Vaccination during pregnancy

Transcription

1 Vaccination during pregnancy Karin Batty 11 September 2013

2 Transplacental antibody transfer Transport of IgG across the placenta 1 Active, selective, intracellular process Increases with advancing gestational age 17 weeks process begins 33 weeks maternal and fetal IgG equalise* 40 weeks fetal IgG higher than maternal* *For some antibodies 2

3 Transplacental antibody transfer Fetal IgG influenced by 1 IgG concentration in maternal blood Type of vaccine Time between vaccination and delivery Gestational age at delivery Transplacental antibodies in the newborn Can reduce the risk of vaccine-preventable diseases in the early weeks-months of life 2-7

4 Which vaccines? All inactive and subunit vaccines BUT Disease risk vs. emotional risk Influenza Hepatitis B Pertussis Tetanus Focus on influenza and pertussis (Tdap) vaccines

5 Maternal influenza disease risks Higher risk of influenza complications 8, 9 Pneumonia Longer hospital stay Delivery complications 10 Preterm delivery (4x) Fetal distress (2.5x) Caesarean delivery (4x) Death Risk increases with advancing gestational age 8, 9

6 Neonate/infant influenza disease risks Neonate 10 Preterm delivery (4x) Small gestational age Infants <6 months 8 Highest risk influenza and complications in <23 months age group No licensed flu vaccine

7 Neonate/infant pertussis disease risks Infants <6 months11, 12 Highest risk of hospitalisation and death in <12 months age group Incomplete vaccine course until 5 months

8 Maternal benefits from influenza vaccination Limited data on immunogenicity and efficacy for pregnant women Seroresponse Slightly lower/similar, pregnant vs. non-pregnant woman of the same age3, Acute/febrile respiratory illness Similar presentation rates, vaccinated pregnant vs. unvaccinated pregnant women of the same gestation 17 13, 16, Except a landmark RCT in Bangladesh 18 Febrile respiratory illness 36% reduction, vaccinated pregnant women vs. unvaccinated pregnant women

9 Fetal/infant benefits from maternal influenza vaccination Odds of prematurity and small for gestational age reduced 19 Significantly reduces the risk of disease in the infant for several months5, 18, 20, 21 Decreased MAARI* and AOM* events infants <12 months Course of PCV7 with maternal flu vaccination vs. PCV7 without maternal flu vaccination22, 23 *MAARI medically attended acute respiratory infection *AOM acute otitis media

10 Infant benefits from maternal pertussis vaccination Reduces the risk of severe disease for 4 6 weeks2, 11 Indirect newborn protection1, 24 Infants <6 months most likely to get pertussis from their mother 25

11 How is safety monitored? Population-based cohort studies Retrospective and database review studies Clinical trials Post-marketing surveillance and adverse event reporting systems, e.g. Vaccine Adverse Event Reporting System (VAERS)

12 Inactive vaccines are safe in pregnancy Pregnant women and inactive vaccines U.S. since 1957 (tetanus and IPV vaccines) Worldwide since the 1970s (tetanus vaccines) Clinical trials since 1988 (other inactive vaccines) No evidence of harm identified On the course of the pregnancy, fetus or newborn

13 Prospective influenza safety studies Heinonen et al., through 1965 n=2,291 influenza vaccine (650 in first 4 months gestation) Children followed up for 7 years Eick et al., through 2005 n=1,169 influenza vaccine

14 Retrospective influenza safety studies France et al., through 2005 n=3,160 vaccinated vs. 37,969 not vaccinated Black et al., through 2002 n= 3,719 vaccinated vs. 45,866 not vaccinated Pool & Iskander, VAERS review 2000 through 2003 Estimated 2 million doses 26 AEFI reports Moro et al., VAERS review 1990 through 2009 Estimated 11.8 million doses 148 AEFI reports

15 First trimester influenza safety Sheffield et al., n=10,225 (439 first trimester) No increase in major malformation rates Decrease in overall stillbirth rate

16 Retrospective Tdap safety Zheteyeva et al., VAERS review 2005 through June 2010 Tdap not routinely recommended pregnant women during this time 132 AEFI reports 55 reports were Tdap administration during pregnancy No unexpected pattern maternal, fetal, or infant AEFIs Injection site reactions most frequent non-pregnancy AEFI

17 Why vaccinate? Influenza vaccine Timing Tdap vaccine Maternal protection Pregnancy/fetal protection + Newborn protection Vaccinate anytime during pregnancy At the beginning of flu vaccination programme, or As soon as a woman identified as being pregnant during flu season Direct newborn protection + Indirect newborn protection Vaccinate between weeks gestation Ideal timing weeks, or Before 36 weeks

18 Barriers and motivators Vaccine accessibility Accessible at no/low cost to patients Knowledge Accurate and consistent information dissemination33, 34, 36 Influenza disease risks Safety and efficacy of the vaccines Two-for-one benefit 34 Erroneous information from family and friends needs to be countered by the provider 34 Providers may be knowledgeable but fail to convey the facts to women 34

19 Barriers and motivators Influence of health professionals Most women accept the vaccine If providers explain the threat of influenza and recommend maternal vaccination Women perceive an indifferent provider as a barrier to vaccination 34 Wiley et al., 2013, n= Women who received a recommendation were 20x more likely to have been vaccinated 68% of unvaccinated women would have had the vaccine if it had been recommended

20 Messages Maternal, fetal and infant benefits Influenza and Tdap vaccines are safe during pregnancy Timing of vaccination Accurate and consistent information Clear health professional recommendation

21 Questions?

22 References 1. Esposito S, Bosis S, Morlacchi L, Baggi E, Sabatini C, Principi N. Can infants be protected by means of maternal vaccination? Clinical Microbiology and Infection. 2012;18(Suppl 5): van Rie A, Wendelboe AM, Englund JA. Role of maternal pertussis antibodies in infants. Pediatric Infectious Disease Journal The Global Pertussis Initiative May;24(5):S Englund J, Mbawuike I, Hammill H, Holleman M, Baxter B, Glezen W. Maternal immunization with influenza or tetanus toxoid vaccine for passive antibody protection in young infants. Journal of Infectious Diseases. 1993;168(3): Steinhoff MC, Omer SB, Roy E, Arifeen SE, Raqib R, Altaye M, et al. Influenza immunization in pregnancy Antibody responses in mothers and infants. New England Journal of Medicine. 2010;362(17): Eick AA, Uyeki TM, Klimov A, Hall H, Reid R, Santosham M, et al. Maternal influenza vaccination and effect on influenza virus infection in young infants. Archives of Pediatrics & Adolescent Medicine. 2011;165(2): Mooi FR, de Greeff SC. The case for maternal vaccination against pertussis. The Lancet Infectious Diseases. 2007;7(9):

23 References 7. Gall SA, Myers J, Pichichero M. Maternal immunization with tetanus diphtheria pertussis vaccine: effect on maternal and neonatal serum antibody levels. American Journal of Obstetrics and Gynecology. 2011;204(4):334.e Omer SB, Bednarczyk RA, Madhi SA, Klugman KP. Benefits to mother and child of influenza vaccination during pregnancy. Human Vaccines & Immunotherapeutics. 2012;8(1): Fortner KB, Kuller JA, Rhee EJ, Edwards KM. Influenza and tetanus, diphtheria, and acellular pertussis vaccinations during pregnancy. Obstetrical and Gynecological Survey. 2012;67(4): Cox S, Posner S, McPheeters M, Jamieson D, Kourtis A, Meikle S. Hospitalizations with respiratory illness among pregnant women during influenza season. Obstetrics and Gynecology. 2006;107(6): Crowcroft NS, Pebody RG. Recent developments in pertussis. The Lancet. 2006;367(9526): Halperin S, De Serres G. Pertussis. In: Evans A, Brachman P, editors. Bacterial infections of humans: Epidemiology and control. New York: Springer; p

24 References 13. Hulka J. Effectiveness of polyvalent influenza vaccine in pregnancy. Report of a controlled study during an outbreak of Asian influenza. Obstetrics and Gynecology. 1964;23(6): Murray D, Imagawa D, Okada D, St Geme J. Antibody response to monovalent A/New Jersey/8/76 influenza vaccine in pregnant women. Journal of Clinical Microbiology. 1979;10(2): Sumaya C, Gibbs R. Immunization of pregnant women with influenza A/New Jersey/76 virus vaccine: reactogenicity and immunogenicity in mother and infant. Journal of Infectious Diseases. 1979;140(2): Munoz F, Greisinger A, Wehmanen O, Mouzoon M, Hoyle J, Smith F, et al. Safety of influenza vaccination during pregnancy. American Journal of Obstetrics and Gynecology. 2005;192(4): Black SB, Shinefield HR, France EK, Fireman BH, Platt ST, Shay D, et al. Effectiveness of influenza vaccine during pregnancy in preventing hospitalizations and outpatient visits for respiratory illness in pregnant women and their infants. American Journal of Perinatology. 2004;21(6): Zaman K, Roy E, Arifeen S, Rahman M, Raqib R, Wilson E, et al. Effectiveness of maternal influenza immunization in mothers and infants. New England Journal of Medicine. 2008;359(15):

25 References 19. Omer SB, Goodman D, Steinhoff MC, Rochat R, Klugman KP, Stoll BJ, et al. Maternal influenza immunization and reduced likelihood of prematurity and small for gestational age births: A retrospective cohort study. PLoS Medicine. 2011;8(5):e Benowitz I, Esposito DB, Gracey KD, Shapiro ED, Vazquez M. Influenza vaccine given to pregnant women reduces hospitalization due to influenza in their infants. Clinical Infectious Diseases. 2010;51(12): Poehling K, Szilagyi P, Staat M, Snively B, Payne D, Bridges C, et al. Impact of maternal immunization on influenza hospitalizations in infants. American Journal of Obstetrics and Gynecology. 2011;204(Suppl 6):S Omer SB, Zaman K, Roy E, Arifeen SE, Raqib R, Noory L, et al. Combined effects of antenatal receipt of influenza vaccine by mothers and pneumococcal conjugate vaccine receipt by infants: Results from a randomized, blinded, controlled trial. Journal of Infectious Diseases. 2013;207(7): van Santen KL, Bednarczyk RA, Adjaye-Gbewonyo D, Orenstein WA, Davis R, Omer SB. Effectiveness of pneumococcal conjugate vaccine in infants by maternal influenza vaccination status. Pediatric Infectious Disease Journal. 2013;32(11): Healy CM, Baker CJ. Infant pertussis: What to do next? Clinical Infectious Diseases. 2012;54(3):

26 References 25. Bechini A, Tiscione E, Boccalini S, Levi M, Bonanni P. Acellular pertussis vaccine use in risk groups (adolescents, pregnant women, newborns and health care workers): A review of evidences and recommendations. Vaccine. 2012;30(35): Skowronski DM, Janjua NZ, Sonfack Tsafack EP, Ouakki M, Hoang L, De Serres G. The number needed to vaccinate to prevent infant pertussis hospitalization and death through parent cocoon immunization. Clinical Infectious Diseases. 2012;54(3): Heinonen OP, Shapiro S, Monson RR, Hartz SC, Rosenberg L, Slone D. Immunization during pregnancy against poliomyelitis and influenza in relation to childhood malignancy. International Journal of Epidemiology, 1973;2(3): France EK, Smith-Ray R, McClure D, et al. Impact of maternal influenza vaccination during pregnancy on the incidence of acute respiratory illness visits among infants. Archives of Pediatrics and Adolescent Medicine. 2006;160(12): Pool V, Iskander J. Safety of influenza vaccination during pregnancy. American Journal of Obstetrics and Gynecology. 2006;194(4): Moro PL, Broder K, Zheteyeva Y, Walton K, Rohan P, Sutherland A, et al. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, American Journal of Obstetrics and Gynecology. 2011;204(2),146.e141-7

27 References 31. Sheffield JS, Greer LG, Rogers VL, Roberts SW, Lytle H, McIntire DD, et al. Effect of influenza vaccination in the first trimester of pregnancy. Obstetrics and Gynecology. 2012;120(3): Zheteyeva YA, Moro PL, Tepper NK, Rasmussen SA, Barash FE, Revzina NV, et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. American Journal of Obstetrics and Gynecology Jul;207(1):59.e McCarthy EA, Pollock WE, Nolan T, Hay S, McDonald S. Improving influenza vaccination coverage in pregnancy in Melbourne Australian and New Zealand Journal of Obstetrics and Gynaecology. 2012;52(4): Meharry P, Colson E, Grizas A, Stiller R, Vázquez M. Reasons why women accept or reject the trivalent inactivated influenza vaccine (TIV) during pregnancy. Maternal and Child Health Journal. 2013;17(1): Wiley KE, Massey PD, Cooper SC, Wood NJ, Ho J, Quinn HE, et al. Uptake of influenza vaccine by pregnant women: A cross-sectional survey. The Medical Journal of Australia. 2013;198(7): Eppes C, Wu A, You W, Cameron KA, Garcia P, Grobman W. Barriers to influenza vaccination among pregnant women. Vaccine. 2013;31(27):