Vaccines safety evaluation

Farrington, C.P., Relative incidence estimation from case series for vaccine safety evaluation. Biometrics, 51(1) 228-235,1995. 

Brennan, F.R. and Dougan, G., Non-clinical safety evaluation of novel vaccines and adjuvants New products, new strategies, Vaccine, 23, 3210, 2005. 

Considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications Nonclinical safety evaluation of pediatric drug products Nonclinical safety evaluation of drug and biological combinations Immunotoxicity studies for human pharmaceuticals (ICH S8)... 

The purpose of this chapter is to review and discuss the preclinical safety evaluation strategy for vaccine approaches to the prophylaxis and treatment of viral diseases. This chapter will discuss the newer approaches to vaccination and will include recombinant proteins, peptides, polysaccharides, DNA plasmids, and viral vectors with and without adjuvants. It is outside the scope of this chapter to discuss whole cells expressing immunogens, live attenuated viruses, bacteria, or parasites. 

Includes vaccines but more relevant to other biologies International Conference on Harmonization (ICH) S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals 1997... 

Sheets RL, Stein J, Manetz TS, Andrews C, Bailer R, Rathmann J, Gomez PL. Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, ebola, severe acute respiratory syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. Toxicol Scis 2006 91 620-30. 

Goldenthal KL, Cavagnaro JA, Alving CR, Vogel FR. Safety evaluation of vaccine adjuvants. National Cooperative Vaccine Development Working Group. AIDS Res Hum Retroviruses 1993 9 S45-S49. 

Kennedy RC, Shearer MH, Hildebrand W. Nonhuman primate models to evaluate vaccine safety and immunogenicity. Vaccine 1997 15 903-8. 

Reports on adverse events after the administration of the two hepatitis B vaccines licensed in the US (Engerix-B and Recombivax HB) have been compared in two different surveillance systems VAERS and Vaccine Safety Datalink (VSD) (8). VSD is a computerized record linkage system designed to allow more rigorous evaluation of... 

Chen RT, Pool V, Takahashi H, Weniger BG, Patel B. Combination vaccines postlicensure safety evaluation. Clin Infect Dis 2001 33(Suppl 4) S327-33. 

Other selection criteria may be considered. The mini-pig is a good model for studying intracutaneous or topical vaccines.29 For a mucosal vaccine, Glueck30 used the baboon to investigate a novel adjuvant for intranasal immunization, based on the physiological and pharmacology similarity with man. However, other species should be considered first, and certainly rats, mice, and rabbits have been used. For further discussion, see safety evaluation of toxin adjuvants delivered intranasally by Lang.31... 

Dempster AM, Haworth R. Pre-clinical safety evaluation of viral vaccines. In Cavagnaro JA, ed. Preclinical Safety Evaluation of Biopharmaceuticals. John Wiley Sons Inc. Hoboken, New Jersey. 2008 31 683-712. 

Tang RS, Spaete RR, Thompson MW, MacPhail M, Guzzetta JM, Ryan PC, Reisinger K, Chandler P, Hilty M, Walker RE, Gomez MM, Losonsky GA. Development of a PIV-vectored RSV vaccine Preclinical evaluation of safety, toxicity and enhanced disease and initial clinical testing in healthy adults. Vaccine. 2008 26 373-6382. 

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