Bharat Biotech temporarily slows down Covaxin production for facility optimisation
India Today
Bharat Biotech on Friday said that it was temporarily slowing down production of Covaxin for facility optimisation that will be required to ensure that production of vaccine continues to meet increasing global regulatory requirements.
Bharat Biotech on Friday announced it was temporarily slowing down production of its Covid-19 vaccine, Covaxin, across its manufacturing facilities for facility optimisation as it had already completed its supply obligations to procurement agencies and foresaw a decrease in demand.
"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 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 company said in the statement.
The company said that during the recent WHO post Emergency Use Listing (EUL) inspection, it agreed with the WHO team on the scope of the planned improvement activites and indicated that they will execute these changes ‘as soon as practical’.
The company further said that the World Health Organisation had conveyed to them that these activities would not change the risk-benefit ratio of the vaccine and that the vaccine was effective and no safety concerns existed. WHO stated “The vaccine is currently under the WHO Emergency Use Listing (EUL)”.
Bharat Biotech said that it was working on 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.
