Bharat Biotech to upgrade facility
The World Health Organisation (WHO) on Saturday suspended supply of Bharat Biotech’s COVID vaccine, Covaxin, to allow the manufacturer to upgrade facilities and address deficiencies found during an inspection last month.
A statement issued by the WHO said the suspension was in response to the outcomes of its post EUL (emergency use authorisation) inspection, held between March 14–22, 2022, and the need to conduct process and facility upgrades to address recently identified GMP (good manufacturing practice) deficiencies.
While there will be interruption in supply of Covaxin, the risk assessment to date does not indicate change in the risk-benefit ratio, the WHO said, adding that available data indicate the vaccine is effective and no safety concern exists.
‘Will meet standards’
In a statement issued on April 1, Bharat Biotech said it was fully committed to implementing facility improvements and upgrades to ensure that the production of Covaxin meets all global regulatory requirements.
“For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,” said the Company. It added that as a vaccine manufacturer safety is the primary consideration for any vaccine, and hence safety and efficacy will continue to be of paramount importance.
Announcing a temporary slowing down of Covaxin production for facility optimisation, the company said for the coming period, the company will focus on pending facility maintenance, process and facility optimisation activities.
While the company on Sunday said it did not have anything to add to the earlier statement, it said upgrades were due as all existing facilities were repurposed for the manufacture of Covaxin, with continuous production during the past year, to meet the public health emergency of COVID-19.
“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 noted.
It further explained that during the recent WHO post Emergency Use Listing Procedure (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 was also pleased to learn from the WHO, that the necessary optimization 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”.
Bharat Biotech further explained that 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. As per the Company more than a million doses of Covaxin were introduced under clinical trial mode, where safety of subjects was actively documented.
(With inputs from PTI)
