A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data.

The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person.

Safety of MF59 adjuvant.

The need to enhance the immunogenicity of purified subunit antigens has prompted the development of new adjuvants. The adjuvant emulsion MF59 has been tested in animals in combination with different antigens and finally evaluated in humans. It was licensed after the successful outcome of preclinical and clinical testing.

Protection against tick-borne encephalitis with a new vaccine formulation free of protein-derived stabilizers.

Background: Vaccination against tick-borne encephalitis (TBE) has been successfully employed for many years in TBE-endemic countries. Post-marketing experience gained from widespread use, however, prompted the development of improved TBE vaccines, the most modern versions of which do not contain the commonly used protein-derived stabilizers (human albumin or polygeline) of former vaccines.

Method: This article summarizes both the medical need for and clinical experience with a new TBE vaccine formulation (pediatric and adult versions).

Post-marketing surveillance of immediate allergic reactions: polygeline-based versus polygeline-free pediatric TBE vaccine.

Scattered cases of immediate allergic reactions occurred in the nineties after widespread use of the original (polygeline-based) pediatric tick-borne encephalitis (TBE) vaccine and were reported to Pharmacovigilance, Chiron Vaccines. Although, still indicating a very rare frequency of about two cases per 100,000 doses sold, the benefit/risk assessment resulted in its withdrawal from the market in early 1998. An intensive evaluation revealed that polygeline used as a vaccine stabilizer was the most probable cause of the reported allergic reactions.

Biologics safety preclinical, clinical and regulatory.

Biologicals offer particular challenges for all concerned, whether they be scientific researchers, profit-oriented companies (including not yet profit-producing start-ups), public health-focused regulators, physicians, or, most importantly, patients. One of the most important of these challenges is safety. Hence, this conference was organised by Vision in Business (the trading name of Analysis and Networking Ltd) to provide practical solutions and advice for comprehensive, effective safety testing.

Electronic Reporting for Clinical Drug Safety and Pharmacovigilance. 29 - 30 October 2002, Amsterdam, The Netherlands.

The 31 January 2003 deadline for electronic reporting to the European Agency for the Evaluation of Medicinal Products has helped to focus industry and regulator attention alike. This conference provided a wide perspective on background and scope, recent successes, and possible future developments by specialists from regulators, pharmaceutical industries, software vendors and more. Organised by IIR Conferences Ltd, attendees had the opportunity to gain an overview of all major aspects of electronic reporting of individual case safety reports, to broaden their knowledge, and to network with individuals concerned by these issues.

Immediate allergic reactions after vaccinations--a post-marketing surveillance review.

Unlabelled: Immediate systemic allergic reactions after vaccination with commonly used vaccines are very rare. Consequently, the risk of these reactions cannot be verified before widespread use. A data analysis of spontaneously reported suspected adverse drug reactions following the administration of 15 marketed vaccines, from 1994 to 1998, shows an average reporting rate for "allergic" reactions of one case report per 450,000 vaccine doses sold.