On Saturday, the World Health Organization (WHO) suspended the procurement of India’s Bharat Biotech COVID-19 vaccine Covaxin by United Nations (UN) agencies due to concerns over a deficient manufacturing process.
WHO suspends the supply of Bharat Biotech's Covaxin to UN procurement agencies citing good manufacturing practices deficiencies.
— Runjhun Sharma (@Runjhunsharmas) April 2, 2022
“This suspension is in response to the outcomes of WHO post EUL [Emergency Use Lifting] inspection (March 14-22) and the need to conduct process and facility upgrade to address recently identified GMP [Good Manufacturing Practice] deficiencies,” the WHO said.
The Organization also urged countries that have already received the vaccines to take appropriate action but failed to specify what this might entail. In addition, the WHO warned of supply disruption amid the suspension of the product for exports.
The press release said that Bharat Biotech has committed to abiding by the outcomes of the inspection by addressing the GMP deficiencies and developing a “corrective and preventive action plan” for the Drugs Controller General of India (DCGI) and the WHO. The company has vowed to suspend the production of Covaxin for exports until then.
The statement also indicated no change in the risk-benefit ratio and deemed the vaccine effective with no apparent safety concerns.
On Friday, the Indian vaccine manufacturer said that it is fully committed to improving the facility and upgrading the production of vaccines to meet global regulatory requirements. “For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,” the company added.
Reacting after the World Health Organization (WHO) suspended supplies of Covaxin through United Nations agencies, Bharat Biotech said, "Received some feedback, will do those modifications. WHO has said nothing related to safety or efficacy."
— ANI (@ANI) April 4, 2022
Furthermore, Bharat Biotech stated that it will be reducing the production of Covaxin amid reduced demand due to a fall in infections and a wider immunisation campaign. “For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities,” it added.
Bharat Biotech today announced the temporary slowing down of production of COVAXIN across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand: BharatBiotech pic.twitter.com/URkHLDh4VC
— ANI (@ANI) April 1, 2022
On Sunday, the company mentioned that upgrades were due for all of its facilities. The company noted, “Certain highly sophisticated equipment that were required to enhance the process stringency were unavailable during the COVID-19 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time.”