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Annals of Internal Medicine

Editorial

Adult Immunization 2012: Politics, Process, and Progress

T his issue of Annals marks the sixth consecutive publi- cation of the annual update of the Advisory Commit-

tee on Immunization Practices (ACIP) Adult Immuniza- tion 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 be- hind key changes.

E CONOMICS AND THE P OLITICS OF V ACCINATION

P

OLICY

Recommendations 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 pro- visional until published in Morbidity and Mortality Weekly Report (1). Vaccine coverage mandated through the Afford- able Care Act should increase access to vaccines but could further politicize this process. Budget concerns could delay, and even prevent, incorporation of ACIP recommenda- tions, including those that also influence insurance cover- age in the private sector (4).

T RANSITION TO E VIDENCE-B ASED P ROCESSES

In October 2010, the ACIP adopted an evidence- based process modeled after the GRADE (Grading of Rec- ommendations, Assessment, Development, and Evaluation) guidelines. The committee now evaluates quality of evi- dence, benefits and harms, values and preferences of af- fected 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.

M ALE HPV VACCINATION: B ACKGROUND AND R ATIONALE

HPV-Related Disease Burden

Human 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 Vaccines

The 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 vac- cines currently available. The quadrivalent vaccine (HPV4 [Gardasil, Merck & Co., North Wales, Pennsylvania]) pro- tects 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, Re- search 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, recur- rent respiratory papillomatosis, or penile cancer (9, 10).

HPV Vaccination: Not Just for Girls

The committee’s recommendations for HPV vaccina- tion 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 in- creases in HPV vaccine coverage are also blunted (13). Evidence-based data review supports the cost-effectiveness of vaccinating young MSM, but targeted vaccination strat- egies may stigmatize individuals. Such strategies require self-identification of risk factors and thus may not be successful.

H EPATITIS B VACCINATION FOR D IABETICS

Hepatitis B vaccination is now routinely recom- mended 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 recom-

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© 2012 American College of Physicians

Editorial

Adult Immunization 2012

mendation 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 hepati- tis B vaccine efficacy decreases somewhat with patient age, failing to offer vaccine leads to 100% susceptibility (that is, zero efficacy) (18).

T DAP D URING P REGNANCY

Tetanus, diphtheria, and acellular pertussis (Tdap) booster is designed to protect infants from pertussis. The practice of cocooning infants and young children by vac- cinating 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 soon- er: Tdap should be given during pregnancy, preferably af- ter 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).

I NFLUENZA V ACCINATION: E GG A LLERGY C LEARANCE

AND I NNOVATION

Egg 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 al- lergic reaction. Egg-allergic patients must get the inacti- vated 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 Intrader- mal, 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 reac- tions. 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).

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that play a key role in triggering immune response (20). 244 7 February 2012 Annals of
that play a key role in triggering immune response (20). 244 7 February 2012 Annals of

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Annals of Internal Medicine

Volume 156 • Number 3

T HE ACP’ S C OMMITMENT TO H ELPING S HAPE

N ATIONAL V ACCINE P OLICY

The American College of Physicians has established its first-ever Adult Immunization Technical Advisory Com- mittee. The College has representation at all ACIP meet- ings and on many ACIP vaccine working groups. Vaccines are vital to ensuring our nation’s health. The newly re- leased fourth edition of the ACP Guide to Adult Immuni- zation (21) can help physicians incorporate and improve vaccination strategies in their own practices.

Sandra Adamson Fryhofer, MD Emory University Atlanta, GA 30309

Requests for Single Reprints: Sandra Adamson Fryhofer, MD, 1938 Peachtree Road, Suite 502, Atlanta, GA 30309.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline .org/authors/icmje/ConflictOfInterestForms.do?msNum M11-3040.

Ann Intern Med. 2012;156:243-245.

References

1. 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. Recommended immunization

schedule for persons aged 0 –18 years—United States, 2012. MMWR. 2012;61. [Forthcoming]

3. 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]

4. Affordable Care Act and Immunization. Accessed at www.healthcare.gov/news

/factsheets/2010/09/affordable-care-act-immunization.html on 1 November

2011.

5. Ahmed F, Temte JL, Campos-Outcalt D, Schu¨nemann 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]

6. Moscicki AB, Palefsky JM. Human papillomavirus in men: an update. J Low

Genit Tract Dis. 2011;15:231-4. [PMID: 21543996]

7. 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]

8. 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]

9. U.S. Food and Drug Administration. FDA Vaccine, Blood & Biologics:

Gardasil. Accessed at www.fda.gov/BiologicsBloodVaccines/Vaccines/Approved Products/UCM094042 on 1 November 2011.

10. U.S. Food and Drug Administration. FDA Vaccine, Blood and Biologics:

Cevarix. Accessed at www.fda.gov/BiologicsBloodVaccines/Vaccines/Approved- Products/ucm186957.htm on 1 November 2011.

11. Palefsky JM, Giuliano AR, Goldstone S, Moreira ED Jr, Aranda C, Jessen

H, et al. HPV vaccine against anal HPV infection and anal intraepithelial neo- plasia. N Engl J Med. 2011;365:1576-85. [PMID: 22029979]

12. Centers for Disease Control and Prevention (CDC). Recommendations on

the use of quadrivalent human papillomavirus vaccine in males—Advisory Com- mittee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60:1705-8. [PMID: 22189893]

13. Centers for Disease Control and Prevention (CDC). National and state vacci-

www.annals.org

Adult Immunization 2012

Editorial

nation coverage among adolescents aged 13 through 17 years—United States, 2010. MMWR Morb Mortal Wkly Rep. 2011;60:1117-23. [PMID: 21866084]

14. 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]

15. National Diabetes Information Clearing House (NDIC). National Diabetes

Statistics, 2011: Fast Facts on Diabetes. Accessed at http://diabetes.niddk.nih.gov /dm/pubs/statistics/#fast on 1 November 2011.

16. Thompson ND, Perz JF. Eliminating the blood: ongoing outbreaks of hep-

atitis B virus infection and the need for innovative glucose monitoring technolo- gies. J Diabetes Sci Technol. 2009;3:283-8. [PMID: 20144359]

17. 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]

18. Hepatitis B vaccination for adults with diabetes policy considerations. Pre-

sented at a meeting of the Advisory Committee on Immunization Practices.

Center for Disease Control and Prevention, Atlanta, Georgia, 27 October 2010. Available at www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct10/03-5 -hepb-VaccAdultDiabetes.pdf.

19. Centers for Disease Control and Prevention (CDC). Updated recommen-

dations 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 Immu- nization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60:

1424-6. [PMID: 22012116]

20. 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]

21. American College of Physicians. Guide to Adult Immunization: A Team-

Based Manual. 4th ed. Philadelphia: American Coll Physicians; 2010.

ANNALS OF INTERNAL MEDICINE JUNIOR INVESTIGATOR AWARDS

Annals of Internal Medicine and the American College of Physicians recognize excellence among internal medicine trainees and junior inves- tigators with annual awards for original research and scholarly review articles published in Annals in each of the following categories:

Most outstanding article with a first author in an internal medicine residency program or general medicine or internal medicine sub- specialty fellowship program

Most outstanding article with a first author within 3 years following completion of training in internal medicine or one of its subspecialties

Selection of award winners will consider the article’s novelty; method- ological rigor; clarity of presentation; and potential to influence practice, policy, or future research. Judges will include Annals Editors and repre- sentatives from Annals’ Editorial Board and the American College of Physicians’ Education/Publication Committee.

Papers published in the year following submission are eligible for the award in the year of publication. First author status at the time of manuscript submission will determine eligibility. Authors should indicate that they wish to have their papers considered for an award when they submit the manuscript, and they must be able to provide satisfactory documentation of their eligibility if selected for an award. Announcement of awards for a calendar year will occur in January of the subsequent year. We will provide award winners with a framed certificate, a letter documenting the award, and complimentary registration for the Ameri- can College of Physicians’ annual meeting.

Please refer questions to Mary Beth Schaeffer at mschaeffer@acponline .org.

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Beth Schaeffer at mschaeffer@acponline .org. www.annals.org 245 7 February 2012 Annals of Internal Medicine Volume 156
Beth Schaeffer at mschaeffer@acponline .org. www.annals.org 245 7 February 2012 Annals of Internal Medicine Volume 156
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Annals of Internal Medicine

Volume 156 • Number 3