Objective: To establish a sustainable updated literature data warehouse for global vaccine safety assessment, and provide data support for evidence-based vaccine safety assessment. Methods: Semi-automated construction and updating of a literature data warehouse were achieved through the continuous integration of standard operating steps of evidence-based reviews with artificial intelligence technologies. Following the standard procedure of a systematic literature review, the literatures about vaccine safety assessment published before November 29, 2020 were retrieved from 9 databases including OVID, Scopus, Web of Science, Cochrane Library, and ClinicalTrails.org in English and Wanfang, CNKI, VIP, and SinoMed in Chinese. Literatures were screened for two rounds in a semi-automatic manner (by artificial intelligence literature processing system and manual work) according to the inclusion/exclusion criteria. Furthermore, the literatures were classified according to the types of vaccines and adverse events. The updating strategy was established, and the literature data warehouse was updated regularly. Experts were organized to select specific vaccine safety topics and carry out special demonstration studies. Results: More than 0.41 million articles were retrieved. According to the inclusion/exclusion criteria, 23 304 articles were included after two rounds of screening. At present, we have selected and completed three prior topics as demonstration studies, including the systematic review of "DPT (diphtheria, pertussis and tetanus) vaccine and encephalopathy/encephalitis", and the classified management of literatures about allergic purpura and brachial plexus neuritis. Conclusions: The sustainable updated literature data warehouse of vaccine safety can provide high-quality research data for vaccine safety research, including evidence support for immunization related policy-making and adjustment and vaccine safety-related methodological research or clinical tool development; and further demonstration studies can provide references for building a new methodological framework system for timely and efficient completion of the evidence-based assessment of vaccine safety.
Artificial Intelligence ; Data Warehousing ; Humans ; Tetanus ; Tetanus Toxoid ; Whooping Cough/prevention & control*

HPV vaccination is the most effective way for preventing the cervical cancer. To respond the WHO calling for cervical cancer elimination, some Chinese provincial governments are launching the Free HPV Vaccination Programs for teenagers. Basing on the current stage of domestic utilization and the global immunization strategies of HPV vaccination, this paper provides a comprehensive review of the key aspects in the process of HPV vaccination, including subjects and priority vaccination population, vaccination dose and time interval, the principal of vaccination replacement, and the vaccination suggestion on special populations, etc. The article above contents and gives the advice on the immunization strategy of HPV vaccination in China.
AIDS Vaccines ; Adolescent ; BCG Vaccine ; China ; Diphtheria-Tetanus-Pertussis Vaccine ; Female ; Humans ; Immunization Programs ; Influenza Vaccines ; Measles-Mumps-Rubella Vaccine ; Papillomavirus Infections/prevention & control* ; Papillomavirus Vaccines ; Respiratory Syncytial Virus Vaccines ; SAIDS Vaccines ; Uterine Cervical Neoplasms ; Vaccination

Objective: To analyze the dropout of adsorbed diphtheria, tetanus and acellular pertussis combined vaccine (DTaP) routine immunization in China in 2019. Methods: DTaP vaccination data in all counties in China were collected through National Immunization Program Information Management System in 2019. Cumulative dropout rate and vaccination rate of DTaP in different provinces were calculated. According to the P₂₅, P₅₀ and P₇₅ values of DTaP dropout rate for all counties by province, counties in each province were divided into four groups (Q₁-Q₄). The DTaP average dropout rate of four groups and absolute difference (difference in DTaP average dropout rate between Q₄ and Q₁) were calculated. Spearman rank correlation was used to analyze the relationship between absolute difference and provincial DTaP dropout rate, DTaP₁ and DTaP₃ vaccination rate. Results: DTaP₁ vaccination rate ranged from 92.98% to 99.94% by province, with a median of 99.55%. Provincial DTaP dropout rate ranged from 0.36% to 28.66%, with a median of 3.54%. The provincial DTaP dropout rate was more than 10% in Gansu and Guizhou, about 28.66% and 17.19%. Absolute difference ranged from 4.02% to 39.22%, with a median of 10.16%. Provinces with the largest absolute difference were Gansu, Qinghai, Liaoning and Guizhou, about 39.22%, 34.48%, 23.31% and 21.33%, respectively. Correlation analysis indicated that the absolute difference was positively correlated with provincial DTaP dropout rate, with a correlation coefficient of 0.492 (P=0.004). It was negatively correlated with DTaP₁ and DTaP₃ vaccination rate. Correlation coefficients were -0.542 (P=0.001) and -0.562 (P=0.001), respectively. Conclusions: There are significant county-level differences in DTap dropout rate in most provinces, with relatively high difference in western provinces.
Humans ; Infant ; Whooping Cough/prevention & control* ; Diphtheria-Tetanus-Pertussis Vaccine ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Vaccination ; China ; Immunization, Secondary ; Immunization Schedule ; Antibodies, Bacterial

OBJECTIVE: To investigate the status of vaccination in children with human immunodeficiency virus (HIV) infection. METHODS: A questionnaire survey was performed in 148 children in Hunan province, China who were registered in China's Acquired Immune Deficiency Syndrome Comprehensive Response Information Management System up to December 31, 2016 and were aged <15 years at the time of confirmed diagnosis of HIV infection. The information on vaccination, diagnosis of HIV infection, and diagnosis and treatment of related diseases was collected. RESULTS: Of the 148 children with HIV infection, there were 70 boys (47.3%) and 78 girls (52.7%); 140 children had an age of 3.8 (0.2-14.8) years at the time of confirmed diagnosis, and 8 children refused to answer this question. Mother-to-child transmission was found in 133 children (91.7%), blood transmission in 1 child (0.7%), and unknown in 14 children (9.5%). Of the 148 children, 129 (87.2%) received antiviral therapy and 19 (12.8%) did not receive such treatment. The vaccination rates of hepatitis B vaccine, bacille Calmette-Guérin vaccine, poliomyelitis live attenuated vaccine and diphtheria-pertussis-tetanus vaccine ranged from 70.9% to 77.7%, which was significantly lower than the national level (≥97%); the vaccination rates of the other vaccines in the National Immunization Program gradually decreased with age. No severe adverse effects were reported after vaccination. CONCLUSIONS Mother-to-child transmission is the main route of HIV infection in Chinese children. The diagnosis of children with HIV infection is significantly delayed, with low vaccination rates. Efforts should be made to strengthen early diagnosis, early treatment and vaccination in children with HIV infection, in order to improve their quality of life.
Adolescent ; Child ; Child, Preschool ; China ; Diphtheria-Tetanus-Pertussis Vaccine ; Female ; HIV ; HIV Infections ; Humans ; Infant ; Male ; Quality of Life ; Vaccination

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
Adolescent ; Adult ; Common Cold ; Constipation ; Diphtheria Toxoid ; Diphtheria ; Dyspepsia ; Female ; Humans ; Immunization ; Incidence ; Infant ; Infant, Newborn ; Korea ; Obstetric Labor, Premature ; Pregnancy ; Pregnancy Outcome ; Pregnant Women ; Prospective Studies ; Tetanus Toxoid ; Tetanus ; Vaccination ; Whooping Cough

PURPOSE: Despite effectiveness and safety of maternal tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination, Tdap vaccination coverage during pregnancy remains quite low. We assessed the knowledge, attitude and practice on maternal Tdap vaccination among pregnant women. METHODS: This study was a cross-sectional survey of pregnant women who visited tertiary obstetrics and gynecologic units in Seoul and Gyeonggi province of Korea. Individual questionnaires were administered to assess knowledge, attitude and practice on maternal immunization with Tdap. RESULTS: The questionnaires were completed by 184 pregnant women; 158 (86%) had not received information from doctors about pertussis and Tdap, and 166 (90%) did not know the need for Tdap vaccination. Only 7% of pregnant women unlikely to receive Tdap vaccine during current pregnancy answered 3 or more of the 5 knowledge-based questions correctly. By logistic regression analysis, recommendation by doctor (adjusted odd ratio [OR], 236.2; 95% confidence interval [CI], 12.6–4,432), belief that the vaccine is effective (adjusted OR, 40.21; 95% CI, 2.35–687.7), and belief that the vaccine is safe (adjusted OR, 19.83; 95% CI, 1.54–255.9) were significantly important factors to respondents’ intention to be vaccinated. CONCLUSIONS: Most pregnant women seem to be neither recommended nor adequately informed about Tdap vaccination. Information given by health care professionals is very important to increase Tdap coverage among pregnant women.
Cross-Sectional Studies ; Delivery of Health Care ; Diphtheria Toxoid ; Diphtheria ; Female ; Gyeonggi-do ; Humans ; Immunization ; Intention ; Korea ; Logistic Models ; Obstetrics ; Pregnancy ; Pregnant Women ; Seoul ; Tetanus Toxoid ; Tetanus ; Vaccination ; Whooping Cough

PURPOSE: This report describes the results of a survey of the characteristics of pertussis in children from a single institution and compares it to data from the Korea Centers of Disease Control (KCDC). METHODS: We retrospectively evaluated the medical records of 17 and 6 patients diagnosed with pertussis and parapertussis, respectively, at Soonchunhyang University Bucheon Hospital from January 2005 to January 2017. RESULTS: Of the 17 patients with pertussis, 9 were under 1 year of age (52.9%), 3 were aged between 1 and 10 years (17.6%), and 5 were over 10 years of age (29.4%). Seven patients (41.2%) had never received diphtheria-tetanus-acellular pertussis vaccines, of which 5 were infants below 2 months of age and 2 were 10 years old and lived in China. Four patients showed the initial symptoms of cough in China. The sources of infection were the parents (2 cases) and the siblings (8 cases). All patients showed prolonged severe cough and the average duration of cough was 26 days. Severe symptoms, including dyspnea, cyanosis, apnea, and seizures, were observed in the children under 2 months of age. According to the recent 10-year KCDC data, the highest rate of pertussis diagnosis was noted in infants (47.8%), followed by adolescents (18.7%). Six patients with parapertussis also presented with prolonged severe cough without any other severe symptoms. Lymphocytosis was not found, unlike the patients with pertussis. CONCLUSION: The possibility of pertussis and parapertussis should be considered among patients with prolonged severe cough, especially in infants and adolescents.
Adolescent ; Apnea ; Bordetella parapertussis ; Bordetella pertussis ; Child ; China ; Cough ; Cyanosis ; Diagnosis ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Dyspnea ; Gyeonggi-do ; Humans ; Infant ; Korea ; Lymphocytosis ; Medical Records ; Parents ; Retrospective Studies ; Seizures ; Siblings ; Whooping Cough

OBJECTIVES: Vaccinations against diphtheria and tetanus are essential in providing immunity against these bacterial infections. The potency of diphtheria and tetanus toxoid vaccines can be measured using the in vivo toxin neutralization assay. The limit of potency of this assay was determined only for children. Therefore, we assessed the potency of adult vaccines using this assay to identify the feasibility of limit for adult vaccines. METHODS: Fifteen lots of tetanus-reduced diphtheria and tetanus-diphtheria-acellular pertussis vaccines were used. In vivo toxin neutralization and lethal challenge assays were conducted on each vaccine to calculate the potencies of the toxoids. National reference standards for toxins and antitoxins were used for in vivo toxin neutralization assay. RESULTS: All 15 lots satisfied the limits of potency for lethal challenge assay. The potency of diphtheria and tetanus toxoids exceeded 1 and 8 units/mL, respectively, for in vivo toxin neutralization assay. CONCLUSION: Although additional studies are required for new assays and limits, the current level of potency for adult vaccines as determined by in vivo toxin neutralization assay, was demonstrated in this study. Such efforts to improve assays are expected to promote the development of diphtheria and tetanus vaccines for adults and to contribute to vaccine self-sufficiency.
Adult* ; Antitoxins ; Bacterial Infections ; Child ; Diphtheria Toxoid ; Diphtheria* ; Humans ; Tetanus Toxoid* ; Tetanus* ; Toxoids ; Vaccination ; Vaccines* ; Whooping Cough

OBJECTIVE: To study the clinical features and risk factors of pertussis in children. METHODS: A retrospective analysis was performed for the clinical data and laboratory markers for immune function of 253 hospitalized children with pertussis. A total of 314 hospitalized children with cough were used as the control group. Quantitative real-time PCR was used to detect Bordetella pertussis DNA. The clinical data of both groups were collected to analyze the risk factors for pertussis. RESULTS: A total of 23 typical clinical parameters were compared between the pertussis and control groups, and there were significant differences in only 10 clinical parameters between the two groups (P<0.01). As for the complications observed in the two groups, the pertussis group had a significantly lower incidence rate of myocarditis than the control group (P<0.05). The pertussis group had significantly lower levels of serum globulin and IgM than the control group (P<0.05). Compared with the control group, the pertussis group had a significantly higher proportion of children with a lack of diphtheria-pertussis-tetanus immunization or timely immunization and a contact history of suspected pertussis patients (P<0.05). A lack of vaccine immunization or timely immunization and a contact history of suspected pertussis patients were risk factors for pertussis (P<0.05). CONCLUSIONS The clinical features are not typical in children with pertussis. Quantitative real-time PCR for detecting Bordetella pertussis DNA helps with the early diagnosis of atypical pertussis. Infants/toddlers should be immunized in time and be isolated from suspected pertussis patients to reduce the incidence of pertussis.
Bordetella pertussis ; Child ; Diphtheria-Tetanus-Pertussis Vaccine ; Humans ; Retrospective Studies ; Risk Factors ; Whooping Cough

Although tetanus and diphtheria have become rare in developed countries, pertussis is still endemic in some developed countries. These are vaccine-preventable diseases and vaccination for adults is important to prevent the outbreak of disease. Strategies for tetanus, diphtheria, and pertussis vaccines vary from country to country. Each country needs to monitor consistently epidemiology of the diseases and changes vaccination policies accordingly. Recent studies showed that tetanus–diphtheria–acellular pertussis vaccine for adults is effective and safe to prevent pertussis disease in infants. However, vaccine coverage still remains low than expected and seroprevalence of protective antibodies levels for tetanus, diphtheria, and pertussis decline with aging. The importance of tetanus–diphtheria–acellular pertussis vaccine administration should be emphasized for the protection of young adult and elderly people also, not limited to children.
Adult* ; Aged ; Aging ; Antibodies ; Child ; Developed Countries ; Diphtheria ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Epidemiology ; Humans ; Infant ; Pertussis Vaccine ; Seroepidemiologic Studies ; Tetanus ; Vaccination* ; Vaccines ; Whooping Cough* ; Young Adult