Health Advisory

13-Valent Pneumococcal Conjugate Vaccine (PCV 13)

To: Vaccines for Children Providers
From: Immunization Program
Date: March 25, 2010

– Please Distribute Widely –

In February 2010, a new 13-valent pneumococcal conjugate vaccine (PCV 13) was licensed by the U.S. Food & Drug Administration (FDA). In March 2010, the Advisory Committee on Immunization Practices (ACIP) released provisional recommendations for the use of PCV 13 to prevent invasive pneumococcal disease (IPD) in children. PCV 13 succeeds the 7-valent pneumococcal vaccine (PCV 7) used in the routine childhood immunization schedule since 2000. PCV 13 contains the seven serotypes in PCV 7 (4, 6B, 9V, 14, 18C, 19F and 23F) and six additional serotypes (1, 3, 5, 6A, 7F and 19A).

Routine infant immunization with PCV 7 since 2000 has markedly decreased the rate of IPD in young children, but IPD from non-PCV 7 serotypes has increased. In 2007, 64 percent of 427 IPD cases observed in a national surveillance program were caused by the serotypes covered by PCV 13, but not by PCV 7. Overall, 42 percent of the cases were caused by serotype 19A.

To further reduce IPD among children youger than 5 years old, it is essential to maintain high vaccination rates with PCV 13. 

For the ACIP recommendations and a full report in the MMWR, please refer to the following links:
http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5909a1.htm

Ordering PCV 13
As of March 18, vaccine orders placed for PCV 7 will be replaced by PCV 13 for all provider practices.  Practices should stop using PCV 7 as soon as they receive their first PCV 13 vaccine shipment.

Upon receipt of PCV 13, all remaining PCV 7 should be removed from your refrigerator, labeled DO NOT USE, and returned to McKesson. To receive the return mailing labels, please list the number of doses and lot numbers of PCV 7 in the “expired and returned” column of your Vaccine Accountability & Order form when the next order form is submitted. The Immunization Program will then mail you a Return Authorization form to include with the PCV 7 vaccine, and a UPS mailing label for shipping the vaccine to McKesson. This vaccine does not need to be returned with ice packs or in a cooler. The Vaccine Information Statement (VIS) for PCV 13 is being cleared for publication at CDC and will be posted on the CDC website.  CDC has recommended that practices may “use the current PCV 7 VIS and supplement it verbally with the package insert or ACIP recommendations.” 

ACIP Provisional Recommendations
Please refer to the following table for specific schedules for children younger than 24 months. For children who have completed the PCV 7 vaccination series, a single supplemental dose of PCV 13 is recommended for all children 14 through 59 months of age. For children who have underlying medical conditions, a single supplemental PCV 13 dose is recommended through 71 months of age. Children 6 to 18 years of age with high-risk medical conditions may receive a single dose of PCV 13.*   PCV 13 should be given at least eight weeks after the last dose of PCV 7 or 23-valent pneumococcal polysaccharide vaccine (PPSV 23) when indicated.

Recommended schedules for administering doses of PCV 13 to children
<24 months of age, by PCV vaccination history and age

Age at examination (months)

Vaccination history:

total # of PCV 7 and/or PCV 13 doses received previously

Recommended PCV 13 Regimen1

2 through 6 months

0 doses

3 doses, 8 weeks apart;

fourth dose at age 12–15 months

1 dose

2 doses, 8 weeks apart;

fourth dose at age 12–15 months

2 doses

1 dose, 8 weeks after the most recent dose; fourth dose at age

12-15 months

7 through 11 months

0 doses

2 doses, 8 weeks apart;

third dose at 12-15 months

1 or 2 doses before age 7 mo

1 dose at age 7–11 months, with

a second dose at 12–15 months,

≥ 8 weeks later

12 through 23 months

0 doses

2 doses, ≥ 8 weeks apart

1 dose before age 12 mo

2 doses, ≥ 8 weeks apart

1 dose at ≥12 mo

1 dose, ≥ 8 weeks after the most recent dose2

2 or 3 doses before age 12 mo

1 dose, ≥ 8 weeks after the most recent dose2

4 doses of PCV 7 or other age-appropriate, complete PCV 7 schedule

1 supplemental dose, ≥ 8 weeks after the most recent dose*

Footnotes:

1. Minimum interval between doses is 8 weeks except for children vaccinated at age <1 year, for whom minimum interval between doses is 4 weeks.

2. No additional PCV 13 doses are indicated for children 12 through 23 months of age who have received 2 or 3 doses of PCV 7 before age 12 months and at least 1 dose of PCV 13 at age 12 months or older.

* ACIP did not define underlying or high-risk medical conditions. However, a list of conditions is provided in MMWR 2010;59:9.

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