Official batch control of influenza vaccines: Is it still useful?

Introduction: The governmental quality control of human vaccines is a long established tradition in many European countries. In Germany, vaccines have been controlled by a governmental agency since 1935. In the beginning, vaccine production and control was a purely national activity.

New bone post-processing tools in forensic imaging: a multi-reader feasibility study to evaluate detection time and diagnostic accuracy in rib fracture assessment.

Purpose: The aim of this multi-reader feasibility study was to evaluate new post-processing CT imaging tools in rib fracture assessment of forensic cases by analyzing detection time and diagnostic accuracy.

Materials And Methods: Thirty autopsy cases (20 with and 10 without rib fractures in autopsy) were randomly selected and included in this study. All cases received a native whole body CT scan prior to the autopsy procedure, which included dissection and careful evaluation of each rib.

Considerations of strategies to provide influenza vaccine year round.

There is potential for influenza vaccine programmes to make a substantial impact on severe disease in low-resource settings, however questions around vaccine composition and programmatic issues will require special attention. Some countries may benefit from immunization programmes that provide year-round supply of vaccine; however the best way to ensure adequate vaccine supply has yet to be determined. In this report, we discuss vaccine composition, availability, and programmatic issues that must be considered when developing year-round influenza immunization programmes.

[From the licensure of vaccines to the recommendation of the Standing Committee on Vaccination in Germany : criteria for the assessment of benefits and risks].

Vaccines are among the most effective preventive measures in modern medicine and have led to a dramatic decline and-for a few diseases-even to the elimination of severely infectious diseases. There are some particularities of the risk-benefit assessment of vaccines compared with that of therapeutic drugs. These include the fact that vaccines are applied to healthy individuals with the aim of preventing an infectious disease, while therapeutic drugs are administered to sick people to cure them of an already acquired disease.

Summary of knowledge gaps related to quality and efficacy of current influenza vaccines.

Influenza viruses are a public health threat, as they are pathogenic, highly transmissible and prone to genetic changes. For decades vaccination strategies have been based on trivalent inactivated vaccines, which are regulated by specific guidelines. The progress in scientific knowledge and the lessons learned from the A(H1N1)2009 pandemic have highlighted further the need to improve current guidelines, including the immunogenicity criteria set by the CHMP in 1997, and to promote the discussion on the shortcomings encountered, e.

A global regulatory science agenda for vaccines.

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products.

Enhancing the reproducibility of serological methods used to evaluate immunogenicity of pandemic H1N1 influenza vaccines-an effective EU regulatory approach.

Haemagglutination-inhibition (HI) and virus neutralisation (VN) assays are routinely applied to evaluate influenza vaccine immunogenicity for regulatory approval. Despite their frequent use both assays are currently only poorly standardised causing considerable inter-laboratory variation of serological results that is particularly evident for pandemic influenza vaccines. The present study was conducted in association with the European Medicines Agency (EMA) to directly compare assay variability between vaccine manufacturer's and European regulatory agency's laboratories in an influenza pandemic scenario.

Structure-Activity Study of Dihydrocinnamic Acids and Discovery of the Potent FFA1 (GPR40) Agonist TUG-469.

The free fatty acid 1 receptor (FFA1 or GPR40), which is highly expressed on pancreatic β-cells and amplifies glucose-stimulated insulin secretion, has emerged as an attractive target for the treatment of type 2 diabetes. Several FFA1 agonists containing the para-substituted dihydrocinnamic acid moiety are known. We here present a structure-activity relationship study of this compound family suggesting that the central methyleneoxy linker is preferable for the smaller compounds, whereas the central methyleneamine linker gives higher potency to the larger compounds.

First-in-human clinical trials with vaccines--what regulators want.

Several factors should be taken into account when it comes to the first exposure of humans to a novel vaccine.

Stability of vaccines - bridging from stability data to continuous safety and efficacy throughout shelf life - an always reliable approach?

Stability studies are important tools to reliably ensure that efficacy and safety of medicinal products will remain unchanged from release of drug product until the end of shelf life. For complex medicinal products such as biological medicinal products, including vaccines, design and conduct of such studies requires particularly careful considerations in order to ensure that technical data resulting from stability studies are indeed indicative for unchanged clinical performance. Ideally, relevance of specifications controlled by stability studies as well as definition of shelf life should be justified by acceptable clinical data obtained with product at the end of the shelf life claimed.

Vaccination safety update.

Introduction: In Germany, a large number of biased reports against vaccination have recently been published in all of the news media, and particularly on the internet. This paper discusses the safety profile of modern vaccines and their continuous surveillance and shows why the current criticism of vaccination on safety grounds is unjustified.

Methods: The authors have performed a selective literature search to enable a proper distinction to be drawn between scientifically justified and unjustified reports on the potential adverse effects of vaccination.