Hyderabad: Amid the reports of delayed production of its COVID-19 vaccine due to unsatisfactory test batch and quality issues, Hyderabad-based manufacturer Bharat Biotech on Thursday said every batch of Covaxin is subjected to more than 200 quality control tests, followed by submission samples to Central Drugs Laboratory (CDL).
“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,” read Bharat Biotech`s statement.
The statement came after reports that test batches of Covaxin from the Bengaluru plant were not satisfactory and got rejected leading to delayed production. Earlier, speaking to ANI, NK Arora, chairperson of the Working Group of the National Technical Advisory Group on Immunisation said, “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 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, it said. Giving details of its manufacturing and quality checks, Bharat Biotech said it maintains an uncompromising policy on safety and quality.
“Bharat Biotech has not sought Indemnity from the Government of India for any adverse events from Covaxin,” the statement added. Bharat Biotech informed that 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 and manufacture it large scale. “Covaxin is the only vaccine to have demonstrated efficacy against the delta variant in phase III human clinical trials,” the statement claimed. The company said fake news and false and misleading narratives result in unintended consequences of creating panic in the country`s population resulting in vaccine hesitancy.