Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV.

Industrial-scale inactivated polio vaccine (IPV) production dates back to the 1960s when at the Rijks Instituut voor de Volksgezondheid (RIV) in Bilthoven a process was developed based on micro-carrier technology and primary monkey kidney cells. This technology was freely shared with several pharmaceutical companies and institutes worldwide. In this contribution, the history of one of the first cell-culture based large-scale biological production processes is summarized. Also, recent developments and the anticipated upcoming shift from regular IPV to Sabin-IPV are presented. Responding to a call by the World Health Organization (WHO) for new polio vaccines, the development of Sabin-IPV was continued, after demonstrating proof of principle in the 1990s, at the Netherlands Vaccine Institute (NVI). Development of Sabin-IPV plays an important role in the WHO polio eradication strategy as biocontainment will be critical in the post-OPV cessation period. The use of attenuated Sabin strains instead of wild-type Salk polio strains will provide additional safety during vaccine production. Initially, the Sabin-IPV production process will be based on the scale-down model of the current, and well-established, Salk-IPV process. In parallel to clinical trial material production, process development, optimization and formulation research is being carried out to further optimize the process and reduce cost per dose. Also, results will be shown from large-scale (to prepare for future technology transfer) generation of Master- and Working virus seedlots, and clinical trial material (for phase I studies) production. Finally, the planned technology transfer to vaccine manufacturers in low and middle-income countries is discussed.

Does uncollected medication reduce the validity of pharmacy dispensing data?

PURPOSE: When using pharmacy data as collected in the InterAction database (IADB) for pharmacoepidemiology studies, we tend to ignore the fact that filled prescriptions are not always collected by the patient. This study investigated whether unclaimed prescriptions pose a validity threat for pharmacy data, by estimating the percentage of filled prescriptions that are not collected, the percentage of patients who do not collect their filled prescriptions and describing the items remaining unclaimed. METHODS: Prospective study in three independent pharmacies in the region that is covered by the IADB. All prescriptions that entered these pharmacies on 3 days in 1 week in October 2002 were monitored for a month with respect to whether and when they were claimed. RESULTS: A total of 3946 prescriptions concerning 3082 patients were filled. The majority of prescriptions were collected the day they were filled. In total 18 prescription items (0.46%) were not collected within 1 month; excluding health products and homeopathic drugs 13 remained. These 13 covered a variety of drug groups; 0.45% of the patients did not claim their medication within 1 month. CONCLUSIONS: Primary non-compliance due to not claiming medication has little impact on the validity of pharmacy dispensing data in the region under study.