Every batch of Covaxin is subjected to over 200 quality control tests at Bharat Biotech’s facilities, followed by submission samples to Central Drugs Laboratory (CDL), only based on approval/release by CDL, are batches released commercially, Bharat Biotech has claimed via a statement.
“Since early June, manufacturing of Covaxin has commenced at our 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,” said the statement.
It also notified that 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 statement added, “Vaccine manufacturing, testing and release at Bharat Biotech follow validated, stringent GMP processes which were established over 20 years, with several billion doses of vaccines supplied within India and globally.”
Since vaccines are administered to healthy individuals, safety is always our vital and primary criteria, and we have an uncompromising policy on safety and quality, whatsoever. This is evident from the safety contours of Covaxin with a supply of approximately 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, it further mentioned.
The statement said 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.
The SARS COV2 strains provided under material transfer agreements to Bharat Biotech are also readily available at the ICMR-NIV and is accessible to any organisation that wishes to manufacture a similar COVID-19 vaccine, it said.
It emphasised that vaccinology, vaccine manufacturing, testing and release is a complex multi-factorial science involving inputs from more than 30 scientific and technological disciplines. This is evident from the fact that since the beginning of the pandemic, only two vaccine companies have been able to supply COVID-19 vaccines to the Government of India.
The company released the statement in response to the articles on social media and media outlets regarding the quality of Covaxin.