Autor(es): Kopecko D J

Resumo: The high, worldwide incidence of Campylobacter jejuni-associated diarrheal disease has recently prompted the development of anti-Campylobacter vaccines. However, the association of C. jejuni infections with subsequent development of Guillain-Barré syndrome has increased concerns from a pathogenesis standpoint and from a vaccine development and regulation standpoint. This brief overview describes the purpose and process of Food and Drug Administration review of vaccine products and highlights some important considerations pertinent to Campylobacter vaccine development.

Palavras-Chave: Vaccination; Campylobacter; Investigational drugs; Drug regulation; Food law; Dosage; Government regulation; Medication administration; Campylobacter infections; Infections

Imprenta: The Journal of Infectious Diseases, v. 176, supl 2, p. 189-191, 1997

Descritores: Guillain-Barre Syndrome - Pathogenesis ; Guillain-Barre Syndrome - Vaccine ; Guillain-Barre Syndrome - Immunology ; Guillain-Barre Syndrome - Public health

Data de publicação: 1997

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