Vaccine policy in the US Disease Prevention and Control: Vaccination Recommendations and Travel Medicine Update Lisa A. Klatka, DO, MS Medina County Health Department Medina, OH Manufacturers publish product information FDA licenses vaccines Advisory Committee on Immunization Practices (ACIP) issues recommendations Centers for Disease Control and Prevention (CDC) publishes VISs, Pink Book Immunization Action Coalition (IAC) distributes educational materials Resources Manufacturers product information Vaccine information statement (VIS) Published recommendations of the ACIP (MMWR, meeting minutes) CDC Pink Book (Epidemiology and Prevention of Vaccine-Preventable Diseases) Ask the experts, Needle Tips, etc. The Travel Consultation Review of itinerary Assessment for malaria prophylaxis Education Food safety Insect bite avoidance Safety and security Administration of recommended vaccines Vaccination guidelines Obtain vaccination history Ensure the traveler is up to date with routine vaccinations Consider accelerated schedules Assess need for additional vaccinations based on itinerary Destination Length of stay Planned activities and lodging Legal requirements for entry Hepatitis A recommendations All children at age 1 year (12-23 months). People age 12 months or older who are traveling to or working in an area of the world except the United States, Canada, Western Europe, Japan, New Zealand, and Australia Men who have sex with men Users of illicit drugs, injectable or noninjectable People who anticipate having close personal contact with an international adoptee from a country of high or intermediate endemicity during the first 60 days of arrival in the U.S. People who have blood clotting disorders People who work with HAV-infected primates or with HAV in a research laboratory setting (no other groups have been shown to be at increased risk for HAV infection because of occupational exposure) People with chronic liver disease Any person who wishes to be immune to hepatitis A I-1
Postexposure prophylaxis Susceptible persons should receive a single dose of single-antigen hepatitis A vaccine or immune globulin (IG) (0.02 ml/kg) as soon as possible. For healthy persons aged 12 months 40, single antigen hepatitis A vaccine at the age-appropriate dose is preferred. For persons aged >40, IG is preferred; vaccine can be used if IG cannot be obtained. For children aged <12 months, immunocompromised persons, persons who have had chronic liver disease diagnosed, and persons for whom vaccine is contraindicated, IG should be used. International travel Recommended for travel to high or intermediate risk countries One dose of single-antigen hepatitis A vaccine administered at any time before departure can provide adequate protection for most healthy persons Older adults, immunocompromised persons, and persons with chronic liver disease or other chronic medical conditions planning to depart to an area in <2 weeks should receive the initial dose of vaccine and also simultaneously can be administered IG (0.02 ml/kg) at a separate anatomic injection site Travelers who elect not to receive vaccine, are aged <12 months, or are allergic to a vaccine component should receive a single dose of IG (0.02 ml/kg) Contacts of international adoptees >99% of international adoptees from countries with high/intermediate prevalence of hepatitis A 1-6% of adoptees are acutely infected Risk to contacts of adoptees is 100x Vaccine recommended for anyone who will be a close contact within 60 days of arrival Hepatitis B Recommendations All children age 0-18 Household contacts and sexual contacts of HBsAg-positive people Injection drug users Sexually active people not in a long-term, mutually monogamous relationship MSM People with HIV STD clients Hemodialysis patients Diabetics under age 60 Employees with potential exposure to BBP Clients and staff of institutions for DD Inmates of long-term correctional facilities Travelers to areas with prevalence of HBsAg 2% People with chronic liver disease Hepatitis B vaccination for diabetics Outbreaks of HBV infection in LTC facilities Increased prevalence of HBV infection in diabetics aged 18-59 ACIP recommendations: Vaccinate adults with diabetes aged 18-59 Vaccine may be administered to adults with diabetes aged 60 and older Adherence to infection control practices Hepatitis B vaccination in HCWs How do we ensure HCWs vaccinated in the remote past are protected? Options Assess vaccination history, serologic response to vaccine, and source patient Pre-exposure anti-hbs Challenge dose of hepatitis B vaccine I-2
Meningococcal Vaccine Recommendations Routinely at age 11-12 Booster dose at age 16 Certain children aged 9-23m Children aged 24m and older and adults at increased risk Unvaccinated first-year college students aged 19-21 living in residence halls Meningococcal vaccines 1978 quadrivalent polysaccharide vaccine (Menommune) for age 2+ 2005 quadrivalent conjugate vaccine (Menactra) for age 11-55 2007 FDA approves Menactra age 2-10 Expanded to age 9 months in 2011 2010 Menveo approved for 11-55 Expanded to 2-55 in 2011 Groups at higher risk Persons aged 11-18 Persons aged 2 and older who: Have complement deficiency or asplenia Travel to or reside in risk areas Work with N. meningitidis cultures Military recruits College freshmen living in dormitories Infants under age 2 MCV4-D (Menactra) Indications: Persistent complement component deficiency Resident of or traveler to risk area During outbreaks caused by a vaccine serogroup Not infants with functional or anatomic asplenia 2 doses, 3 months apart (minimum interval 8 weeks) Vaccine dosing 2010 ACIP recommends adolescent booster After 5 protective antibody levels about 50% Routine vaccination at age 11-12 Booster dose at age 16 If vaccinated age 13-15, booster at age 16-18 Minimum interval 2 months If 1 st dose age 16+, no booster needed People with immune disorders get 2 doses, 2 months apart All others get one initial dose Booster doses every 5 if at continued risk Booster at 3 if 1 st dose at age 2-6 Booster dose for adolescents/young adults If first dose before age 16 Up to age 21 I-3
MMR Licensed for age 12 months and up Usual schedule 2 doses at age 12-15 months and 4-6 Minimum interval 28 days between doses May be given at age 6 months or older if at increased risk Adults born in or after 1957 Certain adults born before 1957 MMR for travelers Children age 6-11 months should receive one dose of MMR Children age 12 months or older, adolescents and adults should provide evidence of immunity 2 doses of MMR or other live measles vaccine Serologic evidence of immunity Diagnosed measles infection Born before 1957* Pneumococcal Vaccine Recommendations PCV 13 Routine use at age 2-59 months High-risk children aged 60-71 months May consider in children through age 18 PPSV High risk children age 2 or older Second dose in children at very high risk** Adults aged 65 and older Adults aged 18-64 at increased risk Risk factors for pneumococcal disease Sickle cell disease** Anatomic or functional asplenia** Chronic cardiac, pulmonary, renal disease CSF leaks HIV infection Immunosuppression** Cochlear implant Pneumococcal vaccines PCV7 licensed in 2000 Prevents 7 strains responsible for 80% of cases of invasive pneumococcal disease PCV13 licensed in 2010 Indicated for prevention of Invasive pneumococcal disease Otitis media PPSV 14-valent vaccine licensed in 1977 23-valent vaccine licensed in 1983 Adults aged 65 and older At-risk children aged 2 and older 2008 indication expanded to include all smokers age 19 and older and those with asthma 2011 PCV-13 approved for age 50+ I-4
Poliomyelitis Vaccine Recommendations Routine vaccination for children through 17 2,4, 6-18m, 4-6 Not routinely recommended for US residents aged 18 and older Recommended for previously unvaccinated adults at high risk Booster dose recommended for previously immunized adults traveling to endemic areas Afghanistan Angola Armenia Azerbaijan Bangladesh Benin Bhutan Burkina Faso Burundi Cameroon Central African Republic Chad China Congo Côte d Ivoire Democratic Republic of the Congo (DRC) Djibouti Equatorial Guinea Eritrea Global status on polio Ethiopia Gabon Gambia Georgia Ghana Guinea Guinea-Bissau India Iran Kenya Kazakhstan Kyrgyzstan Liberia Mali Mauritania Namibia Nepal Niger Nigeria Pakistan Russia Rwanda Senegal Sierra Leone Somalia Sudan and South Sudan Tajikistan Tanzania Togo Turkmenistan Uzbekistan Uganda Zambia Tdap Tetanus, diphtheria, acellular pertussis Two products licensed in US Adacel ages 11-64 Boostrix ages 10 and up Licensed for use at intervals of at least 5 since last Td Single dose replacing a dose of Td Catch-up series Tdap + 2 Tds Tdap One-time dose recommended at age 11-64, then boost every 10 with Td. 5 if needed for wound management HCW who have not received Tdap previously Tdap can be administered regardless of the interval since the last Td Tdap should be given to: All people between 11-64 Certain adults aged 65+ Incompletely vaccinated children aged 7-10 (off-label) Tdap and pregnancy Pregnancy is not a contraindication to Tdap ACOG recommends considering Tdap in 2 nd or 3 rd trimester (2009) ACIP recommends Tdap in pregnancy after 20 th week gestation If not vaccinated during pregnancy, should receive immediately postpartum ACOG: Tdap may be considered during the second or third trimester (2009) 2011 ACIP recommends Tdap during pregnancy (second or third trimester) July 2011 FDA approves Boostrix for ages 65+ I-5
HPV Gardasil (2006) Quadrivalent (HPV 6,11,16, and 18) Licensed for males and females aged 9-26 2006 for prevention of cervical cancer in women 2008 prevention of vulvar and vaginal cancer added 2009 approved for males for prevention of genital warts 2010 expanded to protection against anal cancer 2011 recommended by ACIP for males Cervarix (2009) Bivalent (HPV 16 and 18) HPV Recommendations Females HPV2 (Cervarix) or HPV4 (Gardasil) routinely at age 11-12, up to age 26 May be given as early as age 9 Males HPV4 routinely at age 11-12, up to age 21 Males 9-10 and 22-26 may be vaccinated Recommended in immunocompromised men and MSM up to age 26 May complete series after 27 th birthday Zoster Shingles (herpes zoster) Affects 30% of people with history of varicella Greatest risk over age 50 Zostavax Licensed in 2006 for adults aged 60+ Expanded to age 50 and up in 2011 More effective at younger age ACIP has not changed recommendation for routine use at age 60 Japanese encephalitis JE-VAX No longer manufactured Ixiaro (licensed in 2009) Licensed for age 17 and older Two 0.5 ml doses, 28 days apart (IM) Booster dose recommended after 1 year Need for additional booster doses not determined Ixiaro booster dose Long-term immunity unknown at time of licensure 3 clinical trials showed 97-99% seropositive at 2 months 58-83% at 12 months 48-82% at 24 months Trial of Ixiaro booster at 15 months Near 100% seropositive at 12 months Children under 17 desiring JE vaccination Ixiaro not licensed for this age group Clinical trials ongoing Parents may: Enroll in clinical trial Seek JE vaccination overseas Find a provider that will prescribe Ixiaro offlabel I-6