Over 1 Million Doses of Covaxin Introduced in Clinical Trial Mode
New Delhi:
Bharat Biotech said on Friday that it is temporarily slowing production of its COVID-19 vaccine Covaxin at its manufacturing units for facility optimization as it has already fulfilled its supply commitments to procurement agencies and expects a decline in demand.
The company further said that following the recent WHO inspection after Emergency Use Listing (EUL), it is working on further improvements and upgrades to ensure production of Covaxin continues to comply with ever-increasing global regulatory requirements.
“For the foreseeable future, the company will focus on ongoing activities in facilities maintenance, process and optimization,” Bharat Biotech said in a statement. As all existing facilities were repurposed to produce Covaxin, with continuous production over the past year to meet the public health emergency of COVID-19, these upgrades had to be made, the company added.
“Certain highly advanced equipment needed to improve the rigor of the process was not available during the COVID-19 pandemic. It should be emphasized that the quality of Covaxin has not been compromised at any time,” it said.
Bharat Biotech further said that during WHO’s recent inspection following the Emergency Use Listing inspection, it agreed with the World Health Organization (WHO) team on the scope of the planned improvement activities and indicated that they will be implemented as soon as possible. .
The company was also pleased to learn from WHO that the necessary optimization work ‘does not indicate a change in the risk-benefit ratio (for Covaxin) and the data available to WHO indicate that the vaccine is effective and does not pose any safety concerns. ‘” it added.
The WHO has further stated that the vaccine is currently under the Emergency Use Listing (EUL), it added.
This WHO risk assessment is based on the delivery of hundreds of millions of doses of Covaxin worldwide, with the product demonstrating an excellent safety and efficacy profile in detailed and thorough post-marketing surveillance activities, the company claimed.
More than 1 million doses of Covaxin were introduced in the clinical trial mode, actively documenting the safety of subjects. Finally, Covaxin was extensively evaluated in approximately 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications.
“Based on this extensive amount of data and a wealth of empirical evidence from India and worldwide, this strongly supports the WHO conclusions on the safety and efficacy of Covaxin,” it added.
Despite this excellent track record of safety and efficacy, Bharat Biotech said it is “working diligently on further improvements and upgrades to ensure production of Covaxin continues to meet ever-increasing global regulatory requirements”.
Since patient safety is the number one consideration for any new vaccine, there can be no compromises in meeting operational excellence goals, the company noted.
As a vaccine manufacturer, safety is the primary consideration for any vaccine, and therefore safety and efficacy will remain paramount.
The company strongly affirms that the continued use of Covaxin is beneficial in the global fight against COVID-19, the company said.
