The Hyderabad-based manufacturer Bharat Biotech said on Thursday (August 5) that every batch of Covaxin is subjected to more than 200 quality control tests followed by submission samples to the Central Drugs Laboratory (CDL).
A statement from the indigenous vaccine manufacturer said: “Only based on approval/release by CDL are batches released commercially.”
The statement came after reports that test batches of Covaxin from the Bengaluru plant were not satisfactory and got rejected, causing production delays.
NK Arora, chairperson of the Working Group of the National Technical Advisory Group on Immunisation, told ANI that the test batches of that plant were not satisfactory and got rejected, which led to delay in ramping up production. “But now the batches have been approved by the competent authority and will be available for public consumption.”
The Hyderabad-based company said all batches of Covaxin are manufactured and released only from its 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,” it said.
Bharat Biotech said it maintains an uncompromising policy on safety and quality. “Bharat Biotech has not sought indemnity from the government for any adverse events from Covaxin,” the statement said.
Bharat Biotech said manufacturing of Covaxin commenced 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 the company’s 120-day timeline for manufacturing, testing, release, regulatory approvals and distribution,” read the release.
The vaccine manufacturer said it is the only company to develop a vaccine indigenously in India. “Covaxin is the only vaccine to have demonstrated efficacy against the delta variant in Phase III human clinical trials,” the statement claimed.
The company also stressed that 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 vaccines to the government.”