Vaccines and Preventable Diseases:

PCV7 (Prevnar®) Shortages and Reinstatement of the 3rd Dose in PCV7 Vaccination
July 8, 2004

Questions and Answers

What is CDC recommending?

Production problems that caused shortages of the pneumococcal conjugate vaccine (PCV7, marketed as Prevnar™) appear to have been resolved and supplies are now adequate to allow healthcare providers to routinely administer three doses of the vaccine to their young patients. Effective immediately, the CDC, in consultation with the Advisory Committee on Immunization Practices (ACIP), American Academy of Family Physicians (AAFP), and the American Academy of Pediatrics (AAP), recommends that providers administer three doses of PCV7. The fourth dose should still be deferred for healthy children until further production and supply data demonstrate convincingly that a 4-dose schedule can be sustained. The full, 4-dose, series should continue to be given to children at increased risk for pneumococcal disease because of certain chronic conditions (e.g., sickle cell disease, anatomic asplenia, chronic heart or lung disease, diabetes, cerebrospinal fluid leak, cochlear implant, or an immunocompromising condition).

Alaska Native children and American Indian children living in Alaska, Arizona, or New Mexico and Navajo children in Utah and Colorado currently have a risk of invasive pneumococcal disease more than twice the national average. These groups of children should receive the standard 4-dose PCV7 series despite the shortage.

Why is CDC taking this action?

In February 2004, production of Prevnar™, a 7-valent pneumococcal conjugate vaccine manufactured by Wyeth Vaccines (Collegeville, PA), failed to meet demand, resulting in shortages. To conserve the limited supply, CDC recommended that the fourth dose be withheld from healthy children. In March, when it became clear that production would be curtailed for several months, CDC recommended that the third dose also be withheld. Production problems appear now to have been resolved and deliveries are projected to be adequate to permit every child to receive at least three doses.
This recommendation reflects CDC's assessment of the existing national PCV7 supply and will be changed if the supply changes.

What are the health implications of delaying the 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. PCV is a highly effective vaccine. In 2003, the incidence of invasive pneumococcal disease among children less than two years of age was 69 percent lower than it was during 1998–99, before universal recommendation for the vaccine. There is evidence of high, short-term effectiveness of the 3-dose primary series of the PCV7 administered at 2, 4, and 6 months. Preliminary data from CDC’s Active Bacterial Core Surveillance program indicate that effectiveness, at least for the short term, is not greatly compromised by delaying administration of the fourth dose in healthy children.

What does the vaccine protect against?

The vaccine can help prevent serious pneumococcal diseases, such as meningitis and blood infections. 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. Before a vaccine was available, each year pneumococcal infection caused more than 700 cases of meningitis, 13,000 blood infections and about 5 million ear infections.

What should those parents do whose children missed a dose of the vaccine?

Parents should contact their healthcare provider if their child missed a dose of PCV7.

What should providers do?

The highest priority for catch-up vaccination is to ensure that children less than 5 years of age at high risk for invasive pneumococcal disease are fully immunized. Second priorities include vaccination of healthy children aged less than 24 months who have not received any doses of pneumococcal conjugate vaccine and healthy children aged less than 12 months who have not yet received 3 doses.

Because of the frequency of health-care provider visits for children during their first 18 months, catch-up vaccination might occur at regularly scheduled visits for most children who receive vaccines from their primary-care provider. Programs that provide vaccinations but do not see children routinely for other reasons should consider a notification process to contact undervaccinated children.

Recommended Regimens While the PCV7 Shortage Exists

Age at examinations (months)	Previous pnumococcal conjugate vaccination history	Recommended Regimen
2-6	0 doses	3 doses 2 months apart
	1 dose	2 doses 2 months apart
	2 doses	1 dose
7-11	0 doses	2 doses 2 months apart, 3rd dose at 12-15 months
	1 dose before age 7 months	1 dose at 7-11 months, with another dose at 12-15 months (>= 2 months later)
	2 doses before age 7 months	1 dose at 7-11 months
12-23 months	0 doses	2 doses >= 2 months apart
	1 dose before age 12 months	2 doses >= 2 months apart
	1 dose at >= 12 months	1 dose >= 2 months after the most recent dose
	2 doses before age 12 months	1 dose >= 2 months after the most recent dose
24-59, Healthy children		1 dose >= 2 months after the most recent dose, and another dose >= 2 months later
24-59, High risk‡	Any incomplete schedule comprising <3 doses	1 dose >= 2 months after the most recent dose, and another dose >= 2 months later
24-59, High risk‡	Any incomplete schedule comprising 3 doses	1 dose >= 2 months after the most recent dose

 

Notes for Recommended Regimen

Note* For children vaccinated at age <1 year, the minimum interval between doses is 4 weeks. Doses given at >= 12 months should be at least 8 weeks apart.

Note† When the shortage is completely resolved, providers should consider administering a single dose to unvaccinated, healthy children 24-59 months old with priority to children 24-35 months old, children of African-American descent, children of American-Indian descent but not otherwise identified as high risk‡, and children who attend group day care centers.

Note‡Children with sickle cell disease, asplenia, chronic heart or lung disease, diabetes, cerebrospinal fluid leak, cochlear implant, HIV infection or another immunocompromising condition and children of Alaska Native or American Indian descent in areas with a demonstrated risk of invasive pneumococcal disease more than twice the national average (Alaska, Arizona, New Mexico and Navajo populations in Utah and Colorado).

Related MMWR

• Related MMWR

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