Vaccine Supply and Shortages
Safe and effective vaccines are central to the prevention and control of communicable diseases. As a consequence, any shortage of vaccine places children and adults at risk for vaccine-preventable diseases. Vaccine shortages have been a problem in the past and are likely to be a problem in the future.
For instance, since 2000 the United States has experienced shortages of influenza, diphtheria-tetanus-acellular pertussis (DTaP), tetanus and diphtheria (Td), measles-mumps-rubella (MMR), varicella, and pneumococcal conjugate vaccines. (1,2)
In October 2004, one of two manufacturers of the inactivated influenza vaccine announced that it would not be able to provide trivalent inactivated (killed) virus vaccines (TIV) for that influenza season. This caused both a TIV shortage and an imbalance in the distribution to those who need it the most. Healthcare providers place their vaccine purchase orders well in advance of when vaccine is to be given and in this case before the vaccine became available. Thus some providers had all the vaccine that they would normally need whereas others had none.
The national recommendation to reduce or eliminate the content of the preservative thimerosal in vaccines given to children less than 6 months of age, required that the manufacturers of DTaP revise their manufacturing process of these vaccines, requiring more vaccine to be produced for the same number of doses and requiring a different packaging system. This contributed to the shortages of these vaccines in addition to the reasons given above. (2)
In response to severe shortages of a number of vaccines in 2001, both the US General Accounting Office (3) and Department of Health and Human Services’ (DHHS) National Vaccine Advisory Committee (NVAC) (4) considered the causes of the shortages and ways to strengthen the supply of routinely recommended vaccines. They came to similar conclusions.
In conjunction with other groups interested in immunizations, NVAC examined 5 potential solutions: financial incentives to vaccine manufacturers; changes in the regulatory process; government-directed programs; vaccine stockpiles; and liability protections. (4)
NVAC concluded that disruptions to the supply of routinely administered vaccines are likely to continue to occur. Therefore, they proposed both short- and long-term solutions to DHHS. Some of these solutions are:
To address NVAC’s recommendations, CDC completed site visits with the manufacturers, began development of a national vaccine stockpile strategic plan and contracted for additional stockpile purchases of varicella, H. influenzae type b, hepatitis A, hepatitis B and pneumococcal conjugate vaccines, among other things. (2)
The Vaccines for Children (VFC) Act mandates vaccine stockpiles be maintained—to provide a six-month supply—of the various childhood vaccines. (1) These stockpiles could be used to mitigate short-term supply disruptions.
Stockpiled vaccines are owned by the federal government but stored by the manufacturer until CDC requests them—this is called a “buy and hold” arrangement. By doing it this way, the manufacturer rotates the stored vaccine by selling the oldest doses in the stockpile (when their shelf life goes below 12 months) and then replaces them with newly manufactured doses. That way the vaccine in the stockpile does not go out of date.
Expanding the stockpiles to include all the recommended childhood vaccines has encountered an unexpected obstacle: an accounting rule published by the Securities and Exchange Commission in 1999. The intent of the rule was to prevent deceptive accounting practices. While the rule may acomplish this in most circumstances, some of the companies that produce vaccines argue that this rule keeps them from classifying payments for stockpiled vaccines as “revenue” on their balance sheets. A solution to this problem may require congressional intervention.
Vaccine shortages repetitively emphasize the fragility and lack of redundancy of the vaccine supply.
1. CDC (2004). Current Vaccine Delays and Shortages.
2. Santoli JM, Klein JO, Georges P, and Orenstein WA (2004). Disruptions in the Supply of Routinely Recommended Childhood Vaccines in the United States. The Pediatric Infectious Disease Journal, 23(6):553-554.
3. General Accounting Office (2002). Childhood vaccines. Ensuring an adequate supply poses continuing challenges. GAO-02-987:1-46.
4. National Vaccine Advisory Committee (2003). Strengthening the Supply of Routinely Recommended Vaccines in the United States: Recommendations From the National Vaccine Advisory Committee. JAMA, 290:3122-3128.
|© Copyright 2007. National Network for Immunization Information (NNii). The information contained in the NNii Web site should not be used as a substitute for the medical care and advice of your health care provider. There may be variations in treatment that your health care provider may recommend based on individual facts and circumstances.|