Vaccines and Preventable Diseases:
Decreased Availability of Pneumococcal Conjugate Vaccine (PCV-7)
During 2001 and 2002
Questions about the 2002 shortage of PCV-7 are answered at:
www.cdc.gov/vaccines/vac-gen/shortages/faqs_shortages_3-7-02.htm
Information below this line was current on December 19, 2001
Deliveries of Prevnar, the new Pneumococcal Conjugate Vaccine (PCV-7), marketed by Wyeth Lederle Vaccines, have been delayed resulting in shortages for some providers and health departments. State immunization programs, private providers and local health departments have reported to NIP difficulty in obtaining enough PCV-7 to immunize all children for whom the vaccine is recommended. On August 28, 2001, NIP estimated that 34 State immunization programs had less than a one month inventory of PCV-7. NIP recommends that a minimum of one month inventory is necessary at the State level in order to avoid shortages among providers.
Until supplies are replenished, the CDC recommends that all providers defer the vaccination of children older than 2 years except those 2-5 years old who are at increased risk of pneumococcal disease (e.g., children with sickle cell disease or anatomic asplenia, chronic illness, or who are immunosuppressed including those with human immunodeficiency virus infection). Providers with insufficient vaccine to vaccinate all these children should give highest priority to vaccinating all infants less than 12 months and children 1-5 years at increased risk. Catch up vaccinations for healthy children 1-2 years and booster doses for healthy children who have completed the primary series may be deferred. Records should be kept so that the deferred vaccinations can be given when vaccine becomes available.
View MMWR
December 21, 2001 / 50(50); 1140-2
View MMWR
September 14, 2001 / 50(36);783-4
December 19, 2001
- Is there a shortage of PCV-7?
There are spot shortages of PCV-7 being reported to the Centers for Disease Control and Prevention’s National Immunization Program (NIP). State immunization programs, private providers and local health departments have reported to NIP difficulty in obtaining enough PCV-7 to immunize all children for whom the vaccine is recommended. Over one half of all childhood vaccine is purchased through CDC contracts and distributed to providers through state immunization programs. On August 28, 2001, NIP estimated that 34 State immunization programs had less than a one month inventory of PCV-7. NIP recommends that a minimum of one month inventory is necessary at the State level in order to avoid shortages among providers.
- What caused the shortage?
Provider demand for PCV-7 has been much greater than anticipated. The manufacturer, Wyeth Lederle, feels that they have adequate production capacity to meet U.S. demand for the vaccine. However, several temporary manufacturing difficulties have prevented Wyeth Lederle from producing at full capacity for the past several months.
- Which children should receive the available doses?
Until supplies are replenished, the CDC recommends that all providers defer the vaccination of children older than 2 years except those 2-5 years old who are at increased risk of pneumococcal disease (e.g., children with sickle cell disease or anatomic asplenia, chronic illness, or who are immunosuppressed including those with human immunodeficiency virus infection). Providers with insufficient vaccine to vaccinate all children <2 years and those at increased risk of pneumococcal disease should give highest priority to vaccinating all infants less than 12 months and children 1-5 years at increased risk. Catch up vaccinations for healthy children 1-2 years and booster doses for healthy children who have completed the primary series may be deferred. Records should be kept so that the deferred vaccinations can be given when vaccine becomes available.
- How long will the shortage last?
The duration of the shortage is uncertain, but it is expected the shortage will last at least through December, 2001. NIP calculates that the national need for PCV is about 2 million doses per month. The manufacturer may be able to ship on average about 1.7 million doses each month for the remainder of 2001. When supply catches up to demand, there will still be an interim period when inventories will need to be restored before the supply shortage can be declared officially over.
- What's being done to address the situation?
Prioritizing the available vaccine as described above should decrease demand and eventually end the spot shortages. Once the spot shortages are alleviated and the supply inventories are increased to adequate levels, the current "routine" recommendations should be restored. In the meantime, prioritizing the use of PCV-7 should help assure that those children at highest risk of disease receive the vaccine.
- Why are some locations experiencing shortages and other locations are not?
PCV-7 shortages among providers (and States) reflect the inventory amounts that were in provider offices or storage depots at the time the manufacturer began having problems in meeting the supply demands. Those with a greater amount of inventory have up until now been able to meet the demands of their practices, while those with smaller inventories and unfilled orders began reporting shortages.
- Should the manufacture have anticipated the demand?
Anticipated demand may not correlate with anticipated production. In this instance, unanticipated problems with the production process are reasons cited for the supply shortage.
- What if my child has only received one dose of the vaccine -- is he protected or will he have to start over?
Although prelicensure trials have shown efficacy of a partial vaccination series, the duration of protection and whether protection occurs for all serotypes included in the vaccine is not clear. If a child has missed one or more dose of the primary series, they should resume vaccination where they left off when more vaccine is available. There are no safety or efficacy implications in doing so. Completing the primary series is a higher priority than delivering the 12-15 month booster dose on schedule and the latter should be deferred before the former.
- What diseases does the PCV-7 protect against?
The vaccine is highly effective in preventing invasive pneumococcal disease in young children. Prior to the introduction of PCV-7, pneumococcal infections caused approximately 700 cases of meningitis, 17,000 cases of bacteremia – blood stream infections – and 200 deaths each year in children under age five. Meningitis is the most severe type of pneumococcal disease. About five percent of children under 5 years old with pneumococcal meningitis will die of their infections.
- Can we anticipate an increase in disease in those areas where shortages exist?
Because vaccine is available to immunize those at highest risk and because deferral of vaccine for others is likely to be short, we don't anticipate an increase in disease or outbreaks of disease.
Return to Archive of Vaccine Shortages in the Spotlight
This page archived for historical purposes on January 30, 2007
Content Source: National Center for Immunization and Respiratory Diseases