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Despite its successes, the U.S. vaccine system is fragile and needs significant improvements, the authors report. Since 2000, vaccines against nine of the twelve vaccine-preventable diseases of childhood have been in short supply. As of 2004 only four commercial companies produce vaccines for young children, and vaccines for seven of the preventable diseases of childhood are manufactured by only one company. The rising cost of vaccines, due partly to compliance with regulations and liability concerns, threatens the widespread availability of vaccines for children. The most recent estimates (2000) of the cost to develop a new vaccine range from $110 million to $802 million, and five vaccines recently reviewed by the National Vaccine Advisory Committee took from two to twenty-one years from Phase I clinical trials to licensing.

Safety concerns, such as the problem with the rotavirus vaccine in 1998 as well as unfounded and unproven concerns about other vaccines threaten to lead to decreased vaccine coverage and outbreaks of vaccine-preventable infectious diseases. Adult immunizations, while effective, have not been as effective as childhood vaccines. However, even the most effective ones do not have the wide coverage of childhood vaccines.

"Although immunization can be counted as one of the major successes of medicine, the recent short supplies of childhood vaccines and the recent problems with influenza vaccine are a clear sign of the importance of continuing to improve the system for vaccine development and manufacture," Dr. Orenstein emphasizes. "Manufacturers need to have adequate returns on their investments, healthcare providers need to be fairly reimbursed, resources should be available to monitor vaccine effectiveness and safety, and loopholes need to be closed in the v
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Contact: Holly Korschun
hkorsch@emory.edu
404-727-3990
Emory University Health Sciences Center
10-May-2005