its phase-3 trials were under way.
A WHO EUL would open the doors of several countries for the desi vaccine and put to rest concerns about travel restrictions being imposed on those who have taken jabs not yet approved by WHO. Several countries have been mulling the vaccine passport concept, with Israel and seven European Union (EU) nations — Bulgaria, Croatia, Czech Republic, Denmark, Germany, Greece and Poland — already putting in place vaccine passport systems, even as EU is gearing up to implement the system from July 1.
“We’ve been in discussions with the WHO prequalification team and they know exactly what we are doing and what status we are in,” said the top official at Bharat Biotech, which had earlier said that it expects the EUL in the July- September quarter this year.
The official indicated that based on the first feedback that the company received from WHO, a nod may not be a long-drawn process as the cell line and a majority of the company’s facilities, including filling lines, have already been audited and approved by WHO for other vaccines like Typhoid, Polio and Rotavirus.