MINNESOTA DEPAR ARTMENT OF HEALTH DISEASE CONTR ONTROL OL NEW EWSLETTER Volume 26, Number 4 (pages 29-36) May/June 1998 Recommended Childhood Immunization Schedule, Minnesota, 1998 The 1998 Recommended Childhood Immunization Schedule is included in this issue of the Disease Control Newsletter. The schedule is based on recommendations jointly issued by the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP), and endorsed by the Immunization Practices Task Force of the Minnesota Department of Health (MDH), as chaired by G. Scott Giebink, M.D. Please note the following changes from the 1997 MDH schedule and, in some cases, from the ACIP/AAP/ AAFP 1998 schedule: Polio: The age range at which the third dose of polio vaccine may be given, with either the all-opv, all-ipv, or sequential IPV/OPV schedules, is consistently stated as 6-18 months of age. The 1997 schedule displayed it as 12-18 months of age and stated that the third dose could be given as early as 6 months with an all-opv schedule. For the 1998 schedule, the ACIP and AAP agree on this broader timing for both the all-opv and the all-ipv schedules. However, they differ on the timing of the third dose in the sequential IPV/ OPV schedule, with the ACIP endorsing 12-18 months and the AAP 6-18 months. At its January 20, 1998 meeting, the MDH Immunization Practices Task Force voted to support the position of the AAP and recommended that the third dose in all three polio vaccine options be given any time between 6 and 18 months. MMR: The recommended age range for routine administration of the second dose of MMR is now 4-6 years of age rather than extending to 11-12 years. This is the current joint recommendation of the ACIP, AAP, and AAFP and is part of a national strategy to reach the goal of achieving and maintaining measles elimination in the United States. All children who receive their second dose of MMR at entry to kindergarten will be in compliance with the Minnesota School Immunization Law which requires proof of two doses in order to enroll in 7th grade. The first dose must be given on or after the child s first birthday to be in compliance with the law. Adolescent visit: The health visit at age 11-12 years is once again highlighted to prompt an immunization assessment of all adolescents to verify that they have received two doses of MMR and the three-dose hepatitis B series, and either have a history of varicella disease or have received vaccine. Adolescents lacking any of these vaccines should be given the remaining doses and also a booster for tetanus and diphtheria (Td). Subsequent Td boosters are then recommended every 10 years. Reminder: By state law, all students in grades 7 through 12 are required to have evidence of a Td booster at 11 years of age or older as well as two doses of MMR. Influenza: For the first time, the schedule includes a recommendation that all children 6 months of age and older wishing to obtain immunity from influenza may be considered for vaccination. In addition to protecting the health of children at high risk for complications from influenza, both the AAP and the ACIP now encourage vaccination of all children, especially those who gather in schools and residential institutions, to minimize disruption of routine activities during the influenza season. continued... INSIDE: Hepatitis B Vaccination: New School Requirements.......... 32 Rabies: Current Epidemiology and Post-Exposure Prophylaxis Recommendations............ 32 Lyme Disease Vaccine......... 35
Recommended Childhood Immunization Schedule Minnesota, 1998 Bars indicate range of acceptable ages; green bars indicate catch-up vaccination. Vaccines below dotted line are for selected populations. Note: routine early adolescent immunization visit (purple column) includes a Td booster and assessment of need for HBV, MMR, and varicella vaccines. Vaccine Hepatitis B 1 z Age Diphtheria, Tetanus, Pertussis 2 Birth 1 mo 2 4 6 12 15 Hepatitis B - 1 Hepatitis B - 2 Hepatitis B - 3 18 2 yrs 4-6 yrs 11-12 yrs Hepatitis B 1 (1-3) DTaP DTaP DTaP DTaP Td DTaP 2 14-18 yrs Haemophilus influenzae type b 3 Polio 4 Hib Hib Hib 3 Hib 3 Polio Polio Polio 4 Polio Measles, Mumps, Rubella 5 Varicella 6 Hepatitis A 7 MMR - 1 Varicella MMR-2 5 MMR-2 5 Varicella Hepatitis A Influenza 8 Influenza (yearly) Pneumococcal 9 1. Hepatitis B (HBV): Infants born to HBsAg-negative mothers should receive 2.5 µg of Merck vaccine (Recombivax HB) or 10 µg of SmithKline Beecham (SB) vaccine (Engerix-B). Give 2nd dose >4 weeks after the 1st dose and 3rd dose at 6-18 months of age. Infants born to HBsAg-positive mothers should receive 0.5 ml hepatitis B immune globulin (HBIG) within 12 hours of birth, and either 5 µg of Recombivax HB or 10 µg of Engerix-B at a separate site. The 2nd dose is recommended at 1-2 months of age and the 3rd dose at 6 months of age. Infants born to mothers whose HBsAg status is unknown should receive either 5 µg of Recombivax HB or 10 µg of Engerix-B within 12 hours of birth. The 2nd dose of vaccine is recommended at 1 month of age and the 3rd dose at 6 months of age. Children and adolescents who have not previously received 3 doses of hepatitis B vaccine should be given HBV-2 >4 weeks after HBV-1, and HBV-3 >4 months after HBV-1 and >8 weeks after HBV-2. 2. Diphtheria, Tetanus, Pertussis (DTP): Children should receive DTaP (diphtheria and tetanus toxoids and acellular pertussis vaccine) instead of whole-cell DTP because of its fewer adverse reactions and equal or greater efficacy. Whole-cell DTP may be given in certain situations (e.g., where inadequate DTaP supplies exist or combinations with other vaccines are desired). Children who have a true contraindication to whole-cell pertussis vaccine should receive DT (which is for pediatric use) and not DTP or DTaP. Td (tetanus and diphtheria toxoids, adsorbed, for adult use) is recommended at 11-12 years of age if at least 5 years have passed since the last dose of DTP, DTaP, or DT. Subsequent routine Td boosters are recommended every 10 years. DTaP-4 may be given as early as 12 months of age if at least 6 months have passed since DTaP-3, and if the child is considered unlikely to return at 15-18 months of age. 3. Haemophilus influenzae type b (Hib): Three Hib conjugate vaccines are licensed for infant use. If PRP-OMP (PedvaxHIB from Merck) is given at 2 and 4 months of age, a dose at 6 months is not required. After completing the primary series, any Hib conjugate vaccine may be used as a booster. Pneumococcal 4. Polio: A schedule of 2 doses of inactivated polio vaccine (IPV) followed by 2 doses of oral poliovirus vaccine (OPV) is recommended. All-OPV or all-ipv schedules are also acceptable, and are preferred in some situations. E.g., OPV alone may be useful for children on catch-up schedules, whenever parents or providers decline extra injections, and in children likely to travel to polioendemic countries. IPV alone is recommended for immunocompromised persons and their family contacts or to minimize the risk of vaccine-associated paralytic polio. 5. Measles, Mumps, Rubella (MMR): MMR-2 is recommended at 4-6 yrs, but may be given during any visit, provided >4 weeks has elapsed since the 1st dose and both doses are given >12 months of age. 6. Varicella: Give varicella vaccine to all susceptible children at 12-18 months of age. Unvaccinated children >18 months who lack a reliable history of chickenpox should also be vaccinated. Children <12 years should receive 1 dose; those >13 years should receive 2 doses 4-8 weeks apart. 7. Hepatitis A: Give hepatitis A vaccine to children and adolescents who are at increased risk of infection, as defined by ACIP*, and consider for all other persons >2 years of age wishing to obtain immunity. A booster should be given >6 months after the initial dose. 8. Influenza: Give influenza vaccine annually to children >6 months of age who have specific risk factors, as defined by ACIP*, and consider for all others wishing to obtain immunity. Children <12 years should receive split virus vaccine in a dosage appropriate for their age (0.25 ml if 6-35 months of age or 0.5 ml if >3 years). Children <9 years of age who are receiving influenza vaccine for the first time should receive 2 doses separated by at least 4 weeks. 9. Pneumococcal: Give pneumococcal vaccine to children >2 years of age at increased risk of acquiring systemic pneumococcal infections or increased risk of serious disease if they become infected. Give a 2nd dose to children at highest risk of serious pneumococcal infection, as defined by ACIP*. This includes those <10 years of age if >3 years from 1st dose and those >10 years of age if >5years from 1st dose. Based on recommendations of the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP), and endorsed by the Immunization Practices Task Force of the Minnesota Department of Health (MDH). * For current ACIP recommendations or other questions, call the Minnesota Immunization Hotline at (612) 623-5100 or toll-free (800) 657-3970. Minnesota Department of Health, April 1998 IC# 141-0188 30
For Children Who Start Late or Have Fallen Behind Provide MMR and varicella at >12 months. Administer a 2nd dose of MMR at 4-6 years, but may be given during any visit provided at least 4 weeks have passed since the first dose. For vaccines given in a series, it is not necessary to start over. Refer to the tables below for recommended schedule and minimum intervals between doses. Determine the number of previous doses of each vaccine received, find that number in the first column, and read across to the appropriate column for the next dose and minimum interval. Table 1. Catch-up schedule for children 4 months through 6 years (DTaP, Polio, HBV, and Hib) Number of Doses to be given and minimum intervals previous doses of each vaccine First dose Second dose Third dose Fourth dose Fifth dose None DTaP Polio 10 DTaP: 4 weeks after 1st dose Polio: 4 weeks after 1st dose DTaP: 4 weeks after 2nd dose Polio: 4 weeks after 2nd dose 12 DTaP: 6 months after 3rd dose Polio: 4 weeks after 3rd dose 15 DTaP 15 : 6 months after 4th dose HBV HBV: 4 weeks after 1st dose HBV: 8 weeks after 2nd dose 13 One Two Three Four Hib (exception, see 11 below) Hib: If current age < 12 months, 4 weeks after 1st dose. If current age 12 months to <5 years, give final dose 8 weeks after 1st dose (exception, see 11 below). Hib: If current age < 12 months, 4 weeks after 2nd dose (exception: see 14 below). If current age 12 months to <5 years, give final dose 8 weeks after 2nd dose (exception, see 11 below). Hib 14 : Only necessary for children age 12 months to <5 years who received 3 doses <12 months of age. Table 2. Catch-up schedule for children age 7 and older (Td, Polio, and HBV) Number of previous doses of each vaccine Doses to be given and minimum intervals First dose Second dose Third dose Booster dose None Td Polio 10 Td: 4 weeks after 1st dose Polio: 4 weeks after 1st dose Td: 6 months after 2nd dose Polio: 4 weeks after 2nd dose Td: every 10 years (exception, see 2 on reverse side) Polio: see 15 below HBV HBV: 4 weeks after 1st dose HBV: 8 weeks after 2nd dose 13 HBV: none One Two Three 10. Polio: Children who begin the series >6 months of age may receive an all-opv schedule to reduce the number of injections. 11. Hib: Any child who receives >1 dose at >15 months of age needs no further doses. Vaccine is not generally recommended for children >5 years. 12. Polio: For those receiving IPV alone, an interval of 6 months between IPV-2 and IPV-3 will provide optimal response and is preferred. 13. HBV: The minimum interval between HBV-2 and HBV-3 is 8 weeks; however, an interval of 4-12 months will result in higher final titers of anti-hbs. 14. Hib: If PRP-OMP was given for the first 2 doses, no more than 3 doses are needed, with the final dose given at 12-15 months and at least 8 weeks from the previous dose. If a 3rd dose of HbOC or PRP-T is given >12 months of age, a 4th dose is not needed. 15. Polio, DTaP: Children on an IPV/OPV sequential schedule should receive all 4 doses, regardless of the age when first initiated. In such cases, the minimum interval between the last 2 doses is 4 weeks. Neither the 4th polio in an all-ipv or all-opv schedule nor the 5th DTaP is necessary if the previous dose was administered after the 4th birthday. Children who present with a mild acute illness, with or without fever, should not be deferred for vaccination. Only true contraindications to vaccination should be followed. (See MDH Guide to Contraindications.) Use all clinical encounters to screen for and provide needed vaccines. Providers should take measures to avoid missing opportunities to vaccinate. Special Notes on Immunization Reporting adverse reactions: Report adverse reactions to vaccines through the federal Vaccine Adverse Event Reporting System (VAERS). For information on reporting reactions following vaccines administered by private physicians, call the 24-hour national toll-free information line (800) 822-7967. Report reactions to vaccine administered in public clinics to the Minnesota Department of Health, (612) 623-5414 or toll-free (800) 657-3723. There are no contraindications to simultaneous administration of vaccines recommended for routine use in children. For children 12-18 months of age, multiple vaccines may be administered over 1 or 2 visits, but are strongly encouraged in 1 visit for children who have fallen behind. Disease reporting: Report suspect cases of vaccine-preventable diseases to the local health department or to the Minnesota Department of Health, 717 Delaware Street S.E., Minneapolis, Minnesota 55440, (612) 623-5414 or tollfree (800) 657-3723. 31
Hepatitis B: While the schedule indicates in the footnote that the second dose may be given at 1-2 months of age, we encourage giving the second dose at 1 month of age. The footnote states that infants born to HBsAg-positive mothers should receive their 2nd dose at 1-2 months of age. While this is the current recommendation within the combined ACIP, AAP, and AAFP schedule, the 1997 schedule published by the MDH recommended that the 2nd dose be given at 1 month of age and we continue to urge this more timely vaccination. The 1998 schedule provides optimum ages for vaccination. Tables 1 and 2 on page 31 provide vaccination schedules for children who have fallen behind. These two tables include minimum intervals needed for catch-up. We encourage providers to follow optimal schedules whenever possible, and use minimum ages and intervals by exception only. For questions about the schedule, call the Minnesota Immunization Hotline at 612/623-5100 or 1-800/ 657-3970. Hepatitis B Vaccination - New School Requirements The 1998 Legislature has amended the School Immunization Law (MN Statutes Section 123.70) to include a hepatitis B vaccination requirement. The revised law requires hepatitis B immunization for kindergartners beginning in the 2000-01 school year and for 7th graders beginning in the 2001-02 school year. In the interim, we continue to recommend and encourage that all children and adolescents receive hepatitis B vaccine. Hepatitis B immunization consists of a three-dose series. As is true for other immunizations that require a series of doses, a provision in the law allows students who have started a vaccination series to remain in school with a designated time frame to complete the series. The options for medical exemption or conscientious exemption also apply to hepatitis B immunization. While this amendment to the law was not initiated by MDH, it is consistent with MDH policy and recommendations. Routine hepatitis B immunization has been recommended for all infants and adolescents since late 1993 in Minnesota, and in the past several years immunization rates of 2-3 year olds have increased from an estimated 26 percent to 78 percent. While it is encouraging to note the growing acceptance of universal infant hepatitis B vaccination, catch-up efforts will be needed to reach unvaccinated children who will be enrolling in 7th grade in the fall of 2001. With this new revision to the School Immunization Law, Minnesota joins 29 other states in making hepatitis B immunization a requirement for school enrollment. The hepatitis B vaccine available through the Minnesota Vaccines for Children (MnVFC) Program may be administered to any child from birth through 18 years who meets MnVFC eligibility criteria. The t common risk factors for hepatitis B virus infection both nationally and in Minnesota are sexual contact, use of contaminated needles (e.g., drug use, tattooing, body piercing), being a household contact of a chronic carrier, and being a health-care worker. Previous programs that have targeted these high-risk populations have not been successful in lowering the rate of reported disease, except for those directed to health-care workers. For this reason, a comprehensive strategy has been recommended by CDC which includes 1) prenatal testing of pregnant women and appropriate follow-up of their infants; 2) routine vaccination of infants, children, and adolescents; and 3) targeted vaccination of highrisk adults. We encourage providers to begin NOW to assess hepatitis B vaccine status of all pediatric patients and to vaccinate those that are not yet vaccinated. A concerted effort NOW will ease the "bolus effect" that will otherwise occur as the time for the school law implementation draws closer. Rabies: Current Epidemiology and Post-Exposure Prophylaxis Recommendations INTRODUCTION It is estimated that 36,000 human cases of rabies occur each year worldwide. As expected, the highest rates are from countries in Asia (3 per 100,000 persons per year), where dog bites are common (1). Human cases occur infrequently in the United States, with generally fewer than five cases reported each year. The last human rabies case in Minnesota occurred in 1975 and was related to a cat bite. This is predominantly related to the decline in the number of domestic animal cases since the 1950 s due to aggressive canine vaccination programs. However, the recent epizootic of raccoon rabies along the East coast and the rising number of human cases attributed to bats in the U.S. have changed the current epidemiology of rabies. The raccoon rabies continued... 32
500 450 400 350 300 250 200 150 100 50 Figure 1. Cases of Animal Rabies Identified, Minnesota, 1960-1997 Identified, Minnesota, 1960-1997 0 1960 1965 1970 1975 1980 1985 1990 1995 Year epizootic was first documented in Virginia in 1977 and now has spread throughout t of the northeastern states and westward into eastern Ohio. Furthermore, 21 (58%) of the 36 human cases identified in the U.S. since 1980 have been associated with bat variants of the rabies virus; only one of these cases had a documented history of a bat bite (2). Because of recent concerns about appropriate post-exposure prophylaxis (PEP) of individuals who are exposed to bats and recent changes in the recommendations for PEP, we summarize here the current epidemiology of animal rabies in Minnesota, and review new PEP recommendations from the Centers for Disease Control and Prevention (CDC) (2). EPIDEMIOLOGY OF ANIMAL RABIES IN MINNESOTA In the U.S. the primary animal reservoirs for rabies include bats, foxes, raccoons, and skunks. These wild animal reservoirs are geographically dispersed and have distinct antigenic differences. Among terrestrial animals there are five rabies virus variants, while there are eight variants among bats. The bat variants seldom are found in terrestrial animals. In Minnesota the primary reservoir species is the striped skunk (Mephitis mephitis). (MDH). Animals are submitted for testing if there has been concern of suspected rabies transmission to humans or other animals. For animals diagnosed with rabies, the Minnesota Board of Animal Health conducts an onsite visit to evaluate possible human and animal contacts. Staff in the Acute Disease Epidemiology Section maintain data on animals submitted to the laboratory for rabies virus testing. Thus, data on animal rabies in the state are based on a laboratory system and may not accurately reflect the occurrence of disease in animals throughout the state. The number of cases of rabies in animals has varied widely by year in Minnesota (Figure 1). For example in 1981, nearly 500 cases were observed versus only 23 cases in 1994. Every 6 to 10 years the number of animal cases peaks and is primarily dependent on the number of rabid skunks in the population. In 1994, the number of rabid animals reported was at an all time low. It is speculated that flooding or disease in the skunk population accounted for this temporary decline. Between 1993 and 1997, 8,841 animals were tested in Minnesota for rabies virus. Of these, 225 (2.6%) were positive (Table 1). During that time, the only wild animal species testing positive were skunks, bats, and raccoons, with skunks having the highest positivity rate. Rabid domestic animals included cows, dogs, cats, and horses. POST-EXPOSURE PROPHYLAXIS In assessing the need for PEP, providers should consider the animal species involved, the type of exposure and disposition of the animal. Rabies is usually transmitted when infectious saliva penetrates the skin from a bite or when saliva comes in contact with a mucous membrane or fresh open continued... Table 1. Animals Tested for Rabies Virus, Minnesota, 1993-1997 Wild Skunk Bat Raccoon Domestic Cat Dog Cow No. Tests Performed 408 635 631 3211 2425 577 No. Tests Positive 138 21 2 14 15 31 Percent Positive 33.8 3.3 0.3 0.4 0.6 5.4 The diagnosis of rabies in animals is made by direct immunofluorescent antibody staining of rabies viral antigen in brain material submitted to the Minnesota Department of Health Horse Others TOTAL 92 862 8841 4 0 225 4.3 -- 2.6 33
Figure 2. Evaluation of a Dog, Cat or Ferret Exposure* Animal rabid Administer complete postexposure prophylaxis Animal not available for observation or testing At time animal is caught, it is behaving strangely or is ill Laboratory test for rabies wound (defined as less than 24 hours old). Exposure to Domestic Animals If the animal has symptoms of rabies, the animal should be immediately euthanized and tested, and PEP should be considered pending test results. Following exposure to domestic animals unavailable for testing or observation, PEP should be provided. Stray or unwanted animals can be tested for rabies immediately, and PEP can be administered if the animal tests positive for rabies virus. Following exposure to healthy pet dogs, cats or ferrets, a 10- day quarantine period may be indicated (Figure 2). Bites from dogs, cats and ferrets should be reported to local animal control officials who can assist with quarantine and follow-up procedures. Bites from animals such as pigs, horses and cattle should be assessed on a case-by-case basis. Cat, dog, ferret exposure Animal not rabid Do not administer postexposure prophylaxis Animal sickens or dies Animal available for observation or testing Animal is behaving normally Place in quarantine (usually 10 days) Animal remains healthy Do not administer postexposure prophylaxis * If unusual circumstances exist, contact MDH at (612) 623-5414 Exposure to Wild Animals Exposure to skunks, bats or raccoons warrants PEP. In general, PEP is not indicated following exposure to rabbits, rats, mice, or small rodents such as squirrels, gophers or hamsters. In the case of bats, exposure can be difficult to assess. Bats have small sharp teeth and puncture wounds from them can be difficult to detect so the absence of teeth marks does not rule out a significant exposure. In situations where there is a reasonable possibility that contact with a bat occurred (e.g., a sleeping person awakes to find a bat in the room, or an adult witnesses a bat in the room with a previously unattended child or mentally disabled or intoxicated person), PEP should be given (2). This statement represents the current position of CDC on this issue. We at MDH recognize that this policy will result in increased use of PEP, often unnecessarily. However, it is clear that a number of human rabies cases infected with a bat strain in the U.S. have had no documented exposure and recent epidemiologic data suggest that transmission of rabies virus can occur through minor bites from bats (3). Furthermore, PEP is safe and effective in preventing disease and rabies is 100% fatal. Administration of PEP Immediate and thorough washing of all bite wounds and scratches with soap and water is perhaps the t effective means of preventing rabies virus transmission. Tetanus and antibiotic prophylaxis should be given as indicated. PEP involves the administration of rabies vaccine and human rabies immune globulin (HRIG) (Table 2). There are three rabies vaccines licensed in the United States: human diploid cell vaccine (HDCV), rabies vaccine adsorbed (RVA), and purified chick embryo cell culture (PCEC). HRIG should be given to previously unvaccinated patients. A recent decision by the Advisory Committee on Immunization Practices regarding HRIG administration states that: If anatomically feasible, the full dose of HRIG should be thoroughly infiltrated in the area around and into the wound(s) and the remainder should be administered at an anatomical site distant from vaccine administration (2). For more information on rabies diagnosis or PEP, contact the Acute Disease Epidemiology Section, MDH, at 612/ 623-5414. By mid-summer MDH should also have a brochure available on bat rabies; contact the Acute Disease Epidemiology Section for copies. REFERENCES 1. Fishbein DB, Robinson, LE. Rabies. New Engl J Med 1993;329:1632-38. 2. CDC. Human rabies - Texas and New Jersey, 1997. MMWR 1998;47:1-5. 3. CDC. Human rabies - Montana and Washington, 1997. MMWR 1997;46:770-4. 34
Table 2. Type of Treatment and Regimen for Rabies Postexposure Prophylaxis by Vaccination Status of Patient Vaccination Status Not previously vaccinated Previously vaccinated Treatment Local wound cleansing Human rabies immune globulin (HRIG) Vaccine Local wound cleansing Vaccine Regimen* All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. 20 IU per kg body weight. As much as possible of the full dose should be infiltrated into and around the wound(s), and the remainder should be administered intramuscularly at an anatomical site distant from vaccine administration. HRIG should not be administered in the same syringe as vaccine. Because HRIG may partially suppress active production of antibody, no more than the recommended dose should be given. 1.0 ml of human diploid cell vaccine (HDCV), rabies vaccine adsorbed (RVA), or purified chick embryo cell culture (PCEC) vaccine administered intramuscularly (deltoid area ), on days 0, 3, 7, 14, and 28 (day 0 indicates the first day of treatment). All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. HRIG should not be given. 1.0 ml of HDCV, RVA, or PCEC administered intramuscularly (deltoid area ) on days 0 and 3. * These regimens are applicable for all age groups, including children. The deltoid area is the only acceptable site of vaccination for adults and older children. For younger children, the outer aspect of the thigh may be used. Vaccine should never be administered in the gluteal area. Any person with a history of pre-exposure vaccination with HDCV, RVA, or PCEC; previous postexposure prophylaxis with HDCV, RVA, or PCEC; or previous vaccination with any other type of rabies vaccine and a documented history of antibody response to the previous vaccination. Update: Lyme Disease Vaccine On May 26, 1998, an advisory committee to the Food and Drug Administration (FDA) cautiously recommended approval of LYMErix vaccine (produced by SmithKline Beecham). However, the committee expressed a number of serious concerns including: Lack of data on the need, frequency and timing for booster shots Lack of data on safety for people with arthritis, undiagnosed Lyme disease and the elderly Unlike other vaccines, it takes a year for LYMErix to build up immunity in t people The vaccine was tested only in people over age 15 Lack of data on long-term effects (clinical trials have lasted only 20 months). The vaccine has NOT yet been licensed by the FDA (as of May 29, 1998). However, SmithKline Beecham has initiated a national advertising campaign for their LYMErix vaccine. This campaign will stimulate consumer interest but may cause confusion about the status and intended use of the vaccine. In data presented to the committee, the vaccine was reported to be 79% effective after three doses and 50% after two, in clinical trials involving 10,937 people in Lyme endemic areas. After the FDA approves the license for continued... 35
the vaccine, the Advisory Committee on Immunization Practices (ACIP) will develop their recommendations for clinical practice. This ACIP statement is not expected to be made until October or later. Another pharmaceutical company, Pasteur Merieux Connaught, has also applied to the FDA to license its Lyme disease vaccine, ImuLyme. It is not known when the FDA s advisory committee will make recommendations for their vaccine. This is a good opportunity to remind people they need to continue taking preventive actions when in wooded, brushy areas within endemic counties. Those actions include wearing light colored clothes, regularly checking for deer ticks, using insect repellents according to directions, and watching for early signs and symptoms of Lyme disease. For more information about Lyme disease, contact the Acute Disease Epidemiology Section at 612/623-5414. For questions about the Lyme vaccine, contact the Acute Disease Prevention Services Section at 612/623-5237 or the Immunization Hotline at 1-800/657-3970. Anne M. Barry, J.D., M.P.H. Commissioner of Health Division of Disease Prevention and Control Agnes T. Leitheiser, R.N., M.P.H............ Division Director Kristine A. Moore, M.D., M.P.H......................Editor Kimberly Moore.........................Production Editor Michael T. Osterholm, Ph.D., M.P.H...... State Epidemiologist CHANGING YOUR ADDRESS? Please correct the address below and send it to: DCN MAILING LIST Minnesota Dept of Health 717 Delaware Street, Box 9441 Minneapolis, MN 55440