Covaxin Supply Disrupted in July Due to Stability Issues in Bharat Biotech's Bengaluru Plant

Covaxin supplies were disrupted in July as batches from Bharat Biotech’s new fermentation plant in Bengaluru faced some stability issues and couldn’t be used as it were rejected for supply.

Stability studies are conducted on vaccines and various other pharmaceutical products to determine or modify the maximum shelf-life. However, experts say that it is a regular phenomenon when batched of drugs and vaccine fail to qualify the stability test, Times of India reported.

Sources said that the disruption at Bharat Biotech’s plant assumed significance since it has led to slowdown in the vaccination. However, it informed that there is no quality issue with the vaccine as such.

“It is a new facility with large-scale fermentation plant. The trial batches were disrupted during standardisation process and therefore, the supply of Covaxin was less than expected. It has been sorted out now and supplies have also started. It will be full-scale very soon,” an official reportedly said.

Covid task force member NK Arora also admitted that the supply of Covaxin slowed down due to quality issues at the company’s biggest plant globally. He said that the government is expecting 10-12 crore doses from Bharat Biotech.

“The initial couple of batches did not pass quality issues…It was not of the right quality. But the third and fourth batches have now come up which have moved forward. We hope in the next four or six weeks the vaccine production will really ramp up from Bharat Biotech,” he told NDTV.

Meanwhile, the government informed the parliament that WHO has begun the review process for Emergency Use Listing of Covaxin. All documents required for Emergency Use Listing (EUL) have been submitted to WHO by Bharat Biotech for COVID-19 vaccine Covaxin as of July 9 and the review process by the agency has commenced, Minister of State for Health Bharati Pravin Pawar told Rajya Sabha on Tuesday.

Responding to a question on whether it has come to the notice of the government that COVID-19 vaccine Covaxin used in India is not recognised by many countries, Pawar said the government is aware that Covaxin at present is not part of WHO Emergency Use Listing (EUL).

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