Adult Immunization 2012: Politics, Process, and Progress
Authors: Sandra Adamson Fryhofer
Journal: Annals of Internal Medicine (2012)

Editorials7 February 2012Adult Immunization 2012: Politics, Process, and ProgressFREESandra Adamson Fryhofer, MDSandra Adamson Fryhofer, MDFrom Emory University, Atlanta, GA 30309.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-156-3-201202070-00389 Annals Author Insight Video - Sandra A. Fryhofer, MD In this video, Sandra A. Fryhofer, MD, offers additional insight into her editorial, "Adult Immunization 2012: Politics, Process, and Progress." SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail This issue of Annals marks the sixth consecutive publication of the annual update of the Advisory Committee on Immunization Practices (ACIP) Adult Immunization Schedule (1). For the first time, the adult schedule and the schedule for children and adolescents (2) are designed to be combined. This editorial highlights the rationale behind key changes.Economics and the Politics of Vaccination PolicyRecommendations by the committee do not become policy of the Centers for Disease Control and Prevention (CDC) until they are signed by the CDC Director and accepted by the Secretary of the U.S. Department of Health and Human Services. This allows for discretionary oversight (3). These recommendations are considered provisional until published in Morbidity and Mortality Weekly Report(1). Vaccine coverage mandated through the Affordable Care Act should increase access to vaccines but could further politicize this process. Budget concerns could delay, and even prevent, incorporation of ACIP recommendations, including those that also influence insurance coverage in the private sector (4).Transition to Evidence-Based ProcessesIn October 2010, the ACIP adopted an evidence-based process modeled after the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) guidelines. The committee now evaluates quality of evidence, benefits and harms, values and preferences of affected populations, and economic impact (5). Votes of the ACIP expanding routine human papillomavirus (HPV) vaccination to males and hepatitis B vaccination to young adult diabetics were the first to use this approach.Male HPV Vaccination: Background and RationaleHPV-Related Disease BurdenHuman papillomavirus types 6 and 11 are associated with genital warts and recurrent respiratory papillomatosis; types 16 and 18 are linked to cervical, vaginal, vulvar, anal, penile, and oropharyngeal cancer (6–8). Rates of HPV-related oropharyngeal cancer are increasing in men. Risk factors for both men and women include having multiple sex partners and engaging in oral sex. For men, having sex with other men is also a major risk factor (6–8).Anal cancer is on the rise, with 1600 new cases in women and 900 new cases in men each year. The overall rate and absolute number of anal cancer cases are higher in women (1.4 per 100 000) than in men (1 per 100 000). However, incidence is highest in men who have sex with men (MSM), especially if they are HIV-positive (25 to 100 per 100 000) (6).FDA Licensing Distinctions Between HPV VaccinesThe HPV vaccine is a prophylactic vaccine. It is most effective if given before exposure to the virus. Immune response is more robust when the vaccine is administered to younger persons (9, 10).There are distinct differences in the U.S. Food and Drug Administration's (FDA) licensing for the 2 HPV vaccines currently available. The quadrivalent vaccine (HPV4 [Gardasil, Merck & Co., North Wales, Pennsylvania]) protects against types 6, 11, 16, and 18, and is FDA-approved for both females and males aged 9 to 26 years (9). The bivalent vaccine (HPV2 [Cevarix, GlaxoSmithKline, Research Triangle Park, North Carolina]) protects against types 16 and 18 but is FDA-approved only for females (10). Both vaccines prevent cervical cancer; however, only HPV4 is FDA-approved for prevention of vulvar, vaginal, and anal cancer. Efficacy of the HPV4 vaccine for anal intraepithelial neoplasia in MSM ranges from 50% to 78% (11). Only HPV4 protects against genital warts. Although the rationale for protection is certainly plausible, clinical HPV vaccine data are not available for oropharyngeal cancer, recurrent respiratory papillomatosis, or penile cancer (9, 10).HPV Vaccination: Not Just for GirlsThe committee's recommendations for HPV vaccination differ from FDA licensing directives. The new, routine HPV4 vaccination recommendation for males—like females—starts at age 11 years but stops short of gender parity. It extends routine vaccination to males only through age 21 years, whereas vaccinating females through age 26 years is established CDC policy. A subgroup of MSM, as well as immunocompromised and HIV-positive males, “should” be vaccinated through age 26 years (12).Extending HPV4 vaccine coverage to males is more cost-effective when female coverage rates are low; the 2010 National Immunization Survey data on teenagers show just that (13). Fewer than half (48.7%) of teenage girls has received at least one HPV vaccine dose; only about one third (32%) has received all three doses. Trends for increases in HPV vaccine coverage are also blunted (13). Evidence-based data review supports the cost-effectiveness of vaccinating young MSM, but targeted vaccination strategies may stigmatize individuals. Such strategies require self-identification of risk factors and thus may not be successful.Hepatitis B Vaccination for DiabeticsHepatitis B vaccination is now routinely recommended for unvaccinated diabetic adults through age 59 years. This age cutoff was chosen on the basis of disease risk and cost-effectiveness. There is also a softer recommendation that, at physician discretion, hepatitis B vaccine “may” be administered to older diabetics.Diabetic patients aged 23 to 59 years have more than twice the risk for hepatitis B than people without diabetes. For diabetics aged 60 years or older, risk for hepatitis B was increased 1.5 times, but this increase was not statistically significant (14).Nearly one third of patients older than age 65 years have type 2 diabetes (15). Ironically, this group was left out of routine vaccination—initial discussions investigating the need for hepatitis B vaccination in diabetics began with recognition of outbreaks of hepatitis B infection in older patients in assisted-living facilities due to sharing blood glucose–monitoring equipment (16, 17). Although hepatitis B vaccine efficacy decreases somewhat with patient age, failing to offer vaccine leads to 100% susceptibility (that is, zero efficacy) (18).Tdap During PregnancyTetanus, diphtheria, and acellular pertussis (Tdap) booster is designed to protect infants from pertussis. The practice of cocooning infants and young children by vaccinating family and household contacts (and health care personnel) is still recommended. The change is when to vaccinate pregnant mothers. Previous guidance stated that unvaccinated mothers should be given Tdap immediately postpartum; the new strategy begins protection even sooner: Tdap should be given during pregnancy, preferably after 20 weeks of gestation. Protective maternal antibodies then pass to the fetus. Further study is needed to ensure that maternal antibodies do not blunt the infant's own immune response to pertussis vaccination (19).Influenza Vaccination: Egg Allergy Clearance and InnovationEgg allergy is no longer a contraindication to influenza vaccination. Data from at least 17 studies of more than 2600 egg-allergic patients have debunked concerns that traces of ovalbumin egg protein could trigger a serious allergic reaction. Egg-allergic patients must get the inactivated flu shot because that is what has been studied. No skin tests are needed before vaccinating, and the entire vaccine dose can be given at one time. Patients should be observed for 30 minutes after receiving the vaccine (20).A new intradermal flu formulation (Fluzone Intradermal, sanofi pasteur, Swiftwater, Pennsylvania) is now an option for adults aged 18 to 64 years. Its microinjector apparatus features an ultrafine, 0.06-in needle that causes less pain on injection but induces more injection-site reactions. It is also 30% more expensive than prefilled syringes. The dermal layer of skin is rich in dendritic cells that play a key role in triggering immune response (20).The ACP's Commitment to Helping Shape National Vaccine PolicyThe American College of Physicians has established its first-ever Adult Immunization Technical Advisory Committee. The College has representation at all ACIP meetings and on many ACIP vaccine working groups. Vaccines are vital to ensuring our nation's health. The newly released fourth edition of the ACP Guide to Adult Immunization(21) can help physicians incorporate and improve vaccination strategies in their own practices.Sandra Adamson Fryhofer, MDEmory UniversityAtlanta, GA 30309References1. Advisory Committee on Immunization Practices. Recommended Adult Immunization Schedule: United States, 2012. Ann Intern Med. 2012;156:211-7. LinkGoogle Scholar2. Centers for Disease Control and Prevention. Recommended immunization schedule for persons aged 0–18 years—United States, 2012. MMWR. 2012;61. [Forthcoming] Google Scholar3. Hinman AR, Orenstein WA, Schuchat A; Centers for Disease Control and Prevention (CDC). Vaccine-preventable diseases, immunizations, and MMWR—1961-2011. MMWR Surveill Summ. 2011;60 Suppl 4 49-57. [PMID: 21976166] MedlineGoogle Scholar4. The Affordable Care Act and Immunization. Accessed at www.healthcare.gov/news/factsheets/2010/09/affordable-care-act-immunization.html on 1 November 2011. Google Scholar5. Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine. 2011;29:9171-6. [PMID: 21839794] CrossrefMedlineGoogle Scholar6. Moscicki AB, Palefsky JM. Human papillomavirus in men: an update. J Low Genit Tract Dis. 2011;15:231-4. [PMID: 21543996] CrossrefMedlineGoogle Scholar7. D'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, et al. Case-control study of human papillomavirus and oropharyngeal cancer. N Engl J Med. 2007;356:1944-56. [PMID: 17494927] CrossrefMedlineGoogle Scholar8. Marur S, D'Souza G, Westra WH, Forastiere AA. HPV-associated head and neck cancer: a virus-related cancer epidemic. Lancet Oncol. 2010;11:781-9. [PMID: 20451455] CrossrefMedlineGoogle Scholar9. U.S. Food and Drug Administration. FDA Vaccine, Blood & Biologics: Gardasil. Accessed at www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM094042 on 1 November 2011. Google Scholar10. U.S. Food and Drug Administration. FDA Vaccine, Blood and Biologics: Cevarix. Accessed at www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm186957.htm on 1 November 2011. Google Scholar11. Palefsky JM, Giuliano AR, Goldstone S, Moreira ED, Aranda C, Jessen H, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011;365:1576-85. [PMID: 22029979] CrossrefMedlineGoogle Scholar12. Centers for Disease Control and Prevention (CDC). Recommendations on the use of quadrivalent human papillomavirus vaccine in males—Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60:1705-8. [PMID: 22189893] MedlineGoogle Scholar13. Centers for Disease Control and Prevention (CDC). National and state vaccination coverage among adolescents aged 13 through 17 years—United States, 2010. MMWR Morb Mortal Wkly Rep. 2011;60:1117-23. [PMID: 21866084] MedlineGoogle Scholar14. Centers for Disease Control and Prevention (CDC). Use of hepatitis B vaccination for adults with diabetes mellitus: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2011;60:1709-11. [PMID: 22189894] MedlineGoogle Scholar15. National Diabetes Information Clearing House (NDIC). National Diabetes Statistics, 2011: Fast Facts on Diabetes. Accessed at diabetes.niddk.nih.gov/dm/pubs/statistics/#fast on 1 November 2011. Google Scholar16. Thompson ND, Perz JF. Eliminating the blood: ongoing outbreaks of hepatitis B virus infection and the need for innovative glucose monitoring technologies. J Diabetes Sci Technol. 2009;3:283-8. [PMID: 20144359] CrossrefMedlineGoogle Scholar17. Centers for Disease Control and Prevention (CDC). Notes from the field: deaths from acute hepatitis B virus infection associated with assisted blood glucose monitoring in an assisted-living facility—North Carolina, August-October 2010. MMWR Morb Mortal Wkly Rep. 2011;60:182. [PMID: 21330968] MedlineGoogle Scholar18. Hepatitis B vaccination for adults with diabetes policy considerations. Presented at a meeting of the Advisory Committee on Immunization Practices. Center for Disease Control and Prevention, Atlanta, Georgia, 27 October 2010. Google Scholar19. Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months—Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60:1424-6. [PMID: 22012116] MedlineGoogle Scholar20. Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60:1128-32. [PMID: 21866086] MedlineGoogle Scholar21. American College of Physicians. Guide to Adult Immunization: A Team-Based Manual. 4th ed. Philadelphia: American Coll Physicians; 2010. Google Scholar Comments0 CommentsSign In to Submit A Comment Sandra Adamson, Fryhofer, MD, MACP10 February 2012 Flu Vaccination for Egg Allergic Patients: A Clarification The 2012 Adult Immunization Schedule has a new feature. It includes a handy table listing "Contraindications and Precautions to Commonly Used Vaccines in Adults." (1) Some Annals readers have suggested the "contraindications table" listing for influenza vaccinations is confusing in light of new ACIP (Advisory Committee on Immunization Practices) guidance. (2)As indicated on the table for every vaccine, "severe allergic reaction (e.g., anaphylaxis) after previous dose or to a vaccine component" is a contraindication. This is clear. But for TIV (trivalent inactivated influenza vaccine), the additional phrase, "including egg protein," might seem inconsistent with new ACIP guidance. (2) More clarity could have been provided by specifying that milder allergic reactions to eggs are not a contraindication to influenza vaccination.Egg allergy is no longer a contraindication for TIV influenza vaccination for those with mild symptoms (hives only). Egg allergy is no longer an absolute contraindication for patients with more serious symptoms if benefits of flu protection outweigh the risks of vaccine egg protein exposure. Many TIV package inserts have been revised to say only "severe allergic reaction (e.g. anaphylaxis) to egg protein" is a contraindication. However, egg allergic patients with more serious reactions should be vaccinated only after thoughtful evaluation and in a closely monitored setting, with adequate anaphylaxis management available- -not in drive through clinics or at the grocery store. (2)Another source of confusion is the description on the table used for TIV: "Influenza, injectable trivalent" (1) does not indicate that TIV is the "inactivated" vaccine. TIV is "injectable," but it is also "inactivated," in contrast to LAIV (live attenuated influenza vaccine), the nasal flu vaccine. The type of influenza vaccine is important. Only use of TIV (inactivated) influenza vaccine in egg allergic patients has been studied. Contraindications for LAIV on the table are clear. (2)Flu Vaccination for Egg Allergic Patients: A New FrontierSymptom severity Severity of egg allergy symptoms should be assessed. New CDC guidance published in August 26, 2011, edition of MMWR (2) contains an algorithm for assessing severity of egg allergy symptoms. Patients with history of mild egg allergy symptoms (hives "only") can be given TIV, but should be observed for at least 30 minutes after vaccination. (2) No skin tests are needed; the results aren't predictive. (2) There's no need to divide the dose; single dose studies showed no serious reactions; so you can give the entire vaccine dose at one time. (2) Patients with more "serious" egg related symptoms (hypotension, wheezing, nausea, vomiting, or any reaction requiring epinephrine or emergency medical attention) should be referred to "physician with expertise in management of allergic conditions for further evaluation." (2) Reassuring data presented at the June 2011 ACIP meeting revealed that egg allergy/flu vaccine studies have specifically included more than 200 patients with histories of severe anaphylaxis related to egg ingestion. These patients also tolerated influenza vaccine. (2, 3)Ovalbumin content The August 26, 2011 MMWR (2) also contains a table listing published maximum content of egg protein (ovalbumin) in many flu vaccines. Available studies have shown that vaccines with ovalbumin content up to 1.4 mcg/ml (adult dose) or 0.7 mcg/0.5 ml (pediatric dose) have been well tolerated. (2)Type of influenza vaccine (TIV only) Only TIV (trivalent inactivated) should be given because that is what has been studied. (2)Be prepared Be on alert for adverse reactions and have emergency medications (like epinephrine) available. Observe egg allergy patients for at least 30 minutes after receiving influenza vaccination. (2, 4)In perspective It is safer to give influenza vaccine in the context of egg allergy than previously thought. (2) Influenza infection causes 200,000 hospitalizations and up to 49,000 deaths each year. (5) For many, maybe most, egg allergic patients, it is safer to get vaccinated than to risk getting the flu. Summary of extensive discussion at the June 22-23, 2011 ACIP proceedings is available on line. (3)Sandra Adamson Fryhofer MDReferences1. Advisory Committee on Immunization Practices. Recommended Adult Immunization Schedule: United States, 2012. Ann Intern Med. 2012:156:211-7.2. Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011; 60:1128-32. [PMID: 21866086]3. Summary Report ,ACIP June 22-23, 2011 meeting. CDC website. Assessed February 9, 2012. Available at http://www.cdc.gov/vaccines/recs/acip/downloads/min-jun11.pdf).4 CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60(No. RR-2). 5 " Have You Heard?" CDC Recommendations for Influenza Antiviral Medications Remain Unchanged, CDC website. Assessed February 9, 2012, Available at http://www.cdc.gov/media/haveyouheard/stories/Influenza_antiviral.htmlConflict of Interest:I am a member of the ACP Adult Immunization Technical Advisory Committee Author, Article, and Disclosure InformationAuthors: Sandra Adamson Fryhofer, MDAffiliations: From Emory University, Atlanta, GA 30309.Corresponding Author: Sandra Adamson Fryhofer, MD, 1938 Peachtree Road, Suite 502, Atlanta, GA 30309.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-3040. PreviousarticleNextarticle Advertisement Annals Author Insight Video - Sandra A. Fryhofer, MD In this video, Sandra A. Fryhofer, MD, offers additional insight into her editorial, "Adult Immunization 2012: Politics, Process, and Progress." FiguresReferencesRelatedDetailsSee AlsoRecommended Adult Immunization Schedule: United States, 2012Advisory Committee on Immunization Practices† Metrics Cited byThe case for semi-mandatory HPV vaccination in China 7 February 2012Volume 156, Issue 3Page: 243-245KeywordsFood and Drug AdministrationHepatitis BHuman papillomavirusImmune responseInfantsMale male sexual contactMedical risk factorsPertussisPregnancyVaccines ePublished: 7 February 2012 Issue Published: 7 February 2012 Copyright & PermissionsCopyright © 2012 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...