Covaxin gets GMP compliance certificate from Hungarian authorities

Bharat Biotech International Ltd has received a certificate of Good Manufacturing Practice (GMP) compliance for Covaxin, its indigenously developed covid-19 vaccine, from the Hungarian authorities, the Hyderabad- based company said on Thursday.

The approval, received from the National Institute of Pharmacy and Nutrition, Hungary, is for manufacturing Covaxin.

The certificate is now listed on the EudraGMDP database, which hosts Europe’s manufacturing authorizations and certificates for good manufacturing practices. “Bharat Biotech intends to submit documentation for emergency use authorization in several additional countries worldwide,” the company said.

“With this approval, Bharat Biotech has achieved another significant milestone in innovating and manufacturing vaccines at global quality standards and moving forward in the ongoing fight against the covid-19 pandemic. The recognition complements our commitment of driving world-class innovation and being a front-runner in the research and development of vaccines.”

Responding to reports raising doubts on the quality of its covid vaccine, the pharmaceutical major said all batches of Covaxin have so far been manufactured at its manufacturing facility at Genome Valley, and were released following full audits and approvals by regulatory authorities.

“Every batch of Covaxin is subjected to over 200 quality control tests at our facilities, followed by the submission of samples to Central Drugs Laboratory (CDL), Government of India. Only based on approvals by the CDL, batches are commercially released,” it added.

Since early June, Covaxin is also being manufactured at its Malur and Ankleshwar facilities, and the products will be dispatched only in September, following the 120-day window for manufacturing, testing, regulatory approvals, and distribution, it added. Bharat Biotech follows stringent GMP processes, which were established over 20 years, with several billion doses of vaccines supplied in India and globally, the company said.

“Since vaccines are administered to healthy individuals, safety is always our vital, primary criteria, and we have an uncompromising policy on safety and quality. This is evident from the excellent safety contours of Covaxin with an impressive supply of about 70 million doses till date. It is emblematic that Bharat Biotech has not sought indemnity from the Government of India for any adverse events from Covaxin.”

Furthermore, the company said whole-virion inactivated Vero Cell vaccines —the technology platform for Covaxin—involves extremely complex manufacturing processes as the critical ingredient is based on live viruses, and requires 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 highly purified and safe vaccines,” it said.

Covaxin is the only vaccine to demonstrate efficacy against the delta variants in phase III human clinical trials, the company claimed.