The Regulatory Evaluation of Vaccines for Human Use
A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to result in the prevention, amelioration, or therapy of any disease or infection (US Food and Drug Administration. Guidance for Industry: content and format
- PDF / 659,770 Bytes
- 15 Pages / 504.57 x 720 pts Page_size
- 57 Downloads / 161 Views
1
Introduction Vaccines, whether prophylactic (measles, polio, HPV, etc.) or therapeutic (HIV or other chronic infectious diseases, etc.), are subject to the same regulations as other biological products and are required to be manufactured to meet strict standards set by National Regulatory Authorities (NRA) such as the US Food and Drug Administration (FDA). While vaccine manufacturers have the primary legal responsibility for assuring the safety, quality, and effectiveness of the products they manufacture and distribute, it is the NRAs who have the legal authority of enforcement to ensure product quality, safety, and effectiveness. Moreover, NRAs are responsible for the review and authorization of clinical trials, approval of licensing applications and lot release, and monitoring the performance of the product throughout its lifecycle. The FDA also publishes guidance documents, although not legally enforceable, which provide sponsors and manufacturers with FDA’s current thinking on various regulatory and scientific topics (Table 1). Biological products, including vaccines, are distinguished from chemical pharmaceuticals primarily due to their derivation from living organisms with an innate molecular complexity that cannot be defined by physical or chemical means alone. In addition, the intrinsic variability of living organisms, and the potential for contamination of materials with adventitious agents, which may come from starting materials or the environment, requires special quality control and quality assurance mechanisms. Moreover, vaccines are inherently more difficult to develop, characterize, and manufacture than most pharmaceutical products. The manufacture of most vaccines requires the growth or expression of the immunizing agent (i.e., bacteria, virus, virus-like particles, recombinant proteins, etc.) in living cells. Establishing the conditions
Sunil Thomas (ed.), Vaccine Design: Methods and Protocols, Volume 2: Vaccines for Veterinary Diseases, Methods in Molecular Biology, vol. 1404, DOI 10.1007/978-1-4939-3389-1_51, © Springer Science+Business Media New York 2016
773
774
Norman W. Baylor
Table 1 Current guidance documents applicable to development, manufacture, licensure, and use of vaccinesa Guidance documents Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (PDF—57 KB),12/2011 Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines, 10/2011 Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, 2/2010 Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications, 11/2007 Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, 9/27/2007 Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines, 5/31/2007 Guidance for
Data Loading...
