Hyderabad: After the vaccine manufacturer Bharat Biotech provided additional data sought by World Health Organization (WHO), Covaxin has inched a step closer to WHO’s emergency use listing (EUL) with the global body accepting manufacturer’s expression of interest (EoI) for the inactivated vaccine.
The pre-submission meeting of the Indian 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 website. 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 media.
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 US 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.
He 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.
“The good thing is that we already have several WHO prequalified vaccines. It’s not like a new company going for WHO prequalification. All our QC, QA, everything is audited already for our other vaccines… so when they come, they make an assessment of everything, almost. They look at the quality management systems, quality control, engineering, warehouse, everything,” the official said.
“The vero cell line that we are using for Covaxin is the same line that we use for the Rotavirus vaccine also. WHO has already seen it and our QC labs, water systems, everything has been audited and approved by WHO (for the other vaccines),” he added.