'Uncompromising policy on quality': Bharat Biotech junks reports on Covaxin safety concern

Covaxin, the Bharat Biotech-made vaccine against COVID-19 , is subjected to over 200 quality control tests and the shots are released commercially only after regulatory approvals by a government body, the Hyderabad-based company said on Thursday.

"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…," the company said.

The remarks came against the backdrop of what the company said were "recent articles in social media and media outlets regarding the quality of Covaxin".

"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," Bharat Biotech said.

In a recent TV interview, COVID task force member NK Arora said the first couple of batches of the vaccine produced in Bharat Biotech's Bengaluru plant — one of the largest such facility globally — were not of the right quality.

While he meant that these batches did not make it to India's ambitious vaccination programme, tweets and media reports suggesting that Covaxin had quality issues followed the interview.

Arora said he had been misquoted on the subject and the interpretation that Covaxin was facing quality issues was wrong.

The government maintains both Covaxin and Covishield, the Oxford Astrazeneca vaccine made locally by Serum Institute of India, are safe. Experts say an effective vaccination drive is India's best bet against the pandemic, especially at a time when concerns over a possible third wave are looming.

In the interview, Arora was answering a question on Covaxin's supply shortfall, which critics say has slowed down the vaccination programme and forced the government to revise its inoculation targets repeatedly.

"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," said Bharat Biotech, which has manufactured the Made-in-India vaccine with the State-run Indian Council of Medical Research (ICMR)'s help.

The company stressed that batches of the vaccine were released commercially "based on approval/release" by the Indian government's Central Drugs Laboratory (CDL), which says it tests vaccines and antisera meant for human use.

"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," the company said.

Bharat Biotech said it was the only company to develop a vaccine indigenously in India and manufacture it large scale "in a matter of 15 months". It added Covaxin "is the only vaccine to have demonstrated efficacy against the delta variant in phase III human clinical trials".

The company also explained that the inactivated vaccine platform used by Covaxin ensured the product was safe.

"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," it said.