| | Increasing Influenza Vaccination Rates: The Need to Vaccinate Throughout the Entire Influenza SeasonAbstract The burden of influenza on affected individuals and the healthcare system, as well as on society, is substantial. Although the supply of an effective and safe influenza vaccine was limited in previous years, advances in manufacture and distribution have alleviated such shortages. In most seasons, millions of doses go unused, and large numbers of unvaccinated, at-risk persons are left vulnerable to infection and its complications. According to insurance claims data, high-risk patients are seen by their healthcare providers on average 2.2 times between the peaks in vaccination (November) and in disease activity (February), yet they remain unvaccinated. The current 2- to 3-month time frame over which patients are traditionally immunized is too short to fully implement immunization recommendations and inconsistent with the duration of influenza activity. Both healthcare providers and patients should reevaluate their approach to influenza vaccination and recognize the need to extend the immunization time period into January and beyond. To increase influenza immunization rates, the Centers for Disease Control and Prevention (CDC) and other professional societies recommend an expanded immunization season, with vaccination offered at every opportunity between October and May. Annual influenza vaccination of persons at risk for either complications of influenza infection or for transmitting influenza virus is the most important component of the US public health strategy for preventing influenza-associated morbidity and mortality.1 Historically, most healthcare practitioners have offered influenza vaccination to their at-risk patients each year from September to about November, and vaccination rates decrease precipitously before year's end. This approach to vaccination was conceived at a time when fewer individuals were in target groups for vaccination and when the vaccine supply was limited, necessitating prioritization of doses to the most vulnerable persons. The vaccine supply is now plentiful,2 and target groups have expanded to include approximately 3 of every 4 Americans.3 The most recent expansion calls for universal vaccination of all children through 18 years of age.4 Some have postulated that widespread pediatric vaccination may yield a herd immunity affect. Current evidence is modest, though, and herd immunity, though possible,5, 6, 7 needs further study. Adoption of a new paradigm that includes a much longer vaccination period—starting in the autumn and continuing through the entire influenza season—is critical to protecting the large number of at-risk persons. According to the Centers for Disease Control and Prevention (CDC), vaccine administered after the influenza season has begun is beneficial. As a consequence, current CDC recommendations emphasize that immunization providers should offer influenza vaccine and even schedule immunization clinics throughout the entire influenza season, from October to May. Influenza: The illness and its impact  Influenza is an acute and potentially serious viral infection that affects 1 or 2 of every 10 Americans annually.8 Classic influenza, generally an uncomplicated and self-limited illness, is characterized by respiratory as well as constitutional signs and symptoms (e.g., nonproductive cough, high fever, chills, headache, sore throat, myalgia, and malaise).9 Additional symptoms unique to children include abdominal pain, diarrhea, and vomiting. Influenza infection can lead to serious sequelae, including secondary bacterial pneumonia, sinusitis, bronchitis, and myocarditis, as well as croup, bronchiolitis, and acute otitis media in children.1, 8, 10 Influenza can also exacerbate underlying medical conditions; it can trigger acute myocardial infarction or stroke11, 12 and increase the rate of death from coronary heart disease (odds ratio, 1.3).13 Complications of the acute infection are most common in young children, the elderly, and persons of any age with underlying medical conditions that place them “at risk” (e.g., diabetes mellitus, asthma, cardiovascular disease).14 Influenza has a substantial impact on both affected individuals and society. A typical case of influenza results in 3 to 4 days of bed rest and an additional 5 to 6 days of restricted activity.15 Absenteeism from work and school was attributed to influenza in a study of >12,000 US households with ≥1 school-aged child reporting influenza-like illness.16 Influenza-associated “presenteeism” (ill but still at work or school) has been shown to decrease job performance,17, 18 and infection is associated with functional decline in older adults.19 An average of >200,000 hospitalizations and 36,000 deaths due to influenza occurred annually in the United States during the 1990s.20, 21 The current hospitalization and mortality rates attributable to influenza are even higher owing to increased numbers of at-risk persons (e.g., individuals who are elderly, have diabetes, or are immunocompromised). To provide perspective, the number of influenza deaths in the United States is on the same order of magnitude as the number of deaths from colorectal cancer and breast cancer.22 The economic impact of annual influenza epidemics is substantial. Based on 2003 data, which included >334,000 hospitalizations (3.1 million hospitalization days), 41,000 deaths, and 31.4 million outpatient visits, Molinari and colleagues23 estimated direct medical costs (in 2003 US dollars) of $10.4 billion (95% confidence interval [CI], $4.1-$22.2 billion) and projected lost earnings of $16.3 billion (95% CI, $8.7-$31.0 billion). Adding indirect costs related to death (lost productivity and intrinsic value of human life), the total economic burden was $87.1 billion (95% CI, $47.2-$149.5 billion). This exceeds the combined direct and indirect annual costs of arthritis in the United States ($82 billion).24 Vaccine safety and efficacy Multiple studies, in multiple settings, have consistently demonstrated the safety and efficacy of both trivalent inactivated influenza vaccine (TIV) and live attenuated vaccine (LAIV) in mitigating clinical illness and decreasing the risk of associated complications. Influenza vaccines, like all vaccines, are not 100% effective. Efficacy varies based on the antigenic match between circulating and vaccine strains and the age and immune status of vaccine recipients. Further, clinical study findings vary based on the outcome measured (e.g., culture-confirmed influenza infection, prevention of medically attended acute respiratory illness). Estimates of TIV efficacy against laboratory-confirmed influenza in healthy adults <65 years range from 70% to 90% when the antigenic match is good25, 26, 27, 28 to 50%-77% when the antigenic match is suboptimal.25, 27, 28, 29, 30, 31 In this same population, LAIV provides significant reductions in days of illness, days of work lost, days with healthcare provider visits, and use of prescription antibiotics and over-the-counter medications. Efficacy against laboratory-confirmed infection is lower in older persons (for whom only TIV is currently approved), but the true benefit of vaccination for this group is the reduction in risk of serious complications and death. Influenza vaccination (TIV) is 30% to 70% effective in preventing hospitalization for pneumonia and influenza in community-dwelling elderly persons32, 33 and up to 80% effective in preventing death among elderly nursing home residents.34, 35, 36, 37 Studies have also confirmed vaccine efficacy in children (TIV is approved for use in all children aged ≥6 months; LAIV is approved for use in children aged ≥24 months without asthma). In a 5-year study, TIV reduced laboratory-confirmed influenza A infection by 77% to 91% in children aged 1 to 15 years.38 During a season marked by a suboptimal antigenic match, TIV was 51% effective in children 6 months to 8 years of age against medically-attended, clinically-diagnosed pneumonia or influenza.39 Across 2 influenza seasons, 1 marked by a drifted influenza strain, LAIV was 92% effective against laboratory-confirmed influenza in children 60 to 71 months of age.40, 41 Both types of influenza vaccine are contraindicated in individuals with a history of hypersensitive reaction to eggs or egg proteins. The most frequent side effect associated with TIV is soreness at the vaccination site.42 For LAIV, the most frequent side effect is runny nose. Guillain-Barré syndrome (GBS) was associated with the 1976 swine influenza vaccine, but evidence of a connection between GBS and subsequent vaccines has been inconsistent.1 The CDC advises that it is “prudent” to avoid vaccinating persons with a history of GBS who are not at high risk for severe influenza complications. However, the potential risk of infection may outweigh concerns about GBS for those at high risk. Vaccination recommendations Based on the available evidence, the CDC has recommended that certain groups of persons should receive annual influenza vaccination (Table 1).1, 4 In sharp contrast to prior years in which only high-risk persons were targeted for vaccination, the most current CDC recommendations suggest influenza vaccination of any person wanting to reduce his or her risk of influenza or the potential of transmitting the illness. The current target groups for influenza vaccination include approximately 218 million Americans, or 73% of the US population.3 In 2006, the CDC's Advisory Committee on Immunization Practices signaled its intent to move toward a universal influenza immunization recommendation43 and in early 2008 voted to recommend extending pediatric recommendations to all children from 6 months through 18 years.4  | Annual influenza vaccination is recommended for: | | |  • Any person, including a school-aged child, who wishes to reduce the likelihood of becoming ill or of transmitting the infection to others | | | • Any person at risk for influenza complications: | | | — Children aged 6–59 mo⁎† | | | — All persons aged ≥50 yr | | | — Children and adolescents on long-term aspirin therapy | | | — Pregnant women | | | — All persons (adults and children) with a chronic disease (e.g., asthma, diabetes mellitus, cardiovascular disease) excluding hypertension | | | — All persons (adults and children) who are immunosuppressed | | | — All persons (adults and children) with a condition that can compromise respiratory function, handling of secretions, or increase the risk for aspiration (e.g., cognitive dysfunction, spinal cord injury, seizure disorder, other neuromuscular disorder) | | | — Residents of nursing homes and other chronic-care facilities | | | • Any person at risk of transmitting influenza: | | | — Healthcare personnel | | | — Healthy household contacts (including children) and caregivers of: | | | ∘ Children aged ≤59 mo† | | | ∘ Adults aged ≥50 yr | | | ∘ Persons (adults and children) with a medical condition that increases their risk for severe complications of influenza | | | | |
| ⁎ On February 27, 2008, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices voted to expand its recommendations for annual influenza vaccination to include all children 6 months through 18 years. †Children aged <6 months cannot be vaccinated and should be protected through vaccination of close contacts. |
Despite these recommendations from the CDC and other professional organizations (eg, the American Academy of Family Physicians [AAFP], American Academy of Pediatrics [AAP], American College of Obstetricians and Gynecologists, American College of Physicians, American Medical Association [AMA]), influenza vaccination rates remain low (Figure 1).1 Approximately 60% of adults ≥65 years and only 10% to 40% of other target groups were vaccinated in 2005.1 The current level of vaccination falls far short of the Healthy People 2010 national health objectives of 90% for persons ≥65 years and 60% for younger persons who have risk factors.44 Worse, the majority of US healthcare workers themselves fail to get the influenza vaccine each year.45 Most persons recommended for influenza vaccination should receive a single dose each year. The exception is children 6 months to 9 years of age who are receiving influenza vaccine for the first time. They should receive 2 doses administered ≥1 month apart.14 No influenza vaccine is currently licensed for children aged <6 months; these vulnerable infants should be protected indirectly through vaccination of close contacts. In 2006, approximately 150 million Americans in target groups lacked the protection conferred by influenza vaccination. This was at a time when the supply was abundant, and millions of vaccine doses were ultimately discarded.2 Vaccine doses left over after one influenza season cannot be used during the following season due to changes in circulating strains (i.e., antigenic drift) and vaccine expiration.14 Strategies to increase influenza vaccination As the number of people for whom influenza immunization is recommended has increased, so has the challenge of reaching them all. The US Public Health Service (USPHS) Healthy People 2010 influenza immunization goals will not be achieved without a change in the influenza immunization paradigm. This requires efforts on 3 fronts: (1) consumer demand for influenza immunization needs to be high and sustainable from season to season; (2) there must be an adequate vaccine supply; and (3) the healthcare system should use all opportunities to vaccinate (e.g., at routine healthcare visits, during hospitalizations) throughout the influenza season. Although the influenza season often peaks in February (Figure 2),1 it can last for many months afterward in the United States. Therefore, vaccination into January and beyond is beneficial. Consumer Demand Surveys show that many Americans have misperceptions about their risk of influenza, whether they should get vaccinated, vaccine efficacy, and the safety of influenza vaccines. For instance, in a randomized, nationally representative sample of unvaccinated Medicare beneficiaries, the most common explanations were that they were “unaware of vaccination's need” and “concerned that the vaccine causes influenza” and “could cause side effects.”46 Approximately half of adult respondents to a survey conducted before the 2006 to 2007 influenza season indicated they did not plan to be immunized. Their reasons included thinking that influenza is not serious enough to warrant immunization (43%), that they are not at risk for influenza/complications (37%), that the vaccine is not effective (19%), and that vaccination in a prior year makes revaccination unnecessary (15%).47 Healthcare providers can influence their patients' decisions regarding vaccination. A first step is to set a good example for their patients by vaccinating themselves and their staff.48, 49 Getting an annual influenza vaccination should be viewed as a professional responsibility. Vaccination reduces the risk that healthcare workers will get influenza and be unable to work at a time when the healthcare system's needs are greatest. Even more importantly, it reduces the risk that healthcare workers will transmit a potentially deadly virus to the patients in their care. Once vaccinated, healthcare workers are in a better position to strongly recommend influenza vaccination to all at-risk patients.50, 51 In this supplement to The American Journal of Medicine, Johnson and colleagues52 report that many unvaccinated persons (54%) have never discussed influenza vaccination with their healthcare provider. Yet most adults (79%) are likely to follow their physician's recommendation that they be vaccinated. As reviewed in detail by Stinchfield,53 influenza vaccination rates also may be positively affected by other interventions that increase vaccine access, increase demand, and overcome practice-related barriers. Communication between healthcare providers and at-risk patients may be especially important for influenza vaccination later in the season. Fishbein and associates54 found that specific inquiries or discussion of vaccination status with patients led to vaccination rates in December and afterward that were comparable to rates earlier in the season, when patients tended to be self-motivated to seek vaccination. Physician-to-patient education about the importance of getting vaccinated throughout the season (October through May) is increasingly being supported by consumer awareness campaigns sponsored by the CDC and a variety of medical groups (e.g., American Lung Association [ALA], AMA, Childhood Influenza Immunization Coalition, National Foundation for Infectious Diseases, National Influenza Vaccine Summit). All of these groups' Web sites provide information about influenza vaccination to consumers and healthcare providers.55, 56, 57 Vaccine Supply Ample influenza vaccine should be available now and for the foreseeable future in the United States. Although there have been fluctuations in supply (and 1 large disruption during the 2004 to 2005 season), shortages came at a time when there were fewer vaccine manufacturers. As a consequence, production problems involving a single manufacturer had a larger relative impact on overall supply than they would now that several additional companies are manufacturing and distributing influenza vaccine. A record 121 million influenza vaccine doses were available for the US market in 2006; 130 million doses were expected to be produced in 2007 and 150 million in 2008.2 While total vaccine supply continues to grow and manufacturers strive to deliver vaccine as early as possible, the realities of the production process prevent all doses from being delivered at once or before the start of the season. Healthcare providers should begin vaccinating as soon as vaccine is available and continue until no more vaccine is distributed for the season. Inherent complexities in the manufacture of a biological product like influenza vaccine mean that many doses (∼30%) are delivered in November and later.58 Because protection is achieved very quickly (within 2 weeks) after immunization,59, 60 it is medically relevant to continue vaccination into January and beyond. In fact, vaccination throughout the entire influenza season, not just in the early months as has been the practice in recent years, is the only way to fully utilize all available vaccine and to meet the recommendations of the CDC, AAFP, AAP, AMA, and other groups, as well as to meet the Healthy People 2010 goals. Extending the Vaccination Season One way to meet the challenge of protecting more Americans from influenza is to recognize the need for and the value of vaccination throughout the influenza season.61 According to data gathered by the CDC, the peak in influenza activity between 1976 and 2006 occurred well after the start of the year (Figure 2).1 Half of all cases (up to 30 million a year) occur after the peak, which usually occurs in February or later. These findings are corroborated in the following study of influenza vaccination and diagnosis visits from 2004 to 2007. Data for the study were obtained from the electronic healthcare claims submitted by >240,000 physicians in practice across the United States to all types of third-party payers (i.e., Medicare, Medicaid, commercial). A longitudinally stable identifier was assigned to each patient to protect his or her anonymity and was used to track patients over time. The source data are geographically representative and well characterized, providing a high degree of precision and accuracy in projections to the entire US population. Data were monitored at the practitioner level to ensure completeness and consistency in reporting. Multiple outside sources were used to validate estimates from the model. The number of times CDC-defined high-risk patients1 were seen in a physician's office between September 1 and March 31 was determined for 2004 to 2005 and 2005 to 2006, as was the number of patients immunized and the number of influenza diagnosis visits over the same months during the 3 years from 2004 to 2005 through 2006 to 2007. Taken together, these data provide insight into missed immunization opportunities for high-risk patients. Data show an early surge in uptake of influenza vaccination with rates peaking around Thanksgiving, and then immunization rates decrease dramatically for the rest of the season (Figure 3). The early peak in immunization is likely driven by patients who seek out immunization and by media attention during the fall. Healthcare visits resulting in influenza diagnoses peak much later in the season. The gap between the 2 peaks—for vaccination and diagnosis—is a full 16 weeks. Although many believe the drop off in immunization results from poor access to at-risk patients, such is not the case. Approximately 25 million unimmunized, high-risk patients visit their healthcare providers a total of 55 million times, or on average 2.2 times each, during the period between peaks in immunization and disease activity. If these opportunities to vaccinate were used throughout the influenza season, significant improvements in vaccination rates certainly could be made. More recent data for the 2007 to 2008 influenza season show no deviation from the pattern of the previous several years. With record amounts of influenza vaccine distributed in the United States, an even greater surge in vaccination claims took place during October and most of November, followed by a very similar and precipitous decrease in those claims beginning in late November and running through December. Summary Although influenza vaccine is effective, safe, and simple to administer, vaccination rates remain substantially lower than target levels. Access to influenza vaccination is no longer constrained by problems in supply and distribution, as more manufacturers are providing more influenza vaccine to the US market than ever before. Vaccination throughout the entire influenza season, not just in the early months, is the only way to fully utilize the available vaccine and to meet the target vaccination levels established by the USPHS. High-risk patients make office visits on a regular basis throughout the influenza season but fail to receive the vaccine. Thus, healthcare providers are missing important opportunities to vaccinate millions of people, from October to May every year. To increase vaccination rates in at-risk patients, healthcare professionals should emphasize the need for vaccination throughout the influenza season. Author disclosures The authors who contributed to this article have disclosed the following industry relationships: Gregory A. Poland, MD, provided consulting advice and/or performed clinical research trials for Avianax, CSL Limited, GlaxoSmithKline, Merck & Co., Novavax, PowderMed, Protein Science, and Novartis Vaccines. David R. Johnson, MD, MPH, is a full-time employee of Sanofi Pasteur Inc. References 1. 1Centers for Disease Control and Prevention (CDC). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007;56(RR06):1–54. 2. 2Fiore A. Influenza activity in the United States, February 2007. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb07/05-influenza-1-allos_fiore.pdf. 3. 3Centers for Disease Control and Prevention (CDC). 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Statement of author disclosure: Please see the Author Disclosures section at the end of this article. PII: S0002-9343(08)00465-8 doi:10.1016/j.amjmed.2008.05.002 © 2008 Elsevier Inc. All rights reserved. | |
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