Highly purified, safe vaccine: Bharat Biotech on Covaxin quality concerns

New Delhi: With multiple media reports raising questions about the quality of some batches of Bharat Biotech's Covaxin, the vaccine manufacturer has issued a statement clarifying that each batch of Covaxin undergoes over 200 quality control tests at Bharat Biotech's facilities, following which samples are submitted to the Central Drugs Laboratory (CDL), and batches are only issued commercially when the CDL approves or releases them.

The vaccine's quality concerns erupted after an interview in which Dr N K Arora, Chief of the National Immunization Technical Advisory Group (NTAGI), spoke about the initial difficulties encountered by Bharat Biotech's Bangalore plant, which caused a delay in the production of Covaxin.

"The test batches of that plant weren't satisfactory and were rejected, which caused a delay in ramping up production, but now the batches have been approved by the company," he said.

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As per a recent media report in Financial Express, in order to eliminate all doubts over the quality of Covaxin, Bharat Biotech stated that all batches of COVAXIN are manufactured and released only from manufacturing facilities at Genome Valley Hyderabad, which are fully audited and approved by regulatory authorities.

In addition to this, in the issued statement, Bharat Biotech mentioned that vaccine manufacturing, testing, and release at Bharat Biotech follow validated, stringent GMP processes which were established over 20 years ago, with several billion doses of vaccines supplied within India and globally.

It further added, "Since vaccines are administered to healthy individuals, safety is always our vital, primary criteria and we have an uncompromising policy on safety, and quality, whatsoever. This is evident from the excellent safety contours of COVAXIN with an impressive supply of ~ 70 million doses to date. It is emblematic that Bharat Biotech has not sought indemnity from the Government of India for any adverse events from COVAXIN"

Bharat Biotech further stated that 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.

In response to false information spread on social media, Bharat Biotech stated that fake news and false and misleading narratives have unintended consequences, such as instilling fear in the population, causing vaccine hesitancy, and lengthening the country's timelines to return to normalcy and restore livelihoods.

Therefore, Bharat Biotech requested media organizations and influencers to use caution, restraint, and detailed analysis in their reportage and their external communication.