Bharat Biotech said on Friday it is temporarily slowing down production of its COVID-19 vaccine Covaxin at its manufacturing units for facility optimization, as it has already met its supply obligations to procurement agencies and plans a drop in demand. The company further stated that after the recent WHO Emergency Use List (EUL) post inspection, it is working on further improvements and upgrades to ensure Covaxin production continues to meet. ever-increasing global regulatory requirements.
“For the coming period, the company will focus on maintenance, process and standby plant optimization activities,” Bharat Biotech said in a statement. With all existing facilities repurposed to manufacture Covaxin, with continued production over the past year to respond to the COVID-19 public health emergency, these upgrades were due, the company added. “Certain highly sophisticated equipment that was needed to improve the rigor of the process was unavailable during the COVID-19 pandemic. It must be emphasized that the quality of Covaxin has never been compromised at any time,” he declares.
Bharat Biotech further stated during the recent WHO inspection after the emergency use list, that it agrees with the World Health Organization (WHO) team on the scope planned improvement activities and indicated that they will be carried out as soon as possible. “The company was also pleased to learn from the WHO that the necessary optimization work” does not indicate a change in the benefit-risk ratio (for Covaxin) and that the data, available to the WHO, indicates that the vaccine is effective and has no safety issues. exists,’” he added.
The WHO further stated that the vaccine is currently under its Emergency Use List (EUL), she added. This WHO risk assessment is based on the supply of hundreds of millions of doses of Covaxin worldwide, during which the product demonstrated an excellent safety and efficacy profile in post-marketing surveillance activities detailed and thorough, the company said.
Over one million doses of Covaxin have been entered into clinical trial mode, where subject safety has been actively documented. Finally, Covaxin has been extensively evaluated in approximately 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications. “Based on this large data set as well as a wealth of empirical evidence from India and around the world, this is a strong rationale for the WHO conclusions on safety and efficacy of Covaxin,” he added.
Read also :