Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Close this folderAccess to drugs and vaccines II
View the documentTwenty-five years of essential medicines: progress and agenda for regulators
View the documentEssential drugs list: South African experience
View the documentThe role of government and essential drugs - Indonesian experience
View the documentThailand’s experience in access to medicines
View the documentCurrent vaccine shortages in the United States of America
View the documentExpanding access to essential medicines and vaccines: lessons learnt in Brazil
View the documentRecommendations
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Current vaccine shortages in the United States of America

Mr Mark A. Elengold, United States of America

The number of licensed vaccine manufacturers in the USA fell from 26 in 1967 to 17 in 1980, and down to 12 in 2002. There are currently shortages of a number of vaccines, including DT, TT, MMR, varicella, pneumococcal polysaccharide conjugates and influenza.

The three major causes for the current vaccine shortages in the USA are the limited production capacity, vaccine use and the economic situation.

The production capacity of vaccines is limited by the following factors:

• aging and inflexible plants;

• differences in regulatory requirements in different countries;

• scientific challenges, e.g. use of different adventitious agents and additives in different countries; and

• costly GMP requirements.


Vaccine use changes as a result of changes in recommendations, and in response to changes in public acceptance. Such changes can make it difficult for manufacturers to plan their manufacturing.

The difficult economic situation is related to:

• the uncertainty of the market;
• the complexity of the product; and
• the low price generally paid for preventative measures.


The USA currently faces a number of challenges including:

• ensuring the supply of vaccines;
• developing new vaccines;
• combination vaccines; and
• supplying vaccines at an affordable price to developing countries.


In order to increase vaccine availability, the USA should:

• improve early and frequent communication among the relevant parties;
• develop research that facilitates product development, improvement and safety;
• allow fast track and accelerated approval;
• increase the price of vaccines;
• limit liability by, e.g. offering indemnities to manufacturers; and
• seeking a balance between the risks and benefits of vaccines.

 

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