Texas Immunization Branch Influenza Update July 24 th, 2008

Influenza Update ACIP Recommendation Influenza Vaccine –Strains –Types/Indications –Manufacturing/Supply Texas Influenza Program –Vaccines For Children –Adult Program –Legislation Links to Influenza Websites

Influenza Recommendations For Children 6 Months – 18 Years of Age Advisory Committee on Immunization Practices (ACIP) recently revised the influenza recommendations to include all children 6 months – 18 years beginning before or during the influenza season if feasible, but not later than the influenza season. Previously, children 5-18 years of age were only recommended to receive the influenza vaccine if they were at higher risk for influenza complications. In addition, annual vaccination of all children aged 6 months through 4 years (59 months) continue to be a primary focus of vaccination efforts because these children are at higher risk for influenza complications compared with older children

Children and Adolescents at High-risk For Influenza Aged 6 months to 4 years; chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological or metabolic disorders (including diabetes mellitus); who are immunosuppressed (including immunosuppression caused by medications or by human immunodeficiency virus);

Children and Adolescents at High-risk For Influenza who have any condition (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders, or other neuromuscular disorders) that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration; who are receiving long-term aspirin therapy who therefore might be at risk for experiencing Reye syndrome after influenza virus infection; who are residents of chronic-care facilities; and, who will be pregnant during the influenza season.

Adult Recommendations For Influenza Annual vaccination against influenza is recommended for any adult who wants to reduce the risk for becoming ill with influenza or of transmitting it to others. Vaccination also is recommended for all adults in the following groups, because these persons are either at high risk for influenza complications, or are close contacts of persons at higher risk: persons aged >50 years; women who will be pregnant during the influenza season;

Adults at High-risk For Influenza persons who have chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological or metabolic disorders (including diabetes mellitus); persons who have immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus); persons who have any condition (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders, or other neuromuscular disorders) that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration;

Adults at High-risk For Influenza residents of nursing homes and other chronic-care facilities; health-care personnel; household contacts and caregivers of children aged 50 years, with particular emphasis on vaccinating contacts of children aged <6 months; and, household contacts and caregivers of persons with medical conditions that put them at high risk for severe complications from influenza.

Vaccine Strains Vaccines containing the 2008–09 trivalent vaccine virus strains include: A/Brisbane/59/2007 (H1N1)-like, A/Brisbane/10/2007 (H3N2)-like, and B/Florida/4/2006-like All 3 vaccine virus strains were changed for the season Vaccine Strains: A/Solomon Islands/3/2006 (H1N1)-like, A/Wisconsin/67/2005 (H3N2)-like, and B/Malaysia/2506/2004-like viruses

Vaccine Composition 2 types of vaccines (same strains in both) Trivalent Inactivated Influenza Vaccine (TIV) –Multiple Products Available –Intramuscular Injection –Licensed between 6 months to +85 yrs. Live, Attenuated Influenza Vaccine (LAIV) –Single Product (FluMist®) from MedImmune –Intranasal Spray –Licensed between 2* and 49 yrs. * the previous recommendation was to administer LAIV to person aged 5–49 years

Vaccine Supply During the 2007–08 influenza season, 113 million doses of influenza vaccine were distributed in the United States (est. 141 million were produced). Total production of influenza vaccine for the United States is anticipated to be >140 million doses for the 2008–09 season, depending on demand and production yields

Flu Vaccines Licensed in the US VaccineBrandname/ TradenameManufacturer Total Projected Doses Manufactured Influenza (Age 6 months and older)Fluzone® Sanofi Pasteur 38,000,000 Influenza (Age 6-35 months) Fluzone® Pediatric dose Preservative-free 6,000,000 Influenza (Age 36 months and older)Fluzone® No-Preservative7,000,000 Influenza (Age 4 years and older) Fluvirin® Novartis 28,275,000 Fluvirin® Preservative-free15,225,000 Influenza (Age 18 years and older) Fluarix™ GlaxoSmithKline 13,000,000 FluLaval™23,000,000 Influenza (Age 18 years and older)AfluriaCSL Biotherapies6,000,000 Influenza Live, Intranasal (Age 2-49 years) FluMist®MedImmune12,500,000 TOTAL 149,000,000 CDC US VFC Allocation: 22,000,000

Flu Vaccine Age Indications Fluzone® Sanofi.25 mL Fluzone® Sanofi.5mL Fluzone® Sanofi.5 mL(no pres.) FluMist® Medimmune LAIV Fluvirin® Norvatis.5mL FluLaval™ GSK.5mL Fluarix™ GSK.5mL Afluria CSL Biotherapies.5mL 6 months 24 mo. 35 mo. 36 mo. 48 mo. …18 yrs…….49 yrs……+85 yrs Note: Children < 9 years of age need 2 doses of influenza vaccine (administered 1 month apart) the first time they receive the vaccine. If they only received 1 dose the first year, they need to receive 2 doses the following year.

Flu Season The Flu Season generally runs from early September to late May CDC encourages ‘flu campaigns’ to continue until the vaccines expires (June)

Influenza Disease Influenza viruses causes disease among all age groups –Rates of infection are highest among children –Risk of complications, hospitalizations, and death are highest among person aged > 65 years, young children, and persons with medical conditions that increase risk Children deaths due to flu-associated complications : : : : : 76

Texas Immunization Branch Influenza Programs Texas Vaccines For Children Program –Federal funded program for eligible children 0-18 years of age –Projected 809,270 doses (20% increase from year) State purchased vaccine –Used by HSRs for high-risk adults –Projected 110,000 doses for Local Health Departments –Can purchase direct from manufacturer, from a 3 rd party distributor, and off State of Texas Contract

Texas VFC Population Children 0-18 in Texas: 6,899,555 –VFC Eligible Children : 4,091,148 –Non-eligible VFC: 2,367,118 VFC Doses for Texas ( ) –289,500 (.25 mL) –519,770 (.5 mL) 809,270 total doses for +4,000,000 children

Influenza Coverage Levels The 2006 NIS estimated 30.5% of children (6 to 23 months) within Texas has received one or more doses of Influenza Vaccine (US 32.2%) Texas 2007 Bi-Annual Childcare Assessment Survey estimated 18.1% of children surveyed,19-59 months of age, received one or more doses Influenza Vaccine The 2007 Texas Behavioral Risk Factor Surveillance System estimated 66.7%, adults 65 and older had received a flu shot

Influenza Coverage Levels 2007 NIS-Adult Survey currently estimated national percent vaccinated against the flu –37.3 % of High Risk Adults, years of age, –42.2 % of all adults, years of age –68.8 % of all adults 65+ Adolescent Immunization Rates* (one of the new influenza target population) for year olds –MMR (2 doses): 86.9% –Hepatitis B (3 doses): 81.3% –Td/Tdap: 49.4% (higher in older age group) –Meningococcal Conjugate: 11.7% 2006 National Immunization Survey (13-17 year olds)

Texas Influenza Legislation House Bill (HB) 3184, which requires the DSHS to publish information about the benefits of annual vaccination against influenza; and, together with the Department of Family & Protective Services (DFPS), ensure the information is annually distributed to parents of children attending child-care in August or September. A newly created Flu Fact Sheet for Child-Care Settings will be mailed in September to child-care facility centers in Texas for distribution to all enrolled children.

Texas Influenza Legislation Senate Bill (SB) 811, which requires the DSHS to allow each health care provider participating in the vaccines for children program to: 1.select influenza vaccines from the list of all influenza vaccines that: (i) within the limits of the vaccines annually allocated by the CDC to the department for the vaccines for children program; or (ii) not offered in the annual allocation under Subparagraph (i), but are available from the Centers for Disease Control and Prevention of the United States Public Health Service and for which the Centers for Disease Control and Prevention awards to the department additional funds; and 2.use both inactivated influenza vaccines and live, attenuated influenza vaccines.

Challenges Vaccine Supply (annual uncertainty) Universal Recommendation vs. prioritization of high- risk groups Vaccine Distribution (pre-booking) Vaccine delivery and reimbursement systems Vaccine uptake (especially in new recommended groups Vaccine coverage levels (13 additional cohorts added to annual campaign with existing resources) Vaccine Funding and over-reliance on public health

Links To Influenza Websites CDC Influenza webpage DSHS Immunization Branch Website MMWR Recommendations for Health Care Personnel Influenza Vaccination of Health-Care Personnel: Recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) and the ACIP. February 24, Vaccine Information Statements (VIS) The Vaccine Information Statements are not available at this time. Refer to the following website for updates CDC’s Flu Gallery contains educational materials for promoting influenza vaccination. The Gallery contains printed materials such as flyers and posters, in color and black and white, English and Spanish. It is available at: