November 3, 2008 To: Hospitals, Providers, Local Health Departments From: New York State Department of Health, Bureau of Communicable Disease Control, Immunization Program HEALTH ADVISORY: USE OF PENTACEL TO ADMINISTER HAEMOPHILUS INFLUENZAE TYPE B (HIB) VACCINE; HIB VACCINE SHORTAGE TO CONTINUE THROUGH MID-2009 Please distribute immediately to all patient and primary care areas. SUMMARY Pentacel is a combination vaccine manufactured by Sanofi Pasteur and contains diphtheria, tetanus, acellular pertussis (); inactivated polio (); and Haemophilus influenzae type B (Hib) vaccines. Hib vaccine has been in short supply nationwide since December 2007 when manufacturing of the Hib-containing vaccines produced by Merck was stopped temporarily due to concerns about bacterial contamination. On October 15, 2008, Merck released a statement announcing that their Hib-containing vaccines, Pedvax Hib and Comvax, will not be returning to the market until mid-2009. Currently, Pentacel is more readily available than Sanofi Pasteur s ActHIB (single antigen Hib vaccine). This is true for both vaccines supplied by the Vaccines for Children (VFC) Program and vaccines in the private market. Therefore, providers are urged to integrate Pentacel into their vaccination practices so that more infants can be protected with Hib vaccine. The incorporation of Pentacel into pediatric practices can be complex. The purpose of this advisory is to provide guidance for integrating Pentacel into office vaccination practices. o According to the CDC s interim recommendations for use of Hib vaccine during the shortage, all infants should continue to receive the primary series according to the age appropriate schedule. However, the routine Hib booster at age 12-15 months should be deferred except for specified high-risk groups. If a child has missed the optimal time for vaccination with Hib, vaccination can proceed according to the recommended catch-up schedule. 1
o Therefore, until the Hib supply improves, Pentacel may be used only for the first three doses of the,, and Hib vaccination series for all infants, and also for the booster dose for high-risk children only. o Pentacel can be administered to any child 6 weeks old through 4 years of age who does not have a contraindication to any component of the vaccine, and for whom, and Hib are indicated. Pentacel comes packaged as two separate components. A single-dose vial of liquid - vaccine is used to reconstitute a single-dose vial of lyophilized Hib vaccine. Both components have their own lot numbers which must be documented and reported to the New York State Immunization Information System (NYSIIS). Guidance for proper reconstitution and reporting of both lot numbers to NYSIIS is included in this advisory. BACKGROUND In December 2007, Merck & Co. issued a voluntary recall of ten lots of its Pedvax HIB (monovalent Hib vaccine) and two lots of COMVAX (Hib/hepatitis B vaccine) due to concerns about the company s ability to assure sterility for certain specific vaccine lots. Through routine testing of manufacturing equipment, Merck identified the presence of the bacteria Bacillus cereus (B. cereus). Because of the short-term reduction in available doses of Hib-containing vaccines, the CDC, in consultation with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians, and the American Academy of Pediatrics, recommend that providers temporarily defer administering the routine Hib vaccine booster dose administered at age 12-15 months except to children in specific high-risk groups. For more information on the use of Hib during the shortage, please see the MMWR 2007; 56 (50); Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedVaxHIB and Comvax). It can be viewed at the MMWR website at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5650a4.htm. HIB SUPPLY IN THE VACCINES FOR CHILDREN (VFC) PROGRAM Recently, the Centers for Disease Control and Prevention (CDC) have primarily made Hib vaccine available in the form of Pentacel for VFC participants. The incorporation of Pentacel into pediatric practices can be challenging. The guidance and tables presented below offer assistance for integrating Pentacel into office vaccination practices. For practices using single-antigen and vaccines, transition to Pentacel is relatively straightforward. These practices could begin using Pentacel as the first dose in the primary series for two month olds. Infants who have already been started on single entity vaccines can finish the series with separately administered,, and Hib vaccines or Pentacel. See below for options for practices administering single antigen vaccines. For practices using Pediarix (//HepB), the situation is somewhat more complex. Confusion and administration errors may result when both Pediarix and Pentacel are in use simultaneously in the same practice. These two combination vaccines have some components that overlap and some that do not. Both Pediarix and Pentacel contain and. However, the third component of Pediarix is hepatitis B () vaccine whereas the third component of 2
Pentacel is Hib vaccine. For practices incorporating Pentacel, it may be easiest to begin with the administration of Pentacel to newborns, while infants already started on Pediarix finish the series with Pediarix. Table 1 shows the typical age indications and intervals between doses for Pentacel combination vaccine. Pentacel must be given according to the guidelines established for addressing the Hib shortage, until an adequate supply of Hib is reestablished. If a child has missed the optimal time for vaccination with Hib, vaccination can proceed according to the recommended catch-up schedule. Table 1: Intervals and Ages for Pentacel Parameter Minimum age for any dose Minimum interval between doses 1 and 2 Minimum age for dose 2 Minimum interval between doses 2 and 3 Minimum age for dose 3 Minimum interval between doses 3 and 4 Minimum age for dose 4 Maximum age for any dose Age/interval 6 weeks of age 4 week interval 10 weeks of age 4 week interval 14 weeks of age 6 month interval (determined by component; minimum interval for dose 3-4 is two months for Hib and four weeks for ). 12 months of age (determined by and Hib components). Note that both the minimum interval AND age must be met for the fourth dose of or Hib (as Pentacel or any other formulation) to be counted as valid. 4 years, 364 days of age (i.e., do not administer at age 5 years or older) Examples of Schedules Using Pentacel and/or Pediarix for Healthy Children During the Hib Shortage Please refer to the tables below for guidance on schedules for Pentacel, Pediarix and the single vaccine series for, Hib,, and for healthy children during the Hib vaccine shortage only. Tables 2 and 3 provide examples of how to introduce Pentacel into your practice using two different schedules. Tables 4 and 5 review the schedules for the separate use of,, Hib,, and Pediarix. 3
Table 2: Schedule for, Hib,, and Using Pentacel for First Three Doses (not including the birth dose) Pentacel Pentacel Pentacel Table 3: Schedule for the use of, Hib,, and Using Pentacel for First Dose Only and Pediarix for Remainder of Doses Pentacel Hib Pediarix Hib Pediarix Table 4: Schedule for the use of, Hib, and Without Pentacel or Pediarix Hib Hib Hib Table 5: Schedule for the use of, Hib,, and Using Pediarix Only (No Pentacel) Hib Hib Hib Pediarix Pediarix Pediarix 4
PENTACEL PACKAGING AND ADMINISTRATION Pentacel is supplied as a 5-dose package containing 10 vials in total: 5 vials of the - component and 5 vials of the lyophilized Hib component. A single-dose vial of liquid - vaccine is used to reconstitute a single-dose vial of lyophilized Hib vaccine. The vaccine components should be stored together in the refrigerator and maintained at a temperature of 2 to 8 C (35 to 46 F). When reconstituting, gently shake the vial of - component, withdraw the entire liquid content and inject into the vial of the lyophilized Hib vaccine component. Shake the vial now containing --Hib (Pentacel) vaccine thoroughly until a cloudy, uniform suspension results. Withdraw and administer a 0.5 ml dose of Pentacel vaccine intramuscularly. Pentacel vaccine should be used immediately after reconstitution. The individual components of Pentacel should never be administered separately. RECORDING PENTACEL VACCINE LOT NUMBERS IN NYSIIS Two distinct lot numbers for the components of Pentacel are included, one on the - vial and one on the Hib powder vial. Providers should document both lot numbers separately for the - and Hib components in the patient s medical record. NYSIIS has a single field for lot number. Therefore, both lot numbers should be placed in the single lot number field with a forward slash (/) separating the two lot numbers. For recording Pentacel in NYSIIS, first enter the - lot number, followed by a forward slash (/), and then enter the Hib lot number. For example, if the lot number for the - component is A1111B and the lot number for the Hib component is C2222D, the following would be entered into the NYSIIS lot number field: A1111B/C2222D. Any questions regarding how to record Pentacel or any other vaccine in NYSIIS can be directed to NYSIIS staff at 518-473-2839. MORE INFORMATION For more information on the use of Pentacel, please see the MMWR 2008;57(39); Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, and Haemphilus b Conjugate Vaccine and Guidance for Use in Infants and Children, at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a5.htm For more information on vaccine supply or the VFC Program, please call your local health department or the New York State Department of Health Immunization Program at 518-473- 4437. 5