Welcome to the CIC Education Hour

Transcription

1 Welcome to the CIC Education Hour

2 Protecting Mothers and Infants Through Maternal Immunizations

3 Objectives Describe the rationale for maternal immunization Outline current US maternal immunization recommendations for influenza and pertussis Explain the impact of maternal immunization on maternal and infant infection Discuss how vaccine uptake in pregnant women may be improved Identify resources for promoting and educating community and providers about importance of maternal vaccinations

4 Questions for Presenters? Ask Questions Here

5 Frequently Asked Questions 1. Will I be able to get a copy of the slides after the webinar? Yes a copy will be posted on the ImmunizeCA.org site 2. Will I receive a copy of the webinar recording? Yes - a copy will be posted on the Immunize.org site

6 C. Mary Healy, MD Infectious Disease Specialist, Infectious Diseases Section Associate Professor of, Baylor College of Medicine 6

7 Rebeca Montealegre Boyte Health Educator Supervisor, Information & Education Section California Department of Public Health, Immunization Branch 7

8 Maternal Immunization C. Mary Healy, MD Baylor College of Medicine Houston, Texas California Immunization Coalition August 23 rd, 2018

9 Disclosures Research Support: Centers for Disease Control and Prevention; Cancer Prevention Research Institute of Texas Consultant: Novavax Inc. Honoraria: Medscape, Up to Date Page 1

10 Which of the following best describe maternal immunization recommendations? A B C D E Influenza and pertussis vaccines are recommended during every pregnancy, regardless of prior receipt It is safe to give vaccines only in the second or third trimesters Additional vaccines may be recommended for pregnant women depending on individual risk Both A and C are true What maternal immunization recommendations? Page 2

11 Reality Pregnant women and their young infants are at risk from vaccine-preventable diseases (VPD) 1,2 Many VPDs are more severe in neonates and young infants than in other age groups 1,2 Neonatal immunization is a limited strategy 1 Variable immune responses due to immaturity Multiple doses of vaccine are still needed Disease can precede immunological response Maternal immunization offers the prospect of a 2 for 1 strategy 1,2 1 Clin Obstet Gynecol. 2012;55: Clin Infect Dis. 2014;59:560-8 Page 3

12 History of Maternal Immunization 1879: Vaccinia Virus 1938: Whole cell pertussis vaccine 1,2 1961: Tetanus vaccine 1,2 Millions of mother and infant lives saved Maternal and Neonatal Tetanus Elimination : Influenza vaccination 4 Protection of the woman 1 Clin Obstet Gynecol. 2012;55: Clin Infect Dis. 2014;59: Public Health Rep. 1964; 75:944. Page 4

13 Challenges Persist In resource-rich countries 1,2 Perceived risk versus benefit Licensing pathways are lacking Concerns about liability National Vaccine Compensation Program covers vaccineassociated injuries in mother/fetus Unfamiliar advocacy role for healthcare providers In resource-poor countries 1,2 Lack of trust in government Cultural barriers Although many medical contacts during pregnancy, not an established immunization platform 1 1 Clin Obstet Gynecol. 2012;55: Clin Infect Dis. 2014;59:560-8 Page 5

14 Mimicking Nature s Gift From N. Engl. J. Med, Zinkernagel RM, Maternal Antibodies, Childhood Infections, and Autoimmune Diseases, 345, Copyright Page (2001) 6 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society."

15 Safety (mother and infant) 1,2 Immunogenicity 1,2 Placental transfer 2 Optimal timing 2 Disease burden 2 Considerations Maternal > Infant Infant > Maternal Clin Obstet Gynecol. 2012;55: Page 7

16 Vaccines Recommended for All Pregnant Women 1 Inactivated Influenza Vaccine (IIV) Pertussis (Tdap in the US) Tetanus 1 Page 8

17 Vaccines Recommended For Pregnant Women In Special Circumstances 1 When risk of infection is high Underlying predisposing condition Travel to endemic area Outbreak Occupational or lifestyle exposure Examples include: Hepatitis A and B; Meningococcal PS; Pneumococcal PS; Rabies Cautiously recommended when risks are high IPV; anthrax; JE; Yellow fever 1 Page 9

18 Which of the following best describe maternal immunization recommendations? A B C D E Influenza and pertussis vaccines are recommended during every pregnancy, regardless of prior receipt It is safe to give vaccines only in the second or third trimesters Additional vaccines may be recommended for pregnant women depending on individual risk Both A and C are true What maternal immunization recommendations? Page 10

19 Which of the following best describe maternal immunization recommendations? A B C D E Influenza and pertussis vaccines are recommended during every pregnancy, regardless of prior receipt It is safe to give vaccines only in the second or third trimesters Additional vaccines may be recommended for pregnant women depending on individual risk Both A and C are true What maternal immunization recommendations? Page 11

20 Vaccines Recommended for All Pregnant Women Inactivated Influenza Vaccine (IIV) Pertussis (Tdap in the US) Tetanus Page 12

21 The following is true about influenza vaccination during pregnancy: A Live or inactivated influenza vaccine may be administered to pregnant women B Influenza vaccination during pregnancy is associated with a lower risk of preterm delivery and higher infant birthweight C There is a decreased risk of influenza in mother and infant D Influenza vaccine should not be administered to pregnant women who received a H1N1 influenza vaccine during the previous season E B and C are true Page 13

22 Influenza Recommendations 1 IIV should be administered to any woman who is or might be pregnant during the influenza season IIV may be administered at any time during pregnancy Live influenza influenza vaccine (LAIV) should not be administered during pregnancy 1 MMWR 2017; 66:1 20 Page 14

23 Maternal-Young Infant Influenza Burden of disease substantial fold increased risk of complications and death in pregnant women (typically in 2 nd and 3 rd trimester) If little maternal influenza-specific IgG, increased risk of complicated influenza in young infant 1-3 No infant vaccine until 6 months doses, 4 weeks apart (uptake is suboptimal) IIV recommended for all pregnant women uptake ~15% H1N1 pandemic ~50% 1 Clin Obstet Gynecol. 2012;55: Clin Infect Dis. 2014;59: MMWR 2016; 65:1 54 Page 15

24 Influenza and Pregnant Women Increased susceptibility to complications 1,2 Altered respiratory capacity Depressed cellular immunity Increased risk of hospitalization compared to non-pregnant women 1,2 During the 2009 pandemic, 20% of hospitalized pregnant women died 3 Increased risk of spontaneous abortion, preterm delivery, low birth weight infant MMWR 2016; 65: Clin Infect Dis. 2014;59: MMWR 2011;60:1193 Page 16

25 Safety Of Influenza Vaccine Fell et al. 1 reported 22,340 pregnant women who were given influenza vaccine; found that compared to the infants of unvaccinated women infants of vaccinated were less likely to be Small for gestational age (RR 0.9) < 32 weeks gestation (RR 0.73) Experience fetal death (RR 0.66) No increased risk for fetal anomalies when influenza vaccine given in pregnancy, including first trimester 2,3 Systematic reviews confirm these findings 4 1 Am J Public Health 2012;102:e33 2 JAMA 2012:308: J Pediatr. 2017;187: BJOG 2015;122:17-26 Page 17

26 Repeated Influenza Vaccination Case-control study over 2 influenza seasons comparing women with spontaneous abortions and women with livebirths 1 Doubling of risk of spontaneous abortion when mother received IIV within prior 28 days Larger effect seen in women who had received IIV in previous season Odds increased in older women 1 Vaccine 2017:; 35: Page 18

27 Repeated Influenza Vaccination 1,2 Effect was seen in only one season (the first) Six previous studies failed to find any association Effect of confounders other than age? Biological plausibility? How does a vaccine previous year affect current immune response in this window Cannot and should not be considered causal 1 Vaccine 2017:; 35: Page 19

28 Benefits of Maternal IIV Vaccine For Neonates and Infants Are Striking Reduces risk of prematurity by 40% 1 Reduces the risk of being small for gestational age 1 Reduces influenza-related hospitalization by 81-90% 2,3 Reduces influenza-like illness by 64% 3 1 PLOS Med 2011;8:5 2 Clin Infect Dis 2010;51: ; 137:e Page 20

29 The following is true about influenza vaccination during pregnancy: A Live or inactivated influenza vaccine may be administered to pregnant women B Influenza vaccination during pregnancy is associated with a lower risk of preterm delivery and higher infant birthweight C There is a decreased risk of influenza in mother and infant D Influenza vaccine should not be administered to pregnant women who received a H1N1 influenza vaccine during the previous season E B and C are true Page 21

30 The following is true about influenza vaccination during pregnancy: A Live or inactivated influenza vaccine may be administered to pregnant women B Influenza vaccination during pregnancy is associated with a lower risk of preterm delivery and higher infant birthweight C There is a decreased risk of influenza in mother and infant D Influenza vaccine should not be administered to pregnant women who received a H1N1 influenza vaccine during the previous season E B and C are true Page 22

31 Vaccines Recommended for All Pregnant Women Inactivated Influenza Vaccine (IIV) Pertussis (Tdap) Tetanus Page 23

32 Pertussis Recommendations Tdap should be administered during each pregnancy, preferably during weeks 27 through 36 gestation, regardless of history of prior receipt of Tdap (or Td) Giving Tdap earlier in the third trimester may maximize antibody transfer to the infant Tdap should be administered postpartum to women who have never received Tdap or whose vaccination history is unknown Infant contacts (father, family members, caregivers) should be brought up to date with recommended pertussis vaccines, ideally 2 weeks prior to infant contact MMWR Recommendations and Reports 2018 ; 67:1 44 Page 24

33 Pertussis A Poorly Controlled Vaccine-Preventable Disease Cyclical incidence with peaks every 3-5 years Immunity (natural and vaccine-induced) wanes Highly contagious Infection may be unrecognized atypical or asymptomatic in adolescents and young adults Improved detection methods Change to acellular pertussis vaccine? Variations in B. pertussis? Page 25

34 Worldwide Problem United States Australia England & Wales Portugal Page 26

35 Pertussis Infection Who Is At Risk? Images courtesy of vaccine.texaschildrens.org Page 27

36 Pertussis-related Mortality Who Is At Risk? Images courtesy of vaccine.texaschildrens.org Page 28

37 3 week old term-infant Page 29

38 Pertussis In Infants Infants too young to have completed the primary immunization series have up to 20 times higher risk of pertussis 1-3 Complications are highest in infants age < 6 months 1,4 Deaths occur almost exclusively in infants age < 3 months 1,2 1 JAMA 2003; 290:: ; 2 MMWR 2009; 57: Provisional Pertussis Surveillance Report ;121: Image courtesy of vaccine.texaschildrens.org Page 30

39 Pertussis In Young Infants 1,2 Hospitalized Pneumonia Seizures Encephalopathy Deaths 70% 60% 50% 40% 30% 20% 10% % < 6 mo 6-11 mo 1-4 yrs 5-9 yrs yrs 20 yrs Age MMWR 2002; 51:616-8 Image courtesy of the National Foundation for Infectious Diseases (NFID) Page 31

40 Maternal Pertussis Immunization Safe for mother and infant 1-5 Single center, managed care organizations, national surveillance system data Safe when repeated doses given 4 and when given with IIV 5 Immunogenic in randomized controlled trials and prospective cohort studies 6-12 Significantly higher antibody levels in infants at birth and through 2 months of age 6-12 Some studies show mild interference with infant response to the DTaP series, this appears to be clinically insignificant BMJ. 2014;349:g4219; 2 Hum Vaccin Immunother. 2015;11:2872-9; 3 JAMA. 2014;312: JAMA. 2015;314:1581-7; 5 Obstet Gynecol. 2015;126: JAMA. 2014;311: ; 7 Vaccine. 2016;34:151-9; 8 Vaccine. 2014;32: ; 9 Vaccine. 2016;34: Vaccine. 2015;33: Open Forum Infect Dis 2015; 2 (suppl Page Clin Infect Dis doi: /cid/ciy Clin Infect Dis. 2015;61: Clin Infect Dis. 2015;61:1645-7

41 England & Wales Starting October 2012, recommended that pregnant women receive Tdap in weeks gestation Uptake rates quickly reached approximately 60% Page 33

42 Effect On Infant Pertussis England & Wales 1 Infants < 3 months of age Vaccine Effectiveness* Maternal Vaccination at least 7 days before birth 91% (84-95) Infants < 3 months of age by timing of maternal immunization Maternal Vaccination at least 28 days before birth Maternal Vaccination at least 7 days before birth 91% (83-95) 91% (70-96) Maternal Vaccination 0-6 days before or 1-13 days after birth 38% (-95-80) Infants < 2 months of age Maternal Vaccination at least 7 days before birth 90% (82-95) * Vaccine Effectiveness % (95% Confidence Intervals) 1 Lancet 2014; 384: Page 34

43 Effect On Infant Pertussis California Prenatal Tdap more effective than postpartum Tdap in preventing infant pertussis 1 Timing of Prenatal Tdap VE * infants < 8 weeks VE * infants < 12 weeks weeks gestation 85.4% ( ) 71.7% ( ) Any time in pregnancy 63.8% ( ) 53% ( ) * Vaccine Effectiveness % (95% Confidence Intervals) More effective when given in 3 rd than in 2 nd trimester Infected infants of vaccinated mothers: 2 Were less likely to be hospitalized Had significantly shorter hospital stays Did not require intubation 1 Clin Infect Dis 2017;64:3-8 2 Clin Infect Dis 2017;64:9-14 Page 35

44 May Not Prevent Pertussis In Subsequent Infants Tdap-induced antibodies wane relatively quickly 1 Neonates and young infants can only rely on maternal antibodies for protection until active immunization 2 Serological correlates of protection are unknown but are likely higher in newborn infants than in immunized children and adults who can mount a robust immune response 2 1 Clin Infect Dis. 2013;56: Hum Vaccin Immunother. 2016;12: Page 36

45 Limitations of Maternal Tdap Current vaccines do not have optimal immunogenicity 1 Timing of immunization important in infant protection Current data suggest immunizing early in the third trimester is superior to later 2-4 Second trimester? 5 Durability of Tdap-induced maternal antibody in infants is not known 1 Lack of a serological correlate of protection 1 Vaccine uptake Effect on infant response 6 1 Hum Vaccin Immunother. 2016;12: Vaccine 2014; 32: Vaccine 2015; 33: Open Forum Infect Dis 2015; 2:S517 5 Clin Infect Dis 2016;62: Clin Infect Dis. 2015;61: Clin Infect Dis doi: /cid/ciy244 Page 37

46 Maternal Immunization Works! Reality Page 38

47 Why do you think pregnant women refuse to get vaccinated? A B C D E Fears about side effects Don t believe that it will work Failure to hear a strong recommendation from their provider Lack of time to get it organized It s complicated Page 39

48 Why do you think pregnant women refuse to get vaccinated? A B C D E Fears about side effects Don t believe that it will work Failure to hear a strong recommendation from their provider Lack of time to get it organized It s complicated Page 40

49 Reasons Vaccine Uptake in Pregnancy is not Optimal 1,2 Healthcare professionals perceive women do not want to be vaccinated during pregnancy Failure to hear a strong recommendation from the obstetrical care provider Inadequate education of OB care providers Time and confidence to discuss vaccination, reimbursement, vaccine ordering, storage 1 Clin Obstet Gynecol. 2012;55: Clin Infect Dis. 2014;59:560-8 Page 41

50 Reasons Pregnant Women Refuse Vaccines: The Influenza Experience 1,2 Safety risks to the baby The flu vaccine will give me the flu I don t think the vaccine is effective Safety risks to me The flu is not a serious illness 1 MMWR. 2011;60: Vaccine 2013; 31: Page 42

51 The Influenza Experience: Page 43

52 Motivation For A Healthy Pregnancy CDC: Public Health Image Library Page 44

53 Provider Recommendation Is Key Factors that influence a pregnant woman s ultimate decision regarding immunization (0=not important; 5=very important) Fear of shots Cost 5 Extra time for visit Adequate Information Safe for Me Safe for Baby 0% 20% 40% 60% 80% 100% 83% said they would receive a vaccine if their provider recommended it Adapted from: Vaccine. 2015;33: Page 45

54 Tips for Discussion Expect you will be successful! Bundled approach- this is routine obstetric care So, next visit you ll have your glucose tolerance test and Tdap Use direct, unambiguous language Don t hide behind jargon or qualified statements Share that vaccines are recommended by CDC, ACOG, ACNM and by you Be truthful Roll with resistance Answer questions and provide materials as needed It s an ongoing conversation Page 46

55 I recommend Tdap and flu vaccination for you and all of my pregnant patients, because vaccines are the best way to help protect you and your baby against whooping cough and flu which can be dangerous for you and your baby. Page 47

56 Your Tdap vaccine is due today. It s really important that you get immunized against whooping cough. Whooping cough is a serious disease that can cause young babies to stop breathing, get very sick or even die. By getting immunized, you are passing on protective antibodies to your baby. This vaccine is the best way to protect your baby against whooping cough in early life." This vaccine can protect you from the flu. Flu is more likely to cause severe illness for you because changes in your immune system, heart, and lungs during pregnancy make you more prone to severe illness from flu. Also, immunity from vaccination passes into your baby, protecting your baby against flu for the first several months after birth when they are too young to get vaccinated Page 48

57 The Reality About Uptake Pregnant women motivated to improve their health 1 Pregnant women are willing to get vaccines 2-8 Many opportunities for vaccine discussions (for example, 14 visits are recommended by ACOG) Influenza infection risks the health of mother and baby, but influenza vaccine does not Pertussis related deaths occur almost exclusively in infants 3 months of age Maternal immunization is safe and effective 1 Public Health Rep 2013;128:179; 2 Guidelines for Perinatal Care 7 th ed. 2012; 3 Vaccine. 2015;33: ; 4 Hum Vaccin Immunother. 2015:0. [Epub]; 5 Vaccine. 2013;31:3972-8; 6 Qual Health Res. 2015;25: ; 7 Hum Vaccin Immunother. 2013;9: ; 8 Vaccine. 2014;32: Page 49

58 Turning Nature s Gift Into Reality 1,2 Advocate Talk with patients directly Recommend and if possible provide vaccines Identify Paper or E-prompts Educate and Vaccinate Educate clinical and office staff Immunize staff, walk the walk! Integrate: Standing orders, documentation 1 ACOG committee opinion no. 558: Integrating immunizations into practice. 2 Obstet Gynecol. 2013;121(4): Images courtesy of the National Foundation for Infectious Diseases (NFID) Page 50

59 Reasons to establish a strong maternal immunization platform include A Pregnant women and young infants are more susceptible to certain vaccine preventable diseases B For some infections, passively acquired maternal antibodies represent the only protection an infant may have against infection C Some infants do not attend for well-child checks during the first year of life D E It reduces vaccine hesitancy in childhood A and B are correct Page 51

60 Reasons to establish a strong maternal immunization platform include A Pregnant women and young infants are more susceptible to certain vaccine preventable diseases B For some infections, passively acquired maternal antibodies represent the only protection an infant may have against infection C Some infants do not attend for well-child checks during the first year of life D E It reduces vaccine hesitancy in childhood A and B are correct Page 52

61 Conclusions Maternal Immunization to prevent neonatal infections is a reality There is hope for future prevention strategies through expansion of current maternal platform Real challenges exist : Understanding drivers of maternal-child health policy decisions Operational research into feasibility Need for expertise in diverse areas Funding Vaccines that benefit mother and infant are a win-win, 2 for 1 strategy Page 53

62 Pertussis 2018 Epidemics occur every 3-5 years Last epidemic was in 2014 Overall case counts continue to increase Most reported pertussis cases are among teens years of age Cases doubled from 2016 to 2017 Many outbreaks reported in high schools in 2017 Most severe disease outcomes are among infants <4 months of age One infant death reported for 2018 Incidence remains stable Reported as of August 12, 2018

63 Receipt of Prenatal Tdap by maternal characteristics MIHA, 2016* Available at: CID/DCDC/CDPH% 20Document%20Li brary/immunizatio n/miha- FactSheet2016.pdf *Maternal and Infant Health Assessment Survey 2016

64 Receipt of Prenatal Influenza by maternal characteristics MIHA, 2016* Available at: CID/DCDC/CDPH% 20Document%20Li brary/immunizatio n/miha- FactSheet2016.pdf *Maternal and Infant Health Assessment Survey 2016

65 Receipt of Prenatal Tdap, by insurance - MIHA, 2016 Available at: CID/DCDC/CDPH% 20Document%20Li brary/immunizatio n/miha- FactSheet2016.pdf

66 Location of Prenatal Tdap - MIHA, 2016 Where do women who received prenatal Tdap report being vaccinated? 85% at the clinic where they received prenatal care 7% at a pharmacy or supermarket 5% at a different doctor s office 3% at a unknown location Available at:

67 Medi-Cal Member Benefits Medi-Cal covers immunizations given at the prenatal care provider office If your managed care plan requires referral to patient s primary care provider, please contact Amber.Christiansen@cdph.ca.gov. All CDC-recommended adult immunizations, including prenatal Tdap and flu, are also a pharmacy benefit for Medi-Cal members If you don t stock Tdap, call your patient s pharmacy ahead of time to check if Tdap is in stock immunization clinic hours ensure your patient can get immunized there

68 Local Health Departments have access to Prenatal Tdap Starter doses Goal: To help prenatal care providers start to stock Tdap 25,000 doses purchased with one-time state funds. Select clinics that have significant number of Medi- Cal prenatal patients and don t currently stock Tdap for pregnant patients. To find out if your jurisdiction is participating, contact Rebeca.Boyte@cdph.ca.gov.

69 Patient Materials IMM-1145 Download from EZIZ.org IMM-1146

70 Helpful Resources to Make Strong Referrals IMM-1143 Order FREE from your Local Health Department IMM-887

71 Final Thoughts 8

72 Comments and Questions

73 Evaluation

74 Frequently Asked Questions 1. Will I be able to get a copy of the slides after the webinar? Yes a copy will be posted on the ImmunizeCA.org site 2. Will I receive a copy of the webinar recording? Yes - a copy will be posted on the ImmunizeCA.org site

75 Thank you for your support and your participation! 12