The Manitoba Seasonal Influenza Immunization Program Plan 2015-16 Interim Plan June 2015 Public Health Branch Public Health and Primary Health Care Division Manitoba Health, Healthy Living and Seniors (MHHLS)
Table of Contents I. Purpose...... 3 II. Important Program Dates...... 3 III. Eligibility Criteria...... 4 IV. National and Provincial Recommendations............. 5 V. Vaccine Products and Distribution...... 6 VI. Documentation....... 7 a. Adverse Events Following Immunization (AEFI) b. Data Entry MIMS c. Consent d. Storage and Handling Requirements VII. Communications........ 10 VIII. Evaluation............ 10 P a g e 2
I. Purpose The purpose of this document is to provide all immunization providers and regional health authorities (RHAs), including the First Nations and Inuit Health Branch (FNIHB), with the provincial program plan for the 2015-16 influenza (flu) season. II. Important Program Dates Summer: the National Advisory Committee on Immunization s (NACI s) Statement on Seasonal Influenza Vaccine for 2015-16 will be posted on the Public Health Agency of Canada (PHAC) website: www.phac-aspc.gc.ca/naci-ccni/index-eng.php. August 31 st : recommended date to return all unused flu vaccine from the previous (2014-15) season, as per the Vaccine and Biologics Return Policy and Procedure, available online at: www.gov.mb.ca/health/publichealth/cdc/div/docs/iabrpp.pdf. August 24 th : deadline for immunization providers and regions to submit their clinic dates, times and locations to Manitoba Health, Healthy Living and Seniors (MHHLS) for inclusion on MHHLS website and/or through Health Links-Info Santé. Please email information to: vacmda@gov.mb.ca. August / September: the updated seasonal flu website, (www.gov.mb.ca/health/flu/index.html) will go live; updated print materials including promotional/educational resources (e.g. factsheet, poster, brochure, etc.), data entry forms and order forms will be posted on the seasonal flu website. Late-September: MHHLS mails the annual pneumococcal polysaccharide 23 (Pneu-P-23) reminder letters to people turning 65 years of age who have never received a dose of Pneu-P-23 vaccine (excluding those who live in a personal care home). September/ October: Seasonal Influenza Management Protocol will be updated and available online at www.gov.mb.ca/health/flu/pro.html and www.gov.mb.ca/health/publichealth/cdc/protocol/index.html#i. If revisions are made to the protocol, MHHLS will email relevant stakeholders advising of the date in which the updated Protocol is available. 1 st week of October (exact date TBD): the 2015-16 Seasonal Influenza Immunization Campaign will formally begin. Please hold on publicly announcing within your region until this date. TBD: immunization providers can begin placing orders for flu vaccine; orders will be collected and shipped once product arrives in Manitoba (mid/late September); shipment will depend on priority provider types. P a g e 3
III. Eligibility Criteria The National Advisory Committee on Immunization (NACI) recommends flu vaccination for all individuals aged 6 months and older, with particular focus on people at high risk of influenza-related complications or hospitalization as well as people capable of transmitting flu to those at high-risk. For 2015-16, the seasonal flu vaccine is available free-of-charge to all Manitobans over 6 months of age. As with previous years, MHHLS is conducting a targeted, universal program with focus on those at increased risk of serious illness from the flu, their caregivers and close contacts. This includes:* Seniors aged 65 or older Residents of a personal care home or long-term care facility Health care workers and first responders Children 6 to 59 months of age Individuals of Aboriginal ancestry Those with chronic conditions, such as: o Cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma); o Diabetes mellitus and other metabolic disorders; o Cancer, immune compromising conditions (due to underlying disease and/or therapy); o Renal disease; o Anemia or hemoglobinopathy; o Conditions that compromise the management of respiratory secretions and are associated with an increased risk of aspiration; o Children 6 months to adolescents 18 years of age on long term acetylsalicylic acid (i.e. Aspirin) therapy; and, o Children and adolescents with neurologic or neurodevelopment conditions (including seizure disorders, febrile seizures and isolated developmental delay). People who are severely overweight or obese (BMI 40) Healthy pregnant women (the risk of flu-related hospitalization increases with length of gestation) International students and out-of-province visitors are eligible to receive the flu vaccine free-ofcharge regardless of third party insurance and/or MHHLS coverage. Please report all doses administered to non-manitoba residents by indicating on data entry forms, no PHIN. Manitoba children and adolescents 2 to 17 years of age are eligible to receive publicly-funded (i.e. free-of-charge) live attenuated influenza vaccine (FluMist Quadrivalent), provided they do not have any contraindications. For more information on FluMist Quadrivalent including a factsheet and screening questions, please access Manitoba s Seasonal Influenza Immunization Program website at: www.gov.mb.ca/health/flu/index.html. * Eligibility criteria is as per NACI s list of recommended recipients for the 2015-16 flu season for people at high-risk of influenza-related complications or hospitalization. For more information, please refer to NACI s 2015-16 Statement. P a g e 4
IV. National and Provincial Recommendations Every year, NACI releases an updated statement on seasonal flu vaccine. MHHLS and Manitoba s Provincial Vaccine Advisory Committee (PVAC) thoroughly review and examine NACI s annual statement in order to inform provincial recommendations and program details. The decision to include specific influenza vaccines as part of Manitoba s Seasonal Influenza Immunization Program depends on a multitude of factors such as cost-benefit and other programmatic and operational considerations. NACI s updated annual influenza statement for 2015-16 will be available online (www.phac-aspc.gc.ca/naci-ccni/index-eng.php). For the 2015-16 flu season, MHHLS supports the following key NACI recommendations: All people over 6 months of age are recommended to receive the seasonal flu vaccine. However, immunization programs should continue to focus on those at high-risk of influenza-related complications, those capable of spreading flu to individuals at high-risk of complications and those who provide essential community services. All influenza vaccines may be given at the same time as, or at any time before or after administration of, other live attenuated or inactivated vaccines. All children 6 months to 8 years of age who have not previously been immunized against influenza should receive 2 doses (0.5 ml/dose of quadrivalent inactivated vaccine (QIV); 0.1mL per nostril of quadrivalent live attenuated influenza vaccine (QLAIV)), with a minimum interval of 4 weeks between doses. If an individual has an egg allergy, they may still be able to receive the quadrivalent inactivated flu vaccine. Refer to NACI for flu delivery guidelines for egg allergic individuals. Those who are immunized and have egg allergies will need to be observed for at least 30 minutes postimmunization. Data is not currently available to support the use of FluMist Quadrivalent in eggallergic individuals. o Note: all influenza products are manufactured by a process involving chicken eggs, which may result in the vaccine containing trace amounts of residual egg protein. The use of FluMist Quadrivalent for healthy children and adolescents 2 to 17 years of age without contraindications. There is evidence for the preferential use of LAIV in young children (younger than 6 years of age) based on superior efficacy of LAIV compared to TIV, with weaker evidence of superior efficacy in older children. It is anticipated that the superior efficacy for LAIV over TIV extends beyond 6 years of age, but the evidence does not indicate at which specific age the efficacies of LAIV and TIV become equivalent. If QLAIV is not available, NACI recommends that QIV be used in this age group. o For children with immune compromising conditions and/or those with severe asthma or medically attended wheezing in the previous seven days, QIV should be used (as these conditions are a contraindication to QLAIV). For more information about provincial vaccine recommendations and program standards, please access Manitoba s Immunization Program Manual, available online at: www.gov.mb.ca/health/publichealth/cdc/div/manual/index.html. P a g e 5
V. Vaccine Products and Distribution As per the World Health Organization (WHO), all seasonal quadrivalent influenza vaccines for 2015-16 in the northern hemisphere contain: A/California/7/2009 (H1N1)pdm09-like virus; A/Switzerland/9715293/2013 (H3N2)-like virus; B/Phuket/3073/2013-like virus. B/Brisbane/60/2008-like virus. For the 2015-16 flu season, MHHLS is allotted quadrivalent inactivated vaccine (QIV), Fluzone Quadrivalent (Sanofi Pasteur), and quadrivalent live attenuated influenza vaccine (QLAIV) FluMist Quadrivalent (AstraZeneca), as part of the province s Publicly-Funded Seasonal Influenza Immunization Program. Fluzone Quadrivalent, for intramuscular injection, will be supplied in 10- dose, multi-dose vials (Thimerosal reduced) as well as single-dose, pre-filled syringes in packages of 10. As per the product monograph, once a multi-dose vial is punctured and kept stored at 2-8⁰C, Fluzone Quadrivalent can be used to the expiry date indicated on the vial. FluMist Quadrivalent is for intranasal administration only and is supplied in pre-filled single use glass sprayers containing 0.2mL of vaccine (FluMist Quadrivalent is also Thimerosal-free). (Note: FluMist Quadrivalent, as with Fluzone Quadrivalent, must be administered by a health care professional who is registered or licensed to provide health care under an Act of the Legislature and who is authorized under that Act to administer vaccines). Healthy children between 2 and 17 years of age should be offered FluMist Quadrivalent as it provides superior efficacy in children. It can also be offered to healthy people between 18 and 59 years of age who would otherwise decline immunization if only a needle option (Fluzone Quadrivalent) were available. For product information as well as other manufacturer-developed tools and resources, please visit the respective manufacturer s website: Sanofi Pasteur (Fluzone Quadrivalent): www.vaccineshoppecanada.com/document.cfm?file=fluzone_qiv_e.pdf AstraZeneca (FluMist Quadrivalent): www.astrazeneca.ca/en/our-medicines/en-products-az#reff Manitoba uses a mixed provider delivery model for the Manitoba Publicly-Funded Immunization Program, with pharmacists, physicians, physician assistants, nurses, nurse practitioners and public health nurses administering vaccines in private and public health settings. It is important for immunization providers to take this into consideration when they are ordering influenza vaccine because unused vaccines in an immunization provider s fridge cannot be returned and/or redistributed. MHHLS requests that immunization providers consider ordering based on the amount administered last year to reduce potential wastage. If additional doses are required, subsequent orders can be placed with the Provincial Vaccine Warehouse (at no penalty to the immunization provider). Where possible, immunization providers at the same facility should submit one order for flu vaccine (that covers all providers in the facility) to expedite orders and reduce the number of individual orders that are being shipped to one location. MHHLS will send a communiqué to immunization providers, advising of the start date for flu vaccine ordering; any orders received P a g e 6
before the start date will be discarded and the provider will be instructed to resubmit the order on or after the start date. To place an order for influenza vaccine, please submit an order online or via fax with the Vaccines and Biologics Order Form: www.gov.mb.ca/health/publichealth/cdc/protocol/vaccinebiologics.pdf, or through Panorama, if applicable. Provided flu vaccine manufacturers are on time as per contractual obligations with flu vaccine delivery to MB for the 2015-16 season, all flu vaccine orders will be prioritized as per the following three priority groups (ranked in priority order): 1. High-risk populations: First Nations communities, long term care facilities and hospitals. 2. Immunization providers: pharmacists, physicians, physician assistants, nurses, nurse practitioners and public health nurses. 3. Other populations / providers: schools, correctional facilities, etc. Within each of the three priority groups, orders will be processed in the sequence in which the order is received by the provincial vaccine warehouse (on or after the vaccine ordering start date). If one or more flu vaccine manufacturers fail to deliver flu vaccine on time, distribution could be substantially delayed. In the event that this occurs, MHHLS will communicate important flu vaccine distribution and delivery information to immunization providers in a timely manner. VI. Documentation a. Adverse Events Following Immunization (AEFI): In accordance with Manitoba s Public Health Act, health care providers are to report a reportable AEFI within seven (7) days of becoming aware of the AEFI (as per section 59 of The Act). Health care providers are required to report a serious AEFI (see below) within one (1) business day to MHHLS through the regional Medical Officer of Health (MOH) by telephone or email. A reportable AEFI is an event that: 1. Is temporally associated with a vaccine; 2. Has no other clear cause at the time of reporting; and, 3. Is either serious, of special importance or unexpected An AEFI is considered serious if any of the following criteria are met: Results in death; Is life-threatening, that is, where the patient was at real, rather than hypothetical, risk of death at the time of the event/reaction; Requires in-patient hospitalization, defined as any of the following: o Hospital stay lasting 24 hours based on known date/time of admission and discharge o Hospital stay involving all or part of two consecutive days (i.e. admission and discharge date are at least one day apart but specific time of admission is not specified) Results in prolongation of existing hospitalization; P a g e 7
Results in persistent or significant disability/incapacity (if known at the time of reporting); or, Is a congenital anomaly/birth defect. An AEFI is considered of special importance if it is any one of the following: Anaphylaxis Encephalitis (including SSPE) Acute disseminated encephalomyelitis Myelitis Aseptic meningitis / other meningitis (physician diagnosis) Guillain Barre Syndrome Acute cerebellar Ataxia Intussusception Thrombocytopenia (Brighton Collaboration diagnostic certainty level 1: platelet count <150 AND clinical signs/symptoms of spontaneous bleeding) Emerging signal event based on group consensus The foregoing list of Adverse Events of Special Importance (AESI) may be amended periodically based on emerging issues or generation of evidence that enables rejection of the hypothesis that vaccine and event are causally related. An AEFI is considered unexpected if any of the following criteria is met: Is not listed in the most current Health Canada-approved Product Monograph for vaccines marketed in Canada; and/or, Listed in the product monograph but is different in nature, severity, frequency, specificity or outcome. Generally speaking, when in doubt, report! Health care providers can submit completed AEFI reports to the regional MOH listed on Appendix A of the Reporting Form for Adverse Events Following Immunization. AEFI reporting forms can be found online at: www.gov.mb.ca/health/publichealth/cdc/docs/aefi_form.pdf. All MOH recommendations of an individual s AEFI should be recorded in the client s personal health record. MHHLS reviews all submitted AEFI reports. If a link is found between a possible adverse event and a vaccine, public health officials take appropriate actions to ensure the safety of patients. For more information on AEFI, visit: www.gov.mb.ca/health/publichealth/cdc/div/aefi.html. b. Data Entry: Every immunization provider, including the First Nations and Inuit Health Branch (FNIHB), must account for every dose of flu vaccine administered. All immunizations can be entered into the provincial immunization registry in one of two (2) ways: 1. Data entry by update users. P a g e 8
o All immunization providers, with the exception of pharmacists, submit the Seasonal Influenza and Pneumococcal Immunization Data Entry Form for MIMS available online at: www.gov.mb.ca/health/flu/docs/flu_surv10.pdf. NOTE: this form is currently being revised; an updated version will automatically replace it. A limited number of forms are available to order from the Materials Distribution Agency (MDA); once these forms have run out, MHHLS will not be printing more however the form will continue to be available online. (For more information, see section 8 - Communications). Note: public health may be able to enter vaccine information directly into Panorama. o Pharmacists complete and fax the Monthly Immunization Inputting Form for Pharmacists available online at: www.gov.mb.ca/health/publichealth/cdc/div/docs/miifp.pdf to 204-948-2204). NOTE: MHHLS is reviewing the current method of pharmacists submitting inputting forms for manual data entry by MHHLS; any changes to the current process will be communicated in a separate communiqué. 2. Automatically downloaded from the Physician Billing System. MHHLS provincial immunization registry is currently transitioning from the Manitoba Immunization Monitoring System (MIMS) to Panorama and therefore, the exact nature and format of monthly influenza reporting to regional public health is unknown at this time. Information pertaining to influenza reporting will be communicated as available. Weekly and end of season influenza surveillance reports for 2015-16 as well as the previous 6 seasons, can be accessed online at: www.gov.mb.ca/health/publichealth/surveillance/reports.html. c. Consent: As per MHHLS Informed Consent Guidelines for Immunization (updated April 2015) (www.gov.mb.ca/health/publichealth/cdc/protocol/consentguidelines.pdf), verbal and/or written consent must be obtained prior to immunization and must be documented via a consent form, medical chart or electronic health record. To assist with obtaining consent for influenza and Pneu-P- 23 immunizations, a Seasonal Influenza and Pneumococcal Vaccine Consent Form is available online at: www.gov.mb.ca/health/flu/docs/flupneumo_consentform.pdf and can be ordered from the Materials Distribution Agency (see section VII for more information). d. Storage and Handling Requirements: As with all vaccines and biologics, please refer to the online Cold Chain Protocol Immunizing Agents and Biologics and corresponding resources for all storage and handling requirements (www.gov.mb.ca/health/publichealth/cdc/coldchain.html). To report a cold chain break, please complete the online form available at: www.gov.mb.ca/health/publichealth/cdc/docs/ccf.pdf). P a g e 9
VII. Communications All promotional/educational resources (ex: factsheets, posters, brochures) will be available to order, free-of-charge, from the Materials Distribution Agency (MDA), and will also be posted on MHHLS seasonal flu website (www.gov.mb.ca/health/flu/index.html). Many of the resources from last year require updates; a communiqué will be sent out advising of when the updated resources are available. As with previous years, the Province will communicate with immunization providers, RHAs and FNIHB frequently throughout the summer to assist with planning and implementing provincial clinics. Generally, mass letters are faxed to all health care providers in June, advising of the general parameters of the Program (ex: universal, eligibility criteria) and then again in September, specifying the details of the program (resources, vaccine products and ordering, high-risk groups, etc.). The communiqué in September will include important information on when immunization providers can start placing their orders for flu vaccine. All provincial advertising and official program launch will commence around the first week of October (exact date TBD). VIII. Evaluation Health care providers including RHAs (Immunization Coordinators, Public Health Managers and Medical Officers of Health) may be contacted by MHHLS for feedback on this Program Plan and/or other influenza program planning activities coordinated by MHHLS. P a g e 10