Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2020

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At its October 2019 meeting, the Advisory Committee on Immunization Practices (ACIP)* voted to recommend approval of the 2020 Recommended U.S. Adult Immunization Schedule for Persons Aged 19 Years and Older. The 2020 adult immunization schedule, available at https://www.cdc.gov/vaccines/schedules/index.html, † summarizes ACIP recommendations in two tables and accompanying notes. This 2020 adult immunization schedule has been approved by the CDC Director, the American College of Physicians, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American College of Nurse-Midwives. Health care providers are advised to use the tables and the notes together. ACIP’s recommendations on use of each vaccine are developed after in-depth reviews of vaccine-related data, including the epidemiology and burden of the vaccine-preventable disease, vaccine efficacy and effectiveness, vaccine safety, quality of evidence, feasibility of program implementation, and economic analyses of immunization policy ( 1 ). The adult immunization schedule is published annually to consolidate and summarize updates to ACIP recommendations on vaccination of adults and to assist health care providers in implementing current ACIP recommendations. The use of vaccine trade names in this report and in the adult immunization schedule is for identification purposes only and does not imply endorsement by ACIP or CDC. For further guidance on the use of each vaccine, including contraindications and precautions, health care providers are referred to the respective ACIP vaccine recommendations at https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. Changes in recommended use of vaccines can occur between annual updates to the adult immunization schedule. Information on these changes, if made, is available at https://www.cdc.gov/vaccines/acip/recommendations.html. § Printable versions of the 2020 adult immunization schedule and ordering instructions are available at https://www.cdc.gov/vaccines/schedules/hcp/adult.html#note. Changes in the 2020 Adult Immunization Schedule Changes in the 2020 adult immunization schedule for persons aged ≥19 years include new or revised recommendations for hepatitis A vaccine (HepA) ( 2 ); human papillomavirus vaccine (HPV) ( 3 ); influenza vaccine ( 4 ); serogroup B meningococcal vaccine (MenB); pneumococcal vaccine ( 5 ); and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) ( 6 ). Following are the changes to the cover page, Table 1, Table 2, and Notes. Cover page Trademark symbols (®) were added to all vaccine trade names. PedvaxHIB was added to the table of trade names for Haemophilus influenzae type b vaccine. The footnote on the cover page has been edited and now reads “Do not restart or add doses to vaccine series if there are extended intervals between doses.” Table 1 Age ranges: The columns for age groups 19–21 years and 22–26 years have been combined, thereby reducing the number of columns for age ranges from five to four. This change was made because of the change in recommendation for catch-up HPV vaccination for all adults aged ≤26 years. Tetanus, diphtheria, pertussis row: This row has been edited to state that tetanus and diphtheria toxoids (Td) or Tdap may be used for the decennial tetanus booster. Human papillomavirus (HPV) row: The rows for males and females have been combined, reflecting that catch-up vaccination is now recommended for all adults aged ≤26 years. In addition, a blue box has been added for persons aged 27–45 years to indicate that shared clinical decision-making regarding vaccination is now recommended for this group. Pneumococcal conjugate (PCV13) row: The box for persons aged ≥65 years who do not have an additional risk factor or another indication has been changed to blue to indicate that shared clinical decision-making regarding vaccination is now recommended for this group. Meningococcal B (MenB) row: A blue box has been added for persons aged 19–23 years who are not at increased risk for meningococcal disease, indicating that shared clinical decision-making regarding vaccination is now recommended for this group. Legend: A blue box has been added to indicate that shared clinical decision-making is recommended regarding vaccination. The text defining the gray box has been edited and now reads “No recommendation/not applicable.” Table 2 Tdap or Td row: This row has been revised to read that Td or Tdap may be used for the decennial tetanus booster. Human Papillomavirus (HPV) row: This row has been combined into a single row including both males and females, reflecting that HPV vaccine is now recommended for all adults aged ≤26 years. Hepatitis A (HepA) row: The box for persons living with human immunodeficiency virus (HIV) infection (regardless of CD4 count) is now yellow, reflecting the new recommendation that previously unvaccinated persons in this group should be vaccinated. Legend and bar text: The gray box in the Legend has been edited and now reads “No recommendation/not applicable.” The red box has been edited and now reads “Not recommended/contraindicated — vaccine should not be administered.” The text appearing in the red bars has been changed from “Contraindicated” to “Not Recommended.” Notes Edits have been made throughout the Notes section to harmonize language between the child/adolescent immunization schedule and the adult immunization schedule, where possible. A new subsection entitled “Shared Clinical Decision-Making” was added for each vaccine that includes this new ACIP recommendation (e.g., for HPV, PCV13, and MenB). Hepatitis A: The note was revised to include minor changes to the chronic liver disease definition, minor changes for the pregnancy indication, addition of the recommendation for vaccination in settings of exposure, and removal of clotting factor disorders as an indication for vaccination. Hepatitis B: The note was revised to include minor changes to the chronic liver disease definition and minor changes for the pregnancy indication. Human papillomavirus: The note was revised to indicate that HPV vaccination is recommended for all persons aged ≤26 years. A shared clinical decision-making subsection was added for persons aged 27–45 years. Influenza: The note was updated to include a bulleted list indicating when live attenuated influenza vaccine (LAIV) should not be used and minor edits to the guidance for persons with a history of Guillain-Barré syndrome. Measles, mumps, and rubella: The note was revised to clarify recommendations for health care personnel, with a separate bullet for personnel born in 1957 or later with no evidence of immunity and for health care personnel born before 1957 with no evidence of immunity. Meningococcal: The note was revised to include the use of the complement inhibitor ravulizumab as an indication for MenB administration in these patients. A shared clinical decision-making subsection was added that includes a bullet for adolescents and young adults aged 16–23 years who are not at increased risk for meningococcal disease. Under the “Special situations” section, the recommendation to administer a booster dose of MenB 1 year after the primary series and to revaccinate every 2–3 years if the risk remains was added. Pneumococcal: The note has been updated to reflect the updated recommendations for vaccination of immunocompetent (defined as adults without an immunocompromising condition, cerebrospinal fluid leak, or cochlear implants) adults aged ≥65 years. One dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) is still recommended. Shared clinical decision-making is recommended regarding administration of PCV13 to immunocompetent persons aged ≥65 years. Tetanus, diphtheria, and pertussis: The note has been updated to indicate that Td or Tdap may be used in situations where only Td vaccine was indicated for the decennial tetanus, diphtheria, and pertussis booster vaccination, tetanus prophylaxis for wound management, and catch-up vaccination. Varicella: The note has been updated to indicate that vaccination may be considered for persons with HIV infection without evidence of varicella immunity who have CD4 counts ≥200 cells/μL. Additional Information The Recommended Adult Immunization Schedule, United States, 2020 is available at https://www.cdc.gov/vaccines/schedules/hcp/adult.html and in the Annals of Internal Medicine ( 7 ). The full ACIP recommendations for each vaccine are also available at https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. All vaccines identified in Tables 1 and 2 (except zoster vaccines) also appear in the Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger, United States, 2020. ¶ The notes for vaccines that appear in both the adult immunization schedule and the child and adolescent immunization schedule have been harmonized to the greatest extent possible.

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Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices

Elissa Meites, Peter G. Szilagyi, Harrell Chesson … (2019)

Introduction Vaccination against human papillomavirus (HPV) is recommended to prevent new HPV infections and HPV-associated diseases, including some cancers. The Advisory Committee on Immunization Practices (ACIP)* routinely recommends HPV vaccination at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up vaccination has been recommended since 2006 for females through age 26 years, and since 2011 for males through age 21 years and certain special populations through age 26 years. This report updates ACIP catch-up HPV vaccination recommendations and guidance published in 2014, 2015, and 2016 ( 1 – 3 ). Routine recommendations for vaccination of adolescents have not changed. In June 2019, ACIP recommended catch-up HPV vaccination for all persons through age 26 years. ACIP did not recommend catch-up vaccination for all adults aged 27 through 45 years, but recognized that some persons who are not adequately vaccinated might be at risk for new HPV infection and might benefit from vaccination in this age range; therefore, ACIP recommended shared clinical decision-making regarding potential HPV vaccination for these persons. Background HPV is a common sexually transmitted infection, with HPV acquisition generally occurring soon after first sexual activity ( 1 ). Most HPV infections are transient and asymptomatic. Persistent infections with high-risk (oncogenic) HPV types can lead to development of cervical, anal, penile, vaginal, vulvar, and oropharyngeal cancers, usually after several decades ( 1 ). Most new HPV infections occur in adolescents and young adults. Although most sexually active adults have been exposed to HPV ( 4 ), new infections can occur with a new sex partner ( 5 ). Three prophylactic HPV vaccines are licensed for use in the United States: 9-valent (9vHPV, Gardasil 9, Merck), quadrivalent (4vHPV, Gardasil, Merck), and bivalent (2vHPV, Cervarix, GlaxoSmithKline) ( 6 – 8 ). As of late 2016, only 9vHPV is distributed in the United States. The majority of HPV-associated cancers are caused by HPV 16 or 18, types targeted by all three vaccines. In addition, 4vHPV and 9vHPV target HPV 6 and 11, types that cause anogenital warts. 9vHPV also protects against five additional high-risk types: HPV 31, 33, 45, 52, and 58. In October 2018, using results from 4vHPV clinical trials in women aged 24 through 45 years, and bridging immunogenicity and safety data in women and men, the Food and Drug Administration expanded the approved age range for 9vHPV use from 9 through 26 years to 9 through 45 years in women and men ( 6 ). In June 2019, after reviewing evidence related to HPV vaccination of adults, ACIP updated recommendations for catch-up vaccination and for vaccination of adults older than the recommended catch-up age. Methods During April 2018–June 2019, the ACIP HPV Vaccines Work Group held at least monthly conference calls to review and discuss relevant scientific evidence regarding adult HPV vaccination using the Evidence to Recommendations framework. (https://www.cdc.gov/vaccines/acip/recs/grade/downloads/ACIP-evidence-rec-frame-508.pdf). The Work Group evaluated the quality of evidence for efficacy, safety, and effectiveness for HPV vaccination for primary prevention of HPV infection and HPV-related disease using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach (https://www.cdc.gov/vaccines/acip/recs/grade/about-grade.html). Scientific literature published during January 1, 2006–October 18, 2018, was searched to identify clinical trials of any licensed HPV vaccine in adults aged 27 through 45 years. Detailed search methods and results for the GRADE tables are available at https://www.cdc.gov/vaccines/acip/recs/grade/HPV-adults.html. Benefits were based on per-protocol analyses of vaccine efficacy; immunogenicity data were also considered. Harms were any vaccine-related serious adverse events. Of 1,388 references identified, 100 were selected for detailed review, and 16 publications were included in GRADE tables presented at the October 2018 ACIP meeting; tables were updated in June 2019 to include new results from a 9vHPV trial. At the June 2019 ACIP meeting, two policy issues were considered: 1) harmonization of catch-up vaccination for all persons through age 26 years, and 2) vaccination of adults aged >26 years. Two Evidence to Recommendations documents were developed (https://www.cdc.gov/vaccines/acip/recs/grade/HPV-harmonization-etr.html ) ( https://www.cdc.gov/vaccines/acip/recs/grade/HPV-adults-etr.html) and presented along with proposed recommendations; after a public comment period, ACIP members voted unanimously to harmonize catch-up vaccination recommendations across genders for all persons through age 26 years. ACIP members also voted 10–4 in favor of shared clinical decision-making for adults aged 27 through 45 years, recognizing that some persons who are not adequately vaccinated might be at risk for new HPV infection and might benefit from vaccination in this age range. Summary of Key Findings Vaccine efficacy and safety. Data were considered from 11 clinical trials of 9vHPV, 4vHPV, and/or 2vHPV in adults aged 27 through 45 years, along with supplemental bridging immunogenicity data. In per-protocol analyses from three trials, 4vHPV and 2vHPV demonstrated significant efficacy against a combined endpoint of persistent vaccine-type HPV infections, anogenital warts, and cervical intraepithelial neoplasia (CIN) grade 1 (low-grade lesions) or worse. In nine trials, seroconversion rates to vaccine-type HPV after 3 doses of any HPV vaccine were 93.6%–100% at 7 months after the first dose. Overall evidence on benefits was GRADE evidence level 2, for moderate-quality evidence. In nine trials, few serious adverse events and no vaccine-related deaths were reported. Overall evidence on harms was also GRADE evidence level 2, for moderate-quality evidence. In the efficacy trial that was the basis for 9vHPV licensure for adults through age 45 years, per-protocol efficacy of 4vHPV among women aged 24 through 45 years was 88.7% (95% confidence interval [CI] = 78.1–94.8), and intention-to-treat efficacy was 47.2% (95% CI = 33.5–58.2) against a combined endpoint of persistent infections, extragenital lesions, and CIN 1+ related to HPV types 6, 11, 16, or 18 ( 9 ). HPV burden of disease and impact of the vaccination program in the United States. Approximately 33,700 cancers are caused by HPV in the United States each year, including 12,900 oropharyngeal cancers among men and women, 10,800 cervical cancers among women, and 6,000 anal cancers among men and women; vaginal, vulvar, and penile cancers are less common ( 10 ). HPV vaccination for adolescents has been routinely recommended for females since 2006 and for males since 2011 ( 1 ). The existing HPV vaccination program for adolescents has the potential to prevent the majority of these cancers. Mean age at acquisition of causal HPV infection for cancers is unknown, but is estimated to be decades before cancer is diagnosed. In 2017, coverage with ≥1 dose of HPV vaccine was 65.5% among adolescents aged 13 through 17 years ( 11 ). Although coverage with the recommended number of doses remains below the Healthy People 2020 target of 80% for adolescents ( 12 ), the U.S. HPV vaccination program has resulted in significant declines in prevalences of vaccine-type HPV infections, anogenital warts, and cervical precancers ( 13 ). For example, prevalences of 4vHPV vaccine-type infection during 2013–2016, compared with those of the prevaccine era, declined from 11.5% to 1.8% among females aged 14 through 19 years and from 18.5% to 5.3% among females aged 20 through 24 years ( 14 ). In addition, declines have been observed among unvaccinated persons, suggesting protective herd effects ( 15 ). Health economic analyses. Five health economic models of HPV vaccination in the United States were reviewed ( 16 ). The cost effectiveness ratio for the current HPV vaccination program ranged from cost-saving to approximately $35,000 per quality-adjusted life year (QALY) gained ( 16 ). In the context of the existing vaccination program, the incremental cost per QALY for expanding male vaccination through age 26 years was $178,000 in a subset of analyses in one of the five models reviewed using more favorable model assumptions for adult vaccination ( 16 ). In the context of the existing program, expanding vaccination to adults through age 45 years would produce relatively small additional health benefits and less favorable cost-effectiveness ratios. The incremental cost per QALY for also vaccinating adults through age 30 or 45 years exceeded $300,000 in four of five models ( 16 ). Variation in results across models was likely due to uncertainties about HPV natural history, such as prevalence of immunity after clearance of natural infections, and level of herd protection from the existing program. Under the existing program, in a subset of analyses in one of the five models reviewed using more favorable model assumptions for adult vaccination, the number needed to vaccinate (NNV) to prevent one case of anogenital warts, CIN grade 2 or worse (high-grade lesions), or cancer would be 9, 22, and 202, respectively. For expanding recommendations for males through age 26 years to harmonize catch-up vaccination across genders, these NNV would be 40, 450, and 3,260, respectively. For expanding recommendations to include adults through age 45 years, these NNV would be 120, 800, and 6,500, respectively ( 16 ). Rationale Adolescents remain the most important focus of the HPV vaccination program in the United States. Recommendations harmonized across genders will simplify the immunization schedule and be more feasible to implement. HPV vaccination is most effective when given before exposure to any HPV, as in early adolescence ( 1 – 3 ). Clinical trials have indicated that HPV vaccines are safe and effective against infection and disease attributable to HPV vaccine types that recipients are not infected with at the time of vaccination. Because HPV acquisition generally occurs soon after first sexual activity, vaccine effectiveness will be lower in older age groups because of prior infections. Some previously exposed adults will have developed natural immunity already. Exposure to HPV decreases among older age groups. Evidence suggests that although HPV vaccination is safe for adults aged 27 through 45 years, population benefit would be minimal; nevertheless, some adults who are not adequately vaccinated might be at risk for new HPV infection and might benefit from vaccination in this age range. Recommendations Children and adults aged 9 through 26 years. HPV vaccination is routinely recommended at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated. † Adults aged >26 years. Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. (Box). HPV vaccines are not licensed for use in adults aged >45 years. BOX Considerations for shared clinical decision-making regarding human papillomavirus (HPV) vaccination of adults aged 27 through 45 years Ideally, HPV vaccination should be given in early adolescence because vaccination is most effective before exposure to HPV through sexual activity. For adults aged 27 through 45 years who are not adequately vaccinated,* clinicians can consider discussing HPV vaccination with persons who are most likely to benefit. HPV vaccination does not need to be discussed with most adults aged >26 years. HPV is a very common sexually transmitted infection. Most HPV infections are transient and asymptomatic and cause no clinical problems. Although new HPV infections are most commonly acquired in adolescence and young adulthood, some adults are at risk for acquiring new HPV infections. At any age, having a new sex partner is a risk factor for acquiring a new HPV infection. Persons who are in a long-term, mutually monogamous sexual partnership are not likely to acquire a new HPV infection. Most sexually active adults have been exposed to some HPV types, although not necessarily all of the HPV types targeted by vaccination. No clinical antibody test can determine whether a person is already immune or still susceptible to any given HPV type. HPV vaccine efficacy is high among persons who have not been exposed to vaccine-type HPV before vaccination. Vaccine effectiveness might be low among persons with risk factors for HPV infection or disease (e.g., adults with multiple lifetime sex partners and likely previous infection with vaccine-type HPV), as well as among persons with certain immunocompromising conditions. HPV vaccines are prophylactic (i.e., they prevent new HPV infections). They do not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease. * Dosing schedules, intervals, and definitions of persons considered adequately vaccinated have not changed. Administration. Dosing schedules, intervals, and definitions of persons considered adequately vaccinated have not changed ( 3 ).No prevaccination testing (e.g., Pap or HPV testing) is recommended to establish the appropriateness of HPV vaccination. Cervical cancer screening. Cervical cancer screening guidelines and recommendations should be followed ( 17 ). Special populations and medical conditions. These recommendations for children and adults aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of behavioral or medical risk factors for HPV infection or disease. § For persons who are pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy testing is not needed before vaccination. Persons who are breastfeeding or lactating can receive HPV vaccine. Recommendations regarding HPV vaccination during pregnancy or lactation have not changed ( 1 ). Future Research and Monitoring Priorities CDC continues to monitor safety of HPV vaccines and impact of the vaccination program on HPV-attributable outcomes, including prevalences of HPV infections, anogenital warts, cervical precancers, and cancers. ACIP reviews relevant data as they become available and updates vaccine policy as needed. Summary What is already known about this topic? Vaccination against human papillomavirus (HPV) is routinely recommended at age 11 or 12 years. Catch-up recommendations apply to persons not vaccinated at age 11 or 12 years. What is added by this report? After reviewing new evidence, CDC updated HPV vaccination recommendations for U.S. adults. What are the implications for public health practice? Routine recommendations for HPV vaccination of adolescents have not changed. Catch-up HPV vaccination is now recommended for all persons through age 26 years. For adults aged 27 through 45 years, public health benefit of HPV vaccination in this age range is minimal; shared clinical decision-making is recommended because some persons who are not adequately vaccinated might benefit.

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Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season

Lisa Grohskopf, Elif Alyanak, Karen Broder … (2019)

Summary This report updates the 2018–19 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2018;67[No. RR-3]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. A licensed, recommended, and age-appropriate vaccine should be used. Inactivated influenza vaccines (IIVs), recombinant influenza vaccine (RIV), and live attenuated influenza vaccine (LAIV) are expected to be available for the 2019–20 season. Standard-dose, unadjuvanted, inactivated influenza vaccines will be available in quadrivalent formulations (IIV4s). High-dose (HD-IIV3) and adjuvanted (aIIV3) inactivated influenza vaccines will be available in trivalent formulations. Recombinant (RIV4) and live attenuated influenza vaccine (LAIV4) will be available in quadrivalent formulations. Updates to the recommendations described in this report reflect discussions during public meetings of ACIP held on October 25, 2018; February 27, 2019; and June 27, 2019. Primary updates in this report include the following two items. First, 2019–20 U.S. trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/Brisbane/02/2018 (H1N1)pdm09–like virus, an A/Kansas/14/2017 (H3N2)–like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain HA derived from these three viruses, and a B/Phuket/3073/2013–like virus (Yamagata lineage). Second, recent labeling changes for two IIV4s, Afluria Quadrivalent and Fluzone Quadrivalent, are discussed. The age indication for Afluria Quadrivalent has been expanded from ≥5 years to ≥6 months. The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for all persons aged ≥36 months (≥3 years). The dose volume for Fluzone Quadrivalent for children aged 6 through 35 months, which was previously 0.25 mL, is now either 0.25 mL or 0.5 mL. The dose volume for Fluzone Quadrivalent is 0.5 mL for all persons aged ≥36 months (≥3 years). This report focuses on the recommendations for use of vaccines for the prevention and control of influenza during the 2019–20 season in the United States. A brief summary of these recommendations and a Background Document containing additional information are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to U.S.-licensed influenza vaccines used within Food and Drug Administration–licensed indications. Updates and other information are available from CDC’s influenza website (https://www.cdc.gov/flu). Vaccination and health care providers should check this site periodically for additional information.

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Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices

Almea Matanock, Grace Lee, Ryan Gierke … (2019)

Introduction Two pneumococcal vaccines are currently licensed for use in adults in the United States: a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Pfizer, Inc.]) and a 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax 23, Merck and Co., Inc.]). In 2014, the Advisory Committee on Immunization Practices (ACIP)* recommended routine use of PCV13 in series with PPSV23 for all adults aged ≥65 years based on demonstrated PCV13 safety and efficacy against PCV13-type pneumonia among adults aged ≥65 years ( 1 ). At that time, ACIP recognized that there would be a need to reevaluate this recommendation because it was anticipated that PCV13 use in children would continue to reduce disease burden among adults through reduced carriage and transmission of vaccine serotypes from vaccinated children (i.e., PCV13 indirect effects). On June 26, 2019, after having reviewed the evidence accrued during the preceding 3 years (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html), ACIP voted to remove the recommendation for routine PCV13 use among adults aged ≥65 years and to recommend administration of PCV13 based on shared clinical decision-making for adults aged ≥65 years who do not have an immunocompromising condition, † cerebrospinal fluid (CSF) leak, or cochlear implant, and who have not previously received PCV13. ACIP recognized that some adults aged ≥65 years are potentially at increased risk for exposure to PCV13 serotypes, such as persons residing in nursing homes or other long-term care facilities and persons residing in settings with low pediatric PCV13 uptake or traveling to settings with no pediatric PCV13 program, and might attain higher than average benefit from PCV13 vaccination. When patients and vaccine providers § engage in shared clinical decision-making for PCV13 use to determine whether PCV13 is right for a particular person, considerations might include both the person’s risk for exposure to PCV13 serotypes and their risk for developing pneumococcal disease as a result of underlying medical conditions. All adults aged ≥65 years should continue to receive 1 dose of PPSV23. If the decision is made to administer PCV13, it should be given at least 1 year before PPSV23. ACIP continues to recommend PCV13 in series with PPSV23 for adults aged ≥19 years with an immunocompromising condition, CSF leak, or cochlear implant ( 2 ). Background Streptococcus pneumoniae (pneumococcus) can cause serious illness, including sepsis, meningitis, and pneumonia with bacteremia (invasive) or without bacteremia (noninvasive). Since the early 1980s, PPSV23 has been recommended for persons aged ≥2 years with certain underlying medical conditions, and all adults aged ≥65 years ( 3 ). 7-valent pneumococcal conjugate vaccine (PCV7) was introduced into the routine pediatric immunization schedule in 2000 and was replaced by PCV13 in 2010 ( 4 ). In 2012, PCV13 was recommended in series with PPSV23 for adults aged ≥19 years with immunocompromising conditions, CSF leaks, or cochlear implants ( 2 ). In 2014, PCV13 was recommended for all adults aged ≥65 years ( 1 , 5 ). Widespread use of PCV7 and PCV13 in children has led to sharp declines in pneumococcal disease among unvaccinated children and adults by preventing carriage, and thereby transmission, of vaccine-type strains (Figure). In 2014, ACIP recognized that, while in the short-term, routine PCV13 use among adults aged ≥65 years was warranted, in the long-term, continued indirect effects from PCV13 use in children might limit the utility of this recommendation. In addition, models predicted limited public health benefits in the long-term, given the relatively low remaining PCV13-type disease burden ( 1 ). Therefore, ACIP proposed that the recommendation for routine PCV13 use among adults aged ≥65 years be evaluated 4 years after implementation of the 2014 recommendation. FIGURE Invasive pneumococcal disease (IPD) incidence among adults aged ≥65 years, by pneumococcal serotype* — United States, 1998–2017 Source: Active Bacterial Core Surveillance, unpublished data, 2019. Abbreviations: PCV = pneumococcal conjugate vaccine; PCV7 = 7-valent PCV (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F); PCV13 = 13 valent PCV (PCV7 serotypes plus 1, 3, 5, 6A, 19A and 7F). * Serotype 6C showed cross-protection from 6A antigen in PCV13 and was grouped with PCV13 serotypes for IPD. The figure is a line chart showing invasive pneumococcal disease incidence among adults aged ≥65 years, by pneumococcal serotype, in the United States, during 1998–2017. Methods During 2016–2019, using the Evidence to Recommendations Framework, (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13-etr.html) the ACIP Pneumococcal Vaccines Work Group reviewed relevant scientific evidence regarding the benefits and harms of PCV13 use among adults aged ≥65 years without an immunocompromising condition, CSF leak, or cochlear implant, in the context of >5 years of pediatric PCV13 use. The Work Group evaluated the quality of evidence for PCV13 efficacy, effectiveness, safety, and population-level impact on pneumococcal-related disease using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html). A systematic review of scientific literature published from January 1, 2014, to July 3, 2018, was conducted to identify studies evaluating direct and indirect effects of vaccination with PCV13 on invasive pneumococcal disease (IPD), pneumonia (PCV13-type, ¶ all pneumococcal, and all-cause), and mortality (pneumococcal or all-cause). In addition, PCV13 safety was evaluated by looking for severe adverse events, including death, occurring after receipt of PCV13 in adults aged ≥65 years. Title and abstract screening yielded 364 studies for in-depth review. Of these, 344 did not use PCV13 or did not include an outcome or population of interest. Observational studies with <20% adult PCV13 coverage and studies conducted in settings with low pediatric PCV13 coverage were excluded, as were studies evaluating PCV13 safety if PCV13 was administered with another vaccine, because severe adverse events could not be attributed to PCV13. The remaining 20 studies were included in the GRADE tables. The policy question considered was whether PCV13 should be administered routinely to all immunocompetent** adults aged ≥65 years in the context of indirect effects from pediatric PCV use experienced to date. Summary of Evidence PCV13 effectiveness and safety (individual-level benefits and harms). Before the 2014 recommendation, a randomized placebo-controlled Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) conducted in the Netherlands demonstrated 75% (95% confidence interval [CI] = 41%–91%) efficacy against PCV13-type IPD and 45% (CI = 14%–65%) efficacy against noninvasive PCV13-type pneumonia among adults aged ≥65 years ( 6 ). Postlicensure studies included in the GRADE tables in 2019 (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html) demonstrated PCV13 effectiveness against PCV13-type IPD (47%–59%) ( 7 , 8 ), noninvasive PCV13-type pneumonia (38%–70%) ( 9 , 10 ), and all-cause pneumonia (6%–11%) ( 11 , 12 ). PCV13 efficacy was not demonstrated against PCV13-type or all-cause mortality ( 6 ); no studies evaluating PCV13 effectiveness against mortality were identified. Three randomized controlled trials ( 6 , 13 , 14 ) and six observational studies ( 15 – 20 ) that assessed harms were evaluated (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html). The rates of severe adverse events were similar among participants vaccinated with PCV13 versus placebo or PPSV23 (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html). Common reported PCV13-associated adverse reactions included pain, redness, and swelling at the injection site, limitation of movement of the arm in which the injection was given, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain ( 21 ). Overall, PCV13 was assessed to be safe and effective in preventing PCV13-type IPD and noninvasive pneumonia. PCV13 population-level impact (indirect and direct effects) on disease among adults aged ≥65 years. The U.S. pediatric PCV program has been successful in preventing disease among young children through direct protection of vaccinated children as well as in unvaccinated populations through indirect effects (Figure). The incidence of PCV13-type IPD among adults aged ≥65 years declined ninefold during 2000–2014, before the adult PCV13 program was implemented ( 22 ). During the same period, indirect effects of similar magnitude were observed among adults aged ≥65 years at increased risk for IPD because of either older age (≥85 years) ( 22 , 23 ) or presence of underlying chronic medical conditions ( 24 ). Indirect effects on PCV13-type and all-cause pneumonia among adults have also been demonstrated since 2000 ( 25 – 27 ). In 2014, additional reductions in disease incidence among adults aged ≥65 years were expected to occur as a result of ongoing indirect effects of the pediatric PCV13 program, as well as through direct effects of PCV13 use among adults. PCV13 uptake among adults aged ≥65 years increased rapidly, with coverage in 2018 estimated at 47%; coverage with any pneumococcal vaccine was 62%, with PPSV23 was 45%, and with both PCV13 and PPSV23 was 30% ( 23 ). However, from 2014–2017, no further reduction in PCV13-type IPD incidence was observed among adults aged ≥65 years, with the incidence stable at five of 100,000 population (20% of all IPD) ( 22 ). Similarly, since 2014, no impact on PCV13-type IPD incidence has been observed among adults aged 19–64 years, a population only experiencing indirect PCV13 effects during this period. During 2014–2016, no reduction in the incidence of noninvasive pneumococcal pneumonia (all serotypes combined) was observed among adults ( 28 ). One recent unpublished cohort study found a 31.5% reduction in PCV13-type pneumonia and a 13.8% reduction in all-cause pneumonia between 2014–2015 and 2015–2016 ( 29 ). In this study, PCV13-types contributed to 4% of all-cause pneumonia among adults aged ≥65 years during 2015–2016 ( 29 ) compared with the estimated 10% in 2014 ( 1 ). Overall, since the 2014 recommendation for PCV13 use among adults, minimal changes in the incidence of pneumococcal disease among adults at the population-level were observed, through both direct PCV13 effects from vaccinating older adults and continued indirect effects from PCV13 use in children. Economic analyses. Two independent economic models evaluated the expected public health impact and cost effectiveness of continued PCV13 use in series with PPSV23 versus use of PPSV23 alone. These models estimated that, over the lifetime of a single cohort of 2.7 million adults aged 65 years, an expected 76–175 cases of PCV13-type IPD and 4,000–11,000 cases of PCV13-type pneumonia would be averted through continued PCV13 use in series with PPSV23, compared with PPSV23 alone ( 30 ). Applying the total costs to quality adjusted life years (QALY), the estimated cost effectiveness ratios were $200,000 to $560,000 per QALY. In 2014, the estimated cost per QALY for PCV13 use in series with PPSV23 was $65,000 ( 31 ). Considering the range of values for sensitivity analyses for key inputs in these models, the results of the economic analyses were less favorable toward continued PCV13 use for all adults aged ≥65 years compared with PPSV23 alone. Rationale Incidence of PCV13-type disease has been reduced to historically low levels among adults aged ≥65 years through indirect effects from pediatric PCV13 use. Implementation of a PCV13 recommendation for all adults aged ≥65 years in 2014 has had minimal impact on PCV13-type disease at the population level in this age group. However, PCV13 is a safe and effective vaccine that can reduce the risk for PCV13-type IPD and noninvasive pneumonia among persons aged ≥65 years. Balancing this evidence and considering acceptability and feasibility concerns, in June 2019 ACIP voted to no longer routinely recommend PCV13 for all adults aged ≥65 years and instead, to recommend PCV13 based on shared clinical decision-making for adults aged ≥65 years who do not have an immunocompromising condition, CSF leak, or cochlear implant (Table 1) (Table 2). TABLE 1 Recommendations for 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults aged ≥19 years Medical indication group Specific underlying medical condition PCV13 for persons aged ≥19 years PPSV23* for persons aged 19–64 years PCV13 for persons aged ≥65 years PPSV23 for persons aged ≥65 years None None of the below No recommendation No recommendation Based on shared clinical decision-making† 1 dose; if PCV13 has been given, then give PPSV23 ≥1 year after PCV13 Immunocompetent persons Alcoholism No recommendation 1 dose Based on shared clinical decision-making† 1 dose; if PCV13 has been given, then give PPSV23 ≥1 year after PCV13 and ≥5 years after any PPSV23 at age <65 years Chronic heart disease§ Chronic liver disease Chronic lung disease¶ Cigarette smoking Diabetes mellitus Cochlear implant 1 dose 1 dose ≥8 weeks after PCV13 1 dose if no previous PCV13 vaccination 1 dose ≥8 weeks after PCV13 and ≥5 years after any PPSV23 at <65 years CSF leak Immunocompromised persons Congenital or acquired asplenia 1 dose 2 doses, 1st dose ≥8 weeks after PCV13 and 2nd dose ≥5 years after first PPSV23 dose 1 dose if no previous PCV13 vaccination 1 dose ≥8 weeks after PCV13 and ≥5 years after any PPSV23 at <65 years Sickle cell disease/other hemoglobinopathies Chronic renal failure Congenital or acquired immunodeficiencies** Generalized malignancy HIV infection Hodgkin disease Iatrogenic immunosuppression†† Leukemia Lymphoma Multiple myeloma Nephrotic syndrome Solid organ transplant Abbreviations: CSF = cerebrospinal fluid; HIV = human immunodeficiency virus. * Only refers to adults aged 19–64 years. All adults aged ≥65 years should receive 1 dose of PPSV23 ≥5 years after any previous PPSV23 dose, regardless of previous history of vaccination with pneumococcal vaccine. No additional doses of PPSV23 should be administered following the dose administered at age ≥65 years. † Recommendations that changed in 2019. § Includes congestive heart failure and cardiomyopathies. ¶ Includes chronic obstructive pulmonary disease, emphysema, and asthma. ** Includes B- (humoral) or T-lymphocyte deficiency, complement deficiencies (particularly C1, C2, C3, and C4 deficiencies), and phagocytic disorders (excluding chronic granulomatous disease). †† Diseases requiring treatment with immunosuppressive drugs, including long-term systemic corticosteroids and radiation therapy. TABLE 2 Policy options* for use of pneumococcal vaccines in adults aged ≥65 years presented for a vote and considerations by the Advisory Committee on Immunization Practices (ACIP), June 2019 Proposed policy Considerations raised at the June 2019 ACIP meeting Outcome (votes in favor: against) In favor Against ACIP recommends PCV13 for all adults aged ≥65 years who have not previously received PCV13. PCV13 should be given first, followed by a dose of PPSV23 PCV13 is effective against invasive pneumococcal disease and pneumonia Low burden of PCV13-type disease remaining Rejected (6:8) Changing the recommendation could negatively impact the perceived importance of adult pneumococcal vaccine recommendations Population-level impact from PCV13 use among older adults observed to date has been minimal Universal recommendations are easier for clinicians to understand and implement than the recommendation based on shared clinical decision-making Universal PCV13 recommendation for older adults are not a judicious use of resources ACIP no longer recommends PCV13 for adults aged ≥65 years who do not have an immunocompromising condition,† CSF leak, or cochlear implant. All adults aged ≥65 years should receive a dose of PPSV23 Largest public health benefit for older adults is gained through indirect effects from pediatric PCV13 use PCV13 is effective against PCV13-type invasive pneumococcal disease and pneumonia Rejected (1:13) ACIP recommends PCV13 based on shared clinical decision-making for adults aged ≥65 years who do not have an immunocompromising condition,† CSF leak, or cochlear implant and who have not previously received PCV13.All adults aged ≥65 years should receive a dose of PPSV23 Balances the minimal population-level impact of a routine recommendation with the potential for individual-level protection —§ Affirmed (13:1) PCV13 would remain available to patients who want this added protection Abbreviations: CSF = cerebrospinal fluid; PCV13 = 13-valent pneumococcal conjugate vaccine; PPSV23 = 23-valent pneumococcal polysaccharide vaccine. * Policy options listed in the order they were presented to ACIP for a vote. † Includes adults with chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies. § No content for this cell. New Pneumococcal Vaccine Recommendations for Adults Aged ≥65 Years Old PCV13. PCV13 vaccination is no longer routinely recommended for all adults aged ≥65 years. Instead, shared clinical decision-making for PCV13 use is recommended for persons aged ≥65 years who do not have an immunocompromising condition, CSF leak, or cochlear implant and who have not previously received PCV13 (Table 1). CDC guidance for shared clinical decision-making. When patients and vaccine providers engage in shared clinical decision-making for PCV13 use to determine whether PCV13 is right for the specific individual aged ≥65 years, considerations may include the individual patient’s risk for exposure to PCV13 serotypes and the risk for pneumococcal disease for that person as a result of underlying medical conditions (Box). BOX Considerations for shared clinical decision-making regarding use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥65 years PCV13 is a safe and effective vaccine for older adults. The risk for PCV13-type disease among adults aged ≥65 years is much lower than it was before the pediatric program was implemented, as a result of indirect PCV13 effects (by preventing carriage and, thereby, transmission of PCV13-type strains). The remaining risk is a function of each individual patient’s risk for exposure to PCV13 serotypes and the influence of underlying medical conditions on the patient’s risk for developing pneumococcal disease if exposure occurs. The following adults aged ≥65 years are potentially at increased risk for exposure to PCV13 serotypes and might attain higher than average benefit from PCV13 vaccination, and providers/practices caring for many patients in these groups may consider regularly offering PCV13 to their patients aged ≥65 years who have not previously received PCV13: Persons residing in nursing homes or other long-term care facilities Persons residing in settings with low pediatric PCV13 uptake Persons traveling to settings with no pediatric PCV13 program Incidence of PCV13-type invasive pneumococcal disease and pneumonia increases with increasing age and is higher among persons with chronic heart, lung, or liver disease, diabetes, or alcoholism, and those who smoke cigarettes or who have more than one chronic medical condition.* Although indirect effects from pediatric PCV13 use were documented for these groups of adults and were comparable to those observed among healthy adults, the residual PCV13-type disease burden remains higher in these groups. Providers/practices caring for patients with these medical conditions may consider offering PCV13 to such patients who are aged ≥65 years and who have not previously received PCV13. * Ahmed SS, Pondo T, Xing W, et al. Early impact of 13-valent pneumococcal conjugate vaccine use on invasive pneumococcal disease among adults with and without underlying medical conditions—United States. Clin Infect Dis 2019. Epub August 12, 2019. If a decision to administer PCV13 is made, it should be administered before PPSV23 ( 5 ). The recommended intervals between pneumococcal vaccines remain unchanged for adults without an immunocompromising condition, CSF leak, or cochlear implant (≥1 year between pneumococcal vaccines, regardless of the order in which they were received) ( 5 ). PCV13 and PPSV23 should not be coadministered. ACIP continues to recommend PCV13 in series with PPSV23 for adults aged ≥19 years (including those aged ≥65 years) with immunocompromising conditions, CSF leaks, or cochlear implants (Table 1) ( 2 ). PPSV23 for adults aged ≥65 years. ACIP continues to recommend that all adults aged ≥65 years receive 1 dose of PPSV23. A single dose of PPSV23 is recommended for routine use among all adults aged ≥65 years ( 1 ). PPSV23 contains 12 serotypes in common with PCV13 and an additional 11 serotypes for which there are no indirect effects from PCV13 use in children. The additional 11 serotypes account for 32%–37% of IPD among adults aged ≥65 years ( 22 ). Adults aged ≥65 years who received ≥1 dose of PPSV23 before age 65 years should receive 1 additional dose of PPSV23 at age ≥65 years (2), at least 5 years after the previous PPSV23 dose (Table 1) ( 5 ). Future Research and Monitoring Priorities CDC will continue to assess the safety, implementation and the impact of shared clinical decision-making regarding administration of PCV13 to adults aged ≥65 years; the indirect effect of pediatric PCV13 vaccination on disease burden among older adults; and the emergence of nonvaccine serotypes, to inform policy decisions for higher valency conjugate vaccines currently in development. ACIP will continue to review relevant data as they become available and update pneumococcal vaccination policy as appropriate. Before administering PCV13 or PPSV23, health care providers should consult the relevant package inserts ( 21 , 32 ) regarding precautions, warnings, and contraindications. Adverse events occurring after administration of any vaccine should be reported to the Vaccine Adverse Event Reporting System (VAERS). Reports can be submitted to VAERS online, by facsimile, or by mail. More information about VAERS is available at https://vaers.hhs.gov/. Summary What is already known about this topic? In 2014, the Advisory Committee on Immunization Practices (ACIP) recommended 13-valent pneumococcal conjugate vaccine (PCV13) in series with 23-valent polysaccharide vaccine (PPSV23) for all adults aged ≥65 years. What is added by this report? PCV13 use in children has led to sharp declines in pneumococcal disease among adults and children. Based on a review of accrued evidence ACIP changed the recommendation for PCV13 use in adults. What are the implications for public health practice? ACIP recommends a routine single dose of PPSV23 for adults aged ≥65 years. Shared clinical decision-making is recommended regarding administration of PCV13 to persons aged ≥65 years who do not have an immunocompromising condition, cerebrospinal fluid leak, or cochlear implant and who have not previously received PCV13. If a decision to administer PCV13 is made, PCV13 should be administered first, followed by PPSV23 at least 1 year later.

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Journal ID (nlm-ta): MMWR Morb Mortal Wkly Rep

Journal ID (iso-abbrev): MMWR Morb. Mortal. Wkly. Rep

Journal ID (publisher-id): WR

Title: Morbidity and Mortality Weekly Report

Publisher: Centers for Disease Control and Prevention

ISSN (Print): 0149-2195

ISSN (Electronic): 1545-861X

Publication date (Electronic): 07 February 2020

Publication date Collection: 07 February 2020

Volume: 69

Issue: 5

Pages: 133-135

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Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC; University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin; City of Milwaukee Health Department, Milwaukee, Wisconsin; University of Kansas Medical Center, Kansas City, Kansas.

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Corresponding author: Mark S. Freedman, fll0@ 123456cdc.gov , 404-639-6356.

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Publisher ID: mm6905a4

DOI: 10.15585/mmwr.mm6905a4

PMC ID: 7004400

PubMed ID: 32027627

SO-VID: 9f34aefd-8399-4ba6-a6e3-227baaf25202

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Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2020

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Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices

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