Suspension of supply through the UN of hepatitis B vaccine (Revac-B+) manufactured by Bharat Biotech International Limited and termination of prequalification procedures for current applications for other vaccines from Bharat Biotech International Ltd.
WHO conducted a site audit in September 2011 of the Bharat Biotech International Limited (hereafter referred to as Bharat) production plant located in Hyderabad, India 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 of the company.
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.
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 Bharat on 28 November 2011 to terminate the prequalification process for all their products currently under evaluation.
As the manufacturing locations for the currently prequalified products from Bharat ― Hepatitis B and OPV vaccines ― were not audited in September 2011, 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 Bharat.
In the interim, WHO has informed Bharat that supply through UN procuring agencies of Hepatitis B vaccine from the company is suspended. 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 Bharat and that the vaccine is given by the oral route. Intense global efforts to eradicate polio require large quantities of OPV, and have reduced the number of endemic countries to four ― one of which is India, where no polio cases have been recorded since January 2011. The conclusion is not to recommend interim suspension of UN supply of this product.
The appropriate authorities of countries using vaccines produced by Bharat which have not been supplied through UN agencies are encouraged to make their own risk-benefit evaluations when considering further supply of vaccines from Bharat.