‘Highly purified and safe vaccine’: Bharat Biotech allays concerns over Covaxin’s quality

Covid-19 vaccine Covaxin manufacturer Bharat Biotech on Thursday issued a statement to allay any doubts that may have risen regarding the quality of the vaccine being administered in the country. In order to “set the record straight” — Bharat Biotech said in its statement that as of now all Covaxin batches released have been manufactured at its facilities at Genome Valley Hyderabad — which has been fully audited and approved by regulatory authorities. It also informed that before being released for administering every batch of Covaxin is subjected to over 200 quality control tests and samples are submitted to Government of India’s Central Drugs Laboratory (CDL), and only after clearance are the batches released commercially.

In its statement, Bharat Biotech added that manufacturing of Covaxin has begun commenced at at Malur (Karnataka) and Ankleshwar (Gujarat) since June. Based on the 120-day-timeline required for manufacturing, testing, release, regulatory approvals and distribution, the vaccine batches manufactured at these facilities will be available for supplies during September.

The vaccine manufacturer further added that it follows stringent GMP processes established over 20 years and supplied several billion doses of vaccines both within India and abroad. To buttress its point the Covaxin manufacturer informed that although it has supplied approximately 70 million doses it hasn’t sought indemnity from the Government of India for any adverse events arising from the vaccine.

This statement by Bharat Biotech comes after Dr NK Arora, chief of the National Immunisation Technical Advisory Group (NTAGI), was quoted by news agency ANI as saying that the government had initially hoped for a scaled-up production of Covaxin, but the entire process was slowed down by initial glitches – that included issues of quality.

The NTAGI chief was quoted saying that the test batches from Bharat Biotech’s Bengaluru plant were rejected due to quality issues and this led to a delay in ramping up production. However, he added that the Covaxin batches have been approved by the competent authority and will be available for public consumption. “Bharat Biotech is expected to provide 7-10 crore doses per month in the coming weeks,” he told ANI.

Around 47 crore vaccine doses administered in July and second half of June. Vaccine availability will increase quite significantly in August & overall. Bharat Biotech is expected to provide 7-10 crore doses per month in the coming weeks: Dr NK Arora, Chairman, COVID working group pic.twitter.com/BF5ZTPJG12

— ANI (@ANI) August 2, 2021

Read the Full Statement Issued by Bharat Biotech:

“There have been recent articles in social media and media outlets regarding the quality of COVAXIN®️, we hereby wish to set the record straight with the following statements,

• 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®️,

• 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,

• 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,

• 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, 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 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 is accessible to any organization 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,

• Bharat biotech is the only company to develop a vaccine indigenously in India and manufacture it 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,

• 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 organizations and influencers to use caution, restraint, detailed analysis in their reportage and their external communication.”