Hyderabad: Bharat Biotech on Thursday allayed fears over quality of its Covid-19 vaccine Covaxin, saying all batches of the vaccine are manufactured and released only from its manufacturing facilities at Genome Valley (Hyderabad), which are fully audited and approved by regulatory authorities.
The company in a statement said, “Every batch of Covaxin is subjected to more than 200 quality control tests at our facilities, followed by submission samples to Central Drugs Laboratory (CDL) Government of India, only based on approval/release by CDL, are batches released commercially.”
Vaccine manufacturing, testing, and release at Bharat Biotech follow validated, stringent GMP (good manufacturing practice) 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 vital, primary criteria and the company has an uncompromising policy on safety, and quality, whatsoever.
The company added, “This is evident from the excellent safety contours of Covaxin with an impressive supply of nearly 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.”
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 are accessible to any organisation that wishes to manufacture a similar Covid-19 vaccine.
Vaccinology, vaccine manufacturing, testing, and release are 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 two vaccine companies have been able to supply Covid-19 vaccines to the Government of India, the company said.
“Bharat biotech is the only company to develop a vaccine indigenously in India and manufacture it on a large scale. It has accomplished this in a matter of 15 months, with 10 publications and global recognition for India as an innovator and product developer. Covaxin is the only vaccine to have demonstrated efficacy against the delta variant in phase III human clinical trials,” Bharat Biotech added.
On the production front, the company said, since early June, manufacturing of Covaxin has 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,” the Hyderabad-based vaccine maker said.
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