The WHO had conducted a site audit at the BBIL production plant in Hyderabad in September as part of the evaluation of new prequalification applications of two vaccines types. The audit found deficiencies in the implementation of good manufacturing practices and in the quality management system.
The observations have potential implications beyond the directly audited products for another vaccine type that is currently undergoing prequalification and, in particular, for the hepatitis B vaccine Revac-B+ and three formulations of oral polio vaccines (OPV) manufactured by Bharat, that are already on the list of vaccines prequalified by WHO for supply to countries through UN procurement, a WHO circular said. Company officials were not available for comments.
WHO convened an ad hoc committee of experts to review the site audit findings, the response from Bharat and to make recommendations to WHO. Accordingly, WHO issued a letter to BBIL on November 28 to terminate the prequalification process for all their products currently under evaluation.
As the manufacturing locations for the currently prequalified products from BBIL for Hepatitis B and OPV vaccines were not audited in September, WHO has been requested by the ad hoc expert committee to conduct another site audit before a final decision is made on these products. This audit has to be conducted within three months from the date of the notification to BBIL.
In the interim, WHO has informed BBIL that supply through UN procuring agencies of hepatitis B vaccine from the company is suspended. However, WHO does not recommend recall of Revac-B+ already distributed, since the suspension is a precautionary and interim measure and is not based on reported complaints from the field regarding the Revac-B+ product.
For OPV, Bharat products remain prequalified, as a risk-benefit assessment by WHO took into account that the vaccine bulks are supplied by another prequalified manufacturer for formulation and filling by BBIL and that the vaccine is given by the oral route.