Bharat Biotech clarifies concerns over Covaxin quality

Hyderabad: In the wake of concerns regarding quality of some batches of Covaxin from its Bangalore plant, Bharat Biotech on Thursday clarified that its Covid-19 vaccine is safe and is following uncompromising policy on safety and quality.

The Hyderabad-based company's clarification came in view of certain media and social media reports.

"We wish to put to rest any concerns on the quality of Covaxin," the company said, adding each batch of the vaccine was subjected to more than 200 quality control tests at its facilities, followed by submission samples to Central Drugs Laboratory (CDL). Only based on approval or release by CDL are batches released commercially.

The vaccine maker stated that as of date, all batches of Covaxin were manufactured and released from its manufacturing facilities at Genome Valley, Hyderabad, which are fully audited and approved by regulatory authorities.

The company said since early June, manufacturing of Covaxin commenced at its 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," it said.

The clarification came after Covid task force member N.K. Arora told a television channel that the supply of Covaxin has been slowed down because the first few batches at the company's newest facility in Bengaluru were not of the right quality.

The vaccine maker reiterated that 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, it said.

It pointed out that the SARS COV2 strains provided under material transfer agreements to Bharat Biotech are also readily available at the ICMR-NIV and accessible to any organisation that wishes to manufacture a similar Covid-19 vaccine.

Vaccinology, vaccine manufacturing, testing, and release is a complex multifactorial science involving inputs from more than 30 scientific and technological disciplines. This is evident from the fact that since the start of the pandemic, only 2 vaccine companies have been able to supply Covid-19 vaccines to the Government of India, it said.

It further requested media organisations and influencers to use "caution, restraint, detailed analysis in their reportage and their external communication".