Immunization standards

Panacea OPV delisted from WHO's prequalified vaccines list

Geneva, Switzerland
27 February 2012

The World Health Organization (WHO) is this week confirming the removal of oral polio vaccine (OPV) produced by manufacturer Panacea Biotec from its list of prequalified vaccines, meaning Panacea-produced OPV will no longer be supplied through United Nations (UN) agencies. This removal is in response to Panacea's voluntary decision on 7 February to withdraw its OPV from the WHO list of prequalified vaccines, following the findings of an expert committee convened by WHO.

On 9 September 2011 the company had stopped OPV production to introduce a series of process changes recommended following a WHO site audit earlier that month. Panacea's decision to delist its product follows a WHO assessment in January 2012 that further corrective actions need to be implemented. OPV from Panacea manufactured prior to the production halt in September and being supplied through UN agencies can continue to be used, as monitoring and testing of these lots confirm compliance with quality specifications.

Panacea has been an important supplier to the GPEI and UNICEF. Following a request from WHO and UNICEF, industry responded positively with additional availability and it has been possible to secure alternative product to cover the OPV required through UNICEF Supply Division for 2012.

WHO and UNICEF continue to work with industry to ensure security of OPV supply for the global polio eradication effort.