Bharat Biotech on April 1 announced the 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.
In a statement, the vaccine maker said it will focus on the pending facility maintenance, process and facility optimisation activities for the coming period.
The company said upgrades were due at all the existing facilities which were repurposed for the manufacture of Covaxin, with continuous production during the last year, to meet the public health emergency of COVID-19. However, the vaccine maker said “the quality of Covaxin was never compromised at any point in time.”
During the recent World Health Organization (WHO) post-EUL inspection, Bharat Biotech agreed with the WHO team on planned improvement activities and indicated that they will be executed as soon as practical.
The company said it was 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 the WHO, indicates the vaccine is effective and no safety concern exists”.
It further stated that “the vaccine is currently under the WHO Emergency Use Listing (EUL)”.
The 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 1 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 around 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, there is a strong justification for the WHO conclusions on Covaxin safety and efficacy, the company noted.
The Hyderabad-headquartered vaccine maker said that despite this safety and efficacy record, it is working for further improvements and upgrades to ensure that the production of Covaxin continues to meet global regulatory requirements.
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, the company added.
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
