Two-dose presentation of preservative-free Human Papilloma Vaccine from GlaxoSmithKline (GSK) (Cervarix™).
The World Health Organization (WHO) prequalified the one and two-dose presentations of Cervarix™ on 08 July 2009. Cervarix™ is a preservative-free vaccine. For the two-dose presentation it was indicated that a two-dose preservative-free liquid presentation is a novel presentation for UN supported EPI programmes and that supply of this presentation of the product through UN procurement agencies was not expected before revision of the WHO Policy Statement on the use of opened multi-dose vials of vaccine in subsequent immunization sessions (MDVP). Revision of the MDVP is ongoing. UNICEF has issued a request for tender for supply of HPV vaccines.
Subsequent to prequalification, WHO published the document “Assessing the Programmatic Suitability of Vaccine Candidates for WHO Prequalification”. There is a PSPQ critical criterion that vaccines that are in ready to use (no reconstitution) 2-dose vial presentations require adequate preservatives. Under the PSPQ procedure, vaccines which do not meet a critical criterion can be reviewed by the PSPQ Standing Committee (SC) for acceptability.
The SC reviewed the two-dose Cervarix presentation and took into account experience gained with two-dose Synflorix and that risk-benefit estimates of using this presentation in high disease burden countries show that the benefits outweigh the potential risks associated with the presentation.
The two-dose presentation of Cervarix™ remains prequalified and the presentation is considered suitable for supply through UN agencies. Each country considering introduction of this vaccine presentation will need to ensure its programmatic readiness to do so, as described below.
Experience with two-dose Synflorix indicated that special attention to training of health care staff will be required for the proper use of the Cervarix™ two-dose presentation. Specific pre-introduction measures are required to assure programmatic readiness is achieved prior to introduction. Post-introduction evaluations and corrective training actions, where needed, are required to assure appropriate continued use of this presentation.
Each country will also need to ensure the monitoring of its correct use and implementation of any corrective training needed. To mitigate against potential programmatic risk countries should ensure that they:
- Understand the benefits and potential contamination risks of the two-dose unpreserved presentation and understand the need for special training to enhance immunization worker practices.
- Conduct post introduction evaluations to determine levels of Health Care Worker knowledge and compliance with the correct handling of the vaccine; and implement corrective training if needed.
Prior to introduction countries should:
- Ensure training materials are in place in immunization centres prior to the launch of the vaccine.
- Place stickers on refrigerators at all levels indicating that opened vials of the vaccine must be discarded six hours after opening. The stickers should be in place prior to the launch of the vaccine.
As per usual practice, the prequalification status of every vaccine is reviewed at regular intervals. The data gathered following supply of two-dose Cervarix™, can be referred to the WHO Programmatic Suitability for Prequalification Standing Committee (PSPQ SC) for review and advice, and be a basis for a further review of the prequalification status of this presentation of Cervarix™.
Organizations considering direct procurement of Cervarix™ in the two dose presentation should take into consideration the issues relating to this novel presentation and consider whether training in and monitoring of the correct use of the presentation can be implemented in their proposed programme.