Vaccines and Preventable Diseases:
PCV7 (Prevnar®) Shortages and Suspension of the Recommendation for the 3rd and 4th Doses
March 1, 2004
Questions and Answers
What new action is being taken?
Effective immediately, the Centers for Disease Control and Prevention, (CDC) in consultation with the American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), and the Advisory Committee on Immunization Practices (ACIP), recommends that all health-care providers temporarily suspend routine use of both the third and fourth doses of PCV7. Children at increased risk of severe disease should continue to receive the routine, 4-dose series.
This action was taken to minimize shortages of the vaccine until the manufacturer can reach full production. Limiting healthy children to two doses of PCV7 will conserve vaccine and permit more children to get at least two doses. As a result of this action, there should be enough vaccine for all children to get a least two doses.
Children whose 3rd and 4th doses are delayed should receive the missed doses on their first visit to a healthcare provider after supplies return to normal. Healthcare providers should keep track of children who miss vaccinations and recall those patients when they receive adequate supplies of vaccine.
On February 13, 2004, CDC recommended that health-care providers temporarily suspend routine use of the fourth dose of 7-valent pneumococcal conjugate vaccine (PCV7) when immunizing healthy children. Since that recommendation was issued, PCV7 production has been much less than had been expected and shipments have been further delayed, resulting in shortages of vaccine. Widespread shortages may now continue beyond this summer.
Wyeth Vaccines, the sole manufacturer in the United States, markets PCV7 under the trade name Prevnar®.
Why is this new action necessary?
CDC recognizes the concern that suspending the third and fourth doses of PCV7 may cause but we are taking this action because the potential for widespread and serious shortages of PCV7 could occur if the third and fourth doses are not delayed. By delaying the third and fourth doses, we expect to save a large amount of vaccine so that all children will be protected with at least two doses of vaccine.
The United States needs approximately 1.3 million doses of PCV7 each month to provide every infant the full, 4-dose, vaccination series. For the period January – April, 2004, total shipments are estimated to be no more than 55% of the 4-dose need. The production shortfall is markedly worse than was anticipated on February 13 and results from continuing problems with the PCV7 vial-filling production line. This recommendation being taken to minimize shortages until the manufacturer can reach full production capacity. It reflects current CDC’s assessment of the existing national PCV7 supply and may be changed if the supply changes.
What are the health implications of delaying the third and fourth dose?
Four doses of PCV7 provide the best protection, but children who have received three doses should also have a very high level of protection. Children who have had two doses should also have some protection, but the exact level is unknown. Delaying the third and fourth doses of PCV7 is not ideal. However, this step will help ensure that all children receive at least two doses of the vaccine.
What is CDC doing?
Besides recommending delaying the third and fourth dose of vaccine, CDC will continue to work closely with the manufacturer and our partners to monitor the vaccine supply. We will continue to update healthcare providers and the public on the status of vaccine supplies as long as the shortages persist. In addition, we are developing a fact sheet for parents that explains the current situation.
What is the usual recommended schedule for vaccination with PCV7?
The vaccine is recommended for young children in a four-dose schedule: one dose at 2 months, at 4 months, and at 6 months, and one dose between 12 and 15 months. This recommendation suspends the third and fourth doses usually administered at 6 months and between 12 and 15 months for healthy children. PCV7 is not routinely recommended for children 2 years of age or older.
What does the vaccine protect against?
The vaccine can help prevent serious pneumococcal diseases, such as meningitis and blood infections. It can also prevent some ear infections. But ear infections have many causes, and the vaccine is only effective against some of them. Pneumococcal infection can cause serious illness and even death. Invasive pneumococcal disease is the leading cause of bacterial meningitis in the United States. Children under two years of age are at highest risk.
What should physicians do?
Children whose 3rd and 4th doses are delayed should receive the missed doses on their first visit to a healthcare provider after supplies return to normal. Healthcare providers should keep track of children who miss vaccinations and recall those patients when they receive adequate supplies of vaccine.
What should parents do?
Immunizations are one of the most important ways parents can protect their children against serious diseases. Parents should monitor their child’s immunization record and talk with their healthcare provider about their child’s immunization status. Parents should schedule a catch-up appointment with their healthcare provider if their child misses either the third or fourth dose of PCV7.
Related Materials
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This page archived for historical purposes on January 30, 2007
Content Source: National Center for Immunization and Respiratory Diseases