Bharat Biotech says Covaxin made at its Malur, Ankleshwar facilities will be available from September - Moneycontrol

A file image of Covaxin.

Bharat Biotech on August 5 said Covaxin commercial batches will be rolled out from Malur, Karnataka, and Ankleshwar, Gujarat from September.

Both Malur and Ankleshwar plants were repurposed to produce Covaxin.

Bharat Biotech said it had supplied 70 million doses to date.

Currently, the entire production of Covaxin is done from Bharat Biotech’s Genome Valley facilities on the outskirts of Hyderabad, which has a capacity to produce about 10-12 million doses per month. The company said these facilities are fully audited and approved by regulatory authorities.

"Since early June, manufacturing of Covaxin has commenced at our sites at Malur, Karnataka, and Ankleshwar, Gujarat, prior to which engineering batches were also executed to study equipment functionality. Products manufactured from these facilities will be available for supplies during September. This is based on our 120-day timeline for manufacturing, testing, release, regulatory approvals, and distribution," Bharat Biotech said in a statement.

Allaying quality concerns

Bharat Biotech responding to certain reports circulating in social media raising questions on quality of Covaxin, clarified that the COVID-19 vaccine manufacturing, testing, and release follow validated, stringent GMP (good manufacturing practice) processes which were established over 20 years, with several billion doses of vaccines supplied within India and globally.

"Every batch of Covaxin is subjected to more than 200 quality control tests in our facilities, followed by submission samples to government's Central Drugs Laboratory (CDL) in Kasuali, Himachal Pradesh, only based on approval by CDL, are batches released commercially," Bharat Biotech said.

The company further said it has not sought indemnity from the Government of India for any adverse events from Covaxin.

"The whole-virion Inactivated Vero Cell vaccines (Covaxin technology platform) are highly complex to manufacture as the critical ingredient is based on live viruses which require highly sophisticated, multiple level containment and purification methods. Such extensive, high standards of purification naturally lead to significant process losses and low yields resulting in a highly purified and safe vaccine," Bharat Biotech said.

"Fake news and false and misleading narratives result in unintended consequences of creating panic in our population, resulting in vaccine hesitancy, extending our country’s timelines to return to normalcy and restoration of livelihoods," the company added.

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Bharat Biotech says Covaxin made at its Malur, Ankleshwar facilities will be available from September - Moneycontrol
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