Date: December 20, 2007
To: Vaccine Providers
From: Patricia Raymond, Immunization Program Manager
Merck’s recent recall of certain lots of Hib-containing vaccines (PedvaxHIB® and Comvax®) has resulted in a temporary reduction of Hib vaccine supply. Due to this, CDC, in consultation with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians, and the American Academy of Pediatrics, has issued interim recommendations for use of Hib: www.cdc.gov/mmwr/preview/mmwrhtml/mm56d1219a1.htm. In addition to the temporary deferral of Hib for some children, the Rhode Island supply of Hib will now include ActHib, which has a 3 dose primary series. Based on the CDC recommendations, Rhode Island providers should follow the guidelines below for use of State-supplied Hib vaccine:
1. Temporary deferral of the routine Hib vaccine booster dose administered at 12-15 months of age for all children except those who are at increased risk for invasive Hib disease. (See # 2 for definition of high-risk children). To facilitate recalling these children when vaccine supply improves KIDSNET reports may be run for missing Hib doses, or a list of children for whom Hib vaccine was deferred should be maintained.
2. Children at increased risk (American Indian and Alaskan Native children, and children with sickle cell disease, HIV infection, anatomic or functional asplenia, malignancies or other immunocompromising conditions) for invasive Hib disease should continue to receive the recommended booster dose of Hib vaccine at 12-15 months of age.
3. The primary series for all children should be completed on schedule. The number of doses in the primary series for PedvaxHIB and ActHib vaccines differ. The primary series for PedvaxHIB is 2 doses administered at 2 and 4 months of age. The primary series for ActHib is 3 doses administered at 2, 4 and 6 months of age.
4. PedvaxHIB and ActHib vaccines are interchangeable for primary immunization. However, if the first 2 doses (given at 2 and 4 months) are PedvaxHIB the series is complete. If only one of the first 2 doses was PedvaxHIB vaccine, a total of 3 doses of Hib vaccine are needed to complete the primary series.
5. Consult CDC’s Catch-Up Immunization Schedule for the timing of doses for children who start Hib vaccination late or are more than one month behind: www.cdc.gov/vaccines/recs/schedules/default.htm.
6. Report the use of ActHib to KIDSNET using the CPT code: 90648. If your practice uses KIDSNET Immunization Data Sheets to report vaccines, please document this under the “Other” category.
Note: providers should not send the recalled vaccines back to McKesson but rather to Stericycle. Yesterday McKesson forwarded a spreadsheet to Stericycle that lists lot numbers and doses shipped by provider PIN and address. Stericycle will send a standard packet to each provider with detailed instructions on how to send the vaccines to Stericycle.
Hib Disease Reporting Requirements: (www.health.ri.gov/disease/communicable/summarysheet.pdf)
Limited vaccine supply underscores the importance of surveillance for Hib disease in children. Isolates of H. influenzae from sterile sites should be serotyped and cases reported to the Department of Health (HEALTH) Office of Communicable Diseases at 222-2577.