September 11, 2014 Cindy Schulte, RN, BSN Kathy Sen, RN, BSN Vaccine Preventable Disease Surveillance Bureau of Immunization New York State Department of Health (NYSDOH)

What Happened Last Season – NY Recap Influenza activity increased in late November 2013, became widespread by mid-December, and remained widespread through the end of May Influenza A (H1) viruses predominated overall, but influenza B viruses predominated later in the season. Influenza A (H1) viruses predominated until early March 2014, with influenza B viruses predominating from early April through the end of May. 3

4

5

6

7

8

9

10

What Happened Last Season – National Recap Influenza activity increased through November and December before peaking in late December First season since 2009 that Influenza A pH1N1 predominated Characterized overall by lower levels of outpatient illness and mortality than during Influenza A H3N2 predominant seasons Higher rates of hospitalization among adults aged years compared with recent years 11

National Hospitalizations Reported to CDC via FluSurv-NET (covers approximately 8.5% of U.S. population) October 1, April 30, ,634 reported hospitalizations 88% associated with influenza A Persons accounted for 57% of reported hospitalizations 12

National Pneumonia and Influenza Associated Mortality (P&I) P&I Exceeded epidemic threshold for 8 consecutive weeks (1/11/14 - 3/1/14) 13

National Pediatric Deaths 96 laboratory-confirmed, influenza-associated pediatric deaths Affected ages Less than 6 months: months: years: years: years: 19 Of 90 children with known medical history, 54% had at least one high risk medical conditio n Neurologic and pulmonary disease were most common 14

Vaccine Safety Vaccine Safety Datalink (VSD) surveillance for influenza season through April 11, 2014 IIV3 (dose 1): 3,811,478 doses administered (including high-dose and intradermal vaccines) LAIV4 (dose 1): 218,875 doses administered Very limited uptake of IIV4, cell culture-based IIV3 and recombinant IIV3 No signals in VSD Rapid Cycle Analysis during the influenza season for any pre-specified outcomes No new safety concerns detected for IIV or LAIV during the influenza season 16

Vaccine Safety – Pregnancy No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of TIV or LAIV. While the nasal spray is not recommended for pregnant women, scientists were reassured to find that the inadvertent administration of this vaccine to pregnant women did not result in reported unexpected reactions. There was no statistically significant increase in the risk of pregnancy loss in the four weeks after seasonal inactivated influenza vaccination. Provides reassuring findings that flu vaccine given to pregnant women during the first trimester of pregnancy does not increase the risk of spontaneous abortion. 17

Vaccine Effectiveness (VE) VE was measured against influenza A and B virus infections associated with medically attended acute respiratory illness Interim estimates: January 23, 2014 Adjusted: 61% 98% of disease occurring was Influenza A (pH1N1) 62% effective against Influenza A (pH1N1) Influenza B not reported Adults 65 years or older: 51% Against influenza A and B Provides protective benefit to the predominant flu viruses 18

Benefits of Influenza Vaccine Substantial public health benefit provided Vaccine performing within expected range and similar benefits across all age groups Benefits include reduction in flu-related illness, antibiotic use, time lost from work, hospitalization and death 19

Composition of the Influenza Vaccine The strains in the influenza vaccines will be the same as those used in A/California/7/2009(H1N1)pdm09-like virus A/Texas/50/2012(H3N2)-like virus B/Massachusetts/2/2012-like (B/Yamagata lineage) virus B/Brisbane/60/2008-like (B/Victoria lineage) virus (quadrivalent vaccines only) 21

Quadrivalent Influenza Vaccines – Rationale Two lineages of influenza B viruses: Victoria and Yamagata Immunization against virus from one lineage provides only limited cross-protection against viruses in the other Trivalent vaccines contain only one B vaccine virus Only one B lineage is represented Predominant lineage is difficult to predict in advance of the season Quadrivalent vaccines contain one virus from each B lineage 22

Alphabet Soup Trivalent Influenza Vaccine (TIV) replaced with Inactivated Influenza Vaccine (IIV) Includes trivalent (IIV3) and quadrivalent (IIV4) inactivated vaccines IIV refers to inactivated influenza vaccines as a class (egg and cell-culture based) Where necessary, cell-culture-based IIV is referred to as ccIIV/ccIIV3 RIV refers to recombinant hemagglutinin (HA) influenza vaccine (available as a trivalent vaccine only, RIV3) LAIV refers to Live Attenuated Influenza Vaccine (available as a quadrivalent vaccine only, LAIV4) 23

24

Influenza Vaccine Manufacturers Projections for Season Estimate of total doses for : million Sanofi Pasteur: more than 60 million doses (QIV and TIV) Protein Sciences: up to 500,000 doses Novartis: at least 30 million doses (all TIV) CSL: 13.5 million doses MedImmune: 18 million doses (all QIV) GSK: million doses (QIV and TIV) Warning letter from FDA relating to an inspection at GSK FluLaval influenza vaccine manufacturing facility in Canada Fluarix, manufactured at a different facility, will not be impacted 25

Will Patients Who Were Vaccinated Last Year Still Need to Be Vaccinated This Year? Yes! Even though the viruses in the vaccine are the same as in the vaccine, antibodies from the previous year’s vaccination wane over time and may be too low to provide protection after a year. 26

ACIP Recommends a Preference for Using Nasal Spray Flu Vaccine (LAIV) 2014 ACIP voted to recommend a preference for using the nasal spray flu vaccine (LAIV) instead of the flu shot (IIV) in healthy children 2-8 years of age when it is immediately available Studies suggest that the nasal spray flu vaccine can provide better protection than the flu shot in this age group against laboratory-confirmed, medically attended flu illness If the nasal spray flu vaccine is not immediately available, the flu shot should be given so that opportunities to vaccinate children are not missed or delayed 27

Efficacy of High-Dose Versus Standard- Dose Influenza Vaccine in Older Adults Reported in the New England Journal of Medicine, August 2014 Conclusions: Among persons 65 years of age or older, IIV3-High Dose induced significantly higher antibody responses and provided better protection against laboratory-confirmed influenza illness than did IIV3- Standard Dose No current preferential use recommendation from ACIP ed_home& 28

Vaccine Safety Surveillance Surveillance for the influenza season will include enhanced safety monitoring for: Quadrivalent IIV and LAIV vaccines Cell culture-based IIV Recombinant IIV Pregnancy reports Reports of anaphylaxis in persons with history of egg allergy after IIV and LAIV Reports with history of asthma/wheezing after LAIV4 29

Dose Algorithm for 6 Months - 8 Year Olds: First Approach 31 * Doses should be administered a minimum of 4 weeks apart.

Alternative Approach In settings where vaccination history from before July 1, 2010, is available, if a child aged 6 months - 8 years is known to have received either: At least 1 dose of seasonal influenza vaccine, or At least two seasonal influenza vaccines during any previous season, and at least 1 dose of a 2009 (H1N1)- containing vaccine (i.e., seasonal vaccine since or the monovalent 2009 [H1N1] vaccine), Then the child needs only 1 dose for Children in this age group for whom one of these conditions is not met require 2 doses for

Recommendations Regarding Influenza Vaccination of Persons Who Report Allergy to Eggs 34

Influenza Vaccination for Persons with Egg Allergies: Additional Notes 35

Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel Regulation Applies to: Hospitals, general hospitals, nursing homes, diagnostic and treatment centers (all “Article 28 facilities”) Certified home health agencies, long term home health care programs, AIDS home care programs, licensed home care service agencies, limited license home care service agencies (all “Article 36 agencies”) Hospices (as defined in Article 40 of public health law) 37

“Flu Mask Reg” (cont.) Applies to: All personnel in health care and residential facilities and agencies who engage in activities such that if they were infected with influenza, they could potentially expose patients or residents to the disease All persons employed or affiliated with a health care or residential facility or agency, paid or unpaid Does NOT apply to visitors to facilities or family members of patients/residents Areas where patients or residents may be present 38

“Flu Mask Reg” (cont.) Health care and residential facilities and agencies must: Determine and document which persons qualify as “personnel” under the regulation Document the influenza vaccination status of all personnel for the current influenza season Ensure all personnel not vaccinated against influenza for the current influenza season wear a surgical or procedure mask while in areas where patients or residents may be present during the period of time in which influenza is prevalent as determined by the NYSDOH Commissioner Upon NYSDOH request, report the number and percentage of personnel that have been vaccinated against influenza for the current season 39

“Flu Mask Reg” (cont.) Reporting The Healthcare Personnel Influenza Vaccination Report will be the mechanism for reporting personnel influenza vaccination status Must be completed on the Health Electronic Response Data System (HERDS) on the Health Commerce System (HCS) at: More information on reporting pending for this season 40

Proposed Amendments Based on feedback and experience from last influenza season, several amendments to the regulation have been proposed Currently undergoing review by the Public Health and Health Planning Council (PHHPC) Public comment period open through Sept. 15 If approved by PHHPC, we anticipate an effective date of October 15,

Proposed Amendments (cont.) Definition of “patient or resident” Any person receiving services Inpatient or outpatient Overnight residents Adult day healthcare participants Home care and hospice patients Persons presenting for registration or admission 42

Proposed Amendments (cont.) Definition of “Influenza vaccine” Licensed by U.S. Food and Drug Administration (FDA) for active immunization for prevention of influenza or Authorized for such use by U.S. FDA pursuant to an Emergency Use Authorization or as an Emergency Investigational New Drug 43

Proposed Amendments (cont.) Modification of requirements of documentation of vaccination Document prepared by person who administered the vaccine specifying formulation and date or In the case of contract personnel and students, an attestation from the employer or school that the employee or student has been vaccinated and that the employer or school maintains the required documentation 44

Proposed Amendments (cont.) Replace “where patients or residents may be present” with “where patients or residents are typically present” Clarify that mask wear is not required when covered personnel provide services outside the home and not within a healthcare or residential facility 45

Proposed Amendments (cont.) Clarify that personnel who provide speech therapy services may remove the mask when necessary to deliver care Clarify that personnel required to wear a mask may remove the mask when necessary for communication with a person who lip reads 46

HCP Influenza Vaccination Rates through

HCP Influenza Vaccination Rates by Organization Type,

NYSDOH Influenza Like Illness (ILINet) Surveillance Program Health care providers are needed! Why Volunteer? ILINet is the only outpatient influenza surveillance system in the nation. Each week, ILINet providers collect and report patient visit data for influenza-like illness. ILINet providers can submit patient specimens to the Wadsworth Virology Lab for flu testing FREE of charge. For more information, please contact Donna Gowie, ILINet Program Coordinator at (518) or 50

For More Information NYSDOH Seasonal Influenza Information for Health Care Providers /seasonal/providers/ /seasonal/providers/ NYSDOH influenza mask regulation questions Web site: Health Commerce System (HCS) account questions Phone: Option 1 (8am-4:45pm EST, excluding weekends/holidays) 51

For More Information (cont.) CDC Seasonal Influenza Information for Health Professionals ACIP Recommendations: Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) — United States, 2014–15 Influenza Season NYSDOH Seasonal Influenza Website CDC Seasonal Influenza Website CDC Seasonal Influenza Free Patient Education National Adult and Influenza Immunization Summit, Influenza Vaccination Resources