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Bilthoven, Netherlands

Saidu Y.,Vaccinology Unit | de Angelis D.,Novartis | Aiolli S.,Novartis | Stefano G.,University of Siena | Georges A.M.,AmQuidPharma
Therapeutic Innovation and Regulatory Science | Year: 2013

The product pipeline for diseases that disproportionately affect the developing world has considerably expanded over the last decade. Indeed, there are about 134 products for these diseases in the pipeline, including vaccines, drugs, diagnostics, microbicides, and vector control tools, and dozens of these products are currently being evaluated in human trials in developing countries where the disease of interest exists. While these efforts are underway, the need to identify regulatory pathways for licensing these new products is becoming obvious to many manufacturers. In many developing countries, where the need of these products is greatest, the national regulatory authorities often lack the resources and regulatory capacity to review the registration dossiers to approve the use of new products. Given this challenge, new regulatory models are urgently needed to offset product registration. In this paper, we propose how regional regulatory frameworks established by regional harmonization initiatives can be used to set up an integrated regional licensing system, a system that will provide for a single product dossier application and a single review, leading to a single approval that will grant access to all the markets in the region. The proposed model aims at complementing the ongoing regional regulatory harmonization efforts by pooling the activities of different national expertise groups so as to make the best use of the available skills at a reduced cost. By sharing the various regulatory tasks in an integrated manner, the total process will be accelerated and will facilitate product registration in the region. © The Author(s) 2013.

Saidu Y.,Vaccinology Unit | Angelis D.D.,Novartis | Aiolli S.,Novartis | Gonnelli S.,University of Siena | Georges A.M.,AmQuidPharma
Therapeutic Innovation and Regulatory Science | Year: 2013

Adequate medicine regulation requires nations to establish robust regulatory agencies that will subject all pharmaceutical products to pre- and postmarketing evaluation. These agencies are essential for any country wishing to ensure that the medicinal products it authorizes for use in its territory meet internationally agreed standards of safety, quality, and efficacy. Many developing nations, however, lack regulatory systems that can guarantee this set of requirements. As a result, almost all of these nations tend to rely on regulatory decisions made by well-resourced institutions, particularly the US Food and Drug Administration, the European Medicines Agency, and the World Health Organization. In this paper, the authors review the objectives, strengths, and weaknesses of some key regulatory initiatives instituted by these bodies to facilitate product registration in developing countries with constrained regulatory capacities. © The Author(s) 2013.

Soonawala D.,Leiden University | Verdijk P.,Vaccinology Unit | Wijmenga-Monsuur A.J.,Vaccinology Unit | Boog C.J.,Vaccinology Unit | And 3 more authors.
Vaccine | Year: 2013

For global eradication of poliomyelitis, inactivated poliovirus vaccine (IPV) needs to become available in all countries. Using fractional-doses (reduced-doses) may impact affordability and optimize the utilization of the production capacity. Intradermal administration has the potential to lower the dose without reducing immunogenicity. A needle-free jet injector may be a reliable way to administer vaccines intradermally. The primary objective of this randomized controlled trial was to compare the immunogenicity and tolerability of fractional-dose intradermal IPV (Netherlands Vaccine Institute, NVI) booster vaccination administered with a jet injector (PharmaJet) to full-dose and fractional-dose intramuscular vaccination with a needle and syringe. Immunogenicity was assessed by comparing the differences in the post-vaccination log2 geometric mean concentrations of neutralizing antibodies (GMC) between the study groups. A total of 125 Dutch adult volunteers with a well-documented vaccination history were randomized to one of four groups: full-dose intramuscular needle (IM-NS-0.5), full-dose intramuscular jet injector (IM-JI-0.5), 1/5th dose intramuscular needle (IM-NS-0.1), 1/5th dose intradermal jet injector (ID-JI-0.1). Vaccination with the JI was less painful (87% no pain) than vaccination with a NS (60% no pain), but caused more transient erythema (JI 85%, NS 24%) and swelling (JI 50%, NS 5%). Intradermal vaccination caused less vaccination site soreness (ID 16%, IM 52%). At baseline all subjects had seroprotective antibody concentrations. After 28 days, GMC were slightly lower in the ID-JI-0.1 group than in the reference group (IM-NS-0.5). The differences were not statistically significant, but the stringent non-inferiority criterion (i.e. a difference of 1 serum dilution in the microneutralization assay) was not met. After one year, differences in GMC were no longer apparent. In contrast, intramuscular vaccination with a fractional dose administered with a needle (IM-NS-0.1) was statistically inferior to full-dose intramuscular vaccination. This shows that intradermal but not intramuscular delivery of fractional-dose IPV may be sufficient for routine polio vaccination. © 2013 Elsevier Ltd.

Verdijk P.,Vaccinology Unit | Rots N.Y.,Vaccinology Unit | Bakker W.A.M.,Vaccinology Unit
Expert Review of Vaccines | Year: 2011

Following achievement of polio eradication, the routine use of all live-attenuated oral poliovirus vaccines should be discontinued. However, the costs per vaccine dose for the alternative inactivated poliovirus vaccine (IPV) are significantly higher and the current production capacity is not sufficient for worldwide distribution of the vaccine. In order to achieve cost-prize reduction and improve affordability, IPV production processes and dose-sparing strategies should be developed to facilitate local manufacture at a relatively lower cost. The use of attenuated Sabin instead of wild-type polio strains will provide additional safety during vaccine production and permits production in low-cost settings. Sabin-IPV is under development by several manufacturers. This article gives an overview of results from clinical trials with Sabin-IPV and discusses the requirements and challenges in the clinical development of this novel IPV. © 2011 Expert Reviews Ltd.

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