Annual Estimates of Influenza Vaccine Effectiveness for Preventing Laboratory-Confirmed Influenza in the United States

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Annual Estimates of Influenza Vaccine Effectiveness for Preventing Laboratory-Confirmed Influenza in the United States: Influenza is an important cause of morbidity, mortality, and healthcare burden across all age groups. Because influenza viruses are constantly changing and vaccines are reformulated every year, annual estimates of the effectiveness of influenza vaccines in preventing influenza infection and its associated complications are needed in order to evaluate the protection provided by annual, nationwide vaccination programs. Estimating influenza vaccine effectiveness (VE) as soon as possible after the start of a seasonal influenza epidemic or pandemic and monitoring it over time will be essential in order to guide influenza vaccination and control policy. The populations to be studied will include those for whom CDC's Advisory Committee on Immunization Practices recommends receipt of a licensed influenza vaccine. Influenza vaccination can prevent or reduce a number of outcomes, including laboratory-confirmed influenza virus infection, symptomatic illness given infection, severe illness and related complications due to influenza, the likelihood of transmitting the virus to others, or a combination of these. Thus, accurate estimation of vaccine effectiveness requires a multi-component approach, including accurate assessment of vaccination status, laboratory-confirmed disease outcomes, timing of illness and vaccination, and assessment of other factors that may affect vaccine use and immune response to vaccination. In addition, serological assessment of vaccine response and influenza antibody outcomes among vaccinated and unvaccinated individuals is also needed in order to understand vaccine response. Many additional factors can also affect the assessment of VE in observational studies such as the sensitivity and specificity of outcome measures, specimen collection methods, timing of vaccination, the setting for case and control recruitment, and the ratio of influenza illness to non-influenza respiratory illness. Moreover, a number of potential modifiers of vaccine response and vaccine effectiveness have been identified, including individual factors, environmental factors, and viral and infectious disease factors. Thus, applicants must describe plans to identify and control for a variety of potential confounders in each proposed analysis.