Crs Report for Congress Received through the Crs Web Vaccine Policy Issues Updated May 19, 2005

By Thaul, Susan

Book Id: WPLBN0000009134
Format Type: PDF eBook
File Size: 0.2 MB
Reproduction Date: 2008

Title:	Crs Report for Congress Received through the Crs Web Vaccine Policy Issues Updated May 19, 2005
Author:	Thaul, Susan
Volume:
Language:	English
Subject:	Government publications, Legislation., Government Printing Office (U.S.)
Collections:	Government Library Collection
Historic Publication Date:
Publisher:	Government Printing Office


Citation APA MLA Chicago Thaul, S. (n.d.). Crs Report for Congress Received through the Crs Web Vaccine Policy Issues Updated May 19, 2005. Retrieved from http://gutenberg.us/

Excerpt
Summary: This report’s focus is on vaccination, one of the most cost-effective methods available to prevent infectious diseases. Whether a vaccine’s target is naturally occurring or present because of hostile intent, the issues policy makers must deal with include vaccine development, production, availability, safety, effectiveness, and access. Vaccines are biologics: their basic components begin as living material. They introduce bacteria or dead or weakened viruses into a person or animal to stimulate an immune reaction that the body will remember if assaulted by the same pathogen in the future.

Table of Contents
Contents Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 What Is A Vaccine? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Procedures for the Approval and Regulation of Biololgics . . . . . . . . . . . . . . 2 Stakeholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Laws Approved by the 107th Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Legislative Activity in the 108th Congress . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Continuing Legislative Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Production Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Production Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Possible Legislative Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Financial Incentives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Improved Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Ensuring Safety and Effectiveness May Delay Availability . . . . . . . . 11 Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Side-Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Insufficient Knowledge and Inadequate Risk Communication . . . . . . 15 Assessment of Competing Products . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Production of Generic Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Possible Legislative Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Improving Post-Licensure Adverse-Event Surveillance . . . . . . . . . . . 16 Education and Risk Communication . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Studies in Pharmacoepidemiology and Pharmacoeconomics . . . . . . . 17 Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Possible Legislative Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Coordination of Government Financing Programs . . . . . . . . . . . . . . . 19 Payment for Vaccination and Follow-Up Care . . . . . . . . . . . . . . . . . . 20 Global Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20