INFLUENZA UPDATE MCAAP Webinar Susan M. Lett, MD, MPH Medical Director, Immunization Program MA Department of Public Health

Transcription

1 INFLUENZA UPDATE MCAAP Webinar Susan M. Lett, MD, MPH Medical Director, Immunization Program MA Department of Public Health

2 Presenter Disclosure Information I, Susan Lett, have been asked to disclose any significant relationships with commercial entities that are either providing financial support for this program or whose products or services are mentioned during our presentations. I have no relationships to disclose. I may/will discuss the use of vaccines in a manner not approved by the U.S. Food and Drug Administration. But in accordance with ACIP recommendations. MDPH

3 Outline Influenza Season Summary Influenza Immunization Rates in MA Recommendations for Prevention and Control of Influenza Influenza Resources Vaccine Supply MDPH

4 Inlfuenza Season MDPH

5 Influenza Season Record breaking in its severity High levels of outpatient clinic and emergency department visits for ILI High influenza-related hospitalization rates in all age groups High mortality rates (for 16 weeks) Elevated and geographically widespread activity across the country for an extended period (for 19 weeks) Influenza A(H3N2) viruses predominated overall Influenza B viruses were reported more frequently than influenza A viruses from early March until mid-june Vaccine 40% overall against flu A and B 24% against H3N2 65% against H1N1 49% against B strains MDPH

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7 Overall hospitalization rates (all ages) as well as the 3 adult age groups are the highest ever recorded in the CDC surveillance system, breaking the previously recorded highs recorded during ; a high severity H3N2-predominant season. MDPH

8 CDC FluView In MA, one pediatric flu-related death. Highest number reported excluding pandemics. 80% of deaths in children who are unvaccinated.

9 Influenza like Illness (ILI) in MA ILI Clusters (October-September) pdf MDPH

10 Select Flu Immunization Rates MDPH

11 MA Flu Vaccination Rates MA MA US Everyone 6 mos+ 50% #2 50% 42% Children 6 mos 17 yrs 72% #2 74% 58% Children 6 mos 4 yrs 82% 76% 68% Children 5 12 yrs 71% #3 74% 60% Adolescents yrs 65% #1 72% 47% Adults % 44% 37% Adults y/o 41% #1 40% 31% Adults HR y/o 49% 46% 39% Adults y/o 47% 46% 40% Adults % 58% 60% and National Immunization Survey (NIS) and Behavioral Risk Factor Surveillance System (BRFSS) MDPH

12 Healthcare Provider Influenza Vaccination Rates Annual influenza vaccination is the best method of preventing influenza and potentially serious complications. The current Healthy People 2020 goal for influenza vaccination among healthcare personnel is 90%. Acute care hospitals, both nationally and in MA, have surpassed the Healthy People 2020 goal and should be congratulated. However, rates for healthcare workers in general and in nursing homes/long term care settings are much lower. Healthcare Personnel Setting MA MA US US All Healthcare Personnel NA 60% 1 79% 78% Acute Care Hospitals 94% 2 93% 2 92% 92% Nursing Homes (MA)/Long Term Care settings* (US) 75% 2 71% 2 68% 67% Source: 1 MA BRFSS for 2017 Calendar Year 2 Influenza Vaccination of Health Care Personnel in MA Nursing Homes and Acute Care Hospitals 3 CDC Health Care Personnel Influenza Survey, MMWR Influenza Vaccination Coverage Among Health Care Personnel United States, Influenza Season, MMWR, September 28, 2018 / 67(38); *Long Term Care settings included nursing homes, home health agencies, home health care settings, assisted living facilities, or other LTC settings MDPH

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14 Recommendations for Prevention and Control of Influenza 1. Antivirals 2. Vaccine 3. Take Every Day Actions MDPH

15 CDC Antiviral Treatment Recommendations Antiviral treatment is recommended as early as possible for any patient with confirmed or suspected influenza who is: Hospitalized Has severe, complicated, or progressive illness Is at high risk for influenza complications MDPH

16 People at High Risk for Influenza Complications for Whom Antiviral Treatment is Recommended Children <2 years old (although all children <5 years old are considered at high risk for complications, highest risk is for children <2 years old) Adults age 65 years and over Pregnant/postpartum women Children <18 years old receiving long-term aspirin therapy American Indians/Alaska Natives People with underlying medical conditions (e.g., pulmonary, cardiac, immunosuppression, neurologic and neurodevelopment conditions) Residents of nursing homes/chronic care facilities MDPH

17 CDC Antiviral Treatment Recommendations, cont Antiviral treatment can be considered for any previously healthy, symptomatic outpatient not at high risk with confirmed or suspected influenza on the basis of clinical judgment, if treatment can be initiated within 48 hours of illness onset Clinical benefit is greatest when antiviral treatment is administered early Now 4 FDA-approved antivirals are recommended for use in the United States: oral oseltamivir, inhaled zanamivir, and intravenous peramivir and baloxavir marboxil (Xofluza ) MDPH

18 Baloxavir Marboxil Baloxavir Marboxil = targets viral polymerase (new mechanism of action) Trade name: Xofluza Oral, single dose Just licensed on October 24, 2018 NEJM September-6-18 Treatment of acute, uncomplicated influenza in healthy outpatients years Baloxavir associated with: Reducing viral load better than placebo or oseltamivir (within 1 day) Significantly shorter time to alleviation of symptoms than placebo, but similar to oseltamivir in alleviating flu symptoms No safety concerns, but development of resistance in some patients MDPH

19 Influenza Prevention and Control, Overview Published in MMWR August 24, 2018 Format same as last season MMWR publication focuses on recommendations Selected references Figure Main tables Supplemental materials Background document with additional references 4 page summary ssionals/acip/acip _summary-ofrecommendations.pdf 03a1.htm?s_cid=rr6703a1_w MDPH

20 Some Abbreviations IIV = Inactivated influenza vaccine LAIV = Live attenuated influenza vaccine RIV = Recombinant influenza vaccine Prefixes: SD = standard dose HD = high dose a = adjuvanted cc = cell culture-based Numeric suffixes (e.g., IIV3, RIV4) indicate trivalent or quadrivalent, respectively A few others: ACIP = Advisory Committee on Immunization Practices HA = Hemagglutinin VE = Vaccine Effectiveness MDPH

21 Influenza Vaccine Options, Inactivated (IIV) Trivalent (IIV3) Quadrivalent (IIV4) Standard Dose High Dose Adjuvanted Standard Dose Many brands Some with age indication down to 6 months (dose volume varies) High dose and adjuvanted are 65 yrs Intramuscular (jet injector option for one) Recombinant (RIV4) Quadrivalent 18 years Intramuscular Live Attenuated (LAIV4) Quadrivalent 2 49 years Intranasal MDPH

22 Groups Recommended for Vaccination Routine annual influenza vaccination is recommended for all persons 6 months of age who do not have contraindications While vaccination is recommended for everyone in this age group, there are some for whom it is particularly important People aged 6 months who are at increased risk of complications and severe illness due to influenza Contacts and caregivers of persons <5 years of age 50 years of age with medical conditions that put them at higher risk for severe complications from influenza MDPH

23 Groups at Increased Risk for Flu Complications and Severe Illness Children aged 6 through 59 months and adults aged 50 years (children under 6 months of age are also at high risk, but cannot be vaccinated); Persons with chronic pulmonary (including asthma) or cardiovascular (excluding isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus); Immunosuppressed persons; Women who are or will be pregnant during the influenza season; Children and adolescents (aged 6 months 18 years) who are receiving aspirin- or salicylate-containing medications (who might be at risk for Reye syndrome after influenza virus infection); Residents of nursing homes and other long-term care facilities; American Indians/Alaska Natives; and Persons who are extremely obese (BMI 40). MDPH

24 ACIP Flu Statement - Updates Principal changes and updates for Influenza vaccine composition for LAIV4 an option for Vaccines for egg-allergic persons Two labeling changes for existing vaccines MDPH

25 Vaccine Strain Selection: Influenza Season Vaccine Strain Selection: Influenza Season U.S. Influenza Vaccine Composition: The World Health Organization (WHO) has recommended two new vaccine viruses for the influenza season A/Michigan/45/2015 (H1N1)pdm09-like virus A/Hong Kong/4801/2014 (H3N2)-like virus B/Brisbane/60/2008-like (B/Victoria lineage) virus B/Phuket/3073/2013-like (B/Yamagata lineage) virus. A/Michigan/45/2015 (H1N1)pdm09-like virus A/Singapore/INFIMH /2016 (H3N2)- like virus B/Colorado/06/2017-like virus (B/Victoria lineage) B/Phuket/3073/2013-like virus (B/Yamagata lineage) MDPH

26 ACIP LAIV4 Recommendations for (1) Can choose any appropriate vaccine (IIV, RIV4*, or LAIV4) LAIV had not been recommended for or Low effectiveness vs. influenza A(H1N1)pdm09 among children 2 through 17 yrs during and Thought due to poor fitness of the H1N1pdm09 virus in the vaccine In February 2018, ACIP reviewed additional data Two analyses of previous seasons data from observational studies Manufacturer data on shedding and immunogenicity of new H1N1pdm09 vaccine virus indicating improved fitness For , LAIV4 is an option for those for whom it is appropriate No U.S. VE data yet on new formulation with the new H1N1pdm09 * RIV4 not licensed for those <18 years MDPH

27 ACIP LAIV4 Recommendations for (2) Recommendations of the ACIP and American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP): ACIP makes no preferential recommendations for any one vaccine type when more than one is appropriate; AAP recommends IIV as the primary choice for children. American Academy of Family Physicians (AAFP) also voted for a preferential recommendation for IIV for nonpregnant patients 2-49 years Recommendations share the same principle that influenza vaccination is an important preventive strategy! MDPH

28 Shared Principles and Goals for Influenza Prevention Shared the goal of increasing influenza vaccination coverage to protect as many individuals as possible. A health care provider s strong recommendation is a critical factor affecting whether or not your patient get influenza vaccine. MDPH

29 Who Should NOT Receive LAIV4 Persons aged <2 years or >49 years (for whom notlicensed by FDA) Labeled contraindications in package insert: History of severe allergic reaction to any vaccine component (other than egg protein*) or to a previous dose of influenza vaccine Concomitant aspirin- or salicylate-containing therapy in children or adolescents (risk of Reye syndrome) ACIP also recommends LAIV not be used in these situations: Pregnancy Immunocompromised persons Children <5 with a history of asthma or wheezing Caregivers and contacts of personsrequirement a protected environment Persons who have received influenza antivirals within previous 48 hours * The ACIP recommends vaccination of persons with egg allergy. This differs from the FDA approved labelling for most influenza vaccines. MDPH

30 Precautions to Use of LAIV4 Some similar to other influenza vaccines: Moderate of severe illness with or without fever Guillain-Barré syndrome within 6 weeks following a previous dose of influenza vaccine Additional precautions specific to LAIV4 Asthma in persons aged 5 and older Other medical conditions that predispose to increased risk of severe influenza illness e.g., other chronic pulmonary diseases; cardiovascular disease (excluding isolated hypertension); renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus); MDPH

31 Influenza Vaccination of Persons with Egg Allergy Mostly unchanged, except that LAIV4 is an option Egg allergic persons can receive any licensed, recommended vaccine that is otherwise appropriate (IIV, RIV4, or LAIV4) RIV4 not licensed for persons <18 years For persons with a history of severe allergic reaction to egg (any symptom other than hives): The vaccine should be administered in an inpatient or outpatient medical setting, supervised by a health care provider able to recognize and manage severe allergic conditions. No specific post-vaccination observation period recommended ACIP General Best Practices guidelines: providers should consider observing recipients of any vaccine for 15 minutes to avoid injury due to syncope MDPH

32 Updated Licensure Changes Fluarix Quadrivalent (Standard-dose IIV4, GSK) Previously licensed for 3 years; in January 2018 expanded to 6 months One of three IIVs approved for children 6 through 35 months of age Dose volume is same for all ages (0.5mL) Afluria (IIV3, Seqirus) and Afluria Quadrivalent (IIV4, Seqirus): Previously licensed for ages 5 years and older In October 2018*, age indication expanded to ages 6 months and older Dose volume Ages 6 through 35 months: 0.25 ml Ages 36 months (3 years) and older: 0.5 ml * Please note, this change occurred AFTER the publication of the ACIP recommendations. Stay tuned for more guidance on this new labelling change. MDPH

33 IIVs for those 6 through 35 Months Two potential points of confusion Five licensed products, but the dose volumes differ: Fluarix Quadrivalent: 0.5mL FluLaval Quadrivalent: 0.5 ml Fluzone Quadrivalent: 0.25 ml Afluria : 0.25 ml Afluria Quadrivalent: 0.25 ml Dose volume is distinct from number of doses needed: A child aged 6 months through 8 years who needs 2 doses (e.g., a first-time vaccinee) and who gets 0.5mL FluLaval Quadrivalent for a first dose Still needs a second dose of influenza vaccine, 4 weeks later MDPH

34 Number of Doses for Ages 6 Months through 8 Years Guidance is same as last season Children in this age group who have not had 2 doses of trivalent of quadrivalent vaccine before July 1, 2018 need two doses in Previous doses can be from different/non-consecutive seasons. If two doses needed for , should be given 4 weeks apart. MDPH

35 Timing of Vaccination Vaccine should be offered by the end of October. Continue to offer vaccine as long as influenza is circulating and unexpired vaccine is available. Optimally, vaccination should occur before the onset of influenza activity in a community. Specific start time cannot be predicted. Balance concern for possible waning of vaccine induced immunity, unpredictable timing of the influenza season and programmatic considerations (e.g., missed opportunities, shorter vaccination window). Revaccination later in the season of persons who have already been fully vaccinated is not recommended. MDPH

36 Flu Vaccine Reduces Hospitalization in Pregnant Women Pregnant Women Review of medical records of 2 million pregnant women from 4 countries (Australia, Canada, Israel and US) over 6 flu seasons Getting a flu shot decreased a pregnant woman s risk of being hospitalized from flu by an average of 40%. First study to show vaccination protected against hospitalization. Previous studies showed a flu shot can reduce a pregnant woman s risk of flu illness and protect her newborn Other key findings include: Substantial hidden burden of flu among hospitalized women >80% of pregnancies overlapped with flu season,. Flu vaccine protective for pregnant women with underlying medical problems such as asthma and diabetes. Flu vaccine equally protective during all 3 trimesters. Strengthens Rationale for Maternal Vaccination MDPH

37 Make a Strong Recommendation CDC recommends the SHARE method SHARE the reasons why the influenza vaccine is right for the patient given his or her age, health status, lifestyle, occupation, or other risk factors. HIGHLIGHT positive experiences with influenza vaccines (personal or in your practice), as appropriate, to reinforce the benefits and strengthen confidence in influenza vaccination. ADDRESS patient questions and any concerns about the influenza vaccine, including side effects, safety, and vaccine effectiveness in plain and understandable language. REMIND patients that influenza vaccines protect them and their loved ones from serious influenza illness and influenza-related complications. EXPLAIN the potential costs of getting influenza, including serious health effects, time lost (such as missing work or family obligations), and financial costs. MDPH

38 Take Everyday Actions to Prevent the Flu 1. Avoid close contact. Avoid close contact with people who are sick. When you are sick, keep your distance from others to protect them from getting sick too. 2. Stay home when you are sick. If possible, stay home from work, school, and errands when you are sick. This will help prevent spreading your illness to others. 3. Cover your mouth and nose. Cover your mouth and nose with a tissue when coughing or sneezing. It may prevent those around you from getting sick. Flu and other serious respiratory illnesses, like respiratory syncytial virus (RSV), whooping cough, and severe acute respiratory syndrome (SARS), are spread by cough, sneezing, or unclean hands. MDPH

39 Flu Resources MDPH

40 MDPH Flu Website MDPH Flu Resources MDPH

41 Other MDPH Sources of Information Weekly and Blog MDPH sends out a weekly Flu Update updates about recent flu activity and associated guidance. If you are interested in receiving these flu updates, please Joyce Cohen (joyce.cohen@state.ma.us). MDPH also writes a weekly blog on flu activity that can be found at MDPH

42 CDC Main Flu Website MDPH

43 CDC Take 3 Campaign MDPH

44 The flu vaccine saves lives in children. The flu vaccine protects you and your baby. The flu vaccine is an important part of managing your chronic disease. The flu vaccine is part of your healthy lifestyle. MDPH

45 National Influenza Vaccination Week December 2-8, 2018 NIVW is a national awareness week focused on highlighting the importance of influenza vaccination. MDPH

46 Clinical Resources Vaccine Administration CDC Vaccine administration webpage for information and materials for health care personnel including IM demonstration video Job aids and infographics Shoulder Injury Related to Vaccine Administration MDPH

47 Vaccine Supply MDPH

48 Influenza Vaccine Supply The total projected supply in the U.S. this season is between 163 to 168 million doses of flu vaccine. Supply: MDPH state-supplied formulations: To find clinics near you, go to Health Map s Vaccine Finder: Private purchase at: Influenza Vaccine Availability Tracking System (IVATS) MDPH

49 MDPH Vaccine Supply Updates Massachusetts is fully universal for all routinely recommended ACIP vaccines. MDPH supplies Men B vaccine for high risk children years of age and VFC eligible patients years of age regardless of risk. High risk children currently includes full and part-time students, 18 and under, that attend one of the schools in the Five College Consortium influenza vaccine is available for sites to order. MDPH has a limited number of LAIV (FluMist) doses. MDPH

50 Hepatitis B Vaccine Shortage(1) Orders for single antigen hep B vaccine reduced 25% except for birth facilities Now anticipate shortage lasting into SPRING 2019 (Updated projection) Recommendations during the shortage: Prioritize the birth dose Prioritize vaccination of infants born to HBsAg-positive moms or unknown status recommendations unchanged If using Pentacel (DTaP-IPV/Hib) or single antigen vaccines consider: Deferring 3 rd dose of single-component HepB vaccine until later within the recommended range of 6-18 months of age for healthy infants born to HBsAg-negative mothers Transitioning to an all Pediarix (DTaP-IPV-HepB) schedule for all 3 doses in the DTaP primary series at 2, 4, and 6 months Substituting 1 or 2 doses of Pediarix for Pentacel in the DTaP primary series, as a temporary measure during the shortage If using Pediarix can continue the infant schedule with no change MDPH

51 Pediatric Hepatitis B Vaccine Shortage (2) Regardless of vaccine formulation(s) used, all providers should prioritize the birth dose and completion of the infant series over catch-up vaccination of older children and adolescents. In populations with high rates of childhood HBV infection (e.g., Alaska Natives, Pacific Islanders, and immigrant families from Asia, Africa, and countries with intermediate or high endemic rates of infection), the first dose of vaccine should be administered at birth and the final dose at age 6 12 months. For more information, see: MDPH Hep B Shortage Advisory CDC Pediatric Hep B Vaccination Guidance During the 2018 Supply Shortage Vaccine-Supply-Update-and-Guidance-Table.pdf CDC Current Vaccine Shortage Website For questions about vaccine ordering, please call the MDPH Vaccine Management Unit at For questions about the schedule, please call the Immunization Program at and ask to speak to an immunization epidemiologist or nurse. MDPH

52 MDPH Immunization Program Contact Information Immunization Program Main Number For questions about immunization recommendations, disease reporting, etc. Phone: Fax: Website: MIIS Help Desk Phone: Fax: Websites: MDPH Vaccine Unit Phone: Fax: Website: (click on Vaccine Management) MDPH