Influenza Vaccine for the 2014-2015 Season

Report
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 2014.
 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.
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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 50-64
years compared with recent years
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National Hospitalizations Reported
to CDC via FluSurv-NET (covers
approximately 8.5% of U.S. population)
 October 1, 2013 - April 30, 2014
 9,634 reported hospitalizations
 88% associated with influenza A
 Persons 18 - 64 accounted for 57% of reported
hospitalizations
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National Pneumonia and Influenza
Associated Mortality (P&I)
 P&I
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Exceeded epidemic threshold for 8 consecutive weeks
(1/11/14 - 3/1/14)
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National 2013-14 Pediatric Deaths
 96 laboratory-confirmed, influenza-associated
pediatric deaths
 Affected ages
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Less than 6 months: 18
6-23 months: 24
2-4 years: 8
5-11 years: 27
12-17 years: 19
 Of 90 children with known medical history, 54% had
at least one high risk medical condition
 Neurologic and pulmonary disease were most common
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Vaccine Safety
 Vaccine Safety Datalink (VSD) surveillance for 2013-
2014 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 20132014 influenza season for any pre-specified outcomes
 No new safety concerns detected for IIV or LAIV
during the 2013-2014 influenza season
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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.
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2013-14 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
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Benefits of 2013-14 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
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Composition of the 2014-15 Influenza
Vaccine
• The strains in the 2014-15 influenza vaccines will be
the same as those used in 2013-14
 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)
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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
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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)
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Influenza Vaccine Manufacturers
Projections for 2014-15 Season
 Estimate of total doses for 2014-15: 153 - 158 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: 28 - 33 million doses (QIV and TIV)
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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
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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 2013-14 vaccine, antibodies from the
previous year’s vaccination wane over time and may
be too low to provide protection after a year.
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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
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Efficacy of High-Dose Versus StandardDose 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 IIV3Standard Dose
 No current preferential use recommendation from
ACIP
www.nejm.org/doi/full/10.1056/NEJMoa1315727?query=featur
ed_home&
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Vaccine Safety Surveillance 2014-15
 Surveillance for the 2014-2015 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
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Dose Algorithm for 6 Months - 8 Year Olds:
First Approach
* Doses
should be
administered
a minimum of
4 weeks apart.
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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 2013-14 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 2010-11 or
the monovalent 2009 [H1N1] vaccine),
 Then the child needs only 1 dose for 2014-15
 Children in this age group for whom one of these
conditions is not met require 2 doses for 2014-15
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Recommendations Regarding Influenza Vaccination
of Persons Who Report Allergy to Eggs
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Influenza Vaccination for Persons with
Egg Allergies: Additional Notes
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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)
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“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
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Does NOT apply to visitors to facilities or family
members of patients/residents
 Areas where patients or residents may be present
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“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
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“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: https://commerce.health.state.ny.us/
 More information on reporting pending for this season
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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, 2014
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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
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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
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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
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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
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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
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HCP Influenza Vaccination Rates
2008-09 through 2013-14
100%
90%
88%
80%
70%
60%
50%
54%
60%
47%
47%
47%
Hospitals
Nursing Homes
40%
Overall
30%
HP 2020 Target
20%
10%
0%
2008-09 2009-10 2010-11
2011-12 2012-13 2013-14
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HCP Influenza Vaccination Rates by
Organization Type, 2013-14
100%
80%
85%
87%
88% 94% 89%
81%
83%
76%
HP 2020 Target
60%
40%
20%
0%
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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) 473-4439 or
[email protected]
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For More Information
 NYSDOH Seasonal Influenza Information for Health
Care Providers
www.health.ny.gov/diseases/communicable/influenza
/seasonal/providers/
 NYSDOH influenza mask regulation questions
Email: [email protected]
Web site: http://www.health.ny.gov/FluMaskReg
 Health Commerce System (HCS) account questions
Email: [email protected]
Phone: 866-529-1890 Option 1
(8am-4:45pm EST, excluding weekends/holidays)
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For More Information (cont.)
 CDC Seasonal Influenza Information for Health Professionals
www.cdc.gov/flu/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
www.cdc.gov/mmwr/preview/mmwrhtml/mm6332a3.htm
 NYSDOH Seasonal Influenza Website
www.health.ny.gov/diseases/communicable/influenza/seasonal/
 CDC Seasonal Influenza Website www.cdc.gov/flu/
 CDC Seasonal Influenza Free Patient Education
www.cdc.gov/flu/freeresources/
 National Adult and Influenza Immunization Summit,
Influenza Vaccination Resources
www.izsummitpartners.org/influenza-vaccination-resources/
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