Incidence rates of health outcomes of interest among Chinese children exposed to selected vaccines in Yinzhou Electronic Health Records: A population-based retrospective cohort study |
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| Affiliation: | 1. Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United States;2. School of Public Health, Fudan University 138 Yi Xue Yuan Road, Shanghai 200032, China;3. Yinzhou Center for Disease Control and Prevention, 221 Xueshi Road, Ningbo, Zhejiang 315100, China;1. National Immunization Programme, Chinese Center for Disease Control and Prevention, No. 27 Nanwei Road, Beijing 100050, China;1. Agence de Médecine Préventive, Cité SONAR, Villa 7, Avenue Kwamé Nkrumah, 10PO Box 638, Ouagadougou, Burkina Faso;2. Institute of Global Health, Faculty of Medicine, University of Geneva, 9 Chemin des Mines, 1202 Geneva, Switzerland;3. University Nazi Boni, Bobo-Dioulasso, Burkina Faso;4. Ministry of Health, Ouagadougou, Burkina Faso;5. Department of Pediatrics, University Hospitals of Geneva, Geneva, Switzerland;6. Faculty of Medicine and Biomedical Sciences, University of Yaounde 1, Yaounde, Cameroon |
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| Abstract: | IntroductionOral poliovirus vaccine (OPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP) are widely used in China while Haemophilus influenzae type b vaccines (Hib) and a DTaP, inactivated poliovirus (IPV) and Hib polysaccharide conjugated to tetanus protein (PRP ~ T) combined vaccine (DTaP–IPV//PRP ~ T) have lower coverage. There are limited safety data on these vaccines in Chinese pediatric populations. Methods: To estimate incidence rates (IRs) of health outcomes of interest (HOIs) among children exposed to OPV, DTaP, Hib, and DTaP–IPV//PRP ~ T, we conducted a retrospective cohort study using a population-based electronic health record (EHR) database in Yinzhou district, Ningbo City. Children 0–2 years of age receiving at least one dose of these vaccines between January 1, 2012 and March 31, 2017 were included in the study. Yinzhou EHR database consisted of immunization records and healthcare data of children from hospitals and community health centers in the district. Eight HOIs (i.e., anaphylaxis, febrile seizures, all seizures, asthma, apnea, Kawasaki disease [KD], urticaria/angioedema, Guillain–Barré syndrome [GBS]) were identified using ICD-10 codes. Results: A total of 220,422 eligible children was identified. No cases of apnea, KD, and GBS were observed within 7 days post-vaccination. During 0–7 days post-vaccination for OPV, DTaP, Hib, and DTaP–IPV//PRP ~ T, the IRs of anaphylaxis, febrile seizures, all seizures, urticaria/angioedema and asthma ranged from 0.0 to 50.0, 0.0 to 99.9, 29.1 to 249.8, 297.8 to 949.1, and 992.7 to 2298.2 per 100,000 person-years, respectively, and 0.0 to 0.9, 0.0 to 1.9, 0.6 to 4.6, 5.6 to 17.5, and 18.7 to 42.3 per 100,000 doses, respectively. Conclusion: IRs of some HOIs in our study were comparable with those in the literature while IRs of other HOIs were not due to differences in study design, post-vaccination risk periods assessed, and vaccine types. Future studies should consider medical chart review for validating HOIs obtained in the EHR. |
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| Keywords: | Population-based electronic health records Incidence Vaccine China EPI" },{" #name" :" keyword" ," $" :{" id" :" k0030" }," $$" :[{" #name" :" text" ," _" :" Expanded Program on Immunization OPV" },{" #name" :" keyword" ," $" :{" id" :" k0040" }," $$" :[{" #name" :" text" ," _" :" oral polio vaccine DTaP" },{" #name" :" keyword" ," $" :{" id" :" k0050" }," $$" :[{" #name" :" text" ," _" :" diphtheria tetanus-acellular pertussis vaccine Hib" },{" #name" :" keyword" ," $" :{" id" :" k0060" }," $$" :[{" #name" :" text" ," $$" :[{" #name" :" italic" ," _" :" Haemophilus influenzae" },{" #name" :" __text__" ," _" :" type b vaccine CDC" },{" #name" :" keyword" ," $" :{" id" :" k0070" }," $$" :[{" #name" :" text" ," _" :" Centers for Disease Control and Prevention IR" },{" #name" :" keyword" ," $" :{" id" :" k0080" }," $$" :[{" #name" :" text" ," _" :" incidence rate HOI" },{" #name" :" keyword" ," $" :{" id" :" k0090" }," $$" :[{" #name" :" text" ," _" :" health outcome of interest EHR" },{" #name" :" keyword" ," $" :{" id" :" k0100" }," $$" :[{" #name" :" text" ," _" :" electronic health record AEFIS" },{" #name" :" keyword" ," $" :{" id" :" k0110" }," $$" :[{" #name" :" text" ," _" :" Adverse Event Following Immunization Information System NID" },{" #name" :" keyword" ," $" :{" id" :" k0120" }," $$" :[{" #name" :" text" ," _" :" national identification KD" },{" #name" :" keyword" ," $" :{" id" :" k0130" }," $$" :[{" #name" :" text" ," _" :" Kawasaki disease GBS" },{" #name" :" keyword" ," $" :{" id" :" k0140" }," $$" :[{" #name" :" text" ," _" :" Guillain–Barré syndrome ICD-10" },{" #name" :" keyword" ," $" :{" id" :" k0150" }," $$" :[{" #name" :" text" ," _" :" International Classification of Diseases, Tenth Revision (ICD-10) CI" },{" #name" :" keyword" ," $" :{" id" :" k0160" }," $$" :[{" #name" :" text" ," _" :" confidence interval WHO" },{" #name" :" keyword" ," $" :{" id" :" k0170" }," $$" :[{" #name" :" text" ," _" :" World Health Organization DTP" },{" #name" :" keyword" ," $" :{" id" :" k0180" }," $$" :[{" #name" :" text" ," _" :" diphtheria-tetanus-pertussis DTwP" },{" #name" :" keyword" ," $" :{" id" :" k0190" }," $$" :[{" #name" :" text" ," _" :" whole cell diphtheria-tetanus-pertussis US" },{" #name" :" keyword" ," $" :{" id" :" k0200" }," $$" :[{" #name" :" text" ," _" :" United States MMR" },{" #name" :" keyword" ," $" :{" id" :" k0210" }," $$" :[{" #name" :" text" ," _" :" measles-mumps-rubella IPV" },{" #name" :" keyword" ," $" :{" id" :" k0220" }," $$" :[{" #name" :" text" ," _" :" inactivated polio vaccine PhiD-CV" },{" #name" :" keyword" ," $" :{" id" :" k0230" }," $$" :[{" #name" :" text" ," _" :" 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine HBV" },{" #name" :" keyword" ," $" :{" id" :" k0240" }," $$" :[{" #name" :" text" ," _" :" hepatitis B vaccine |
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