Bharat Biotech on April 1 announces a temporary launch of Covid-19 vaccine production in all its manufacturing facilities, after completing its supply obligations to the procurement agency and estimating demand decline.
In a statement, vaccine makers said they would focus on maintenance activities, processes and optimization of delayed facilities for the coming period.
The company said the upgrade was due to all existing facilities taken back for the manufacture of Covaxin, with sustainable production during the past year, to meet the Emergency of Public Health Covid-19. However, vaccine makers say “Covaxin quality has never been compromised at any time.”
During the recent World Health Organization (WHO) inspection, Bharat Biotech agreed with the WHO team about planned improvement activities and showed that they would be executed as fast practically.
The company said he was happy to learn from WHO that the required optimization work “did not show changes in the risk-benefit ratio (for covaxin) and data, available for WHO, showing this vaccine was effective and there was no security problem there”.
Furthermore, it states that “the vaccine is currently under the list of emergency use WHO (EUL)”.
Risk assessment by WHO is based on the supply of hundreds of millions of covaxin doses globally, where the product has shown excellent safety and efficacy profiles in detailed and thorough post-marketing supervision activities, Bharat Biotech said.
More than 1 million Covaxin doses are introduced under clinical test mode, where the security of the subject is actively documented. Finally, Covaxin is widely evaluated in around 30,000 subjects in more than 10 controlled clinical trials, producing more than 15 publications. Based on this extensive data and many empirical evidence from India and globally, there is a strong justification for the conclusion of WHO about the safety and efficacy of Covaxin, the company notes.
Hyderabad’s center vaccine maker said that despite the recording of this safety and efficacy, it worked for further improvement and an increase to ensure that Covaxin production continued to meet the requirements of global regulations.
For millions who have received Covaxin, the vaccine certificate incurred is still valid because there is no impact on the efficacy and security of vaccines, the company added.
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