Media Statement

Statement regarding Office of the Inspector General Vaccines for Children report

On June 5, 2012 the U.S. Department of Health and Human Service Office of the Inspector General (OIG) released a report on "Vaccines for Children (VFC) Program: Vulnerabilities in Vaccine Management.". CDC's VFC program provides free vaccines to eligible children through a national network that includes all states and U.S. territories and is composed of more than 44,000 participating provider sites. This program plays a significant role in improving access to vaccination for millions of children.

The OIG assessment, conducted in April and May of 2011, included 45 providers from five states and cities. The study was aimed at assessing if VFC providers are meeting their vaccine management requirements, including storing vaccines at proper temperature ranges and appropriate handling of expired vaccines. The OIG logged temperatures in vaccine storage units for two weeks and found that in a majority (76%) of provider offices, there were times when vaccine was exposed to inappropriate temperatures (i.e., for at least 5 cumulative hours during the two-week (or 336 hour) study period. Contrary to some news reports, the OIG did not find that 76% of all vaccine was stored improperly. Thirteen of the 45 providers had expired vaccine that was stored alongside unexpired vaccine. The majority of expired vaccine doses identified in the April-May assessment were seasonal influenza vaccine. It is unlikely that such doses were administered.

CDC is not recommending that parents revaccinate their children. The main concern with improper storage temperatures is that they can make vaccines less effective rather than less safe. The OIG report did not assess vaccine potency or effectiveness. While it is possible that some children have received less potent vaccines due to exposure to improper temperatures, our data do not suggest that this is a common or widespread problem. Our national monitoring indicates vaccines are doing their job at providing protection against disease. Most of the diseases we vaccinate against are at record low levels in the United States. Investigations of recent outbreaks of measles and pertussis have been associated with factors such as vaccine refusal and waning of immunity over time. In fact, patterns in these outbreaks suggest that children are receiving potent and effective vaccines. Our vaccine safety monitoring also indicates that we continue to have the safest vaccine supply in our history.

While the safety and health of our nation’s children has not been compromised by the issues identified by the OIG, the findings are important and underscore that we must do better at ensuring that all vaccines are stored properly at all times, including removing expired vaccine from units where viable vaccines are stored. The vaccines that protect children against serious and even deadly diseases should always be stored properly. CDC and our partners are working with a sense of urgency to address the problems identified in the OIG study.

CDC continues to encourage parents to vaccinate according to the U.S. recommended immunization schedule to provide the best protection for children from 16 serious and deadly diseases. If parents have questions about their child’s vaccinations, they should talk with their child’s doctor.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES