MA Adult Immunization Coaltion Flu Update September 28, 2016

Transcription

1 MA Adult Immunization Coaltion Flu Update September 28, 2016 Susan M. Lett, MD, MPH Medical Director, Immunization Program Division of Epidemiology and Immunization Massachusetts Department of Public Health (MDPH) MDPH

2 Outline Flu Season Vaccine Effectiveness ACIP Flu Recommendations MDPH

3 CDC Influenza Review SUMMARY OF INFLUENZA SEASON MDPH

4 Relatively mild season Peak in early March One of the latest peaks on record Influenza Season National Summary Influenza A (H1N1) predominated. Circulating strains appeared to be an excellent match with the vaccine. Vaccine Efficacy Overall: 50% Flu hospitalization rates lower than previous years. Highest in those >65 yrs, followed by yrs and children <5 years Other respiratory pathogens circulated causing respiratory illness: human rhino/entero, RSV, parainfluenza virus, human metapneumovirus, adenovirus, and human coronavirus. MDPH

5 Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet), Weekly National Summary, and Selected Previous Seasons Week 32 % ILI 0.6%

6 No. of specimens tested No. positive specimens A (Subtyping not performed) A (H1N1) pdm09 A (H3) Positive specimens by type A (H3N2v) B (Lineage not performed) B Victoria lineage Week Cumulative since Week 40 B Yamagata lineage 74,086 27, ,286 3, ,929 1,690 3,703 Presented by Dr. J. Bresee VIC webinar

7 Influenza-like Illness in Massachusetts for Past Three Flu Seasons MDPH 2016

8 CDC Influenza Review INFLUENZA VACCINE EFFECTIVENESS, Presented by Dr. J. Bresee VIC webinar

9 Adjusted VE against medically attended influenza, US Flu VE Network, Vaccine Effectiveness Influenza positive Influenza negative Unadjusted Adjusted* Any influenza A or B virus N vaccinated/ Total (%) N vaccinated/ Total (%) VE % 95% CI VE % 95% CI Overall 514/ / (38 to 51) 47 (39 to 53) 6m 8 y 108/ / (30 to 59) 48 (31 to 61) 9 17 y 33/ / (43 to 75) 64 (44 to 77) y 146/ / (32 to 56) 48 (35 to 59) y 149/ / (8 to 46) 23 (-3 to 43) 65 y 78/ / (8 to 63) 45 (10 to 66) IIV3/4, all ages 472/ / (40 to 53) 49 (41 to 56) * Multivariate logistic regression models adjusted for site, age categories (6m-8y, 9-17y 18-49y, 50-64y, 65y), sex, race/hispanic ethnicity, self-rated general health status, interval from onset to enrollment, and calendar time (biweekly intervals) Presented by Dr. J. Bresee VIC webinar

10 LAIV and IIV vaccine effectiveness ages 2 17 years, by influenza type/subtype, Any influenza H1N1pdm09 B/Yamagata B/Victoria Total, Flu Vaccinated, Flu Presented by Dr. J. Bresee VIC webinar

11 Season: Summary of Data US data, 2-17 year old children US Flu VE data indicate no LAIV effectiveness against A/H1N1pdm09; significant VE for IIV US DoD - no LAIV effectiveness against H1N1 (VE for LAIV 14% [-48, 52]; significant VE for IIV at 68% MedImmune H1N1 LAIV VE higher point estimate but NS [VE for LAIV 47% [-6, 77)]; IIV VE significant and higher [68% (45, 81) ] All three US studies reported higher point estimates of VE for IIV than LAIV Non-US data UK 2-17 yrs - H1N1 LAIV VE higher point estimate but NS [42% (-8.5, 69)]; IIV VE significant and higher Finland national cohort of 2 year olds - significant unadjusted VE against flu A (likely mainly H1N1pdm09) for LAIV (45% [18, 63]); higher point estimates for IIV (78% [46, 91]) Canada 2-17 yrs, crude estimates: H1N1pdm LAIV VE 51% (-38,83) IIV VE 87%(43-97) Presented by Dr. J. Bresee VIC webinar

12 US Flu VE Network: LAIV and IIV VE age 2-17 yrs Any Influenza A or B Mixed H3N H3N H1N H3N H1N1 LAIV3 LAIV4 Total, Flu Vaccinated, Flu Presented by Dr. J. Bresee VIC webinar

13 Some Hypothesis for Change in LAIV Effectiveness Include Suboptimal performance of the new H1N1 A/Bolivia component Possible interference among viruses in quadrivalent vaccine Reduced immunogenicity of LAIV because children now more highly vaccinated Researchers, CDC, FDA and the manufacturer are all committed to gaining insight into the issue and are continuing to review data as it becomes available. MDPH

14 For the influenza season, the ACIP made an interim recommendation that LAIV not be used. MDPH

15 ACIP Influenza Vaccine Recommendations Main Flu CDC Website MDPH

16 ACIP Influenza Vaccine Recommendations--Overview Published in MMWR August 26, 2016 Annual influenza vaccination is recommended for all persons aged 6 months and older. Principal changes LAIV not recommended during the season New/recent vaccine licensures Fluad Flucelvax Quadrivalent Afluria Quadrivalent Changes to egg allergy recommendations Projections for IIV: million doses Supply should be adequate to meet demand. CDC. MMWR 2016; 65: MDPH

17 Vaccine Strain Selection for Seasons For , WHO recommended a new H3N2 component. The B components switched places, from IIV3 to IIV4, compared to the Northern Hemisphere vaccine: A/California/7/2009 (H1N1)pdm09- like virus A/Switzerland/ /2013 (H3N2)-like virus B/Phuket/3073/2013-like virus (Yamagata lineage) for quadrivalent vaccines, B/Brisbane/60/2008-like virus (Victoria lineage) A/California/7/2009 (H1N1)pdm09-like virus A/Hong Kong/4801/2014 (H3N2)- like virus B/Brisbane/60/2008-like virus (Victoria lineage) for quadrivalent vaccines, B/Phuket/3073/2013-like virus (Yamagata lineage) CDC. MMWR 2016; 65:1-52. MDPH

18 New Vaccines for Fluad (Seqirus) MF59-adjuvanted trivalent IIV Licensed for persons aged 65 years and older Immunogenically non-inferior to licensed comparator IIV3 in preclinical studies Flucelvax Quadrivalent (Seqirus) Will replace trivalent Flucelvax for Licensed for persons aged 4 years and older Vaccine viruses propagated in Madin-Darby canine kidney cells instead of eggs Immunogenically noninferior to trivalent formulation Afluria Quadrivalent (Seqirus) Licensed for persons 18 years and older Afluria Trivalent still be distributed and is recommended for use in those 9 years and older (See pages 26, and 33 in the ACIP statement.) MDPH

19 Egg Allergy and Anaphylaxis Background Anaphylaxis after influenza vaccine is rare about 1.3 to 1.5 per million doses This rate is not different from other childhood vaccines Influenza vaccine like other vaccines contain various components that could cause reactions Ovalbumin in current vaccines very small <1 µg/0.5ml for IIV 0.24 µg/0.5 ml for LAIV Latest Studies Studies examining the use of both IIV and LAIV in egg allergic and non-egg allergic patients indicate that severe allergic reactions of persons with egg allergy of any severity are unlikely. (See pages 26, and 33 in the ACIP statement.) MDPH

20 Egg Allergy and Anaphylaxis Background, cont. The Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology states: Special precautions regarding medical setting and waiting periods after the administration of IIV to eggallergic recipients beyond those recommended for any vaccine are no longer warranted. (See pages 1 and 10 in the AAP Flu Policy Statement ) MDPH

21 Changes to Egg Allergy Language, ACIP Persons with an allergy to egg of any severity can receive any licensed and recommended vaccine (IIV, RIV) that is otherwise appropriate for the recipient s age and health status Those who experience hives only can receive any licensed, recommended and appropriate influenza vaccine administered in an any usual immunization setting. For persons with a history of severe allergic reaction to egg (i.e., any symptom other than hives such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention): Selected vaccine should be administered in an inpatient or outpatient medical setting (including but not necessarily limited to hospitals, clinics, and physician offices); Vaccine administration should be supervised by a healthcare provider who is able to recognize and manage severe allergic conditions; You will need to decide if your setting has the trained staff, protocols and equipment in place to safely vaccinate or refer to a provider who does. (See pages 26, and 33 in the ACIP statement.) MDPH

22 Changes to Egg Allergy Language Formulations ACIP and AAP do not express a preference for use of egg-free formulations in those with egg allergy. However, Flublok a recombinant vaccine, is egg-free and approved for those > 18 years of age Some providers may choose to administer RIV3 to their severely egg-allergic patients. Flucelvax, a cell culture vaccine licensed for those >4 years, has a much smaller amount of egg protein since the original virus was grown in eggs, but mass production of that vaccine does not occur in eggs. Flucelvax contains an estimated total egg protein that is less than 50 femtograms (5x10-8 µg) total egg protein (and less ovalbumin) per 0.5 ml dose (See pages 26, and 33 in the ACIP statement. And page 10 in the AAP Flu Policy Statement ) MDPH

23 Changes to Egg Allergy Language Waiting Period, ACIP and AAP Egg-allergic individuals no longer need to wait 30 minutes post vaccination According to the Vaccine Safety Data link, anaphylaxis occurred at a rate of 1.31 per million doses and 60% occurred after 30 minutes However, providers should continue to observe all patients for 15 minutes after vaccination to decrease the risk of injury should they experience syncope (See pages 26, and 33 in the ACIP statement and page10 in the AAP Flu Policy Statement ) MDPH

24 MDPH Flu Resources Click on Information for Healthcare and Public Health Professionals to find many provider resources and helpful links, such as: MDPH Influenza Advisory Control of Flu and Pneumococcal in Long-term care facilities Model Standing Order for IIV (under Vaccine Guidelines and Tools) Sample Flu Consent forms (under Vaccine Guidelines and Tools)

25 MDPH

26 EXTRAS MDPH

27 Influenza-Associated Pediatric Deaths by Week of Death: season to present # Deaths Reported Current Week 32 # Deaths Since October 4, 2015 Influenza A (2009 H1N1) Influenza A (H3N2) Influenza A (Subtype not Determined) Influenza B Influenza A and B Co-infection Type not Determined Total Pediatric Deaths in US: ~50% with no underlying health problems ~75 unvaccinated Number of Deaths Reported = 171 Number of Deaths Reported = 111 Number of Deaths Reported = 148 Number of Deaths Reported = 85 Pediatric Deaths in MA: 1 < 5 years of age years Both vaccinated Both with significant pre-existing health issues 27

28 Massachusetts Laboratory-confirmed Influenza Cases and Influenza-like IlIness (ILI) MDPH 2016

29 AAP Policy Egg Allergy and Anaphylaxis All children with egg allergy can receive any influenza vaccine with no additional precautions from those for routine vaccination. Standard vaccination practice should include the ability to respond to acute hypersensitivity reactions (See pages 1 and 10 in the AAP Flu Policy Statement ) MDPH