Vaccines in Pregnancy MARK H. SAWYER, MD UCSD SCHOOL OF MEDICINE RADY CHILDREN S HOSPITAL SAN DIEGO

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1 Vaccines in Pregnancy MARK H. SAWYER, MD UCSD SCHOOL OF MEDICINE RADY CHILDREN S HOSPITAL SAN DIEGO 1

2 Objectives List vaccines that should be given either during pregnancy or immediately post-partum in order to improve your care of pregnant women Describe the epidemiology and risks of influenza and pertussis in women of childbearing age and in infants so that you can convince pregnant women to get immunized State the current recommendations for the use of vaccines during pregnancy to maximize immunization coverage in your clinic

3 Vaccines During Pregnancy Rationale Routine protection of adult women Special protection because of increased risk of disease during pregnancy (e.g. influenza) Protection of infants immediately after birth through passive transfer of antibody (e.g. pertussis) Protection of infants by prevention of transmission of disease from mother to baby

4 Changes in pregnancy that increase risk of infection Gestation Risk of Hospitalization 1 st trimester 7.6/10,000 2 nd trimester 15.8/10,000 3 rd trimester 26.2/10,000 Modulation of immune response Expansion of vascular volume Decreased lung capacity Increased oxygen consumption Neuzil et al Am J Epidemiol. 1998; 148:

5 H1N1 infection during pregnancy 4-fold higher risk of hospitalization compared to non-pregnant women From April-August 2009 accounted for 10% of all hospitalizations/deaths from H1N1 in California Louie JK et al. NEJM 2009

6 Vaccination of Pregnant Women is Safe Risk to a developing fetus from vaccination of the mother during pregnancy is theoretical. No evidence exists of risk to the fetus from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids. Live vaccines administered to a pregnant woman pose a theoretical risk to the fetus. General Recommendations on Immunization. MMWR 2011;60(RR02):1-60

7 Vaccines with recommendations for use during pregnancy All pregnant women Influenza vaccine Tdap vaccine Hepatitis B vaccine if needed Hepatitis A vaccine if needed High-risk situations (if needed) Polio vaccine Meningococcal vaccine Some travel vaccines

8 Vaccines Not Recommended During Pregnancy MMR vaccine Varicella vaccine LAIV No adverse reactions reported with any of these vaccines administered to pregnant women

9 Thimerosal containing vaccines during pregnancy California law prohibits use of vaccines with more than trace amounts of thimerosal in pregnant women and children <3 years of age Some influenza vaccines contain thimerosal Still no evidence of harm from thimerosal contained in vaccines

10 Pregnancy and Influenza Vaccine Risk of hospitalization more than 4 times higher than among nonpregnant women Risk of complications comparable to nonpregnant women with high risk medical conditions New mothers can give influenza to their babies and other family members ACIP recommends vaccination with inactivated influenza vaccine for ALL women who will be pregnant during influenza season Source: MMWR 2007;56 (RR-6)

11 Immunization of Pregnant Women Protects Their Babies 316 mother-infant pairs in Bangladesh in Mothers immmunized randomly with influenza vaccine or pneumococcal vaccine 63% vaccine effectiveness in preventing lab-confirmed influenza in babies 36% reduction in febrile respiratory illness in mothers Zaman, N Engl J Med 2008; 359

12 CDC NIP Web site Influenza Vaccine Safety in Pregnancy 2000 women who received TIV during pregnancy No adverse fetal effects Matched control study of 252 women immunized within 6 months of delivery No difference in pregnancy outcomes approximately 2,000,000 pregnant women immunized-20 VAERS reports (3 miscarriages)

13 Pertussis in California

14 Acellular pertussis vaccines Why is this happening? don t last very long

15 DTaP Vaccine Effectiveness Misegades L et al., JAMA. 2012;308(20):

16 Tdap Effectiveness Koepke R, J Infect Dis 2014;210:942-53

17 Reported Pertussis-Related Deaths by Age Groups, US, Age-group month month month month years years years >18 years Total 77* Vitek CR et al. Pediatr Infect Dis J 2003; 22(7): National Notifiable Diseases Surveillance System, CDC, 2009

18 Tdap during pregnancy Decision analysis-cost Effectiveness Tdap vaccine coverage rate of 72% for both intra- and post-partum immunization Tdap vaccine effectiveness of 85% 100% transfer of maternal antibody Duration of maternal antibody in the infant of 2 months 10% increase in pertussis cases in infants at 3-4 months of age to account for antibody interference with infant immune response Terranella A, et al. Pediatrics 2013;131:e1748-e1756

19 Geometric Mean Concentrations (GMCs) and Percentage of Placental Transfer of Antibodies to PT, FHA, and PRN in Maternal and Cord Serum Samples Antigen (EU/ml) Number of samples tested Maternal serum GMC (95% CI) [range] Cord serum Maternal serum Cord serum Placental transfer (%) PT ( ) [1-233] 16.2 (14.2) [1-348] 164 FHA ( ) [2-731] 34.8 ( ) [1-850] 162 PRN ( ) [2-292] 17.1 ( ) [2-272] 131 PT=pertussis toxin; FHA=filamentous hemagglutinin; PRN=pertactin; EU, enzyme-linked immunoassay unit de Voer RM, et al. Clin Infect Dis Jul 1;49(1):

20 Two goals for maternal Tdap immunization Protect the mother from getting pertussis and transmitting it to her baby Prenatal, intrapartum, post-natal maternal immunization Re-immunization not recommended Generating maternal antibody so that she transfers it to her baby in utero thus protecting the baby beginning at day one of life Immunization during pregnancy Re-immunization with each pregnancy

21 Tdap during pregnancy works! Amirthalingam G, Lancet 2014; 384(9953):

22 Tdap during pregnancy works! Dabrera G, Clin Infect Dis 2015;60(3):333-7

23 Tdap Safety in Pregnancy VSD study of 123, 494 pregnant women between Jan 2010 and Nov 2012 Tdap vaccination not associated with adverse birth outcome Preterm delivery 6.3% v 7.8% SGA birth 8.4% v 8.3% Pregnancy outcomes Hypertensive 8.2% v 8.0% Chorioamnionitis 6.1% v 5.5% p<.001 Kharbanda JAMA (18):

24 Tom Clark, CDC, ACIP presentation Feb

25 Tdap Pregnancy Recommendation ACIP recommends that providers of prenatal care implement a Tdap immunization program for all pregnant women. Healthcare providers should administer a dose of Tdap during each pregnancy irrespective of the patient s prior history of receiving Tdap. If not administered during pregnancy, Tdap should be administered immediately postpartum. MMWR 2013; 62(07):

26 Cocooning Recommendation Adolescents and adults who have or who anticipate having close contact with an infant aged less than 12 months (e.g., parents, siblings, grandparents, childcare providers, and healthcare providers) and who previously have not received Tdap should receive a single dose of Tdap. MMWR 2011;60:

27 Cocooning works-sort of Quinn H, Pediatrics 2014;134(4)

28 So how are we doing?

29 Tdap vaccine coverage during pregnancy Population of pregnant women in Michigan between November 2011-February 2013 Overall coverage rage 14.3% Some variation by ethnicity; Native Americans>White>Hispanic> Asian>Black>Arab MMWR 2014;63:

30 Tdap coverage around pregnancy-vsd Kharbanda EO et al. Preventive Medicine 2014;67:

31 Tdap during pregnancy-california VSD Kharbanda EO et al. Preventive Medicine 2014;67:

32 Tdap immunization during pregnancyfocused study at Massachusetts General 1467 pregnancies between February 2013-June (82%) received Tdap during pregnancy 92% received Tdap at or beyond 37 weeks gestation 7% received Tdap between weeks gestation Goldfarb I et al, Am J Obstet Gynecol 2014;211:299.e1-5

33 TDAP Vaccination 3 rd Trimester, Kaiser Permanente NCAL 100.0% 75.0% 66.2% 66.8% 76.0% 83.9% 85.3% 83.7% 50.0% 52.7% 32.1% 25.0% 0.0% Q2, 2013 Q3, 2013 Q4, 2013 Q1, 2014 Q2, 2014 Q3, 2014 Q4, 2014 Q1, THE PERMANENTE MEDICAL GROUP, INC. 33

34 Influenza Coverage rates Internet survey conducted by CDC conducted at the end of the season 1,169 survey respondents who were pregnant between October and January 52.2% reported vaccination before or during pregnancy 65.1% had influenza vaccine recommended Vaccine recommended and offered Vaccine offered but not given Not recommended 70.5% 32.0% 9.7%

35 Vaccines in Pregnancy Summary Vaccines are safe for pregnant women Influenza and Tdap vaccines are especially important during pregnancy Give other vaccines when indicated Avoid use of thimerosal-containing vaccines during pregnancy whenever possible but no adverse events have been linked to thimerosal in vaccines Make sure you and your staff are immunized!