'Fake news and false narrative': Bharat Biotech on concerns over Covaxin efficacy, low production

While a section of media and social media are raising concerns on the quality and availability of Covaxin, its manufacturer Bharat Biotech said the vaccine undergoes over 200 quality checks and, so far, has safely delivered over 70 million doses.

Indirectly referring to some reports that said some early batches made in Bengaluru were of poor quality, Bharat Biotech said to date, all batches of Covaxin were manufactured and released only from its manufacturing facilities at Genome Valley in Hyderabad.

Every batch of the vaccine undergoes more than 200 quality control in-house tests, followed by each batch tested at the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh.

Referring to the shortage issue, the company said since early June, manufacturing has commenced at its sites at Malur in Karnataka, and Ankleshwar in Gujarat. Products manufactured from these facilities will be available for supplies during September, based on its 120-day timeline for manufacturing, testing, release, regulatory approvals, and distribution.

Also read: Covaxin receives GMP certificate from Hungary: Bharat Biotech

India currently gets about 2 crore doses of Covaxin and 10 crore doses of Covishield from the Serum Institute of India. Covaxin supplies were projected to increase to around 2.5 crore doses in August. Government sources this week clarified additional 2 million doses of Covaxin will come from August-September and Covishield production will increase by another 2 crore doses.

The whole-virion Inactivated Vero Cell vaccines, the platform used to make Covaxin, 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, said Bharat Biotech.

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 two vaccine companies have been able to supply Covid-19 vaccines to the Government of India. 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," said Bharat Biotech.

Covaxin is the only vaccine to have demonstrated efficacy against the delta variant in phase III human clinical trials, claimed the company.

"Fake news and false and misleading narratives result in unintended consequences of creating panic in our population, resulting in vaccine hesitancy, extending our country's timelines to return to normalcy and restoration of livelihoods. We humbly request media organisations and influencers to use caution, restraint, detailed analysis in their reportage and their external communication," said Bharat Biotech.

Also read: Covaxin supply slows down over quality issues at Bharat Biotech's Bengaluru facility: NK Arora