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Immunization Recommendations Pregnant and Breastfeeding Women Natali Aziz, MD, MS Department of Obstetrics, Gynecology and Reproductive Sciences University of California at San Francisco Antepartum and Intrapartum Management June 5, 2008 Opportunity for Immunization during Pregnancy In the US, ~ 4 million live births each year In the US, >98% of women have at least 1 prenatal visit – Health care opportunity for vaccination! – Immunization effective in pregnant women Protection for – Pregnant woman – Fetus – Neonate – Young infant Obstetric Immunization Challenges Limited well-controlled studies in pregnant cohorts Theoretical concerns about efficacy Theoretical concerns about safety in pregnancy/BF – Vaccine type (e.g., live vaccines) – Additives/adjuvants/preservatives (e.g., thimerosal) – Timing of vaccination Interruption of breastfeeding Impaired newborn/infant immune response to childhood series concerns Lack of harmonization with FDA labels and indications Public perception/risks and legal liability Logistic issues for office-based practice ACIP April 2008 Overview Immune Considerations during Pregnancy Types of Immunizations Immune Globulins Immunization Recommendations – Prior to Conception – During Pregnancy – Postpartum Special Considerations – Traveling during Pregnancy – Immunocompromised Pregnant Women – Vaccine Controversy Summary Immune Considerations in Pregnancy Pregnant women – Altered immune response – Increased risk of some infections – Increased risk of severe outcomes of some infections Fetus, newborn, infant – Immature immune response – Increased risk of some infections – Increased risk of severe outcomes of some infections – Infection sequelae can result in lifelong disability Immunization Types Inactivated vaccines, toxoids, immune globulins – No evidence of harmful effects on fetus/pregnancy – Generally considered safe in pregnancy Live Vaccines – – – – – Theoretical risk of infecting fetus No reports of teratogenicity or classic congenital infections!!! Subclinical infections reported Use discouraged during pregnancy unless high risk Administration during/within 4 wks of pregnancy DOES NOT warrant termination Counsel patient about potential theoretical risks Lack of cases demonstrating harmful effects to fetus! Vaccinations: Inactivated Considered safe if otherwise indicated – Hepatitis B – Influenza – Meningococcal (MPSV4) – Rabies – Tetanus and diphtheria toxoids (Td) CDC May 2007: Guidelines for Vaccinating Pregnant Women Vaccinations: Live-Attenuated Contraindicated during pregnancy or safety not established – – – – – – – – BCG* Influenza* (LAIV, FluMist- intranasal) Measles* Mumps* Rubella* Vaccinia* Varicella* Zoster* *Live, attenuated vaccine. CDC May 2007: Guidelines for Vaccinating Pregnant Women Vaccinations: Special Considerations Special Recommendations – – – – – – – – – – – Anthrax Hepatitis A HPV Japanese encephalitis Meningococcal (MCV4) Pneumococcal Polio (IPV) Typhoid (parenteral and oral Ty21a*) Vaccinia* (high risk exposure only) Yellow fever* Tdap/Pertussis (acellular) *Live, attenuated vaccine. CDC May 2007: Guidelines for Vaccinating Pregnant Women Immune Globulins Considered safe if otherwise indicated – Post-exposure prophylaxis same in pregnancy Hepatitis A and B Measles Rabies Tetanus – Varicella PEP recommended in pregnancy Varicella-zoster immune globulin (VZIG) Purified human immune globulin (VariZIG) Immune globulin intravenous (IVIG) Immunizations Prior to Conception Human Papillomavirus Indication: Girls/women aged 9 to 26 years old Timing: Preconception Dosing: 3-dose series – 0, 2, 6 months Quadrivalent inactivated viral vaccine – HPV 6, 11, 16, 18 – Duration of immunity unknown Category B Animal studies – 300x human dose – No impaired fertility or fetal harm in rats Human studies – Limited safety evidence in pregnancy – No difference in congenital anomalies/SAB in vaccine-exposed pregnancies Use in pregnancy not recommended – despite category B Merck 2006; ACIP 2007; ACOG 2007 Measles, Mumps, Rubella Indication: No evidence of immunity to rubella – Immunity determined by rubella IgG antibody titer or vax documentation – Determination of measles/mumps immunity not needed Timing: Preconception Dosing: Single-dose in low-risk and 2-dose in high-risk women – MMR versus rubella vaccination recommended!!! – 0 and 1 month for individuals at high risk for mumps/measles Live-attenuated vaccine – Immunity: rubella 90% >15 years, ?lifelong; measles 99% lifelong; mumps 75-95% >30 years No rubella congenital defects reported in offspring of women vaccinated just before or during pregnancy! Avoid conception for 28 days after administration Use in pregnancy not recommended – Termination not recommended for inadvertent exposure MMWR 1989; ACIP 1989, 2006; Bar-Oz 2004; Badilla 2007 Varicella Indication: No evidence of immunity to varicella – Immunity determined by varicella IgG antibody titer, vaccination documentation, or clinical history verification Timing: Preconception Dosing: 2-dose series – 0 and 4-8 weeks Live-attenuated vaccine No varicella congenital defects reported in offspring of women vaccinated just before or during pregnancy! Immunization of close contacts of pregnant women safe Avoid conception for 28 days after administration Use in pregnancy not recommended – Termination not recommended for inadvertent exposure Zoster (live) vaccine not recommended in pregnancy ACIP 2006 Tetanus, Diphtheria, Pertussis (Tdap) Indication: No previous dose of Tdap and > 2 years elapsed since last dose of Td Timing: Preconception (Postpartum) Dosing: Single-dose series – Then resume Td series Q 10 years Tetanus and diphtheria toxoids Acellular pertussis inactivated vaccine Limited safety and immunogenicity data in pregnancy! Use in pregnancy not recommended – Termination not recommended for inadvertent exposure ACIP 2005, 2008 Immunizations During Pregnancy Tetanus and Diphtheria Indication: – Not received Primary Td 3-dose series – Last Td booster > 10 years ago – Major/contaminated wound and last Td booster > 5 years ago Timing: Pregnancy (any trimester!) Dosing: – Primary series/3-dose: 0, 1 month, 6-12 months – Booster/Single-dose series Q 10 years – Booster/Single-dose if major/contaminated wound and last Td > 5 years ago; then resume booster/single-dose Q 10 years Tetanus and diphtheria toxoids May consider deferring until PP to administer Tdap if sufficient tetanus protection during pregnancy ACIP 2008; MMRW 2008 Influenza Indication: Influenza season (October-May) Timing: Pregnancy (any trimester!) Dosing: Single-dose series Infection associated with morbid infection during pregnancy Use inactivated vaccine for pregnant women No adverse fetal effects or pregnancy outcomes! Intranasal vaccine (LAIV, FluMist): live-attenuated – NOT recommended for use in pregnant women!!! California mandate of thimerosal-free vaccine for pregnant women Harper 2004; Munoz 2005; Pool 2006 Hepatitis B Indication: Completing hepatitis B vaccination series or at high risk for acquiring infection Timing: Pregnancy Dosing: 3-dose series – 0, 1-2, 4-6 months Inactivated vaccine No adverse fetal effects or pregnancy outcomes! Hepatitis B Efficacy – >80% efficacy after 3 doses in general population – 49% after 2 of 3 doses (HIV-negative pregnant women) vs. 59-70% in non-pregnant Factors assoc with failure to seroconvert (pregnancy) – Smoking OR 7.5 (2.0-27.7) – BMI 34 OR 16.2 (1.7-154.7) – Age 25 year-old OR 3.9 (1.1-14.4) Pre-vaccination testing (anti-HBc Ab) – Cost-effective if prevalence > 20% Post-vaccination testing for certain groups/revax prn Double dose in immunocompromised Levy 1991; Ingardia 1998; CDC 2005 Hepatitis A Indication: Completing hepatitis A vaccination series, PEP, or at high risk for acquiring infection Timing: Pregnancy Dosing: 2-dose series – 0 and 6-12 months (Havrix) or 0 and 6-18 months (Vaqta) Inactivated vaccine Pre-exposure and Post-exposure prophylaxis Pre-vaccination testing recommended in select group Post-vaccination testing not recommended – 94-100% effective Limited safety data in pregnancy – No adverse fetal effects or pregnancy outcomes reported ACIP 2007 Immunizations Postpartum Postpartum Immunization Vaccinations – – – – – – MMR Varicella Tdap Influenza Hepatitis A and B HPV Anti-D-immune globulin does not generally reduce the response to MMR or varicella vaccines – CONSIDER serologic testing 6-8 weeks after vaccination to assure that seroconversion has occurred May administer multiple vaccines at same time Inactivated and live vaccines are safe in breastfeeding – Exception: smallpox vaccine! – Breastfeeding does not adversely affect vax success/safety Special Considerations Pneumococcal Indication: High risk individuals – Chronic diseases or immunocompromised Timing: Preconception, pregnancy, postpartum Dosing: Single series – *Immunocompromised*: single revaccination if > 5 years since receipt of first dose Inactivated vaccine Limited safety data in pregnancy – No reported adverse events MMWR 2005 Pregnant Patient with Splenectomy Indication: Splenectomy Timing: Preconception, pregnancy, postpartum – Ideally 14 days prior to procedure Vaccines – – – – Pneumococcal H. influenzae Meningococcal (MPSV4) Influenza Dosing: – H. influenzae and Meningococcal (MPSV4)- Single series – Pneumococcal- Single revaccination > 5 years from first dose – Annually: Influenza ALL inactivated vaccines Immunocompromised/HIV + Pregnant Women Per routine pregnancy recommendations – MMR, Tdap, and influenza Routinely recommended – Hepatitis A, Hepatitis B, pneumococcal – Double Hepatitis B dose! Not recommended unless indicated otherwise – Meningococcal and H. influenzae Use live-attenuated vaccines cautiously – MMR not recommended in severely immunocompromised (CD4 <200) – Varicella vaccine generally not recommended, especially in severely immunocompromised (CD4 <200) Avoid vaccinations in 3rd trimester due to possible viral load increase! Traveling During Pregnancy Yellow Fever Indication: Travel to endemic area – Waiver letter required during pregnancy Timing: Avoided during pregnancy if possible – Avoid pregnancy for 4 weeks after vaccination Dosing: Single series Live-attenuated vaccine Limited safety data in pregnancy – No increase in adverse pregnancy outcomes – No in crease in congenital anomalies Robert 1999; ACIP 2002; Cavalcanti 2007 Traveling During Pregnancy Poliovirus Indication: Travel to endemic area Timing: Avoided during pregnancy if possible Dosing: Primary or single booster series – Primary/3-dose series: 0, 1-2 months, 6-12 months – Booster/single dose if immunized Inactivated vaccine (IPV) Limited safety data in pregnancy Traveling During Pregnancy Typhoid Indication: Travel to endemic area Timing: Avoided during pregnancy if possible Dosing: Single series Inactivated vaccine Limited safety data in pregnancy Other Vaccines Miscellaneous Rabies – Inactivated vaccine – Pre- and post-exposure prophylaxis deemed safe Japanese encephalitis, plague, cholera – Inactivated vaccines – May be considered in pregnancy Anthrax – Inactivated vaccine – Vaccination in pregnancy recommended in high risk Malaria – Vaccines in development Bacillus Calmette Guerin (BCG) – Live-attenuated vaccine – Not recommended in pregnancy – No harmful effects demonstrated Smallpox (Vaccinia Virus) Contraindicated during pregnancy – Any trimester and breastfeeding period – Within 28 days of conception – Close contacts Live-attenuated vaccine Not associated with teratogenicity “Fetal or neonatal vaccinia infection” – Rare (<50 cases), but lethal – Vaccinia IG not recommended for fetal infection treatment Case reports of maternal transmission to fetus or infant via breast milk following vaccination – Stop breastfeeding until area heals if vaccination indicated!!! Wharton 2003; Garde 2004; ACIP 2001; MMRW 2001; CDC 2007 Vaccine Controversy Autism prevalence has increased – Changes in case definition and increased awareness – ?Actual increase in incidence of autism Multiple large, well-designed studies and systematic reviews have not demonstrated link between vaccines/MMR and autism Studies do not demonstrate association between vaccines and multiple sclerosis or type 1 DM Immunization Safety Review 2004 Vaccine Controversy Multiple large, well-designed epidemiologic studies and systematic reviews have not demonstrated association between thimerosal and autism or other developmental disorders No association b/w thimerosal and CV disease Mercury poisoning and autism DIFFER WHO advisory committee concluded it is safe to continue using thimerosal in vaccines Yoshizawa 2002; WHO 2002; Hviid 2003; Thompson 2007 Thimerosal-Containing Adult Vaccines DTap (Tripedia) – Tdap- thimerosal free!!! DT Td – Except 1 of 2 Sanofi Pasteur vaccines (thimerosal-free) TT Hep A/Hep B combined vaccine (Twinrix) Influenza – Except Fluzone (thimerosal-free; used in CA in pregnancy)!!! – Except FluMist (thimerosal-free; live attenuated) Japanese encephalitis Meningococcal (Menomune A, C, AC, A/C/Y/W-135) CDC 2007 Summary Preconception Immunizations HPV MMR Varicella Tdap Summary Pregnancy Immunizations Td Influenza Hepatitis B Hepatitis A Others – Pneumococcal – Meningococcal – H. Influenzae Summary Postpartum Immunizations MMR Varicella Tdap Influenza Hepatitis A and B HPV Summary Travel Immunizations Tetanus and diphtheria Hepatitis A and B Measles Influenza Meningococcus Japanese and tick-borne encephalitis Yellow Fever Poliovirus (IPV) Typhoid Rabies General Summary Live-attenuated vaccinations – Little or no data demonstrating harm to fetus – Termination not recommended for inadvertent exposure! Vaccinations (live-attenuated and inactivated) generally safe during breastfeeding Smallpox vaccine only reserved for emergency indications during pregnancy or breastfeeding Studies do not demonstrate association between vaccinations/thimerosal to autism or other diseases Immunization Resources http://www.cdc.gov/vaccines http://www.cdc.gov/nip/vacsafe/concerns/autism http://www.cdc.gov/vaccines/recs/ACIP – Advisory Committee on Immunization Practices (ACIP) http://www.immunize.org/vw – Immunization Action Coalition (IAC) – IAC Express email notices, “Vaccinate Women” publication – Ob/Gyn providers http://www.ca-siis.org – California Immunization Registry (CAIR) California Immunization Registry CAIR = Statewide Immunization Information System CA statewide immunization registry network 9 multi-county regional immunization registries Computerized registry system for provider entered info – Assist providers to track patient records – Reduce missed opportunities – Fully immunize all children in California Schools, childcare centers, and WIC can link into regional registries Ultimate goal to integrate 9 regional district http://www.ca-siis.org Vaccine Registries Inadvertent Immunizations During Pregnancy All vaccinations (general) – VAERS: Vaccine Adverse Event Reporting System – 800-822-7967; www.vaers.org HPV Quadrivalent Vaccine – Gardasil/Merck – 1-800-986-8999 Rubella Vaccine in Pregnancy Registry- discontinued in 1989 Varicella – VARIVAX Pregnancy Registry – 800-986-8999 Tdap – BOOSTRIX/GlaxoSmithKline Biologicals (1-888-825-5249) – ADACEL/Sanofi Pasteur at (1-800-822-2463 or 1-800-VACCINE) Smallpox – Centers for Disease Control and Prevention – Smallpox Vaccine in Pregnancy Registry – 404-639-8253 UCSF Reproductive Infectious Disease Consult Service 1-415-719-8726 Free 24-hour availability For medical providers seeking assistance in management of reproductive infectious disease and perinatal HIV issues Acknowledgements Julian Parer, MD, PhD Tekoa King, CNM, MPH Judith Bishop, CNM, MSN, MPH Aaron Caughey, MD, MPP, MPH, PhD Irené Merry and UCSF CME office Deborah Cohan, MD, MPH