The Brazilian health regulator Agencia Nacional de Vigilancia Sanitari (ANVISA) has denied permission to import Bharat BioTech’s Covaxin into the country due to issues related to its manufacturing process.
According to the reports, Covaxin had failed to meet the requirements of the Current Good Manufacturing Practice (CGPM). If the issues are not rectified, it can harm the quality of the vaccine which can endanger the lives of the recipients, ANVISA said in its statement.
A major issue raised by the regulator is that since Covaxin is an inactivated vaccine, the company has to ensure that the virus was completely killed. Otherwise, they fear that live SARS-CoV-2 viruses might be present in the vaccine.
According to a report by The Wire Science, Bharat Biotech had failed to comply with manufacturing standards, including not adhering to demands for documentation and maintaining the integrity of containers and methods of analysis.
The action plan submitted by the company to the regulator has failed to impress ANVISA and has been declared insufficient in the face of quality issues.
“The requirements pointed out during inspection will be fulfilled, the timelines for fulfillment are under discussion with the Brazil NRA and will be resolved soon,” the Hyderabad-based pharma company stated in response to the issue.
The company in partnership with Precisa Medicamentos has an agreement with the Brazilian government to supply 20 million doses of the vaccine.