The Centers for Disease Control and Prevention's public health response to monitoring Tdap safety in pregnant women in the United States

References

• Winter K, Harriman K, Zipprich J, Schechter R, Talarico J, Watt J, Chavez G. California pertussis epidemic, 2010. J Pediatr 2012 Dec; 161(6):1091-6; PMID:22819634; http://dx.doi.org/10.1016/j.jpeds.2012.05.041
   PubMed Web of Science ®Google Scholar
• CDC. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged. MMWR 2011; 60:1424-6. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6041a4.htm; PMID:22012116
   PubMedGoogle Scholar
• CDC. Updated Recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women — Advisory Vommittee on Immunization Practices (ACIP), 2012. MMWR 2013; 62(07):131-135. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6207a4.htm; PMID:23425962
   PubMedGoogle Scholar
• Zheteyeva YA, Moro PL, Tepper NK, Rasmussen SA, Barash FE, Revzina NV, Kissin D, Lewis PW, Yue X, Haber P, et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Am J Obstet Gynecol 2012 Jul; 207(1):59.e1-7; PMID:22727350; http://dx.doi.org/10.1016/j.ajog.2012.05.006
   PubMedGoogle Scholar
• Black S, Eskola J, Siegrist CA, Halsey N, Macdonald N, Law B, et al. Importance of background rates of disease in assessment of vaccine safety during mass immunization with pandemic H1N1 influenza vaccines. Lancet 2009; 374:2115-22; PMID:19880172; http://dx.doi.org/10.1016/S0140-6736(09)61877-8
   PubMed Web of Science ®Google Scholar
• MacDorman MF, Kirmeyer SE, Wilson EC. Fetal and perinatal mortality, United States, 2006. National vital statistics reports; vol 60 no 8. Hyattsville, MD: National Center for Health Statistics; 2012. Available at: http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_08.pdf. Accessed June 9, 2015.
   Google Scholar
• Correa A, Cragan JD, Kucik JE, Alverson CJ, Gilboa SM, Balakrishnan R, et al. Reporting birth defects surveillance data 1968-2003. Birth Defects Res A ClinMol Teratol 2007; 79:65-186; PMID:17278144
   PubMedGoogle Scholar
• Chen RT, Rastogi SC, Mullen JR, Hayes SW, Cochi SL, Donlon JA, Wassilak SG. The vaccine adverse event reporting system (VAERS). Vaccine 1994 May; 12(6):542-50; PMID:8036829; http://dx.doi.org/10.1016/0264-410X(94)90315-8
   PubMed Web of Science ®Google Scholar
• Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen RT. Understanding vaccine safety information from the vaccine adverse event reporting system. Pediatr Infect Dis J 2004 Apr; 23(4):287-94; PMID:15071280; http://dx.doi.org/10.1097/00006454-200404000-00002
   PubMed Web of Science ®Google Scholar
• Medical dictionary for regulatory activities maintenance and support services organization (2010). http://www.meddramsso.com/index.asp. Accessed May 2, 2015.
   Google Scholar
• Moro PL, Broder K, Zheteyeva Y, Walton K, Rohan P, Sutherland A, Guh A, Haber P, DeStefano F, Vellozzi C. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the vaccine adverse event reporting system, 1990-2009. Am J Obstet Gynecol 2011; 204(2):146.e1-7; PMID:20965490; http://dx.doi.org/10.1016/j.ajog.2010.08.050
   PubMedGoogle Scholar
• Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, Barash F, Arana J, Brantley MD, Ding H, et al. Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the vaccine adverse event reporting system. Am J Obstet Gynecol 2011; 205(5):473.e1-9; PMID:21861964; http://dx.doi.org/10.1016/j.ajog.2011.06.047
   PubMedGoogle Scholar
• Moro PL, Museru OI, Niu M, Lewis P, Broder K. Reports to the vaccine adverse event reporting system after hepatitis A and hepatitis AB vaccines in pregnant women. Am J Obstet Gynecol 2014; 210(6):561e1-6
   Google Scholar
• Zheteyeva Y, Moro PL, Yue X, Broder K. Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the vaccine adverse event reporting system. Am J Obstet Gynecol 2013 Jun; 208(6):478.e1-6; PMID:23453881; http://dx.doi.org/10.1016/j.ajog.2013.02.027
   PubMedGoogle Scholar
• Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, Broder K. Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. Vaccine 2015 Jan 15; 33(4):519-22; PMID:25500173; http://dx.doi.org/10.1016/j.vaccine.2014.11.047
   PubMed Web of Science ®Google Scholar
• Baggs J, Gee J, Lewis E, Fowler G, Benson P, Lieu T, Naleway A, Klein NP, Baxter R, Belongia E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics 2011 May; 127(Suppl 1):S45-53; PMID:21502240; http://dx.doi.org/10.1542/peds.2010-1722H
   PubMed Web of Science ®Google Scholar
• McNeil MM, Gee J, Weintraub ES, Belongia EA, Lee GM, Glanz JM, Nordin JD, Klein NP, Baxter R, Naleway AL, et al. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety. Vaccine 2014 Sep 22; 32(42):5390-8; PMID:25108215; http://dx.doi.org/10.1016/j.vaccine.2014.07.073
   PubMed Web of Science ®Google Scholar
• Naleway AL, Gold R, Kurosky S, Riedlinger K, Henninger ML, Nordin JD, Kharbanda EO, Irving S, Cheetham TC, McCarthy NL. Identifying pregnancy episodes, outcomes, and mother-infant pairs in the vaccine safety datalink. Vaccine 2013 Jun 12; 31(27):2898-903; PMID:23639917; http://dx.doi.org/10.1016/j.vaccine.2013.03.069
   PubMed Web of Science ®Google Scholar
• Irving SA, Kieke BA, Donahue JG, Mascola MA, Baggs J, DeStefano F, Cheetham TC, Jackson LA, Naleway AL, Glanz JM, et al; Vaccine Safety Datalink. Trivalent inactivated influenza vaccine and spontaneous abortion. Obstet Gynecol 2013 Jan; 121(1):159-65; PMID:23262941
   PubMed Web of Science ®Google Scholar
• Nordin JD, Kharbanda EO, Benitez GV, Nichol K, Lipkind H, Naleway A, Lee GM, Hambidge S, Shi W, Olsen A. Maternal safety of trivalent inactivated influenza vaccine in pregnant women. Obstet Gynecol 2013 Mar; 121(3):519-25; http://dx.doi.org/10.1097/AOG.0b013e3182831b83
   PubMed Web of Science ®Google Scholar
• Kharbanda EO, Vazquez-Benitez G, Shi WX, Lipkind H, Naleway A, Molitor B, Kuckler L, Olsen A, Nordin JD. Assessing the safety of influenza immunization during pregnancy: the vaccine safety datalink. Am J Obstet Gynecol 2012 Sep; 207(3 Suppl):S47-51; PMID:22920059; http://dx.doi.org/10.1016/j.ajog.2012.06.073
   PubMedGoogle Scholar
• Kharbanda EO, Vazquez-Benitez G, Lipkind H, Naleway A, Lee G, Nordin JD; Vaccine Safety Datalink Team. Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events. Obstet Gynecol 2013 Sep; 122(3):659-67; PMID:23921876; http://dx.doi.org/10.1097/AOG.0b013e3182a1118a
   PubMed Web of Science ®Google Scholar
• Nordin JD, Kharbanda EO, Vazquez Benitez G, Lipkind H, Vellozzi C, DeStefano F; Vaccine Safety Datalink. Maternal influenza vaccine and risks for preterm or small for gestational age birth. J Pediatr 2014 May; 164(5):1051-1057.e2; PMID:24582484; http://dx.doi.org/10.1016/j.jpeds.2014.01.037
   PubMedGoogle Scholar
• Naleway AL, Irving SA, Henninger ML, Li DK, Shifflett P, Ball S, Williams JL, Cragan J, Gee J, Thompson MG; Vaccine Safety Datalink and Pregnancy and Influenza Project. Safety of influenza vaccination during pregnancy: a review of subsequent maternal obstetric events and findings from two recent cohort studies. Vaccine 2014 May 30; 32(26):3122-7.22; PMID:24742490; http://dx.doi.org/10.1016/j.vaccine.2014.04.021
   PubMedGoogle Scholar
• Centers for Disease Control and Prevention. Clinical immunization safety assessment (CISA) project. Available at http://www.cdc.gov/vaccinesafety/Activities/cisa.html Accessed on May 1, 2015
   Google Scholar
• Salmon DA, Akhtar A, Mergler MJ, Vannice KS, Izurieta H, Ball R, Lee GM, Vellozzi C, Garman P, Cunningham F, et al. H1N1 Working group of federal immunization safetytask force. Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program. Pediatrics 2011 May; 127(Suppl 1):S78-86; PMID:21502251; http://dx.doi.org/10.1542/peds.2010-1722L
   PubMedGoogle Scholar
• Halsey NA, Griffioen M, Dreskin SC, Dekker CL, Wood R, et al. Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERS external web site icon. Vaccine 2013 Dec 9; 31(51):6107-12. Epub 2013 Oct 8; PMID:24120547; http://dx.doi.org/10.1016/j.vaccine.2013.09.066
   PubMed Web of Science ®Google Scholar
• Pahud BA, Williams SE, Dekker CL, Halsey N, LaRussa P, et al. Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccination external web site icon. Pediatr Infect Dis J 2013 Feb; 32(2):163-168; PMID:23334340; http://dx.doi.org/10.1097/INF.0b013e318271b90a
   PubMed Web of Science ®Google Scholar
• Clinicaltrials.gov NCT02209623. Tdap safety in pregnant women
   Google Scholar
• Clinicaltrials.gov NCT01974050. PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
   Google Scholar
• Murphy TV, Slade BA, Broder KR, et al. and the advisory committee on immunization practices (ACIP) centers for disease control and prevention (CDC). Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008 May 30; 57(RR-4):1-51. Review. Erratum in: MMWR Morb Mortal Wkly Rep 2008 Jul 4; 57(26):723. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5704a1.htm Accessed May 11, 2015
   PubMedGoogle Scholar
• Pichichero ME, Rennels MB, Edwards KM, Blatter MM, Marshall GS, Bologa M, Wang E, Mills E. Combined tetanus, diphtheria, and 5-component pertussis vaccine for use in adolescents and adults. JAMA 2005 Jun 22; 293(24):3003-11; PMID:15933223; http://dx.doi.org/10.1001/jama.293.24.3003
   PubMed Web of Science ®Google Scholar
• Wang M, Khromava A, Mahmood A, Dickinson N. Pregnant women receiving tetanus diphtheria- acellular pertussis (Tdap) vaccine: 6 years of Adacel vaccine pregnancy registry data. Presented at the 27th international conference on pharmacoepidemiology and therapeutic management, Chicago, IL. Pharmacoepidemiol Drug Saf 2011; 20:S1-364; PMID:21837638; http://dx.doi.org/10.1002/pds.2161
   PubMedGoogle Scholar
• Talbot EA, Brown KH, Kirkland KB, Baughman AL, Halperin SA, Broder KR. The safety of immunizing with tetanus– diphtheria–acellular pertussis vaccine (Tdap) less than 2 years following previous tetanus vaccination: experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak.Vaccine 2010; 20:8001-7; PMID:20875487; http://dx.doi.org/10.1016/j.vaccine.2010.09.034
   PubMed Web of Science ®Google Scholar
• Moro PL. Enhanced surveillance of Tdap safety in pregnancy in the vaccine adverse event reporting system (VAERS). Present ACIP Feb Meet 2014. Meeting available at: http://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2014-02.pdf
   Google Scholar
• Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA 2014; 312(18):1897-1904; PMID:25387187; http://dx.doi.org/10.1001/jama.2014.14825
   PubMed Web of Science ®Google Scholar
• Tita AT, Andrews WW. Diagnosis and management of clinical chorioamnionitis. Clin Perinatol 2010 Jun; 37(2):339-54; PMID:20569811; http://dx.doi.org/10.1016/j.clp.2010.02.003
   PubMed Web of Science ®Google Scholar
• Edwards RK. Chorioamnionitis and labor. Obstet Gynecol Clin North Am 2005 Jun; 32(2):287-96; PMID:15899361; http://dx.doi.org/10.1016/j.ogc.2004.12.002
   PubMed Web of Science ®Google Scholar
• Datwani H, Moro PL, Harrington T, Broder KR. Chorioamnionitis following vaccination in the vaccine adverse event reporting system. Vaccine 2015; 33(27): 3110-3
   PubMed Web of Science ®Google Scholar
• Munoz FM, Bond NH, Maccato M, Pinell P, Hammill HA, Swamy GK, Walter EB, Jackson LA, Englund JA, Edwards MS, et al. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA 2014 May 7; 311(17):1760-9; PMID:24794369; http://dx.doi.org/10.1001/jama.2014.3633
   PubMed Web of Science ®Google Scholar
• Shakib JH, Korgenski K, Sheng X, Varner MW, Pavia AT, Byington CL. Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: pregnancy and infant health outcomes. J Pediatr 2013 Nov; 163(5):1422-6.e1-4; PMID:23896191; http://dx.doi.org/10.1016/j.jpeds.2013.06.021
   PubMedGoogle Scholar
• Donegan K, King B, Bryan P. Safety of pertussis vaccination in pregnant women in UK: observational study. BMJ 2014 Jul 11; 349:g4219; PMID:25015137; http://dx.doi.org/10.1136/bmj.g4219
   PubMed Web of Science ®Google Scholar
• Morgan JL, Baggari SR, McIntire DD, Sheffield JS. Pregnancy outcomes after antepartum tetanus, diphtheria, and acellular pertussis vaccination. Obstet Gynecol 2015; 125(6):1433-8; PMID:26000515
   PubMed Web of Science ®Google Scholar
• Chu HY, Englund JA. Maternal immunization. Maternal Immunization Clin Infect Dis 2014 Aug 15; 59(4):560-8; PMID:24799324; http://dx.doi.org/10.1093/cid/ciu327
   PubMed Web of Science ®Google Scholar