Vaccines are a cost-effective means of preventing many infectious diseases. Successful vaccination campaigns are credited with eradicating life-threatening diseases such as polio and smallpox from the Western Hemisphere. Unfortunately, recent vaccine shortages may threaten the success of current immunization programs.
During the current vaccine shortage, our drug information service has received considerable requests for vaccine-related information. This paper discusses many of the issues inquired about as well as reference sources for vaccine-related information. The objectives of this article are to:
- list vaccines included on the recommended childhood immunization schedule that are currently in short supply.
- discuss the recommendations of the ACIP for managing each vaccine shortage.
- review vaccine-related resources for health care providers.
The Office of Health Policy and Clinical Outcomes, Thomas Jefferson University Hospital, is approved by the American Council on Pharmaceutical Education (ACPE) as a provider of continuing pharmaceutical education and complies with the Criteria for Quality for continuing pharmaceutical education programming. This program (079-999-02-020-H01) is acceptable for 1.0 hour of continuing education credit (0.1 CEUs) in states that recognize ACPE-approved providers. Statements of Credit indicating hours/CEUs will be mailed quarterly to participants who completed this activity and submitted a completed evaluation with payment.
Supply and Demand Problems
The unique nature of vaccines and other biological products presents special challenges during the manufacturing process. Several disasters involving biologicals have prompted legislation to regulate them in a manner different from that of traditional pharmaceuticals. Thus, vaccines are regulated under section 351 of the Public Health Service Act. Title 42 of United States Code 262 categorizes vaccines as biological products, thus subjecting them to the same manufacturing requirements as immunoglob-ulins and other blood products. Although vaccines and other bi-ologicals are subject to the same rigorous premarketing requirements as drugs, they are subject to additional requirements, which include testing and certification for potency, safety, and purity of each lot of vaccine produced. The goal of this additional surveillance is to ensure that impure or subpotent vaccines are identified before they cause significant harm to patients. When problems are identified, a recall is issued that may condemn an entire lot of the product. Recalls resulting from production problems are the primary reason for the current vaccine shortages. Vaccines have been recalled because of a lack of potency, improper packaging, and sterility problems.
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Another major influence on vaccine supplies has been the recent departure of a major manufacturer from the vaccine market, leaving remaining manufacturers scrambling to increase production to meet current demand. External forces resulting in an increased demand for several vaccines have highlighted the problem of reduced vaccine supply. Demand has been increased by supply problems, creating extra pressure on an already overburdened system. When vaccine recalls are due to improper storage or lack of potency, affected patients often require revaccination.
When vaccine shortages occur, it may become necessary to alter vaccination practices and vaccine distribution in order to conserve the supply of vaccines. Manufacturers or wholesalers may chose to allocate a limited supply to each institution to ensure that there is vaccine available for those who need it. This may force the hand of clinicians to alter their use of vaccines during a shortage. When vaccines are scarce, public health officials may issue recommendations to assist clinicians with managing their limited supply. Strategies to conserve vaccine supplies include deferring doses of vaccine until resolution of the shortage, abbreviating vaccination series, and prioritizing vaccine candidates. When vaccines are in limited supply, it may be better to budget available vaccine for initiation of a series for vaccine naive patients rather than complete the series of patients who need to complete a multiple injection series. Fortunately, a delay in the final dose of vaccine in a vaccination series does not affect seroconversion rates upon completion of the series. silagra