This comes a day after Bharat Biotech announced the slowing down of its vaccine production for facility optimisation.
The World Health Organization (WHO) in a statement issued on April 2 confirmed the suspension of supply of Covaxin produced by Bharat Biotech, through UN procurement agencies and gave recommendation to the countries that received the vaccine to take actions as appropriate.
The suspension comes after an EUL inspection done from March 14 to March 22, 2022. “This suspension is in response to the outcomes of WHO post EUL inspection (14-22 March 2022) and the need to conduct process and facility upgrade to address recently identified GMP deficiencies. There will be interruption of supply of Covaxin due to suspension of production for export,” WHO said in its statement.
WHO added, “Bharat has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DCGI) and WHO. In the interim and as a precautionary measure, Bharat has indicated its commitment to suspend its production of Covaxin for export.”
The risk assessment to date does not indicate a change in the risk-benefit ratio. The data, available to WHO, indicates the vaccine is effective and no safety concern exists.
GMP deficiencies refers to good manufacturing practices deficiencies.
On April 1, the Indian vaccine manufacturer Bharat Biotech issued a statement announcing the “temporary slowing down of Covaxin production for facility optimisation“ across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing a decrease in demand. For the coming period, the company said they will focus on pending facility maintenance, process and facility optimization activities.
“As all existing facilities were repurposed for the manufacture of Covaxin, with continuous production during the past year, to meet the public health emergency of Covid-19, these upgrades were due. Certain highly sophisticated equipment which was required to enhance the process stringency was unavailable during the Covid-19 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time,” the statement said.
The company, in its statement, had said that they agreed with the WHO team on the ‘scope of the planned improvement activities’ and indicated that they will be executed as soon as practical.
“The company was also pleased to learn from WHO, that the necessary optimization work does not indicate a change in the risk-benefit ratio (for Covaxin) and the data, available to WHO, indicates the vaccine is effective and no safety concern exists. The WHO has further stated “The vaccine is currently under the WHO Emergency Use Listing (EUL),” the statement issued by the Indian vaccine manufacturer had said.
The company had said that for the millions who had received Covaxin, the vaccine certificates issued still stood valid as there was no impact on the efficacy and safety of the vaccine.
Bharat Biotech added, “This risk assessment by the WHO is based on the supply of hundreds of millions of doses of Covaxin globally, during which the product has demonstrated an excellent safety and efficacy profile in detailed and thorough post-marketing surveillance activities.”