Bharat Biotech monovalent hepatitis B vaccine and oral polio vaccines delisted from WHO prequalification list
The World Health Organization (WHO) is this week confirming the removal of hepatitis B vaccine (HepB) and oral polio vaccine (OPV) produced by manufacturer Bharat Biotech International Limited (hereafter referred to as Bharat) from its list of prequalified vaccines, meaning the vaccine manufactured by Bharat will no longer be supplied through United Nations (UN) agencies. This removal was recommended by an expert committee convened by WHO on 5 April 2012.
WHO conducted a site audit in February 2012 of the Hyderabad (India) plant of Bharat (a follow-up audit to a September 2011 visit which had focused on other products from Bharat). The audit identified that a series of corrective actions need to be implemented to rectify deficiencies in the production process. Following implementation of appropriate corrective measures, Bharat will need to submit new applications for WHO Prequalification of their products. Evaluation by WHO would include review of their submitted dossier, testing of sample batches and a site audit.
Hepatitis B vaccine and OPV produced by Bharat already distributed and being supplied through UN agencies can continue to be used and WHO does not propose a recall of drug product already supplied, as monitoring and testing of such lots confirm compliance with quality specifications.
The global supply to cover demand through UNICEF for 2012 was not directly impacted by this decision but the global supply situation is constrained. WHO and UNICEF will continue to work with industry to ensure security of OPV supply for the coming years.
These decisions extend and replace actions previously announced concerning products from Bharat.