North Dakota Department of Health                         Division of Disease Control                                               Fall 2004

Prevnar Shortage Over

On Sept. 17, 2004, the North Dakota Department of Health (NDDoH) Immunization Program, along with the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics, the American Academy of Family Physicians, and the Advisory Committee on Immunization Practices (ACIP), recommended that providers resume administration of pneumococcal conjugate vaccine (PCV-7) according to the routine four-dose schedule. For the complete Morbidity and Mortality Weekly Report (MMWR) announcement, please visit the following website: www.cdc.gov/mmwr/preview/mmwrhtml/mm5336a8.htm.

The highest priorities for catch-up vaccination are:

• Children younger than 5 at high risk for invasive pneumococcal disease.

• Healthy children younger than 24 months who have not received any doses of PCV-7.

• Healthy children younger than 12 months who have not yet received three doses of PCV-7.

The PCV-7 catch-up schedule can be found on the NDDoH Immunization Program website at: www.health.state.nd.us/disease/Documents/Immunization/PneumococcalConjugateCatchUpSchedule.pdf.

Receiving Vaccine

When receiving vaccine from the NDDoH, it is important that providers count the number of doses received. Vaccine is expensive, and the NDDoH needs to have an accurate inventory of all vaccine in the state. The number of doses received must be equal to the number of doses on the packing slip. If the two totals are not equal, please notify the North Dakota Immunization Program immediately at 701.328.3386 or toll-free at 800.472.2180.

When entering vaccine into the North Dakota Immunization Information System (NDIIS), it is important to enter vaccines by lot number. Entering generic names of vaccines will lead to errors in your clinic’s vaccine inventory. Wasted, expired and transferred doses must be reported to the NDDoH to be taken out of your clinic’s inventory in the NDIIS. Even if a single dose is wasted, it must be reported.

If your clinic’s inventory in the NDIIS is not accurate, please contact the NDDoH at 701.328.3386 or toll-free at 800.472.2180.

What Is the VFC Program?

The Vaccines for Children (VFC) program supplies vaccine to all states for use by enrolled providers. VFC vaccine is provided at no cost to providers. All routine childhood vaccines recommended by the ACIP are available through this program.

The VFC program saves parents and providers out-of-pocket expenses for vaccine purchases and provides cost-savings to states through the Centers for Disease Control and Prevention vaccine contracts. This results in lower vaccine prices and ensures that all states pay the same contract prices, with no cost to the provider.

The VFC program is important because it allows providers to administer vaccines to uninsured children and others who cannot get the recommended vaccinations without financial assistance. The VFC program allows children to stay in their medical home for immunizations. In the past, many children were not vaccinated because their parents either did not have health insurance or their health insurance did not cover immunizations. The VFC program eliminates this barrier to immunizations. 

Children from birth to age 18 who meet at least one of the following criteria are eligible to receive VFC vaccine:

• Medicaid eligible

• Uninsured

• American Indian or Alaska Native

• Underinsured

VFC requirements:

• Screen all children for eligibility: at each visit, children should be asked about VFC eligibility.

• Maintain a record of the screenings: VFC eligibility should be entered into the NDIIS for each vaccination and recorded on the Vaccine Administration Record.

• Follow the recommended immunization schedule as established by the ACIP.

• Do not charge for VFC-supplied vaccine: providers may charge $8 for administration of vaccines (North Dakota state law).

• Provide vaccine information materials (Vaccine Information Statements) at each visit as prescribed by law: required of all providers for VFC and non-VFC vaccine.

• Agree to NDDoH site visits.

• Complete the provider profile and enrollments forms distributed by the ND Immunization Program

North Dakota is a “universal vaccine state,” which means that North Dakota provides free ACIP recommended vaccine for all children in the state, regardless of VFC eligibility. Even though North Dakota is a universal state, providers enrolled in the Prevention Partnership Program must still follow the VFC requirements to receive vaccine. Providers must screen all children at each visit for VFC eligibility and enter VFC eligibility into the registry for each dose of vaccine administered.

Influenza Vaccine Shortage Update

On Oct. 5, 2004, the Centers for Disease Control and Prevention (CDC) announced that Chiron Corp., one of the manufacturers of influenza vaccine in the United States, would not be allowed to ship influenza vaccine due to manufacturing concerns. Chiron Corp. was supposed to supply approximately half of the influenza vaccine in the United States this year.

Due to the loss of the Chiron vaccine supply, the CDC recommended that healthy people forgo influenza vaccination and that the following high-risk groups be vaccinated (in no specific priority):

• Children age 6 to 23 months

• Adults age 65 and older

• People age 2 to 64 who have chronic medical conditions, such as heart disease or asthma

• Women who will be pregnant during influenza season

• Residents of nursing homes and long-term care facilities

• Children age 6 months to 18 years who are on chronic aspirin therapy

• Health-care workers who provide direct patient care

• Out-of-home caregivers and household contacts of children younger than 6 months

The NDDoH conducted a survey to assess the amount of vaccine in the state. Local public health units throughout North Dakota supplied vaccine to long-term care residents. In some areas of the state, depending on vaccine availability, vaccine was supplied only for high-risk long-term care residents; in other areas, vaccine was supplied for all residents and staff of long-term care facilities. Vaccine also was redistributed to areas with extreme shortages.

Shortages of vaccine exist throughout North Dakota, but some areas are experiencing greater shortages than other areas. Because of limited vaccine availability, providers in some areas of the state have decided to prioritize within the CDC recommended priority groups.

The NDDoH, along with the local public health units, will continue to assess vaccine availability throughout the state. For more information about the influenza vaccine shortage, visit www.ndflu.com.

The NDDoH would like to thank all of the private providers and local public health units who redistributed vaccine to other areas of the state. We would also like to thank everyone for working together at the local level in planning and administration of influenza vaccine.

State-Supplied Influenza Vaccine

The NDDoH will supply influenza vaccine to all North Dakota children meeting the CDC recommended high-risk groups. The following children may receive state-supplied influenza vaccine:

• All children 6 to 23 months of age

• High-risk children age 2 to 18 years

• Children and adolescents ages 2 through 18 who are household contacts or out-of-home caregivers of children younger than 6 months

For questions regarding state-supplied influenza vaccine, contact the ND Immunization Program at 701.328.3386 or toll-free at 800.472.2180.

Influenza Immunization Rates in Children Age 6 to 23 Months

Childhood influenza vaccination coverage levels for the 2002-2003 influenza season were released in the Sept. 24, 2004, MMWR. According to the National Immunization Survey (NIS), only 7.4 percent of children age 6 to 23 months received one dose of influenza vaccine in the United States. Only 4.4 percent of children nationwide in the same age group received two doses.

In North Dakota, 14.3 percent of children age 6 to 23 months received one dose of influenza vaccine, and 9.5 percent received two doses. North Dakota’s rates were above the national average.

For the 2002-2003 influenza season influenza vaccine was encouraged for children age 6 to 23 months rather than recommended.  This is one of the major reasons for the low rates. For the 2004-2005 influenza season, influenza vaccination of children 6 to 23 months is a recommendation from the ACIP. Since influenza vaccine is now recommended, it is expected that the immunization rates will increase significantly.

2003 Influenza and Pneumococcal Vaccination Rates for Adults 65 and Older

The Behavioral Risk Factor Surveillance System (BRFSS) consists of a telephone survey each year to determine influenza and pneumococcal vaccination rates in adults. Results from the 2003 survey indicate that 73 percent (16^th in the nation) of North Dakota adults 65 and older had been immunized for influenza during the previous influenza season.  The United States’ average influenza immunization rate was 69 percent. North Dakota’s pneumococcal vaccination rate for adults 65 years and older in 2003 was 71.2 percent (4^th in the nation). The United States’ average pneumococcal vaccination rate was 64.5 percent.

For more information about the BRFSS, visit www.cdc.gov/brfss/. 

Pneumococcal Vaccination During Influenza Vaccine Shortage

The NDDoH encourages all providers to vaccinate ACIP-recommended high-risk patients against pneumococcal disease. The pneumococcal polysaccharide vaccine (PPV-23) can prevent secondary bacterial infections from influenza in high-risk patients. This is especially important this season since many high-risk patients may not be able to be vaccinated against influenza.

The following individuals should receive one dose of PPV-23:

• People older than 65

• People age 2 and older with a chronic medical condition that puts them at high-risk for pneumococcal disease

For more information about who is at high-risk for pneumococcal disease, visit www.cdc.gov/nip/publications/VIS/vis-ppv.pdf.

FluMist®

Three million doses of live attenuated influenza vaccine (FluMist®) were manufactured for the 2004-2005 flu season. Doses of FluMist® are still available. Using FluMist® would be a good alternative to inactivated influenza vaccine for health-care workers, long-term care workers, and contacts of children younger than six months. The following people should not be vaccinated with FluMist®:

• People younger than 5 or older than 49

• People with asthma, reactive airways disease or other chronic disorders of the pulmonary or cardiovascular systems; people with other underlying medical conditions, including such metabolic diseases as diabetes, renal dysfunction, and hemoglobinopathies; or people with known or suspected immunodeficiency diseases or who are receiving immunosuppressive therapies

• Children or adolescents receiving aspirin or other salicylates (because of the association of Reye syndrome with wild-type influenza infection)

• People with a history of GBS

• pregnant women

• People with a history of hypersensitivity, including anaphylaxis, to any of the components of live attenuated influenza vaccine (LAIV) or to eggs

According to the CDC, FluMist® can be used by health-care workers and close contacts of individuals with lesser high-risk conditions. The CDC recommends that:

• Use of inactivated influenza vaccine is preferred for vaccinating household members, health-care workers, and others who have close contact with severely immunosuppressed people (e.g., patients with hematopoietic stem cell transplants) during those periods in which the immunosuppressed person requires care in a protective environment. The rationale for not using LAIV among health-care workers caring for such patients is the theoretical risk that a live, attenuated vaccine virus could be transmitted to the severely immunosuppressed person and cause disease.

• No preference exists for inactivated influenza vaccine use by health-care workers or other people who have close contact with people with lesser degrees of immunosuppression (e.g., people with diabetes, persons with asthma taking corticosteroids, or people infected with human immunodeficiency virus).

• No preference exists for inactivated influenza vaccine use by health-care workers or other healthy people age 5 through 49 in close contact with all other groups at high risk.

• If a health-care worker receives LAIV, that worker should refrain from contact with severely immunosuppressed patients as described previously for seven days after vaccine receipt.

• Hospital visitors who have received LAIV should refrain from contact with severely immunosuppressed people for seven days after vaccination; however, such persons need not be excluded from visitation of patients who are not severely immunosuppressed.

Vaccines of the Future

New vaccines for various diseases are being developed on an ongoing basis. Some of these vaccines could become a part of the routine immunization schedule in the near future.

Menactra™ vaccine from Aventis is the first quadrivalent conjugate meningococcal vaccine for the prevention of meningococcal disease. The vaccine will protect against four of the most common serogroups (A, C, Y, W-135) that cause meningococcal disease in the United States. Menactra™ will most likely be licensed for adolescents and adults age 11 to 55. Currently, immunity from the meningococcal polysaccharide vaccine that is available lasts only approximately five years. The new meningococcal conjugate vaccine will offer longer-lasting immunity. Menactra™ is expected to be approved by the Food and Drug Administration (FDA) in early 2005. The ACIP is discussing routine use of Menactra™ in adolescents.

Two adolescent and adult pertussis-containing vaccines are currently awaiting approval by the FDA. Boosterix™, from GlaxoSmithKline, will be available for adolescents age 11 to 18. Adacel™, from Aventis, will be available for adolescents and adults age 11 to 64. Both vaccines will contain tetanus, diphtheria and pertussis (Tdap) components. Most likely the vaccines will be given as booster shots every 10 years. Both vaccines are expected to be approved in the next one to two years.

Pentacel™, from Aventis, contains DTaP, HIB and IPV. Pentacel™ will most likely be available in 2006 or 2007. The schedule for Pentacel™ is unknown at this time.

Other vaccines being developed for the future are a vaccine against human papilloma virus and a combination MMR and varicella vaccine.

Prevention Partnership Enrollment

Prevention Partnership Enrollment for 2004-2005 was due Nov. 1, 2004. Please send completed forms as soon as possible to:

Pertussis Update

Since June 22, 2004, 720 cases of pertussis have been reported in North Dakota. Usually only about 10 cases of pertussis are reported in North Dakota each year. The number of cases reported has decreased significantly since the beginning of August.

Due to the decrease of cases in North Dakota, the NDDoH recommended that providers discontinue the accelerated DTaP schedule. If a high number of pertussis cases are continuing in certain areas, providers in those areas may want to consider continuing the accelerated DTaP schedule.

According to the CDC, North Dakota has the highest incidence of pertussis in the United States for the first 42 weeks of 2004.

Pertussis cases have been increasing in the United States since 1980. So far in 2004, 11,546 cases have been reported in the United States. Outbreaks have occurred in multiple states, including Wisconsin, Colorado and Maine.

The North Dakota Department of Health would like to thank local public health nurses from around the state for their help investigating pertussis cases!

North Dakota Pertussis Webcast

The NDDoH, along with Aventis Pasteur, created an informative webcast about pertussis called “Pertussis Awareness and Prevention.” The webcast includes information about surveillance, testing, diagnosis, treatment and other issues. Dr. David Greenberg, director of scientific and medical affairs for Aventis Pasteur, moderated the webcast.

The webcast also includes an influenza vaccine supply update. To view the webcast, visit: www.health.state.nd.us/et/WebcastScheduleFrame.htm.

Make Your School a Germ-Free Zone Materials

In September, the NDDoH Immunization Program sent “Make Your School a Germ-Free Zone” posters to private and public schools throughout the state. The posters feature kids coughing and sneezing and emphasize the need to “cover your cough” and “wash your hands often.” Hopefully, the posters will remind kids about having good respiratory hygiene habits to prevent the spread of diseases like pertussis and influenza.

Quality Assurance in Vaccine Storage and Handling

The California Distance Learning Health Network aired a satellite broadcast Wednesday, Dec. 1, 2004, about proper vaccine storage and handling. The broadcast was entitled “Quality Assurance in Vaccine Storage and Handling.” For more information about the broadcast, visit cdlhn.com/default.htm.

PedvaxHIB®

The recommended PedvaxHIB® immunization schedule is as follows:

1. Can RecombivaxHB® vaccine be used for the two-dose adolescent hepatitis B schedule?

   • A.  State-supplied Recombivax HB® vaccine should not be used for the alternative two-dose adolescent hepatitis B schedule. State-supplied Recombivax HB® is the pediatric formulation (5 mcg). The pediatric formulation cannot be used for the two-dose adolescent schedule. If your clinic carries the adult formulation (10 mcg) of Recombivax HB®, it may be used for the alternative adolescent two-dose schedule. The schedule would be two 10 mcg doses of Recombivax HB®, separated by four to six months. This schedule is approved only for children age 11 to 15 years and for Merck’s Recombivax HB® vaccine. Engerix-B®, from GlaxoSmithKline, is not approved for the two-dose schedule.

2. Can North Dakota state-supplied vaccines be administered to children from out-of-state (i.e., Minnesota, South Dakota or Montana)?

   • A.  North Dakota state-supplied vaccines should be administered to out-of-state VFC-eligible children only. Clinics should use private vaccine to immunize out-of-state children who do not meet VFC-eligibility (Native American, uninsured, Medicaid, or underinsured).

3. What are the recommended and minimum intervals between pneumococcal conjugate vaccine doses?

   • A.  The recommended interval between the first three doses of PCV-7 given to children younger than 12 months is eight weeks. The minimum interval is four weeks. The minimum age for the fourth dose is 12 months, and there must be at least eight weeks between the third and fourth doses.

4. Should an adult who has asplenia or had a hematopoietic stem cell transplant receive Haemophilus influenzae type B (Hib) vaccine, even though the vaccine is licensed for children younger than 72 months?

   • A. Yes. The Hematopoietic Stem Cell Transplant recommendations released a few years ago specifically recommended that Hib vaccine should be given to these adults. A single pediatric dose of Hib vaccine should be administered to people without spleens and those who have had a stem cell transplant.

*After release of the Summer 2004 Immunization Newsletter, there was some confusion about varicella vaccine being stored in a freezer box. A freezer box is a box that you may have received with your FluMist® orders last year. FluMist® is the only vaccine that should be stored in this freezer box. Varicella vaccine should be stored in the freezer as usual.

The CDC aired an Influenza Netconference on November 19 at 11 a.m. The netconference focused mainly on antivirals and up-to-date information about influenza. For more information or to view the archived netconference, visit www.cdc.gov/flu/professionals/training/novnetconf.htm.