In November 2012, Inactivated Polio Vaccine (IPV) vaccine from Statens Serum Institut was suspended from supply through United Nations (UN) procurement for the reasons described at the below link:
Suspension of Statens Serum Institute IPV supply through UN procurement
The company prepared and indicated a Corrective and Preventive Action (CAPA) Plan to address the relevant issues. The manufacturing facility has since been purchased by AJ Vaccines who have continued implementation of the CAPA Plan.
Assessment of this implementation included a joint follow-up inspection by the Danish Medicines Agency (DMA) and WHO/Prequalification and further review on CAPA implementation. On 16 October 2017, the DMA issued a Certificate of GMP Compliance for the site.
Based on this, the suspension of supply through UN procurement agencies of inactivated polio vaccine (IPV) produced by AJ Vaccines (former Statens Serum Institut - SII) has been lifted. However, it should be noted that the vaccine is not expected to be available for such supply before 2019.