The World Health Organization (WHO) is today confirming the suspension of supply of inactivated polio vaccine (IPV) produced by Statens Serum Institut (SSI) through UN procurement agencies.
This suspension is in response to the outcomes of a WHO site audit in September 2012 to SSI’s manufacturing facilities in Copenhagen, Denmark.
In October 2012, SSI took a voluntary decision to place a batch of IPV supplied through the UN to Argentina and Panama in quarantine as a precautionary measure until further notice by SSI. The quarantined batch is the only one that had been supplied from SSI through the UN procurement systems. Doses from this batch have not been used for immunizations.
SSI is developing a corrective and preventive action plan, for submission to the Danish Regulatory Authority and WHO. In the interim and as a further precautionary measure, SSI has suspended its production of IPV.
Alternative sources of prequalified IPV are available to the UN and shortage of vaccine is not anticipated. The UN, in particular WHO and UNICEF, continue to work with industry to ensure security of IPV supply.