Bharat Biotech on Friday announced a temporary slow-down of production of its COVID-19 vaccine Covaxin across its manufacturing facilities. The Hyderabad based pharmaceutical company said that having completed its supply obligations to procurement agencies, it is foreseeing a decrease in demand.
For the coming period, the company will focus on pending facility maintenance, process and facility optimisation activities, Bharat Biotech said in a statement.
As all existing facilities were repurposed for the manufacturing of Covaxin, with continuous production during the past year, to meet the public health emergency of COVID-19, these upgrades were due.
Certain highly sophisticated equipment which 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 statement said.
During the recent World Health Organization (WHO) post Emergency Use Listing (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.
The company said, it was also pleased to learn from the WHO, that the necessary optimisation work "does not indicate a change in the risk-benefit ratio (for Covaxin) and the data, available to WHO indicates the vaccine is effective and no safety concern exists". The WHO has further stated that "the vaccine is currently under the WHO Emergency Use Listing (EUL)".
"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," Bharat Biotech said.
More than one million doses of Covaxin were introduced under the clinical trial mode, where the safety of subjects was actively documented. Finally, Covaxin was extensively evaluated in about 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications.
"Based on this wide body of data as well as a wealth of empirical evidence from India and globally, this is a strong justification for the WHO conclusions on Covaxin safety and efficacy. 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," the company said.
"Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives," it added.
Bharat Biotech further said that for the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on the efficacy and safety of the vaccine.
"Bharat Biotech is fully committed to implementing the facility improvements and upgrades to ensure that the production of Covaxin meets all global regulatory requirements. As a vaccine manufacturer safety is the primary consideration for any vaccine, and hence safety and efficacy will continue to be of paramount importance," the company statement said.
Bharat Biotech said that it strongly affirms that continued usage of Covaxon is beneficial in the fight against COVID-19 globally.
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