02 April 2022 | News
As a vaccine manufacturer, safety is the primary consideration for any vaccine
Bharat Biotech has announced the temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand. For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities.
As all existing facilities were repurposed for the manufacture of the vaccine, with continuous production during the past year, to meet the public health emergency of COVID-19, these upgrades were due.
During the recent WHO post EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical.
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. 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 ~30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications.