Update on Update on Maternal ImmunizationMaternal Immunization

November 7November 7thth, 2014, 2014

Richard H. Beigi, MD, MSc.Richard H. Beigi, MD, MSc.Associate Professor & Division DirectorAssociate Professor & Division Director

OB Specialties & Reproductive Infectious Diseases OB Specialties & Reproductive Infectious Diseases Magee-Womens Hospital of the Magee-Womens Hospital of the

University of Pittsburgh Medical CenterUniversity of Pittsburgh Medical Center

Potential COIPotential COIResearch site: Research site:

Novartis Vaccine and Diagnostics: Novartis Vaccine and Diagnostics: GBS Maternal Immunization StudyGBS Maternal Immunization Study

Novavax Inc.Novavax Inc.RSV Maternal Immunization StudyRSV Maternal Immunization Study

Sit on: Sit on: – NVAC MIWG, ACIP Pertussis WGNVAC MIWG, ACIP Pertussis WG

Consultant to (& Contracts with): Consultant to (& Contracts with): – NIH/NIAID, CDC, ACOG, AHRQ, BARDANIH/NIAID, CDC, ACOG, AHRQ, BARDA

Immunization Immunization

Advocacy for pregnant womenAdvocacy for pregnant women

OutlineOutline

Brief Background on ImmunizationBrief Background on Immunization

Maternal ImmunizationMaternal Immunization

InfluenzaInfluenza

TdapTdap

Ongoing policy/research considerationsOngoing policy/research considerations

SummarySummary

HistoryHistory

Jenner 1796 Jenner 1796 – 11stst attempt to control ID through deliberate attempt to control ID through deliberate

inoculationinoculation– Milkmaids –> cowpox…immune to smallpoxMilkmaids –> cowpox…immune to smallpox– Inoculated susceptible persons…no smallpoxInoculated susceptible persons…no smallpox

22ndnd to sanitation & H20 safety to sanitation & H20 safetyOverall disease preventionOverall disease prevention

10 major ID10 major ID’’s controlled extensivelys controlled extensively– Smallpox goneSmallpox gone– Other VPDOther VPD’’s nearly gones nearly gone

Courtesy: SA Plotkin:2006

ImmunizationImmunization

Defined: Defined: – Immunity artificially induced &/or providedImmunity artificially induced &/or provided

Active vs. PassiveActive vs. Passive– Active:Active: Induce body to produce lasting defenses against Induce body to produce lasting defenses against

infection – Vaccines – Ab (IgG)infection – Vaccines – Ab (IgG)Influenza, Hep A/B, HPV, etc. Influenza, Hep A/B, HPV, etc.

– Passive:Passive: Temporary protection given by exogenously Temporary protection given by exogenously produced/pooled Abproduced/pooled Ab

VZIG, HBIG, Placental transfer, etc. VZIG, HBIG, Placental transfer, etc.

Active Immunization highly effectiveActive Immunization highly effective– Most vaccines > 80-90% effective Most vaccines > 80-90% effective

Courtesy: SA Plotkin:2006

Conceptual Basis

Courtesy: SA Plotkin:2006

Conceptual Basis

Vaccine SafetyVaccine Safety

Numerous concerns raisedNumerous concerns raised– GBS, Thimerosol & Autism (multi-dose vials), GBS, Thimerosol & Autism (multi-dose vials),

Anaphylaxis…..Anaphylaxis…..– Storage concernsStorage concerns

IOM ReportsIOM Reports– Insufficient evidence to prove causation for most Insufficient evidence to prove causation for most

vaccine-related problemsvaccine-related problems

1986 – National Childhood Vaccine Injury Act1986 – National Childhood Vaccine Injury ActNational Vaccine Injury Compensation ProgramNational Vaccine Injury Compensation Program– VICPVICP

1990 Vaccine Adverse Events Reporting System1990 Vaccine Adverse Events Reporting System– VAERS – 1990 (CDC+FDA)VAERS – 1990 (CDC+FDA)

PregnancyPregnancyNo direct evidence: No direct evidence: – Risk to fetus with any vaccineRisk to fetus with any vaccine– Theoretical risk – R vs. BTheoretical risk – R vs. B

But…But…– Most live vaccine viruses Most live vaccine viruses ? Viremia ? Viremia

SAB risk greatest 1SAB risk greatest 1stst tri tri

– Avoid live virus vaccinesAvoid live virus vaccinesMMR, Varicella, LAIV, PolioMMR, Varicella, LAIV, Polio

– Avoided 1Avoided 1stst tri vaccination/IG tri vaccination/IGNot evidenced based Not evidenced based

Maternal immunization for newborn benefitMaternal immunization for newborn benefit– 11stst 6 months of life 6 months of life

Pregnancy Unique TimePregnancy Unique Time

Pregnant women motivated to improve healthPregnant women motivated to improve health Pregnancy motivates some to quit smokingPregnancy motivates some to quit smoking

Curry. Psych of Add Behav 2001;15(2)Curry. Psych of Add Behav 2001;15(2)

Frequent HC interactions: PNCFrequent HC interactions: PNC

Motivated to optimize fetus/neonatal outcomesMotivated to optimize fetus/neonatal outcomes Often preferentially over themselvesOften preferentially over themselves

Provider input key!Provider input key!

Maternal Immunization SuccessMaternal Immunization Success Neonatal TetanusNeonatal Tetanus

Substantial progressSubstantial progress 14145% of total neonatal death (5% of total neonatal death (‘‘93-93-’’03)03) 82 82 57 countries 57 countries ““not eliminatednot eliminated””

Maternal Immunization keyMaternal Immunization key WHO: Td during pregnancyWHO: Td during pregnancy

Rh Alloimmunization [Rho(D)] – 1970Rh Alloimmunization [Rho(D)] – 1970’’ss Previous 9-10% total pregnancies affectedPrevious 9-10% total pregnancies affected Now rare in Rh- women (<1% Rh- pregs)Now rare in Rh- women (<1% Rh- pregs)

Rubella post-partum immunization (CRS)Rubella post-partum immunization (CRS)

Vandelaer J. Vaccine 2003;21http://www.who.int/immunization_monitoring/diseases/MNTE_initiative/en/index2.htmlACOG Practice Bulletin #4: Prevention of RhD Alloimunization

Summary Summary 2009 H1N1 & Pregnancy2009 H1N1 & Pregnancy

Validated higher morbidity in pregnancyValidated higher morbidity in pregnancyHospitalization, Critical Care needsHospitalization, Critical Care needs

PTL/PTBPTL/PTB

Validated higher mortality (5-13 fold)Validated higher mortality (5-13 fold)

Validated:Validated:– Importance of influenza vaccine in pregnancyImportance of influenza vaccine in pregnancy

Influenza ImmunizationInfluenza ImmunizationMost promise for Influenza preventionMost promise for Influenza prevention– ImmunizationImmunization– + VE in pregnancy (@ 65% = general population)+ VE in pregnancy (@ 65% = general population)

TIV recommended:TIV recommended:USA: Surgeon General 1960, 1990s : during 2USA: Surgeon General 1960, 1990s : during 2ndnd and 3 and 3rdrd trimester trimester

– 2004 & ACOG: changed to any trimester, Essential PNC Element2004 & ACOG: changed to any trimester, Essential PNC Element

2005 WHO2005 WHOCDC 2010: All persons > 6 mos. ageCDC 2010: All persons > 6 mos. age

AllAll pregnant women in pregnant women in anyany trimester trimester

ACOG: Essential part of PNC (2004)ACOG: Essential part of PNC (2004)– New ACOG CO out September 2014New ACOG CO out September 2014

Stronger case for: Stronger case for:

– Ob Provider RecommendationOb Provider Recommendation– Safety dataSafety data– Neonatal BenefitNeonatal Benefit Thompson MG. CID 2014:58

ACOG CO #608:2014

Influenza vaccination rates during pregnancy, Canada and United States, 1974-2003

Authors, year (reference) PopulationStudyPeriod

Source of Vaccine Data

VaccinationRate (%)

Neuzil et al., 1998 (11) Medicaid population, United States

1974-1993 Medicaid database

<0.1

Mullooly et al., 1986 (10) Managed care organization, United States

1975-1979 Medical record review

<1*

Black et al., 2004 (18) Managed care organization, United States

1997-2002 Vaccine Registry

7.5

Munoz et al., 2005 (19) Clinic population, United States

1998-2003 Clinic Database

3.5

Silverman & Greif, 2001 (35) Hospital-based survey of postpartum women, United States

2000 Self-report 8

Tuyishime et al., 2003 (44) Hospital-based survey of postpartum women, Canada

2002 Self-report 2

NHIS,+ 2003 (34) Population-based telephone survey, United States

2003 Self-report 12.8

*Vaccination rate was 6% during the 1976 swine flu vaccination campaign+NHIS, National Health Interview Survey

Naleway AL. Epidemiol Rev 2006; 28

Influenza Vaccine in PregnancyInfluenza Vaccine in Pregnancy

Ob-Gyn national: 13% get vaccine (Ob-Gyn national: 13% get vaccine (CDC-MMWR;2005(54CDC-MMWR;2005(54))))– Yeager, et. al., Yeager, et. al., Am J PerinatolAm J Perinatol 1999;16:283-6 1999;16:283-6

* 71% were offered influenza vaccine accepted vaccination** 71% were offered influenza vaccine accepted vaccination*

Prior to 2009Prior to 2009– Nationally @ 15% pregnant women Nationally @ 15% pregnant women – 2009 H1N1 2009 H1N1 @ 50% @ 50%

– Sustained @ 50% sinceSustained @ 50% since

Healthy People 2020 Goal: 80%Healthy People 2020 Goal: 80%

CDC. MMWR 2010;59. ACOG. Obstet Gynecol 2004;104CDC. MMWR 2011;60. Ding H. AJOG 2011;204. CDC. MMWR 2010;59. D.Internet Panel Survey, 11-2013. www.cdc.gov

Influenza Vaccine SafetyInfluenza Vaccine SafetyIT IS SAFEIT IS SAFE– Collaborative Perinatal Project 1957-66Collaborative Perinatal Project 1957-66

NIH-sponsored longitudinal studyNIH-sponsored longitudinal study> 50,000 pregnant women immunized> 50,000 pregnant women immunizedoffspring followed for 7 years and assessed for congenital offspring followed for 7 years and assessed for congenital malformations, learning problems, hearing loss, and cancermalformations, learning problems, hearing loss, and cancer

– 2,291 doses TIV given2,291 doses TIV given – No significant increase in adverse reactions in mothers or infants No significant increase in adverse reactions in mothers or infants

– 252 pregnant women who received TIV within 6 months of delivery 252 pregnant women who received TIV within 6 months of delivery matched with 826 unvaccinated pregnant women matched with 826 unvaccinated pregnant women

No difference in pregnancy outcomesNo difference in pregnancy outcomes

– Estimated 2 million pregnant women vaccinated in 2000-03Estimated 2 million pregnant women vaccinated in 2000-03No unexpected adverse events reported to VAERS. No unexpected adverse events reported to VAERS. Three miscarriages reported, not known to be causally related to Three miscarriages reported, not known to be causally related to vaccinationvaccination

– >> 15-20 investigations – SAFE!! 15-20 investigations – SAFE!!Heinonen. Int J Epidemiol 1973;2:229-35Munoz Munoz Am J Obstet GynecolAm J Obstet Gynecol 2005;192:1098-1106 2005;192:1098-1106Pool V. Pool V. Am J Obstet Gynecol 2Am J Obstet Gynecol 2006;194:1200006;194:1200

Influenza Vaccine in PregnancyInfluenza Vaccine in PregnancyEffectiveness and ImmunogenicityEffectiveness and Immunogenicity

Pregnant women given TIV Pregnant women given TIV develop protective develop protective concentrations of anti-influenza concentrations of anti-influenza antibodiesantibodiesMaternal immunization increases Maternal immunization increases the amount of antibody the amount of antibody transmitted to infantstransmitted to infantsLimitations:Limitations:– Effectiveness of vaccine in Effectiveness of vaccine in

pregnant womenpregnant women– Exclusion from clinical trialsExclusion from clinical trials– Studies have not included Studies have not included

specific outcomes such as specific outcomes such as laboratory-confirmed influenzalaboratory-confirmed influenza

0200040006000

80001000012000140001600018000

ELIS

A Un

its

ControlH1N1

ControlH3N2

ControlB

H1N1 H3N2 B

Mother delivery Infant delivery Infant 2 mo

Antibody to influenza A and B in mothers and their infants Antibody to influenza A and B in mothers and their infants following maternal immunization with TIV or TT (control)following maternal immunization with TIV or TT (control)

Englund et al: J Infect Dis 1993;168:647-56

▀ Correlation between level of cord blood antibody and age at time of influenza A/H3N2 infection, suggesting protective effect (26 infants), Puck, et. Al., J Infect Dis 1980;142:844-9

▀ Infants of mothers with antibody to influenza A/H1 had delayed onset and decreased severity of influenza disease (39 mother-infant pairs), Reuman et al, PIDJ 1987;6:398-403

Transplacentally-acquired influenza Transplacentally-acquired influenza Antibody and Disease in InfantsAntibody and Disease in Infants

Transplacentally-acquired influenza Transplacentally-acquired influenza Antibody and Disease in InfantsAntibody and Disease in Infants

MotherMother’’s GIFT Studys GIFT Study

Conclusion:Conclusion: Maternal vaccination benefits: moms & babies < 6 mos old Maternal vaccination benefits: moms & babies < 6 mos old*NNT: 5 maternal vaccinations to prevent 1 case ILI in mom or infant*NNT: 5 maternal vaccinations to prevent 1 case ILI in mom or infant*NNT: 16 maternal vaccinations to prevent 1 proven flu illness in infant*NNT: 16 maternal vaccinations to prevent 1 proven flu illness in infant

RCT 340 moms 2004-05 Bangladesh½ influenza vaccine, ½ pneumococcal vaccine

316 M-I pairs: - 63% flu VE for babies - 30% less ILI for babies - 36% less ILI for moms

Zaman et al. NEJM 2008;359

Summary of BenefitsSummary of Benefits

Flu Maternal Immunization Flu Maternal Immunization

NEJM 2014;371:918-31(Matflu)NEJM 2014;371:918-31(Matflu)– South AfricaSouth Africa– HIV + and HIV- pregnant moms: HIV + and HIV- pregnant moms:

HIV (-)HIV (-)– 2116 pregnant women, trivalent flu vaccine, 2011-2116 pregnant women, trivalent flu vaccine, 2011-’’1212– 2x-blinded, Placebo-RCT, 2x-blinded, Placebo-RCT,

Safety & efficacy: mom/baby- 24 wks after birthSafety & efficacy: mom/baby- 24 wks after birth– PCR-confirmed influenzaPCR-confirmed influenza

Higher titers in moms/babies vaccine (p< 0.001)

VE: 48-50% (moms & babies)VE: 48-50% (moms & babies)

SAFESAFE

Summary of BenefitsSummary of Benefits

Influenza VaccineInfluenza Vaccine

Summary Influenza VaccineSummary Influenza Vaccine: : – Safe in pregnancySafe in pregnancy

Cont’d validation with all ongoing research Cont’d validation with all ongoing research

– Effective (mom and baby)Effective (mom and baby)Out to 6 months for neonateOut to 6 months for neonate

– ? Fetal benefits? Fetal benefits– * Strongly CE (cost-saving)* Strongly CE (cost-saving)

All pregnant women to receive All pregnant women to receive – Ob Provider Recc Key!Ob Provider Recc Key!

*Beigi et al. CID 2009;49

TdapTdap

Tetanus, Diptheria, PertussisTetanus, Diptheria, Pertussis

2 Toxoids and acellular pertussis2 Toxoids and acellular pertussis– Pertussis key Pertussis key

2 Tdap Vaccines since 2005: 2 Tdap Vaccines since 2005: – ADACEL (Sanofi) – licensed for ages 11-64ADACEL (Sanofi) – licensed for ages 11-64– BOOSTRIX (GSK) – licensed for ages 10-18BOOSTRIX (GSK) – licensed for ages 10-18– Both licensed for: Both licensed for:

Single-dose use to add protection against Pertussis Single-dose use to add protection against Pertussis and to replace the next booster dose of Tdand to replace the next booster dose of Td

Poorly control VPDPoorly control VPD

Pertussis (whooping cough)Pertussis (whooping cough)

Highly contagious (80-90%) respiratory Highly contagious (80-90%) respiratory infection caused by infection caused by Bordetella pertussis Bordetella pertussis

- 1906 isolation- 1906 isolation– Fastidious gram-negative coccobacillusFastidious gram-negative coccobacillus– Primarily a toxin-mediated diseasePrimarily a toxin-mediated disease

Outbreaks 1Outbreaks 1stst noted16th century noted16th century

Aerosol dropletsAerosol droplets

Estimated 294,000 deaths worldwide 2002Estimated 294,000 deaths worldwide 2002

Recent outbreaks (CA, WA)Recent outbreaks (CA, WA)

Why the Increase?Why the Increase?

Waning immunityWaning immunityWhole-cell to acellular component Whole-cell to acellular component

Better recognition, surveillance, and diagnostic Better recognition, surveillance, and diagnostic capabilitiescapabilities

Decreased vaccine coverage rates due to Decreased vaccine coverage rates due to vaccine concernsvaccine concerns

Variances in vaccine potencyVariances in vaccine potency

CDC. MMWR. 2006;55(30):817-821.

Pertussis trends 0-11 months of age

Tanaka M. JAMA. 2003 Dec 10;290(22):2968-75.

Pertussis DeathsPertussis DeathsPertussis Deaths in Infants Younger Than 1 Years of Age in 1938 – 1940 and 1990 – 1999 in the United States

1938 - 194024 1990 – 199925*

Age (mo) n % n %

0

1

2

3

4

5

6

7

8

9

10

11

396

1166

1061

791

646

515

502

458

447

417

361

363

5.6

16.4

14.9

11.1

9.1

7.2

7.0

6.4

6.3

5.9

5.1

5.1

35

33

12

4

3

2

1

3

0

0

0

0

38.0

34.8

13.0

4.4

3.3

2.2

1.1

3.3

0.0

0.0

0.0

0.0*Also personal communications with Dr. Tanaka.

Van Rie A. Pediatr Infect Dis J 2005;24

Which Family Members?Which Family Members?

Other25%

Mother32%

Father15%

Sibling20%

Grandparent8%

Bisgard KM, et al. Pediatr Infect Dis J. 2004;23:985-989.

Cocoon StrategyCocoon Strategy

2006 ACIP recommended Tdap 2006 ACIP recommended Tdap immunization of caregivers of newborn immunization of caregivers of newborn infantsinfants– Mothers post-partumMothers post-partum– Close contactsClose contacts– HCWsHCWs

Cocooning programsCocooning programsPostpartum women & household contactsPostpartum women & household contacts

– Labor intensive!Labor intensive!

Healy et al. CID 2011

Considerations for use of Tdap Considerations for use of Tdap in Pregnancyin Pregnancy

Safety in mothers and newbornsSafety in mothers and newborns

Immunogenicity of Tdap in Immunogenicity of Tdap in pregnancy/transplacental transfer of pregnancy/transplacental transfer of antibodyantibody

Interference by maternal antibodiesInterference by maternal antibodies

Programmatic considerationsProgrammatic considerations

VAERSVAERSJan 1 2005-Jun 30, 2010Jan 1 2005-Jun 30, 2010– 129 (1.2%) of 10,350 reports after Tdap involved administration 129 (1.2%) of 10,350 reports after Tdap involved administration

during pregnancyduring pregnancy4 (3.1%) classified as serious4 (3.1%) classified as serious

No deathsNo deaths

20 (15.5%) spontaneous abortion20 (15.5%) spontaneous abortion

6 (4.7%) gestational diabetes6 (4.7%) gestational diabetes

3 (2.3%) oligohydramnios3 (2.3%) oligohydramnios

3 (2.3%) toxemia of pregnancy 3 (2.3%) toxemia of pregnancy

2 (1.6%) congenital abnormality (gastroschisis, PDA)2 (1.6%) congenital abnormality (gastroschisis, PDA)

2 (1.6%) stillbirth2 (1.6%) stillbirth

– No unexpected pattern or unusual eventsNo unexpected pattern or unusual events

Liang, J. ACIP February 23, 2011

Maternal Tdap vaccination Maternal Tdap vaccination leads to higher Ab levels in leads to higher Ab levels in

infantsinfants

Geometric mean concentrations Geometric mean concentrations (GMCs) and % of placental (GMCs) and % of placental

transfer of Ab (n=196)transfer of Ab (n=196)

Antigen Maternal serum GMC (95%CI)

Cord Serum GMC (95% CI)

Placental transfer %

PT 9.9 (8.6-11.3) 16.2 (14.2) 164

FHA 21.5 (18.6-24.8) 34.8 (30.1-40.1) 162

PRN 13.5 (11.7-15.6) 17.1 (15.2-20.5) 131

deVoer RM. Clin Infect Dis 2009 Jul 1;49(1):58-64

Tdap in PregnancyTdap in Pregnancy

Apparent safetyApparent safety– No signals, no biologic plausibilityNo signals, no biologic plausibility

More cost effective during pregnancyMore cost effective during pregnancy– Protects mom earlier >> protection to neonateProtects mom earlier >> protection to neonate

2+ weeks for full Ab response2+ weeks for full Ab response

– Passive Ab – neonatal protection - critical timePassive Ab – neonatal protection - critical timeRemained robust in sensitivity analysisRemained robust in sensitivity analysis

MMWR 2011;60:41

Oct 2012 ACIP Tdap in Pregnancy Oct 2012 ACIP Tdap in Pregnancy RecommendationsRecommendations

Updated RecommendationUpdated Recommendation– Prenatal care providers implement Tdap immunization Prenatal care providers implement Tdap immunization

program (tetanus toxoid, reduced diphtheria toxoid and program (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine) for all pregnant women with acellular pertussis vaccine) for all pregnant women with EVERY EVERY pregnancy, irrespective of previous Tdap historypregnancy, irrespective of previous Tdap history

Guidance on UseGuidance on Use– To maximize maternal antibody response and passive To maximize maternal antibody response and passive

antibody transfer to infant, optimal timing for Tdap is at antibody transfer to infant, optimal timing for Tdap is at 27–36 wks gestation27–36 wks gestation. If not previously vaccinated or . If not previously vaccinated or given during pregnancy, administer immediately given during pregnancy, administer immediately postpartum.postpartum.

MMWR February 22, 2013 / 62(07);131-135

Efficacy DataEfficacy Data

UK data: [UK data: [CID Oct 2014 (Dabrera et al.)CID Oct 2014 (Dabrera et al.)] ] – Case-control, 2012-’13, babies Case-control, 2012-’13, babies << 8 wks 8 wks– N=113 (58,55)N=113 (58,55)– PCR and/or Culture dxPCR and/or Culture dx– Results: Results:

17% vs. 71% got maternal Tdap17% vs. 71% got maternal Tdap

VE: 93% (95% CI: 81-97%)VE: 93% (95% CI: 81-97%)

Safety data compiling: no signals notedSafety data compiling: no signals notedhttp://www.cdc.gov/vaccines/adults/rec-vac/pregnant/whooping-cough/research-materials/research.html

Current ACIP Reccs: Current ACIP Reccs:

Moniz & Beigi Hum Vaccin Immunother 2014;10www.cdc.gov

Immunization MisconceptionsImmunization MisconceptionsProminent with Flu Vaccine

Broughton, Beigi, et . Al. Obstet Gynecol 2009;114 Poor OB office staff knowledge & acceptance of flu vaccine - 1/3 don’t believe in vaccines - 36% think not safe in pregnancy, 65% recc to ob patient

What is the Flu Vaccine ?What is the Flu Vaccine ?Trivalent Inactivated Vaccine – TIV/QIV

- Flu Shot- 2 A’s + 1-2 B

Live-Attenuated Vaccine –LAIV- Flu Mist- Same strains

February each Year- Experts meet to select upcoming strains for next yr

Barriers Cont’dBarriers Cont’d

Safety ConcernsSafety Concerns

Needle issuesNeedle issues

Don’t believe susceptible to flu/pertussisDon’t believe susceptible to flu/pertussis

Not normalized to OB providersNot normalized to OB providers

$$$$

Comfort with interventionsComfort with interventions

Fear of litigation Fear of litigation

Etc., Etc., Etc. Etc., Etc., Etc.

Moniz & Beigi Hum Vaccin Immunother 2014;10

Overcoming BarriersOvercoming Barriers

Georgia and R.I. PRAMS Georgia and R.I. PRAMS – 2006-2007, X-sectional, Seasonal 2006-2007, X-sectional, Seasonal

– 18.4% & 31.9% vaccination rates18.4% & 31.9% vaccination rates

– RI: VaccinationRI: Vaccination

OR=56.6 (37.4-85.6) if HCP encouragedOR=56.6 (37.4-85.6) if HCP encouraged

MGH, 2009 H1N1 & SeasonalMGH, 2009 H1N1 & Seasonal– 370 (53%) PP women, survey370 (53%) PP women, survey

– 81% accepted both H1N1 & Seasonal81% accepted both H1N1 & Seasonal60% desire to protect self60% desire to protect self

60% Ob recommendation60% Ob recommendation

80% desire to protect baby80% desire to protect baby

Ahluwalia IB. Obstet Gynecol 2010;116Goldfarb I. AJOG 2011;204(S)

Complexity of Intervention Complexity of Intervention AcceptanceAcceptance

Moniz & Beigi Hum Vaccin Immunother 2014;10

Promoting Maternal AcceptancePromoting Maternal Acceptance

Moniz & Beigi Hum Vaccin Immunother 2014;10

5050

NATIONAL VACCINE ADVISORY COMMITTEE (NVAC)MATERNAL IMMUNIZATION WORKING GROUP (MIWG)

Federal Advisory Committee Recommendations for Overcoming Barriers to Maternal

Immunization

New Developments - ResearchNew Developments - Research

PhRMAPhRMA– New candidate vaccinesNew candidate vaccines

GBS, RSV, etc. GBS, RSV, etc.

NIH/NIAID/DMID:NIH/NIAID/DMID:– 2011 – Current: 2011 – Current:

““Research on vaccines and antimicrobials in Research on vaccines and antimicrobials in pregnancypregnancy””

Multidisciplinary: FDA, NIH, Industry, Academia Multidisciplinary: FDA, NIH, Industry, Academia

Delineated paradigm & recommendations for Delineated paradigm & recommendations for vaccine/antimicrobial trials in pregnancyvaccine/antimicrobial trials in pregnancy

SummarySummary

Influenza VaccineInfluenza Vaccine– High risk group, Safe, Neonatal protection High risk group, Safe, Neonatal protection – Fetal Protection, CE (Cost-Saving)Fetal Protection, CE (Cost-Saving)– Ob-GynOb-Gyn’’s: 13% in pregnancy 2008 s: 13% in pregnancy 2008

Improvement seen nationally (40-50%) 2013Improvement seen nationally (40-50%) 2013

Much room for growth (80% - HP 2020)Much room for growth (80% - HP 2020)

– Direct OB provider recommendation KEYDirect OB provider recommendation KEY

TdapTdap– Recommended in pregnancy 27-36 wksRecommended in pregnancy 27-36 wks– Neonatal protection (1Neonatal protection (10 0 < 2-4 mos)< 2-4 mos)

SummarySummary

Paradigm shift in OB immunization Paradigm shift in OB immunization – Exciting time for Maternal ImmunizationExciting time for Maternal Immunization

Demonstrated Success - past & presentDemonstrated Success - past & present

Ongoing changes occurringOngoing changes occurring– Recommendations & Expectations Recommendations & Expectations – PhRMA involvementPhRMA involvement– HHS policy/agendaHHS policy/agenda

Foundation for robust advancement Foundation for robust advancement