What’s Up With All Those Other Vaccines? William L. Atkinson, MD, MPH National Immunization Program Feel free to customize. Hepatitis Coordinator’s Conference San Antonio, Texas January 29, 2003

What's New in Immunization The Schedule General Recommendations New vaccines Influenza vaccine for children Meningitis in cochlear implant recipients Meningococcal vaccine recall Adult harmonized schedule Smallpox vaccine redux

The 2003 schedule, released in January 2003 The 2003 schedule, released in January 2003. The only obvious change is the inclusion of “and adolescent” to the title. All other changes were in the footnotes.

The 2003 footnotes.

2003 Hepatitis B Footnote Makes explicit that 4 doses can be administered if there is a birth dose Combination vaccines cannot be given before 6 weeks In 2002, the statement was that “four doses of vaccine may be administered if combination vaccine is used”. For 2003, the birth dose is specifically mentioned. 2. In 2002, the statement was the “except for Hib-containing vaccine which cannot be administered before age 6 weeks. This change was made to include Pediarix, which does not contain Hib.

2003 Hepatitis B Footnote The last dose should not be administered before 6 months for infants born to HBsAg+ mothers These infants should be tested at 9-15 months for HBsAg and anti-HBs For infants born to HBsAg unknown mothers, blood should be drawn from mother ASAP, 2nd dose at 1-2 months, 3rd dose no sooner than 6 months In 2002, the footnote said “…the vaccination series should be completed (third or fourth dose) at age 6 months”. No mention was made of the minimum age for the 3rd dose, or the need for post-vaccination serologic testing. 2. In 2002, the footnote said to draw blood “at the time of delivery”. The timing and minimum ages for the second and third doses was not mentioned in 2002 in the HBsAg unknown section of the footnote.

2003 Hepatitis A Footnote Children and adolescents in high risk states, regions or groups can begin hepatitis A at any visit The 2 doses should be administered at least 6 months apart In 2002, no mention was made of children and adolescents, only “…recommended for use in selected states and regions”. Wording that vaccination can begin at any visit, and minimum spacing of doses was not included in the 2002 footnote.

2003 Influenza Footnote Includes a recommendation for vaccine for household members of persons with high risk medical conditions such as asthma, cardiac diseases, sickle cell disease, HIV and diabetes Encourages vaccination for healthy children 6 to 23 months of age Inclusion of household members of high risk persons is new in 2003. Encouraging vaccination of healthy children 6-23 months of age is new and identical to wording in 2002 ACIP influenza statement.

Detail of catch-up table for children 4 months through 6 years of age.

New Vaccines

DAPTACELTM DTaP Vaccine 4-component DTaP produced by Aventis Pasteur Ltd (Canada) Approved May 2002 for first 4 doses of the series Does not contain thimerosal NIP recommends applying rules for other DTaP products to DAPTACEL, particularly 4th dose at 12-15 months (licensed for 17-20 months), and use for 5th dose if no other DTaP is available. See MMWR Notice to Readers for details.

DAPTACELTM DTaP Vaccine Licensed for the 4th dose at 17-20 months of age Not licensed for 5th dose Apply same schedule as for other DTaP vaccines

DTaP Schedule 4th dose recommended at 15-18 months but may be given earlier if: child is 12 months of age, and 6 months since DTaP3, and unlikely to return at 15-18 months Interchangeability (including 5th dose) complete series with same brand of vaccine if possible use different brand if necessary

Pediarix Has Arrived DTaP – Infanrix Hep B – Engerix B IPV

Injections in the Pediatric Schedule At 2 Month Visit By 18 Months By 18 Years Single antigens 5 19-20 23-24 With Pediarix 3 13-15 17-19 20-21 With COMVAX 4 16-17

Indications for Pediarix Minimum age 6 weeks 3 doses at 2, 4 and 6 months Not approved for booster doses May be used interchangeably with other pertussis-containing vaccines if necessary

Indications for Pediarix Can be given at 2, 4, and 6 months in infants who received a birth dose of hepatitis B vaccine May be used in infants whose mothers are HBsAg positive or status unknown

Response to Hepatitis B Component Anti-HBsAg % >10 mIU/ml GMC Components Separate 100 805 Pediarix 100 1661 Source: Pediarix package insert

COMVAX Minimum age 6 weeks Not approved for use in infants whose mothers are HBsAg positive or status unknown ACIP VFC vote gave de facto approval for off-label use to complete the hepatitis B series with COMVAX if mother HBsAg positive or unknown

Influenza Vaccination of Children Annual vaccination of persons >6 month with chronic illnesses is recommended For 2002-2003: Vaccination of healthy children 6-23 months is “encouraged when feasible” Vaccination of household contacts and out-of-home caretakers is encouraged A recommendation for routine annual vaccination of all children <24 months of age is expected within 3 years. Providers should start now to acclimate their practices to annual recall of all young children.

PCV Shortage Greater than expected demand for vaccine Delays in release of some lots Shortage may continue through first quarter of 2003

PCV Recommendations in Shortage Situation Continue routine vaccination of high-risk children <5 years of age with full PCV series Defer all doses for health children >24 months of age Reduce the number of doses for healthy children <24 months of age

PCV Recommendations When Supplies Improve Children who received a reduced number of doses during the shortage should be “caught up” Most will probably not need a total of 4 doses because of age Use “lapsed schedule” from ACIP statement As a practices’ supply increases, children with deferred doses should be recalled and “caught up”. Because the number of doses in a “lapsed” schedule decreases as the child ages, most children will not need a total of 4 doses. The number of doses needed to complete the series should be based on the child’s CURRENT age, not the age when they started the series. Table 11 in the PCV ACIP statement (2000) addresses lapsed schedules.

Lapsed PCV Schedule Current Age (mos) 7-11 Prior Vaccination 12-23 24-59 Prior Vaccination 1 dose 2 doses 1 dose at <12 mos 2 doses at <12 mos Any incomplete schedule Doses Needed 1 + booster 2 doses* 1 dose* 1 dose Summary of PCV ACIP Table 11 for lapsed schedule. Booster doses are given at 12-15 months. Children now 12-23 months of age should receive 2 doses separated by at least 2 months. Those who received 2 doses at <12 months of age need only a single dose, which should be given at least 2 months after the previous dose. Unvaccinated children 24-59 months of age with high risk conditions should receive 2 doses separated by 2 months. *separated by >2 months. MMWR 2000;49(9):24

Pneumococcal Disease High Risk Conditions Sickle cell disease Functional or anatomic asplenia HIV infection Immunocompromise Chronic illness Cochlear implants

Meningitis Among People with Cochlear Implants Ongoing CDC and FDA investigation of the association between one or more types of cochlear implants and bacterial meningitis 52 cases reported in U.S. 33 (63%) patients <7 years of age

Vaccine Recommendations for People with Cochlear Implants Manage as high-risk for invasive pneumococcal disease PCV and/or PPV, depending on age See ACIP statements or NIP website for details and schedules

National Immunization Program Hotline (800) 232-2522 Email nipinfo@cdc.gov Website www.cdc.gov/nip* *download or order ACIP statements online from the NIP website