Bharat Biotech on Friday 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.
"For the coming period, the company 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," Bharat Biotech said.
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, it said.
During the recent WHO post-EUL inspection, Bharat Biotech 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 the 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)".
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.
"More than 1 million doses of COVAXIN were oriented under the clinical trial mode, where the safety of subjects was actively documented. Finally, COVAXIN has been extensively evaluated in 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications. Based on this wide body of data as well as a wealth of empirical evidence from India and globally, this is a strong justification for the WHO conclusions on COVAXIN safety and efficacy," Bharat Biotech said.
"Notwithstanding this excellent safety and efficacy record, Bharat Biotech is diligently working to further improvements and upgrades to ensure that the production of COVAXIN continues to meet ever-increasing global regulatory requirements. Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives," it said.