Bharat Biotech announced on Friday a temporary decline in the production of its COVID-19 vaccine Covaxin across its manufacturing facilities, after fulfilling its delivery commitments to procurement agencies and anticipating a reduction in demand. The company, in a press release, says that Bharat Biotech will focus on ongoing plant maintenance, process and plant optimization activities for the coming period.
According to sources, the optimization of the facility was also “suggested” by a recently conducted inspection group from the World Health Organization. As all existing facilities were relocated for continuous production of Covaxin over the past year to meet the public health emergency, the upgrades were due, Bharat Biotech said.
Some very sophisticated equipment required to improve process severity was not available during the covid-19 pandemic. It must be emphasized that the quality of Covaxin was never compromised at any point, the company said. During the recent inspection of the World Health Organization after EUL (emergency use Authorization), Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be implemented as soon as possible, the release states.
“Despite this excellent safety and efficacy record, Bharat Biotech is working diligently on further improvements and upgrades to ensure that Covaxin production continues to meet ever-increasing global regulatory requirements. As patient safety is the primary factor for a new vaccine, there can be no compromises when it comes to meeting the goals of operational excellence, “said Bharat Biotech. This risk assessment by the WHO is based on the availability of hundreds of millions of doses of Covaxin globally, during which the product has shown an excellent safety and efficacy profile in detailed and accurate post-marketing monitoring activities.
More than one million doses of the vaccine were introduced during clinical trials, where the safety of subjects was actively documented. The vaccine was extensively evaluated in almost 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications. Based on data as well as a wealth of empirical evidence from India and globally, this is a strong justification for the WHO’s conclusions on the safety and efficacy of Covaxin, the vaccine manufacturer added.
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