Days after some media reports raised concerns about the quality of some batches of Bharat Biotech’s Covaxin, the vaccine maker issued a clarification that all of its batches of vaccine will undergo over 200 quality controls.
“Each batch of Covaxin undergoes more than 200 quality control tests at our facilities, followed by submitting samples to the Central Drugs Laboratory (CDL), Government of India. The batches will only be released commercially based on approval / clearance from CDL, ”said Bharat Biotech.
Recently, some media reports alleged that deliveries of Covaxin were slowing because the first few batches of the vaccine made at Bharat Biotech’s new facility in Bengaluru were “not of the right quality”.
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“We expected a much larger increase in Covaxin production. You (Bharat Biotech) have opened a new facility in Bengaluru. ..It wasn’t the right quality. But now the third and fourth batches that have been pushed forward have come. We hope that in the next four or six weeks Bharat Biotech’s vaccine production will really ramp up, “said Covid. India Task Force member Dr. NK Arora was quoted as saying by NDTV.
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In response to the reports, Bharat Biotech said in a statement: “To date, all batches of Covaxin are only manufactured and approved at the manufacturing facilities in Genome Valley, Hyderabad. The unit has been fully tested and approved by the regulatory authorities. “
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It added that since the beginning of June this year, Covaxin production has started at its other sites (Malur in Karnataka and Ankleshwar in Gujarat). Bharat Biotech said vaccines made from these facilities would be available for shipments in September.
“This is based on our 120-day schedule of manufacture, testing, clearance, regulatory approvals and sales,” the company said in a statement.
“Fake news and false and misleading narratives are causing the unintended consequences of panic among our population, leading to hesitant vaccination, extending our country’s deadlines to return to normal and restore livelihoods. We humbly ask media organizations and influencers to exercise caution, restraint and detailed analysis in their reporting and external communication, “said Bharat Biotech.
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