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VACCINATIONS IN PREGNANCY
Vivien Brown MDCM, CCFP, FCFP, NCMP Past President, Federation of Medical Women of Canada Board Member, Immunize Canada Assistant Professor, University of Toronto
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OBJECTIVES Counsel pregnant women about the role of influenza and Tdap vaccines during pregnancy Identify known barriers to uptake of vaccine during pregnancy Discuss some future directions of immunizations during pregnancy
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CLINICAL IMPORTANCE, KNOWN BENEFITS & SAFETY OF SELECT VACCINATIONS DURING PREGNANCY
Influenza and Pertussis
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INFLUENZA Among the top 10 leading causes of death in Canada
Every season → 10 % of pregnant women diagnosed with influenza ↑ Hospitalization 1 per 1000 pregnant women ↑ Cardiopulmonary complications ↑ Death H1N1 → 5% of deaths occured in pregnant women (1% of the population)
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INFLUENZA Pregnancy complications from maternal influenza infection
↑ Stillbirth and neonatal death, 51% reduction in rate of stillbirth among women who received the influenza vaccine ↑ Preterm birth ↑ Low birth weight infants ↑ Spontaneous abortion
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INFLUENZA VACCINE Recommended for all pregnant women
Primarily indicated for maternal benefits 30% reduction of febrile influenza-like illness Infant benefits → important consideration Infant < 6 months have the highest rate of pediatric influenza hospitalizations No influenza vaccines are licensed for this vulnerable age-group
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SAFETY OF INFLUENZA VACCINE IN PREGNANCY
Active studies of influenza immunization → no evidence of harm to mother or fetus Overall sample size small, especially in 1st trimester Passive surveillance of influenza immunization → no evidence of harm to mother or fetus Decades of use > 100,000 pregnant Canadian women > 488,000 pregnant European women Both adjuvated, unadjuvated and H1N1 vaccines Live attenuated influenza vaccine (FluMistⓇ) not recommended → theoretical risk Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for PHAC, Feb 2014.
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BORDUTELLA PERTUSSIS Respiratory pathogen
First recognized in the middle ages → “the kink” “Wooping cough”
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BORDUTELLA PERTUSSIS One of the top 10 causes of childhood mortality
294,000 pediatric deaths per year, globally Disproportionate burden of morality and morbidity 86% of pertussis-related deaths in infants < 4 months Review of pertussis admissions in Manitoba (n=42) between Proportion < 1.5y 100% Admitted to ICU 33% Required supplemental O2 60% Required intubation and ventilation 26% Mean length of intubation 6.3d (IQR 2-7d) Death 0% Wengiel M and Fanella S (2013) Can J Infect Dis Med Microbiol, 24(3):
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BORDUTELLA PERTUSSIS Whole cell pertussis vaccine introduced in 1943
Incidence of pertussis dropped 156/100,000 (1940s) → 2/100,000 (2011) Vaccine Description DTP/Whole Cell Pertussis Vaccine No longer really used Diptheria toxoid, tetanus toxoid and whole cell pertussis Dtap Acellular pertussis vaccine (also contains diptheria and tetanus antigens) → primary childhood vaccine series Tdap Acellular pertussis vaccine (also contains diptheria and tetanus antigens) → adolescent and adult booster
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INCIDENCE OF LABORATORY-CONFIRMED PERTUSSIS BY AGE GROUP, ENGLAND AND WALES, 1998-2012
Incidence per 100,000 persons aged <3 250 200 150 100 50 Amirthalingam (2013) Euro Surveillance 18:pii=20587
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BORDUTELLA PERTUSSIS IN CANADA: 2012
7x increase in national incidence 4800 cases nationally 104 hospitalizations (2-fold increase) 3 deaths (otherwise healthy) Several Canadian jurisdictions Incidence highest in infants 72.2 cases per 100,000 among infants < 4months
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SOURCE OF INFANT INFECTION?
Infections in adults are common. Household contacts are the major source of infection. Unvaccinated adolescents and adults Remotely vaccinated adolescents and adults Adult cases are not suspected, detected or reported Either Parent 52-58% Sibling 16-43% Non-household contact 4-22% Wiley et al (2013) Vaccine 13:
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MATERNAL VACCINATION Newborn antibody levels stratified whether mothers Tdap Outcome Antibodies Mother did not receive Tdap, mean (SEM) n=52 Mother received Tdap, mean (SEM) n=52 P valueª Dipheria 0.571 (0.157) 1.970 (0.291) < .001 Tetanus 4.237 (1.381) 9.015 (0.981) .004 PT (1.796) (2.768) FHA (4.022) (21.664) .002 PRN (5.765) (56.435) FIM 2/3 82.83 (14.585) ( ) FHA, filamentous hemagglutinin; FIM, fimbriae; PRN, pertactin; PT, pertussis toxin; TdaP, tetanus, reduced diphtheria, and acellular pertussis antigens vaccine. ª Significant at .05 level. Gall. Effect of maternal immunization with Tdap. Am J Obstet Gynecol 2011. Gall Sa, Myers J, Pichichero M (2011) AJOG, 204:344.e1-5.
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EFFICIANCY OF MATERNAL VACCINATION
A Case-Control Study to Estimate the effectiveness of Maternal Pertussis Vaccination in Protecting Newborn Infants in England and Wales, Gavin Dabrera₁₂₃, Gayatri Amirthalinga₃, Nick Andrews₄, Helen Campbell₃, Sonia Ribeiro₃, Edna Kara₃, Norman K. Fry₅, and Mary Ramsay₃ Cases Controls Total No. History of Maternal Pertussis Vaccination, No. (%) Total No. Unadjusted VE, % (95% CI) Adjusted VEª, % (95% CI) 58 10 (17) 55 39 (71) 91 (77-97) 93 (81-97) Dabrera (2015) CID 60(3): Amirthalingam et al (2014) Lancet, 384: 1521 – 1528.
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EFFECTIVENESS OF VACCINCATION DURING PREGNANCY TO PREVENT INFANT PERTUSSIS
Cohort study of 148,981 infants born at Kaiser Permanente Northern California Maternal Tdap > 8d prior to delivery Maternal Tdap post-partum No Maternal Tdap Followed for first year of life for estimates of vaccine efficacy of maternal Tdap vaccination 2 months 12 months Cases of pertussis defined by PCR detection of B. pertussis Baxter et al. Pediatrics; 2017, 139(5):e c
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EFFECTIVENESS OF VACCINCATION DURING PREGNANCY TO PREVENT INFANT PERTUSSIS
Year 2006 2007 2008 2009 2010 Births 30.715 32.569 31.536 31.307 30.465 Tdap Pregnancy 42 137 194 502 3634 Tdap Postpartum 186 983 2951 7604 9653 2011 2012 2013 2014 2015 31.255 32.066 31.743 32.869 34.777 7197 5334 13.953 26.294 30.395 7455 5355 3824 1553 609 Baxter et al. Pediatrics; 2017, 139(5):e c
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SAFE IN PREGNANCY AND Q2Y
Comprehensive review in most recent NACI guidelines Safety data of Tdap for pregnant women and the fetus are available: Several small studies and not RCT data US Vaccine Adverse Event Report System (VAERS) UK Clinical Practice Research Datalink (CPRD) Pharmaceutical registries (GSK and Sanofi Pasteur) Retrospective data from mass vaccination campaign of HCW provides evidence of vaccine safety with short internal with last vaccination (<2y) Kharbanda et al (2014) JAMA, 312(18):
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CURRENT RECOMMENDATIONS AND UPTAKE OF MATERNAL IMMUNIZATIONS IN CANADA
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INFLUENZA 2016-2017 NACI STATEMENT Recommended for all pregnant women
Adults and children with chronic medical conditions People residing in a nursing or chronic care homes People ≳ 65 years of age Children 6-59 months Aboriginal peoples NACI (2016) Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine. PHAC, 2016
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PERTUSSIS 2014 NACI STATEMENT
Universal immunization of pregnant women is not recommended given current epidemiology of pertussis in Canada Depending on regional epidemiology, immunization with Tdap may be offered during pertussis outbreaks in women ≳ 26 weeks gestation, irrespective of their immunization status If an adult dose of Tdap has not been given, pregnancy is an ideal time to evaluate vaccine history and give the adult dose NACI (2014) Update on Pertussis Vaccination in Pregnancy. PHAC, Feb 2014.
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BARRIERS TO IMMUNIZATION DURING PREGNANCY IN CANADA
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PREGNANT WOMEN BARRIERS TO IMMUNIZATION SYSTEM ISSUES HEALTH CARE PROVIDERS
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BARRIERS TO VACCINATION IN PREGNANCY
BARRIERS FOR HEALTH CARE PROVIDERS RECOMMENDING VACCINES Lack of knowledge/education Concerns of vaccine safety and insufficient testing in pregnancy Misperceptions of risk of the disease and disease severity Physician in solo practice Ambiguous guidelines Lack of time Risk of blame if adverse event occurs Inability to track vaccine status of their pregnant patients Uncertainty of who bears responsibility for vaccination discussions Not usual practice to vaccinate MacDougall DM and Halperin SA (2016) Human Vaccines & Immunotherapeutics 12:4,
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PROVIDERS IN 2004 40% → not aware of clinical importance of influenza for pregnant women Factors associated with recommending the influenza vaccine to pregnant women: Provider knowledge Positive attitude toward the influenza vaccine Increased phsycian age Family phsycian Personally been vaccinated OB FP P-Value Discuss 87% 97% 0.02 Recommend 70% 91% 0.002 Provide 13% 86% <0.001 Tong, et al (2008) JOGC 30(5):
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PROVIDERS IN 2015 Midwives were less likely to offer the influenza vaccine Not allowed to administer the vaccine themselves in QC Factors associated with recommending the influenza vaccine to pregnant women: Older age Higher numbers of follow-ups per year Academic practice Desjardins (2016) Poster Presentation SOGC Annual Meeting
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IMPORTANCE OF PHYSICIAN DISCUSSIONS
Having had a physician discussion about the influenza vaccine was associated: More frequent correct responses to knowledge questions Annual receipt of the influenza vaccine Positive attitudes toward influenza vaccination Halperin (2011) Human Vaccines & Immunotherapeutics; 10(12):
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BARRIERS TO VACCINATION IN PREGNANCY
BARRIERS FOR PREGNANT WOMEN RECEIVING VACCINES Lack of recommendation to receive the vaccine Perceived risk of disease and disease severity Concern about vaccine effectiveness Concern about vaccine safety Time to get the vaccine Fear of needles Religion Social family influences Previous adverse reaction
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BARRIERS TO VACCINATION IN PREGNANCY
SYSTEM BARRIERS Reimbursement Liability Compliance with reporting Access to care Ineffective dissemination of information from clinics to patients Cost of vaccine to patients Cost of administering vaccines in clinic Workload/lack of staff Vaccine tracking
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WHAT’S ON THE HORIZON FOR MATERNAL IMMUNIZATION?
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GROUP B STREPTOCOCCUS (GBS)
Colonization ~ 1/5 pregnant women Several recently published vaccine trials Monovalent and trivalent polysaccharide conjugate vaccines of serotypes la,lb,lll There are major serotypes causing infant GBS in Europe/North America RCT of trivalent conjugate vaccine in Belgium and Canada, 86 women/infants Vaccine was immunogenic and safe with good Ab titers in mothers/infants and no safety concerns
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RESPIRATORY SYNCYTIAL VIRUS
Leading cause of viral acute LRTI Lead to high morbidity in infants < 6 mos In different studies: 2-3% of all neonatal deaths due to RSV 20% of hospitalizations in children < 5 due to RSV during winter months Vaccine in pregnant could over neonatal protection
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CONCLUSIONS Influenza vaccine is universally recommended during pregnancy Maternal health Fetal health Infant Health Tdap during pregnancy is safe and likely reduces the incidence of pertussis among young infants Canadian recommendations → under review Barriers at the level of the patient, provider and system This issue is not going to go away GBS vaccine trials RSV vaccine trials
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Vaccination In Pregnancy: What You Need to Know
Household and close neonatal contacts Vaccinate all Promote safety cocoon for upcoming newborn Influenza Consider Oseltamivir 75mg BID x 5 days Tetanus, Diptheria, Pertussis ( CDC) Vaccinate All : in 3rd trimester Provides passive immunity. Most deaths from whooping cough are in those babies too young to receive vaccination. Pneumococcus Vaccinate if High Risk Zika Vaccination in development. Recommend mosquito protection, barrier protection Hep A No apparent risk Use in high risk situation only Hep B Vaccinate Recommended for pregnant women at risk, no apparent fetal risk Japanese Encephalitis No safety data Only provide if benefit >risk (travel to high endemic area) Rabies No indication of fetal effects Provide post-exposure prophylaxis Tdap Risk Dependent Typhoid Risk dependent Consider provision in high risk cases HPV Not routine No evidence Meales, mumps, rubella No known effects but theoretical risk of PTL, LBW Typhoid Oral Use inactivated only Varicella If mother exposed, consider immunoglobulin. Yellow Fever Exposed fetuses have shown no complications
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Quick Facts 1.Are the Vaccines Safe: Yes, inactivated viral, bacterial and toxoid vaccines can be used safely in pregnancy. The most common reactions are local erythema or swelling 2. If women receive a live or live-attenuated vaccination or otherwise in pregnancy they should not be counseled to terminate the pregnancy due to teratogenic risk 3. Live Vaccines in Pregnancy only present a theoretical risk to the fetus. They are not contraindicated if woman is at high risk of exposure. A discussion of the risk and benefit should occur. For instance a study of 304 women exposed to yellow fever immunization did not show increase in major fetal malformation. 4. Can I breastfeed? Women who are immunized can still breastfeed. This includes passive-active, live and non-live vaccinations. 5. If a non-pregnant woman receives a live or live-attenuated vaccination, she should delay pregnancy for 4 weeks. 6. Household contacts can be safely vaccinated and in fact should be vaccinated to promote a cocoon immunization effect similar to herd immunity. 7. The following are not contraindications to vaccination: Breastfeeding, low grade fever, autoimmune disorder, household contact with pregnant women, prior reaction to immunization, personal history of allergies or anaphylaxis to egg protein/neomycin/streptomycin, positive TB skin test.
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Acknowledgements Dr. Mark Yudin and Dr. Vanessa Poliquin for their work on this presentation originally given at the SOGC meetings June 2017 Dr. Pam Liao and Dr. Pretty Verma for their work on the “Cocoon Effect, Evaluating Vaccine in Pregnancy”
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