Expert review of vaccines
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As pregnant women are considered a high-risk group for severe influenza illness, current recommendations advise vaccination of all pregnant women with inactivated influenza vaccine. Nevertheless, rates of maternal influenza vaccination have historically been low, possibly reflecting ongoing concerns about vaccine safety. ⋯ This review summarizes the evidence pertaining to fetal and neonatal outcomes following influenza vaccination during pregnancy for comparative analytic studies published between 2008 and August 2013. Since the majority of these studies are observational in nature, issues related to study quality are also addressed.
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The cost of drug development is commonly cited between US$800 and US$1.8 billion. A similar statistic for vaccines is yet to be estimated, and it is unclear whether the cost of vaccines is similar to drug development. Financial and regulatory policy significantly impacts the extent and cost of pharmaceutical development, and as such it is important that governments should be informed about the costs of developing vaccines. The purpose of this paper is to review the concept of drug and vaccine R&D costs, to review the associated literature and to relate these findings to the area of vaccine industry's financial and regulatory policy.
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Expert review of vaccines · Nov 2013
ReviewStaphylococcal vaccine development: review of past failures and plea for a future evaluation of vaccine efficacy not only on staphylococcal infections but also on mucosal carriage.
Staphylococcal disease represents a universal burden including acute, life-threatening infections as well as chronic infections usually associated with foreign materials. Infections occur notably in permanent carriers of Staphylococcus aureus. ⋯ The end points of these unsuccessful trials were a reduction in mortality or bacteremia, whereas the patient's decolonization was not assessed. Adopting the latter point of view, the aim of this article is to discuss nasal mucosal decolonization as a complementary marker of vaccine efficacy for clinical research in vaccine development.
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Expert review of vaccines · Sep 2013
ReviewIncreasing rates of Salmonella Paratyphi A and the current status of its vaccine development.
Enteric fever caused by Salmonella enterica serovar Typhi and Salmonella enterica serovar Paratyphi is still a major disease burden mainly in developing countries. Previously, S. Typhi was believed to be the major cause of enteric fever. ⋯ Paratyphi are clinically indistinguishable and are commonly termed 'enteric' fever, it will be necessary to have a vaccine available against both S. Typhi and S. Paratyphi A as a bivalent 'enteric fever vaccine'.