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      A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea

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          Abstract

          Background

          Incidence of whooping cough is increasing in Korea. Since 2011, occurrence among adolescents and adults has risen putting vulnerable neonates at risk. National immunization guidelines now include Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccination during pregnancy and as a cocooning strategy (i.e., vaccinating adults and adolescents in contact with neonates). This study assessed post-marketing Tdap (Boostrix®, GSK, Belgium) vaccine safety in subjects ≥ 10 years.

          Methods

          This open, non-comparative multi-center study was conducted over six years at 10 hospitals in Korea. Subjects received Tdap in normal clinical practice according to local prescribing information. All adverse events (AEs) were recorded, classified as expected or unexpected, and severity and relationship to Tdap were assessed.

          Results

          The analysis included 672 Korean subjects (mean age, 44 years; range, 11–81), 451 were women and 211 were pregnant. Ninety subjects experienced 124 AEs (incidence 13.39%) of which six were serious AEs (SAEs) assessed as not related to vaccination, and 51 were non-SAEs related to vaccination (mostly administration site reactions). Overall 65/124 AEs were unexpected; the most common were 14 constipation, 5 dyspepsia, 4 common cold and 4 premature labor cases. One case of common cold was assessed as possibly related to vaccination. Pregnancy outcome was ‘live infant, no apparent congenital anomaly’ in 195 subjects (92.42%) or ‘lost to follow-up’ in 16 subjects.

          Conclusion

          Tdap administration to Korean subjects ≥ 10 years, including pregnant women, for the prevention of diphtheria, tetanus and pertussis was shown to have a well-tolerated safety profile.

          Trial Registration

          ClinicalTrials.gov Identifier: NCT01929291

          Graphical Abstract

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          Most cited references12

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          Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012

          In October 2011, in an effort to reduce the burden of pertussis in infants, the Advisory Committee on Immunization Practices (ACIP) recommended that unvaccinated pregnant women receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) (1). Vaccination of women with Tdap during pregnancy is expected to provide some protection to infants from pertussis until they are old enough to be vaccinated themselves. Tdap given to pregnant women will stimulate the development of maternal antipertussis antibodies, which will pass through the placenta, likely providing the newborn with protection against pertussis in early life, and will protect the mother from pertussis around the time of delivery, making her less likely to become infected and transmit pertussis to her infant (1). The 2011 Tdap recommendation did not call for vaccinating pregnant women previously vaccinated with Tdap. On October 24, 2012, ACIP voted to recommend use of Tdap during every pregnancy. This report summarizes data considered and conclusions made by ACIP and provides guidance for implementing its recommendations. These updated recommendations on use of Tdap in pregnant women aim to optimize strategies for preventing pertussis morbidity and mortality in infants. ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the Director of the Centers for Disease Control and Prevention (CDC) on use of vaccines and related agents for the control of vaccine-preventable diseases in the civilian population of the United States. Recommendations for routine use of vaccines in children and adolescents are harmonized to the greatest extent possible with recommendations made by the American Academy of Pediatrics, the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists. Recommendations for routine use of vaccines in adults are reviewed and approved by the American College of Physicians, AAFP, the American College of Obstetricians and Gynecologists, and the American College of Nurse-Midwives. ACIP recommendations adopted by the CDC Director become agency guidelines on the date published in the Morbidity and Mortality Weekly Report (MMWR). The United States has experienced substantial increases in reported pertussis cases over the past several years. Provisional case counts for 2012 have surpassed the last peak year, 2010, with 41,880 pertussis cases and 14 deaths in infants aged 10 years since previous Td), then Tdap should be administered. Optimal timing is between 27 and 36 weeks gestation to maximize the maternal antibody response and passive antibody transfer to the infant. Wound management for pregnant women As part of standard wound management to prevent tetanus, a tetanus toxoid–containing vaccine might be recommended for wound management in a pregnant woman if ≥5 years have elapsed since the previous Td booster. If a Td booster is recommended for a pregnant woman, health-care providers should administer Tdap. Pregnant women with unknown or incomplete tetanus vaccination To ensure protection against maternal and neonatal tetanus, pregnant women who never have been vaccinated against tetanus should receive three vaccinations containing tetanus and reduced diphtheria toxoids. The recommended schedule is 0, 4 weeks, and 6 through 12 months. Tdap should replace 1 dose of Td, preferably between 27 and 36 weeks gestation to maximize the maternal antibody response and passive antibody transfer to the infant. Cocooning ACIP recommends that adolescents and adults (e.g., parents, siblings, grandparents, child-care providers, and health-care personnel) who have or anticipate having close contact with an infant aged <12 months should receive a single dose of Tdap to protect against pertussis if they have not received Tdap previously. Guidance will be forthcoming on revaccination of persons who anticipate close contact with an infant, including postpartum women who previously have received Tdap. Research Needs Future research needs will address the effectiveness of Tdap vaccination of pregnant women to prevent infant pertussis morbidity and mortality, the impact of timing of Tdap during pregnancy on infant pertussis, and safety of multiple doses of Tdap in pregnant women. CDC will monitor and assess the safety of Tdap use during pregnancy. Results from these studies and monitoring systems will inform future considerations made by ACIP on use of Tdap in preventing infant pertussis morbidity and mortality.
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            The epidemiology of pertussis: a comparison of the epidemiology of the disease pertussis with the epidemiology of Bordetella pertussis infection.

            In the prevaccine era pertussis epidemics followed a cyclic pattern, with peaks every 2 to 5 years. With the marked reduction of pertussis by vaccination, the same cyclic pattern still occurs. Studies relating to reported pertussis and Bordetella pertussis infection have been reviewed and analyzed. The increase in reported pertussis over the last 2 decades is mainly due to a greater awareness of pertussis and perhaps to the use of several less efficacious vaccines. Studies of prolonged cough illnesses in adolescents and adults reveal that 13% to 20% are a result of B pertussis infection. Serologic studies suggest that the rate of B pertussis infection in adolescents and adults is approximately 2.0% per year. The rate of cough illnesses (pertussis) caused by B pertussis infection in adolescents and adults is between 370 and 1500 per 100,000 population. These data suggest that there are between approximately 800,000 and 3.3 million cases per year in the United States. The coming availability of adolescent- and adult-formulated diphtheria and tetanus toxoids and acellular pertussis vaccines for adolescents and adults and their widespread use should reduce the reservoir of B pertussis disease. It is suggested that a universal program of adolescent and adult boosters would decrease the circulation of B pertussis in these age groups and possibly could lead to the elimination of the organism from the population.
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              Strategies to decrease pertussis transmission to infants.

              The Global Pertussis Initiative (GPI) is an expert scientific forum addressing the worldwide burden of pertussis, which remains a serious health issue, especially in infants. This age cohort is at risk for developing pertussis by transmission from those in close proximity. Risk is increased in infants aged 0 to 6 weeks, as they are too young to be vaccinated. Older infants are at risk when their vaccination schedules are incomplete. Infants also bear the greatest disease burden owing to their high risk for pertussis-related complications and death; therefore, protecting them is a high priority. Two vaccine strategies have been proposed to protect infants. The first involves vaccinating pregnant women, which directly protects through the passive transfer of pertussis antibodies. The second strategy, cocooning, involves vaccinating parents, caregivers, and other close contacts, which indirectly protects infants from transmission by preventing disease in those in close proximity. The goal of this review was to present and discuss evidence on these 2 strategies. Based on available data, the GPI recommends vaccination during pregnancy as the primary strategy, given its efficacy, safety, and logistic advantages over a cocoon approach. If vaccination during pregnancy is not feasible, then all individuals having close contact with infants <6 months old should be immunized consistent with local health authority guidelines. These efforts are anticipated to minimize pertussis transmission to vulnerable infants, although real-world effectiveness data are limited. Countries should educate lay and medical communities on pertussis and introduce robust surveillance practices while implementing these protective strategies.
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                Author and article information

                Journal
                J Korean Med Sci
                J. Korean Med. Sci
                JKMS
                Journal of Korean Medical Science
                The Korean Academy of Medical Sciences
                1011-8934
                1598-6357
                22 March 2019
                01 April 2019
                : 34
                : 12
                : e105
                Affiliations
                [1 ]Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea.
                [2 ]GSK, Seoul, Korea.
                [3 ]GSK, Singapore, Singapore.
                [4 ]GSK, Rockville, MD, USA.
                [5 ]GSK, Bangalore, India.
                [6 ]Department of Family Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
                Author notes
                Address for Correspondence: Hee-Cheol Kang, MD, PhD. Department of Family Medicine, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. kanghc@ 123456yuhs.ac
                Author information
                https://orcid.org/0000-0003-0538-3517
                https://orcid.org/0000-0001-5054-8048
                https://orcid.org/0000-0002-4613-6240
                https://orcid.org/0000-0002-7611-4173
                https://orcid.org/0000-0002-6014-3543
                https://orcid.org/0000-0002-3224-6043
                https://orcid.org/0000-0002-0309-7448
                Article
                10.3346/jkms.2019.34.e105
                6439203
                30940999
                493ec9b4-fd0c-443b-b308-5b1e11cd6498
                © 2019 The Korean Academy of Medical Sciences.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 11 December 2018
                : 10 March 2019
                Funding
                Funded by: GlaxoSmithKline;
                Categories
                Original Article
                Infectious Diseases, Microbiology & Parasitology

                Medicine
                korea,post marketing surveillance,safety,tdap vaccine,whooping cough
                Medicine
                korea, post marketing surveillance, safety, tdap vaccine, whooping cough

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