New Delhi: Bharat Biotech said on Friday that production of its COVID-19 vaccine Covaxin would be temporarily slowed across its manufacturing locations, as it has fulfilled its supply obligations to procurement agencies and anticipates a drop in demand.
In a press statement, the company stated that for the time being, Bharat Biotech will focus on pending facility maintenance, process, and facility optimization efforts, news agency PTI reported.
According to reports, a recent World Health Organization inspection team “suggested” the facility optimization.
“As all existing facilities were repurposed for the manufacture of Covaxin with continuous production over the past year to meet the public health emergency, the upgrades were due,” Bharat Biotech was quoted by PTI in its report.
“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,” the company said.
During a recent post-EUL (emergency use authorisation) inspection by the World Health Organization, Bharat Biotech agreed with the WHO team on the scope of the planned improvement actions and stated that they will be carried out as soon as feasible, according to the statement.
“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,” Bharat Biotech said.
WHO’s risk assessment is based on the global distribution of hundreds of millions of doses of Covaxin, during which time the product has exhibited a good safety and effectiveness profile in extensive post-marketing surveillance.
More than one million doses of the vaccine were given out as part of a clinical experiment, with the participants’ safety being closely monitored. In over 30,000 people, the vaccine was tested in more than ten controlled clinical studies, resulting in more than 15 publications.
This is a good explanation for WHO’s judgments on Covaxin’s safety and efficacy, according to the vaccine producer, based on the data as well as a plethora of empirical information from India and throughout the world.
(With PTI Inputs)
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