Prevention and Control of Seasonal Influenza with Vaccines

Prevention and Control of Seasonal Influenza with Vaccines
Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009

Prepared by
Anthony E. Fiore, MD1
David K. Shay, MD1
Karen Broder, MD2
John K. Iskander, MD2
Timothy M. Uyeki, MD1
Gina Mootrey, DO3
Joseph S. Bresee, MD1
Nancy J. Cox, PhD1

1Influenza Division, National Center for Immunization and Respiratory Diseases

2Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Preparedness, Detection and Control of Infectious Diseases

3Immunization Services Division, National Center for Immunization and Respiratory Diseases

The material in this report originated in the National Center for Immunization and Respiratory Diseases, Anne Schuchat, MD, Director; the Influenza Division, Nancy Cox, PhD, Director; the Office of the Chief Science Officer, Tanja Popovic, MD, Chief Science Officer; the Immunization Safety Office, Frank Destefano, MD, Director; and the Immunization Services Division, Lance Rodewald, MD, Director.

Corresponding preparer: Anthony Fiore, MD, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC, 1600 Clifton Road, NE, MS A-20, Atlanta, GA 30333. Telephone: 404-639-3747; Fax: 404-639-3866; E-mail: afiore@cdc.gov.
Summary

This report updates the 2008 recommendations by CDC's Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccine for the prevention and control of seasonal influenza (CDC. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2008;57[No. RR-7]). Information on vaccination issues related to the recently identified novel influenza A H1N1 virus will be published later in 2009. The 2009 seasonal influenza recommendations include new and updated information. Highlights of the 2009 recommendations include 1) a recommendation that annual vaccination be administered to all children aged 6 months--18 years for the 2009--10 influenza season; 2) a recommendation that vaccines containing the 2009--10 trivalent vaccine virus strains A/Brisbane/59/2007 (H1N1)-like, A/Brisbane/10/2007 (H3N2)-like, and B/Brisbane/60/2008-like antigens be used; and 3) a notice that recommendations for influenza diagnosis and antiviral use will be published before the start of the 2009--10 influenza season. Vaccination efforts should begin as soon as vaccine is available and continue through the influenza season. Approximately 83% of the United States population is specifically recommended for annual vaccination against seasonal influenza; however, <40% of the U.S. population received the 2008--09 influenza vaccine. These recommendations also include a summary of safety data for U.S. licensed influenza vaccines. These recommendations and other information are available at CDC's influenza website (http://www.cdc.gov/flu); any updates or supplements that might be required during the 2009--10 influenza season also can be found at this website. Vaccination and health-care providers should be alert to announcements of recommendation updates and should check the CDC influenza website periodically for additional information.

Introduction
In the United States, annual epidemics of seasonal influenza occur typically during the late fall through early spring. Influenza viruses can cause disease among persons in any age group, but rates of infection are highest among children (1--3). Rates of serious illness and death are highest among persons aged ≥65 years, children aged <2 years, and persons of any age who have medical conditions that place them at increased risk for complications from influenza (1,4,5). An annual average of approximately 36,000 deaths during 1990--1999 and 226,000 hospitalizations during 1979--2001 have been associated with influenza epidemics (6,7).

Annual influenza vaccination is the most effective method for preventing influenza virus infection and its complications. Influenza vaccine can be administered to any person aged >6 months who does not have contraindications to vaccination to reduce the likelihood of becoming ill with influenza or of transmitting influenza to others. Trivalent inactivated influenza vaccine (TIV) can be used for any person aged ≥6 months, including those with high-risk conditions (Boxes 1 and 2). Live, attenuated influenza vaccine (LAIV) may be used for healthy, nonpregnant persons aged 2--49 years. No preference is indicated for LAIV or TIV when considering vaccination of healthy, nonpregnant persons aged 2--49 years. Because the safety or effectiveness of LAIV has not been established in persons with underlying medical conditions that confer a higher risk for influenza complications, these persons should be vaccinated only with TIV. Influenza viruses undergo frequent antigenic change (i.e., antigenic drift); to gain immunity against viruses in circulation, patients must receive an annual vaccination against the influenza viruses that are predicted on the basis of viral surveillance data. . Although vaccination coverage has increased in recent years for many groups targeted for routine vaccination, coverage remains low among most of these groups, and strategies to improve vaccination coverage, including use of reminder/recall systems and standing orders programs, should be implemented or expanded.

Antiviral medications are an adjunct to vaccination and are effective when administered as treatment and when used for chemoprophylaxis after an exposure to influenza virus. However, the emergence since 2005 of resistance to one or more of the four licensed antiviral agents (oseltamivir, zanamivir, amantadine and rimantadine) among circulating strains has complicated antiviral treatment and chemoprophylaxis recommendations. Updated antiviral treatment and chemoprophylaxis recommendations will be provided in a separate set of guidelines later in 2009. CDC has issued interim recommendations for antiviral treatment and chemoprophylaxis of influenza (8), and these guidelines should be consulted pending issuance of new recommendations.

In April 2009, a novel influenza A (H1N1) virus that is similar to influenza viruses previously identified in swine was determined to be the cause of an influenza respiratory illness that spread across North America and was identified in many areas of the world by May 2009. The symptoms of novel influenza A (H1N1) virus infection are similar to those of seasonal influenza, and specific diagnostic testing is required to distinguish novel influenza A (H1N1) virus infection from seasonal influenza (9). The epidemiology of this illness is still being studied and prevention issues related to this newly emerging influenza virus will be published separately.

Methods
CDC's Advisory Committee on Immunization Practices (ACIP) provides annual recommendations for the prevention and control of influenza. The ACIP Influenza Vaccine Working Group* meets monthly throughout the year to discuss newly published studies, review current guidelines, and consider revisions to the recommendations. As they review the annual recommendations for ACIP consideration of the full committee, members of the working group consider a variety of issues, including burden of influenza illness, vaccine effectiveness, safety, and coverage in groups recommended for vaccination, feasibility, cost-effectiveness, and anticipated vaccine supply. Working group members also request periodic updates on vaccine and antiviral production, supply, safety and efficacy from vaccinologists, epidemiologists, and manufacturers. State and local vaccination program representatives are consulted. CDC's Influenza Division (available at http://www.cdc.gov/flu) provides influenza surveillance and antiviral resistance data. The Vaccines and Related Biological Products Advisory Committee provides advice on vaccine strain selection to the Food and Drug Administration (FDA), which selects the viral strains to be used in the annual trivalent influenza vaccines.

Published, peer-reviewed studies are the primary source of data used by ACIP in making recommendations for the prevention and control of influenza, but unpublished data that are relevant to issues under discussion also might be considered. Among studies discussed or cited, those of greatest scientific quality and those that measured influenza-specific outcomes are the most influential. For example, population-based estimates that use outcomes associated with laboratory-confirmed influenza virus infection outcomes contribute the most specific data for estimates of influenza burden. The best evidence for vaccine or antiviral efficacy and effectiveness comes from randomized controlled trials that assess laboratory-confirmed influenza infections as an outcome measure and consider factors such as timing and intensity of influenza circulation and degree of match between vaccine strains and wild circulating strains (10,11). Randomized, placebo-controlled trials cannot be performed ethically in populations for which vaccination already is recommended, but observational studies that assess outcomes associated with laboratory-confirmed influenza infection can provide important vaccine or antiviral effectiveness data. Randomized, placebo-controlled clinical trials are the best source of vaccine and antiviral safety data for common adverse events; however, such studies do not have the statistical power to identify rare but potentially serious adverse events. The frequency of rare adverse events that might be associated with vaccination is best assessed by reviewing computerized medical records from large linked clinical databases and medical charts of persons who are identified as having a potential adverse event after vaccination (12,13). Vaccine coverage data from a nationally representative, randomly selected population that includes verification of vaccination through health-care record review are superior to coverage data derived from limited populations or without verification of vaccination; however, these data rarely are available for older children or adults (14). Finally, studies that assess vaccination program practices that improve vaccination coverage are most influential in formulating recommendations if the study design includes a nonintervention comparison group. In cited studies that included statistical comparisons, a difference was considered to be statistically significant if the p-value was <0.05 or the 95% confidence interval (CI) around an estimate of effect allowed rejection of the null hypothesis (i.e., no effect).

These recommendations were presented to the full ACIP and approved in February 2009. Modifications were made to the ACIP statement during the subsequent review process at CDC to update and clarify wording in the document. Vaccine recommendations apply only to persons who do not have contraindications to vaccine use (see Contraindications and Precautions for use of TIV and Contraindications and Precautions for use of LAIV). Data presented in this report were current as of July 17, 2009. Further updates, if needed, will be posted at CDC's influenza website (http://www.cdc.gov/flu).

Primary Changes and Updates in the Recommendations
The 2009 recommendations include three principal changes or updates:

Annual vaccination of all children aged 6 months--18 years should begin as soon as the 2009--10 influenza vaccine is available. Annual vaccination of all children aged 6 months--4 years (59 months) and older children with conditions that place them at increased risk for complications from influenza should continue to be a primary focus of vaccination efforts as providers and programs transition to routinely vaccinating all children.
The 2009--10 trivalent vaccine virus strains are A/Brisbane/59/2007 (H1N1)-like, A/Brisbane/10/2007 (H3N2)-like, and B/Brisbane 60/2008-like antigens.
Most seasonal influenza A (H1N1) virus strains tested from the United States and other countries are now resistant to oseltamivir. Recommendations for influenza diagnosis and antiviral use will be published later in 2009. CDC issued interim recommendations for antiviral treatment and chemoprophylaxis of influenza in December 2008, and these should be consulted for guidance pending recommendations from the ACIP (8).

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Prevention and Control of Seasonal Influenza with Vaccines