Bharat Biotech starts voluntary recall of rabies vaccine after batch theft

Company had tested the batch and released it, but part of it was stolen, for which cold chain storage integrity was unknown. Decision made to recall the entire batch

Hyderabad-based vaccine maker Bharat Biotech on Monday said it has initiated a voluntary recall for a batch of its anti-rabies vaccine Chirorab.

"We have issued a voluntary product recall of a specific batch of Chirorab with batch number 4188. This action was initiated due to the theft of Chirorab from the shipping services provider in Karnataka," the company said in a statement. It added that the company had tested batch No. 4188 and released it, but part of the shipment was stolen, for which cold chain storage conditions are unknown. The action to recall the entire batch has been initiated.

"We are undertaking this voluntary action in accordance with the Principle of Abundant Precaution, keeping patient safety and the public interest in mind," it said.

"The company requests that batch #4188 not be sold and returned to the company. Healthcare providers are requested not to administer Chirorab with batch #4188."

The recall action has been initiated by Chiron Behring Vaccines, which was acquired by Bharat Biotech from GSK in March 2019. In November 2019 Chiron Behring Vaccines re-launched the rabies vaccine Chirorab, which was earlier marketed as Rabipur. The vaccine is manufactured at a WHO-prequalified site in Ankleshwar, Gujarat.

It is an inactivated vaccine used for active pre and post exposure immunisation against rabies. Chirorab is supplied to government hospitals through a tendering process, and also exported to several countries.

The Ankleshwar facility can make 15 million doses of rabies vaccines per year.

In August 2021, Bharat Biotech commercially launched its Covid19 vaccine Covaxin from the Ankleshwar facility. A new filing facility constructed during 2020 was utilized for the production of Covaxin.

The company had deployed multiple production lines at its Hyderabad, Malur, Bengaluru, and Pune campuses to make Covaxin.

• Part of batch was stolen, cold chain integrity not known
• Co decided to recall entire batch
• Rabies vaccine is made at Chiron Behring plant in Ankleshwar
• Chiron Behring was acquired by Bharat Biotech from GSK in 2019
• Ankleshwar plant was re-purposed to make Covaxin in 2021