The World Health Organisation said on Saturday it has suspended supply through United Nations agencies of COVID-19 vaccine?Covaxin, produced by India's Bharat Biotech, to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection. Bharat Biotech on Friday announced temporary slowing down of production of its COVID-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing a decrease in demand.
The company, in a press release, said Bharat Biotech will focus on pending facility maintenance, process and facility optimisation activities for the coming period.
According to sources, the facility optimisation was also "suggested" by a recent World Health Organisation inspection team.
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 said.
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 the recent World Health Organisation's post EUL (emergency use authorisation) 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 possible, the release said.
"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.
This risk assessment by 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 one million doses of the vaccine were introduced under clinical trial mode, where safety of subjects was actively documented. The vaccine was extensively evaluated in nearly 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications.
Based on the data as well as a wealth of empirical evidence from India and globally, this is a strong justification for WHO's conclusions on Covaxin's safety and efficacy, the vaccine maker added.