More than 1 million doses of Covaxin were introduced under clinical trial mode
Bharat Biotech on Friday said it is temporarily slowing down production of its COVID-19 vaccine Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees decrease in demand.
The company further said after the recent WHO post Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.
"For the coming period, the company will focus on pending facility maintenance, process, and facility optimisation activities," Bharat Biotech said in a statement. As all the 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, the company added.
"Certain highly sophisticated equipment which 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," it said.
Bharat Biotech further said during the recent WHO post Emergency Use Listing inspection, it agreed with the World Health Organization (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 optimisation 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'," it added.
The WHO has further stated the vaccine is currently under its Emergency Use Listing (EUL), it 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, the company asserted.
More than 1 million doses of Covaxin were introduced under clinical trial mode, where safety of subjects was actively documented. Finally, Covaxin was extensively evaluated in around 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," it added.
Notwithstanding this excellent safety and efficacy record, Bharat Biotech said it 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, the company noted.
As a vaccine manufacturer, safety is the primary consideration for any vaccine, and hence safety and efficacy will continue to be of paramount importance.
The company strongly affirms that continued usage of Covaxin is beneficial in the fight against COVID-19 globally, it said.