The World Health Organization (WHO) has suspended the supply of Hyderabad based Bharat Biotech's Covaxin for export citing deficiencies in the Good Manufacturing Practices guidelines.
However, the suspension does not affect the safety and efficacy of the inactivated virus vaccine. The WHO clarified that the risk assessment ratio does not indicate change as the data available with them still suggests that the vaccine is effective.
The confirmed suspension comes a day after Bharat Biotech issued a statement that it was reducing its production capacity due to a foreseen decrease in demand for the vaccine.
WHO in a statement stated otherwise. Without highlighting the specific issues in manufacturing, the apex health body also warned countries that have received the vaccine to take appropriate action.
The suspension was announced after the WHO conducted its regular follow-up of facilities after providing Emergency Use Listing. The follow-up was carried out between March 14-22, 2022.
Covaxin received Emergency Use Listing on November 3, 2021 but only after a lot of back and forth with the agency. Even then, the WHO had questions about Bharat Biotech's manufacturing practices but did not specify to the media what it wanted Bharat Biotech to improve.
The vaccine made in collaboration with the Indian Council of Medical Research and National Institute of Virology continues to be a part of WHO's emergency use listing and India's vaccination program.
Bharat Biotech in their statement mentioned that they were complying with the WHO and improving their facilities to deliver to the needs of WHO. They said they would be sharing their updated results soon with the Drugs Controller General of India and the WHO.
In the statement, Bharat Biotech also said that upgrading of their equipment was long overdue, but owing to the continuous production capacities that they were meeting, machines were not available for updation.
The manufacturer stated that safety was of paramount importance to the company. They also said that they would work on and execute changes as soon as possible to meet the 'increasing global requirements'.
This is not the first time Covaxin's quality has been questioned. Covaxin was rejected by the US for not meeting its quality standards and was also suspended in Brazil for political and quality reasons.