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BACKGROUND: The study evaluated the protective effect of 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) against all-cause hospitalized pneumonia in children in Beijing. METHODS: Based on the vaccination record and inpatient medical record database of Beijing, children born in 2017 in Beijing, matched by age, gender, and district of the children with the ratio of 1:4, were selected as the vaccinated and unvaccinated groups according whether if vaccinated with PCV13. The incidence rate and 95 % confidence interval (95 %CI), vaccine effectiveness (VE) and direct medical costs of all-cause hospitalized pneumonia were calculated and compared within the same period of 12 months, 18 months, 24 months and 30 months after the birth of the child. RESULTS: The decreased incidence rates of all-cause hospitalized pneumonia were observed at the four points in the PCV13 vaccinated group compared to the unvaccinated group, which were significant at the points of 12 months (0.42 % vs. 0.72 %, P = 0.001), 18 months (0.90 % vs. 1.26 %, P = 0.002) and 24 months (1.37 % vs. 1.65 %, P = 0.046). The VE of PCV13 against all-cause hospitalized pneumonia within 12 months was the highest as 41.9 % (95 % CI 19.6 %, 58.0 %), followed by 29.3 % (95 % CI 11.4 %, 43.5 %) within 18 months, 17.1 % (95 % CI 0.3 %, 31.1 %) within 24 months and it almost disappeared within 30 months. The VE of 4-dose vaccination within 18 months and 24 months were 39.9 % (95 % CI 20.3 %, 54.7 %) and 27.2 % (95 % CI 8.6 %, 42.0 %), respectively. The median hospitalization cost of the children in the vaccinated group was higher at the four points but without significance. CONCLUSIONS: PCV13 had a certain protective effect on all-cause hospitalized pneumonia, and the booster immunization strategy had the best protective effect with great public health significance to enter the immunization program.

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Objective@#To investigate the incidence of adverse event following immunization (AEFI) with 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) in Jiaxing City, Zhejiang Province, so as to provide insights into safety monitoring and evaluation of PCV13.@*Methods@#Surveillance data of AEFI with PCV13 in Jiaxing City from 2020 to 2022 were collected from the AEFI Monitoring Information Management System of the Immunization Planning System of Chinese Disease Prevention and Control Information System, including demographic information, vaccination time, time of AEFI occurrence and clinical symptoms, and the reported incidence, population and district distribution, and clinical symptoms of AEFI with PCV13 were descriptively analyzed.@*Results@#Totally 455 cases of AEFI with PCV13 were reported in Jiaxing City from 2020 to 2022, with a reported incidence rate of 232.33/105 doses. There were 431, 21 and 3 cases of general, abnormal, coincidence and psychogenic reactions, with reported incidence rates of 220.07/105 doses, 10.72/105 doses and 1.53/105 doses, respectively, and no reports of causal reaction, vaccine quality accident and vaccination accident. The AEFI cases included 258 boys and 197 girls, with a boy/girl ratio of 1.31∶1, and 288 children at ages of less than a year (63.30%). The largest number of AEFI was reported in Haining City (87 cases, 19.12%), and there were 349 AEFI cases (76.70%) within 24 hours following vaccination. The clinical symptoms mainly included redness and swelling, fever and induration, with reported incidence rates of 132.76/105 doses (260 cases), 109.27/105 doses (214 cases), and 55.66/105 doses (109 cases), respectively. There were 450 cases cured and 5 cases improved in 455 cases of AEFI.@*Conclusions@#General reaction is the predominant AEFI in Jiaxing City from 2020 to 2022, with mild symptoms. Most AEFI occurs within 24 hours following vaccination, and has a good prognosis.

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Background: This study is to evaluate the safety of two kinds of PCV13 carriers by monitoring the occurrence of adverse event following immunization (AEFI) after the launch of two kinds of PCV13 carriers in Jiangsu Province, China. Methods: The AEFI Information System (CNAEFIS) of mainland China was used to monitor the incidence and classification of adverse reactions of the CRM197-carrier protein PCV13 and TT-carrier protein PCV13 vaccines. Results: There was no statistical difference between the cumulative reported incidence of AEFI between the two vaccines from 2020 to 2022 (χ2 = 1.991, p < 0.158). 96.62% of the AEFIs were classified as common reactions; rare reactions and coincidental events only accounted for 2.99 and 0.39% of all the AEFI cases, respectively. Redness (2.6 cm-5 cm) is the commonest symptom at the injection site for both vaccines. More than 97% of AEFIs occurred between 30 min and 3 days after administration for both types of PCV13. Conclusion: Both vaccines perform well in terms of safety. We did not identify any new/unexpected safety concern from the NAEFISS during a 4 years timespan.

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Background: 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) has been introduced in Hangzhou since 2017, whereas its current immunization state in children is not clear. Therefore, this study aims to describe the PCV13 vaccination distribution among children born in Hangzhou from 2017 to 2021 to provide data for reducing vaccination differences among different populations. Methods: Descriptive epidemiology was used for data analysis and PCV13 vaccination related information of children was collected from children vaccination management system of Zhejiang Province (ZJCVMS). Results: Among the 649,949 children born in Hangzhou from 2017 to 2021, 169,230 were vaccinated with an average full course vaccination rate of 26.0%. The full course vaccination rates in 5 years were different (P = 0.000) with an increasing trend (P fortrend < 0.01). The first dose vaccination rates were different in 5 years (P = 0.000) with an increasing trend (P fortrend < 0.01). The distribution of age when first dose PCV13 was administered varied, most people at 2 months and least people at 5 months. The full course vaccination rate varied by areas, highest in central urban areas and lowest in remote areas respectively (all P-value < 0.05). Overall, the full course vaccination rate of PCV13 was higher in the registered residence population than the non-registered residence population, which was 136,693 (31.4%) and 32,537 (15.1%) respectively (P = 0.000). The full course vaccination rates were the same between men and women (P = 0.502), which was 87,844 for men (26.0%) and 81,386 for women (26.1%). Conclusion: Although the number of people who received PCV13 full course vaccination and received the first dose vaccination showed yearly increasing trends in Hangzhou, the full course vaccination rate for the whole population was relatively low. In addition, the PCV13 vaccination rates also differed by geography and household registration status. Measures such as expanding vaccination publicity or including national immunization should be taken to increase vaccination rates and reduce the differences in vaccination among groups with different characteristics.

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Although it varies with age and geographical distribution, the global burden of infection with Streptococcus pneumoniae (pneumococcus) remains considerable. The elderly, and younger adults with comorbid conditions, are at particularly high risk of pneumococcal infection, and this risk will increase as the population ages. Vaccination should be the backbone of our current strategies to deal with this infection.Main body: This manuscript reviews the history of the development of pneumococcal vaccines, and the impact of different vaccines and vaccination strategies over the past 111 years. It documents the early years of vaccine development in the gold mines of South Africa, when vaccination with killed pneumococci was shown to be effective, even before the recognition that different pneumococci were antigenically distinct. The development of type-specific vaccines, still with whole killed pneumococci, showed a high degree of efficacy. The identification of the importance of the pneumococcal capsule heralded the era of vaccination with capsular polysaccharides, although with the advent of penicillin, interest in pneumococcal vaccine development waned. The efforts of Austrian and his colleagues, who documented that despite penicillin therapy, patients still died from pneumococcal infection in the first 96 h, ultimately led to the licensing first of a 14-valent pneumococcal polysaccharide in 1977 followed by the 23-valent pneumococcal polysaccharide in 1983. The principal problem with these, as with other polysaccharide vaccines, was that that they failed to immunize infants and toddlers, who were at highest risk for pneumococcal disease. This was overcome by chemical linking or conjugation of the polysaccharide molecules to an immunogenic carrier protein. Thus began the era of pneumococcal conjugate vaccine (PCV), starting with PCV7, progressing to PCV10 and PCV13, and, most recently, PCV15 and PCV20. However, these vaccines remain serotype specific, posing the challenge of new serotypes replacing vaccine types. Current research addresses serotype-independent vaccines which, so far, has been a challenging and elusive endeavor.Conclusion: While there has been enormous progress in the development of pneumococcal vaccines during the past century, attempts to develop a vaccine that will retain its efficacy for most pneumococcal serotypes are ongoing.

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Humans have been struggling for two centuries to reduce the health and economic burden caused by pneumococcal infection. Invasive pneumococcal disease （IPD）， meningitis， and acute otitis media caused by pneumococcus occur worldwide， especially in infants， children and elderly. Pneumococcus is resistant to most antibiotics and vaccines remain the most effective measure against the pneumococcal epidemic. The development of the pneumococcal vaccine was initiated at the beginning of 21 century. In 2014， incidence and mortality of pneumococcal pneumonia and IPD induced by vaccine serotypes decreased accordingly after the introduction of 13-valent pneumococcal conjugate vaccine （PCV）. Subsequently， the new challenge is to further improve the low response of some existing vaccine serotypes， include more serotypes in the PCV， and research on the application of PCV in specific populations. This review briefly describes the development of PCV.

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INTRODUCTION: Streptococcus pneumoniae (S. pneumoniae) is a major pathogen of infectious diseases in children. Surveillance of the distribution of pneumococcus serotypes is important for immunization strategies of pneumococcal polysaccharide conjugate vaccines (PCVs). Areas covered: This article is a systematic review of studies conducted from 2006 to 2016 that document serotypes of S. pneumoniae isolated from children less than 14 years old in the mainland of China. A total of 40 studies were included in this review. Serotypes 19F, 19A, 23F, 14 and 6B were the most common. Serotype prevalence and percentage varied by region and associated strains. The serotype coverage rate of PCV13 was higher than that of PCV10 due to the prevalence of serotype 19A, and there were no significant difference between the coverage rate of PCV13 and PPSV23. Expert commentary: To prevent Chinese children from S. pneumoniae infection, it is necessary for the universal immunization of PCV13 or develop new vaccines that include all the prevalent serotypes in China.

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This review describes development of currently available pneumococcal vaccines, provides summary tables of current pneumococcal vaccine recommendations in children and adults, and describes new potential vaccine antigens in the pipeline. Streptococcus pneumoniae, the bacteria responsible for pneumonia, otitis media, meningitis and bacteremia, remains a cause of morbidity and mortality in both children and adults. Introductions of unconjugated and conjugated pneumococcal polysaccharide vaccines have each reduced the rate of pneumococcal infections caused by the organism S. pneumoniae. The first vaccine developed, the 23-valent pneumococcal polysaccharide vaccine (PPSV23), protected adults and children older than 2 years of age against invasive disease caused by the 23 capsular serotypes contained in the vaccine. Because PPSV23 did not elicit a protective immune response in children younger than 2 years of age, the 7-valent pneumococcal conjugate vaccine (PCV7) containing seven of the most common serotypes from PPSV23 in pediatric invasive disease was developed for use in children younger than 2 years of age. The last vaccine to be developed, the 13-valent pneumococcal conjugate vaccine (PCV13), contains the seven serotypes in PCV7, five additional serotypes from PPSV23, and a new serotype not contained in PPSV23 or PCV7. Serotype replacement with virulent strains that are not contained in the polysaccharide vaccines has been observed after vaccine implementation and stresses the need for continued research into novel vaccine antigens. We describe eight potential protein antigens that are in the pipeline for new pneumococcal vaccines.

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BACKGROUND: Unlike free polysaccharide vaccines, pneumococcal polysaccharide conjugate vaccines (PCVs) induce a T cell-dependent immune response and have the potential to provide an extended duration of protection with repeated vaccinations. METHODS: This was an extension of a previous study in pneumococcal vaccine-naïve adults aged 50-64 years in which adults 60-64 years of age were given 13-valent PCV (PCV13) or 23-valent pneumococcal polysaccharide vaccine (PPSV23) and adults aged 50-59 were given PCV13. In this follow up study conducted about 4 years later, the 60-64 year olds initially given PCV13 received PCV13 or PPSV23, and those initially given PPSV23 received another PPSV23. All adults aged 50-59 years were re-vaccinated with PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after vaccination. RESULTS: A second PCV13 given about 4 years after a first vaccination induced OPA titers that were significantly higher than those following the initial vaccination for 7 of 13 serotypes in the older group, and 6 of 13 serotypes in the younger group, and responses to the remaining serotypes were largely non-inferior. In contrast, OPA titers following revaccination with PPSV23 were statistically significantly lower for 9 of the 13 serotypes, and non-inferior for the remaining serotypes, when compared to the responses to the first PPSV23. OPA titers in the older adults who received PPSV23 after initial PCV13 were significantly higher than those following a first PPSV23 for 10 of the 13 serotypes. CONCLUSION: In adults 50 to 64 years of age, initial vaccination with PCV13 establishes an immune state that results in recall anti-pneumococcal responses upon subsequent vaccination with either conjugated or free polysaccharide vaccine. In contrast, initial vaccination with PPSV23 results in an immune state in which subsequent PPSV23 administration yields generally lower responses compared with the initial responses.

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BACKGROUND: Streptococcus pneumoniae is a major cause of morbidity and mortality among adults 50 years of age and older in the United States. Pneumococcal conjugate vaccines are efficacious against pneumococcal disease in children and may also offer advantages in adults. METHODS: We performed a randomized, modified double-blind trial that compared a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in 831 pneumococcal vaccine naive adults 60-64 years of age. An additional group of 403 adults 50-59 years of age received open-label PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured at baseline, and at 1 month and 1 year after vaccination. RESULTS: In the randomized trial, the month 1 post-vaccination OPA geometric mean titers in the PCV13 group were statistically significantly higher than in the PPSV23 group for 8 of the 12 serotypes common to both vaccines and for serotype 6A, a serotype unique to PCV13, and were comparable for the other 4 common serotypes. The immune response to PCV13 was generally greater in adults 50-59 years of age compared to adults 60-64 years of age. OPA titers declined from 1 month to 1 year after PCV13 administration but remained higher than pre-vaccination baseline titers. CONCLUSIONS: PCV13 induces a greater functional immune response than PPSV23 for the majority of serotypes covered by PCV13, suggesting that PCV13 could offer immunological advantages over PPSV23 for prevention of vaccine-type pneumococcal infection.

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BACKGROUND: The currently recommended single dose of the 23-valent pneumococcal free polysaccharide vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent polysaccharide conjugate vaccine (PCV13). METHODS: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination. RESULTS: Following the enrollment vaccination, OPA titers were significantly greater in the PCV13 group compared to the PPSV23 group for 10 of the 12 serotypes common to both vaccines and to serotype 6A which is unique to PCV13. Responses were noninferior for the other 2 common serotypes. Responses to PCV13 given at 1 year were generally lower in the group that received PPSV23 at enrollment. CONCLUSION: In adults aged 70 years and older previously vaccinated with PPSV23, PCV13 was significantly more immunogenic than PPSV23 for most of the common serotypes and for serotype 6A. The OPA responses after a follow-on dose of PCV13 one year later indicate that a prior dose of PPSV23, but not PCV13, diminishes the response to the subsequent administration of PCV13.

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