'Over 200 tests for every batch': Bharat Biotech on Covaxin quality concern

There has been no compromise in vaccine quality and Bharat Biotech has not even sought indemnity from the government for any adverse effect from Covaxin, the vaccine manufacturer said.
Bharat Biotech on Thursday issued a statement asserting that there is no quality concern regarding Covaxin. (AFP)
Bharat Biotech on Thursday issued a statement asserting that there is no quality concern regarding Covaxin. (AFP)
Published on Aug 05, 2021 08:05 PM IST
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By hindustantimes.com | Written by Poulomi Ghosh

Every batch of Covaxin, the indigenous vaccine against Covid-19 developed by Hyderabad-based Bharat Biotech, undergoes over 200 quality-control tests and then the samples are submitted to the Central Drugs Laboratory. Only after the approval of the CDL, these batches are released commercially, the company said on Thursday issuing a statement in the wake of quality concerns of the vaccine. In a recent interview, the chief of National Immunisation Technical Advisory Group, Dr NK Arora, said the initial batches of Covaxin, produced at the new plant of the company in Bengaluru were not satisfactory level. While he was explaining why there was a delay in getting the expected number of doses from Bharat Biotech, his statement was misinterpreted and concerns were raised over the quality of the initial batches of Covaxin. Later, it was clarified that those batches were never released and now Bharat Biotech too has issued a statement.

"As of date, all batches of Covaxin are manufactured and released only from our manufacturing facilities at Genome Valley Hyderabad, which are fully audited and approved by regulatory authorities, hence we wish to put to rest any concerns on the quality of Covaxin," the company said adding that misleading narratives will create panic and result in vaccine hesitancy.

Citing its credentials, the company said that it is "emblematic" that Bharat Biotech has not sought indemnity from the government for any adverse events from Covaxin. "The whole-virion Inactivated Vero Cell vaccines 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," the company said.

On Thursday, Bharat Biotech received the Good Manufacturing Practices compliance certificate from Hungary marking the first certificate from a European regulator. The company has also submitted documents for emergency use approval in Canada.

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Tuesday, October 26, 2021