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bharat biotech: As demand dips, Bharat Biotech slows Covaxin output for maintenance in Hyderabad | Hyderabad News
HYDERABAD: Bharat Biotech on Friday announced the temporary slowing down of production of its Covid-19 vaccine Covaxin across its manufacturing facilities as it has completed its supply obligations. The company also said that it expected a decrease in demand for the indigenous vaccine.
The Hyderabad-based vaccine maker said that for the coming period, the company will focus on pending facility maintenance, process and facility optimisation. Sources said that the company had hit a peak of about 8 crore doses of Covaxin every month in early 2022.
“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, these upgrades were due,” the company said in a statement. “Certain highly sophisticated equipment, which were required to enhance the process stringency, were unavailable during the pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time,” Bharat Biotech said.
So far, over 30.78 crore doses of Covaxin have been administered in India to those aged 15 years and above under the government’s Covid-19 vaccination drive.
The company also pointed out that during the recent World Health Organisation (WHO) post EUL (emergency use listing) inspection in March this year, it had agreed with WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as it was practical to do so.
Bharat Biotech said it had learnt from 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” and that WHO had further stated that “the vaccine is currently under the WHO 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. More than 1 million doses of Covaxin were introduced under clinical trial mode, where safety of subjects was actively documented,” it pointed out.
The company added that it was working on further improvements and upgrades to ensure that Covaxin production continues to meet the 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. For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety,” it added.
The Hyderabad-based vaccine maker said that for the coming period, the company will focus on pending facility maintenance, process and facility optimisation. Sources said that the company had hit a peak of about 8 crore doses of Covaxin every month in early 2022.
“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, these upgrades were due,” the company said in a statement. “Certain highly sophisticated equipment, which were required to enhance the process stringency, were unavailable during the pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time,” Bharat Biotech said.
So far, over 30.78 crore doses of Covaxin have been administered in India to those aged 15 years and above under the government’s Covid-19 vaccination drive.
The company also pointed out that during the recent World Health Organisation (WHO) post EUL (emergency use listing) inspection in March this year, it had agreed with WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as it was practical to do so.
Bharat Biotech said it had learnt from 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” and that WHO had further stated that “the vaccine is currently under the WHO 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. More than 1 million doses of Covaxin were introduced under clinical trial mode, where safety of subjects was actively documented,” it pointed out.
The company added that it was working on further improvements and upgrades to ensure that Covaxin production continues to meet the 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. For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety,” it added.
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