1.Efficacy and effectiveness of extended-valency pneumococcal conjugate vaccines.
Hyunju LEE ; Eun Hwa CHOI ; Hoan Jong LEE
Korean Journal of Pediatrics 2014;57(2):55-66
The 7-valent pneumococcal protein conjugate vaccine (PCV7) has been shown to be highly efficacious against invasive pneumococcal diseases and effective against pneumonia and in reducing otitis media. The introduction of PCV7 has resulted in major changes in the epidemiology of pneumococcal diseases. However, pneumococcal vaccines induce serotype-specific immunity, and a relative increase in non-vaccine serotypes has been reported following the widespread use of PCV7, leading to a need for extended serotype coverage for protection. PCV10 and PCV13 have been licensed on the basis of noninferiority of immunogenicity compared to a licensed conjugate vaccine. In this article, we aimed to review important data regarding the efficacy and effectiveness of the extended-coverage PCVs published or reported thus far and to discuss future implications for pneumococcal vaccines in Korea. After the introduction of PCV10 and PCV13, within a short period of time, evidence of protection conferred by these vaccines against invasive and mucosal infections caused by most of the serotypes included in the vaccines is accumulating. The choice of vaccine should be based on the changes in the dynamics of pneumococcal serotype distribution and diseases in the region where the vaccines are to be used. Continuous surveillance is essential for the appropriate use of pneumococcal vaccines and evaluation of the impact of PCVs on pneumococcal diseases.
Epidemiology
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Korea
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Otitis Media
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Pneumococcal Vaccines
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Pneumonia
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Vaccines
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Vaccines, Conjugate*
2.Analysis on the implementation of payment policies for four non-national immunization program vaccines in China.
Guang Jie ZHONG ; Ming Han WANG ; Jia Wen GE ; Juan YANG
Chinese Journal of Preventive Medicine 2023;57(11):1843-1847
This study systematically retrieved information on the payment policy of vaccination fees for pneumococcal vaccines, human papillomavirus vaccines, haemophilus influenzae type b vaccines and rotavirus vaccines using a Python-based crawler. The proportion of the population covered by policies among the total applicable population was estimated based on the medical insurance coverage ratio and population data in 2020. This study showed that the payment policies included two categories, government-funded free vaccination policies and medical insurance payment policies. Among the four non-national immunization program vaccines, the free vaccination policies only involved pneumococcal vaccines and human papillomavirus vaccines. Among them, the 13-valent pneumococcal conjugate vaccine, the 23-valent pneumococcal polysaccharide vaccine, and the human papillomavirus vaccine were provided free of charge in 1, 10 and 15 provinces, respectively. For these policies, the corresponding covered population and the proportion among the total applicable population were children aged 6 months to 2 years old (2.5%), older people (1.2% to 21.5%) and middle school girls (1.1% to 12.2%). Medical insurance payment policies were implemented in 14 provinces, and nearly covered the four types of vaccines in the policy implementation areas, with the proportion of the covered population about 10.9% to 41.5% among the total applicable population.
Child
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Female
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Humans
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Infant
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Aged
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Pneumococcal Vaccines
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Vaccination
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Policy
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Immunization Programs
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Papillomavirus Vaccines
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China
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Vaccines, Conjugate
3.Analysis on the implementation of payment policies for four non-national immunization program vaccines in China.
Guang Jie ZHONG ; Ming Han WANG ; Jia Wen GE ; Juan YANG
Chinese Journal of Preventive Medicine 2023;57(11):1843-1847
This study systematically retrieved information on the payment policy of vaccination fees for pneumococcal vaccines, human papillomavirus vaccines, haemophilus influenzae type b vaccines and rotavirus vaccines using a Python-based crawler. The proportion of the population covered by policies among the total applicable population was estimated based on the medical insurance coverage ratio and population data in 2020. This study showed that the payment policies included two categories, government-funded free vaccination policies and medical insurance payment policies. Among the four non-national immunization program vaccines, the free vaccination policies only involved pneumococcal vaccines and human papillomavirus vaccines. Among them, the 13-valent pneumococcal conjugate vaccine, the 23-valent pneumococcal polysaccharide vaccine, and the human papillomavirus vaccine were provided free of charge in 1, 10 and 15 provinces, respectively. For these policies, the corresponding covered population and the proportion among the total applicable population were children aged 6 months to 2 years old (2.5%), older people (1.2% to 21.5%) and middle school girls (1.1% to 12.2%). Medical insurance payment policies were implemented in 14 provinces, and nearly covered the four types of vaccines in the policy implementation areas, with the proportion of the covered population about 10.9% to 41.5% among the total applicable population.
Child
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Female
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Humans
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Infant
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Aged
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Pneumococcal Vaccines
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Vaccination
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Policy
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Immunization Programs
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Papillomavirus Vaccines
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China
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Vaccines, Conjugate
4.A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants
Zhiqiang XIE ; Dongyang ZHAO ; Haitao HUANG ; Jinbo GOU ; Wei ZHANG ; Yongli YANG ; Lili HUANG ; Yanxia WANG ; Xue WANG ; Lifeng XU ; Tao ZHU ; Shengli XIA
Chinese Journal of Preventive Medicine 2020;54(9):947-952
The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants. From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348). The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (<0.001). ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.
Antibodies, Bacterial
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Humans
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Infant
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Meningococcal Vaccines
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adverse effects
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immunology
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Vaccines, Conjugate
5.Expert consensus on immunoprophylaxis of pneumococcal disease (2020 version).
Chinese Journal of Preventive Medicine 2020;54(12):1315-1363
Pneumococcal disease is a serious global public health problem and a leading cause of morbidity and mortality of children and adults in China. Antibiotics are commonly used to treat pneumococcal disease. However, antibiotic resistance to
Adult
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Child
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China
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Consensus
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Humans
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Pneumococcal Infections/prevention & control*
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Pneumococcal Vaccines
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Streptococcus pneumoniae
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Vaccines, Conjugate
6.The surveillance analysis of the adverse events following immunization of the domestic 13-valent pneumococcal polysaccharide conjugate vaccine in Zhejiang Province.
Yu HU ; Zhen HUANG ; Ying WANG ; Hui LIANG ; Xue Jioa PAN ; Ya Ping CHEN ; Lin YUAN ; Shu Yuan YANG ; Jing Jing CHEN ; Yuan Yuan CHEN ; Xue Mei YAN ; Qian TAO ; Xi QIN ; Hua Kun LYU
Chinese Journal of Preventive Medicine 2022;56(11):1625-1629
To evaluate the safety of the domestic 13-valent pneumococcal polysaccharide conjugate vaccine-tetanus toxoid protein (PCV13-TT) after its licensure. The adverse event following immunization (AEFI) and the vaccination data of PCV13-TT in Zhejiang province from July 2020 to October 2021 were collected from national adverse event following immunization surveillance system and Zhejiang provincial immunization information system. Descriptive epidemiological method was used for this analysis. From July 2020 to October 2021, 302 317 doses of PCV13-TT were administered in children under 6 years old in Zhejiang Province and 636 AEFI case reports were received, with a reporting rate of 21.04 per 10 000 doses. Of these AEFI cases, 97.17% were mild vaccine product-related reaction (20.54 per 10 000 doses) and 95.44% occurred in the 0-1 d after vaccination (20.08 per 10 000 doses). The most common clinical diagnoses of AEFI included fever (224 cases), redness (204 cases), and induration (190 cases), while allergic rash (11 cases) was the most common diagnosis among the abnormal reactions. In conclusion,the present results bolstered that the domestic PCV13-TT was generally well tolerated in children under 6 years old in Zhejiang Province.
Child
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Humans
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Child, Preschool
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Vaccines, Conjugate/adverse effects*
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Pneumococcal Vaccines/adverse effects*
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Vaccination
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Immunization
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Polysaccharides
7.Immunogenicity of group A+C meningococcal polysaccharide conjugate vaccine in infants: A phase Ⅲ clinical trial study.
Li Li HUANG ; Xiao Min MA ; Hai Tao HUANG ; Zhi Qiang XIE ; Jin Bo GOU ; Yong Li YANG ; Xue WANG ; Wei ZHANG ; Wang Yang YOU ; Jie Bing TAN ; Li Feng XU ; Guang Wei FENG ; Tao ZHU ; Yanxia WANG
Chinese Journal of Preventive Medicine 2022;56(12):1728-1733
Objective: To evaluate the immunogenicity of group A+C meningococcal polysaccharide conjugate vaccine in infants under 2 years old. Methods: From March 2017 to June 2018, 1 932 healthy infants in Biyang County, Henan Province, who were not vaccinated with meningococcal meningitis vaccine and whose axillary temperature was ≤37.0 ℃, were recruited as participants. The 3 months and 6-11 months old infants were allocated to the experiment group and the control group in a ratio of 1∶1. Infants aged 12-23 months were allocated to the 1-dose group, the 2-dose group and the control group in a ratio of 1∶1∶1, with 276 infants in each group. The infants in the experiment group were intramuscularly injected with freeze-dried group A+C meningococcal polysaccharide conjugate vaccine to be evaluated, and infants in the control group received intramuscular injection of commercially available freeze-dried group A+C meningococcal conjugate vaccine. The venous blood of infants was collected 30 days before the first dose and after the last dose of inoculation, and the antibody seroconversion of each group was determined and compared. Results: The completion rate of immunogenicity study was 95.2% (1 839/1 932). Before inoculation, there was no statistical difference in the geometric mean titer and positive rate of group A+C antibodies between the experiment group and the control group in 3 months and 6-11 months old infants (all P values >0.05). The geometric mean titers and positive rate of group A antibodies in the 1-dose group were higher than those in the control group (all P values <0.05), but there was no statistical difference between the 2-dose group and the control group (all P values >0.05) in infants aged 12-23 months. After inoculation, the differences (95%CI) in the positive conversion rate of group A+C antibodies between the experiment group and the control group were -0.12% (-6.01%-5.77%) and 0.82% (-4.23%-5.86%) in the 3 months old infants. At the age of 6-11 months, the differences were 6.75% (1.71%-11.79%) and -4.32% (-8.73%-0.08%), respectively. At the age of 12-23 months, the differences were 1.02% (-3.80%-5.83%) and -4.40% (-7.79%- -1.01%) in the 2-dose group and -7.22% (-12.90%- -1.54%) and -18.61% (-23.75%- -13.46%) in the 1-dose group, respectively. The geometric mean titers of group A+C antibodies in the 3 months old infants were 48.50 and 63.12, respectively, which had no significant difference from the control group (43.02 and 57.99, respectively) (both P values <0.05). The geometric mean titers of group A+C antibodies in the 6-11 months and 12-23 months old infants were 84.09 and 92.51 (2-dose group), which were higher than those in the corresponding control group (43.10 and 61.83, respectively) (all P values <0.001). Conclusion: Group A+C meningococcal conjugate vaccine has good immunogenicity in infants under 2 years old.
Humans
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Infant
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Child, Preschool
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Meningococcal Vaccines
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Vaccines, Conjugate
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Vaccination
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Neisseria meningitidis
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Polysaccharides
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Antibodies, Bacterial
8.Analysis on the vaccination coverage of 13-valent pneumococcal conjugate vaccine in China from 2017 to 2021.
Ya Ni CHEN ; Ying Xue HU ; Lei CAO ; Hui ZHENG ; Zhi Jie AN
Chinese Journal of Preventive Medicine 2023;57(10):1536-1541
Objective: To explore the vaccination coverage of the 13-valent pneumococcal conjugate vaccine (PCV13) in China from 2017 to 2021. Methods: Using the reported number of PCV13 administrated doses from 2017 to 2021 and the population data from 31 provinces in China, which were collected by the Immunization Program Information System and summarized data at different levels (prefecture, provincial, and national). Collecting batch release data of PCV13 during the same period through the official website of the National Institutes for Food and Drug Control. The average coverage level of PCV13 was calculated by comparing the number of PCV13 vaccinations reported annually to the number of births in that year, and the spatial auto-correlation analysis was conducted in 2021 at the prefecture level. The coverage of PCV13 vaccination was estimated by the total vaccine doses administered each year divided by the number of newborn in the year, as of the administrated dose number per 100 people. Results: From March 2017 to December 2020, the total batch release of PCV13 was 20.06 million, with a total of 71.54, 384.75, 475.45, and 10.8886 million doses each year. During the same period, PCV13 reported doses were 20.2369 million and the vaccination doses from 2017 to 2021 were 4.08, 170.46, 407.52, 599.77, and 8.4185 million doses, respectively. From 2017 to 2021, the ratio of PCV13 doses administrated per 100 infants in each year was 0.25, 10.26, 23.81, 38.16, and 69.90 doses per 100 people, respectively. The range of the ratio in each province increased from 3.85 doses in 2017 to 264.41 doses per 100 people in 2021. The spatial auto-correlation analysis results showed that based on prefecture-level cities, there was spatial clustering in a certain area of PCV13 coverage from 2017 to 2021, and the spatial correlation in 2021 was the highest. The hotspot analysis showed that the hotspot areas with high coverage levels of PCV13 were concentrated in Jiangsu, Zhejiang, Shanghai, Fujian and their surrounding areas. The cold spots with low vaccine coverage were concentrated in Yunnan, Qinghai, Tibet, and their surrounding areas. Conclusion: The average coverage level of PCV13 is low in China with significant regional differences.
Infant
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Infant, Newborn
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Humans
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Vaccination Coverage
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Vaccines, Conjugate
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China
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Pneumococcal Vaccines
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Vaccination
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Tibet
9.Experts' consensus on immunization with meningococcal vaccines in China.
Chinese Journal of Epidemiology 2019;40(2):123-128
Meningococcal vaccines in the Chinese market include meningococcal polysaccharide vaccine, meningococcal polysaccharide conjugate vaccine, and a combined vaccine. Meningococcal conjugate vaccines immunization schedules vary by vaccine manufacturer, and often cause confusion in immunization practices. Based on the epidemiological characteristics of meningococcal disease, serogroup distribution of Neisseria meningitidis, and research progress on the immunogenicity and safety of meningococcal vaccines, we developed an experts' consensus on immunization with meningococcal vaccines to provide guidance for immunization providers and for centers for disease control and prevention staff.
China
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Consensus
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Humans
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Immunization
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Meningococcal Infections/prevention & control*
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Meningococcal Vaccines/administration & dosage*
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Vaccines, Conjugate
10.Analysis on the vaccination coverage of 13-valent pneumococcal conjugate vaccine in China from 2017 to 2021.
Ya Ni CHEN ; Ying Xue HU ; Lei CAO ; Hui ZHENG ; Zhi Jie AN
Chinese Journal of Preventive Medicine 2023;57(10):1536-1541
Objective: To explore the vaccination coverage of the 13-valent pneumococcal conjugate vaccine (PCV13) in China from 2017 to 2021. Methods: Using the reported number of PCV13 administrated doses from 2017 to 2021 and the population data from 31 provinces in China, which were collected by the Immunization Program Information System and summarized data at different levels (prefecture, provincial, and national). Collecting batch release data of PCV13 during the same period through the official website of the National Institutes for Food and Drug Control. The average coverage level of PCV13 was calculated by comparing the number of PCV13 vaccinations reported annually to the number of births in that year, and the spatial auto-correlation analysis was conducted in 2021 at the prefecture level. The coverage of PCV13 vaccination was estimated by the total vaccine doses administered each year divided by the number of newborn in the year, as of the administrated dose number per 100 people. Results: From March 2017 to December 2020, the total batch release of PCV13 was 20.06 million, with a total of 71.54, 384.75, 475.45, and 10.8886 million doses each year. During the same period, PCV13 reported doses were 20.2369 million and the vaccination doses from 2017 to 2021 were 4.08, 170.46, 407.52, 599.77, and 8.4185 million doses, respectively. From 2017 to 2021, the ratio of PCV13 doses administrated per 100 infants in each year was 0.25, 10.26, 23.81, 38.16, and 69.90 doses per 100 people, respectively. The range of the ratio in each province increased from 3.85 doses in 2017 to 264.41 doses per 100 people in 2021. The spatial auto-correlation analysis results showed that based on prefecture-level cities, there was spatial clustering in a certain area of PCV13 coverage from 2017 to 2021, and the spatial correlation in 2021 was the highest. The hotspot analysis showed that the hotspot areas with high coverage levels of PCV13 were concentrated in Jiangsu, Zhejiang, Shanghai, Fujian and their surrounding areas. The cold spots with low vaccine coverage were concentrated in Yunnan, Qinghai, Tibet, and their surrounding areas. Conclusion: The average coverage level of PCV13 is low in China with significant regional differences.
Infant
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Infant, Newborn
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Humans
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Vaccination Coverage
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Vaccines, Conjugate
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China
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Pneumococcal Vaccines
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Vaccination
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Tibet