ABSTRACT
To analyze the coverage rate of adult herpes zoster (HZ) vaccine and the incidence of Adverse event following immunization (AEFI) in Jiangsu province, China. The vaccination information of HZ vaccine in people aged 50 years and above in Jiangsu province in 2023 and the AEFI information of HZ vaccine from 2020 to 2023 were collected through the Jiangsu Province vaccination management information system and China AEFI information management system, and the vaccination rate and AEFI incidence of HZ vaccine were analyzed. The overall vaccination rate among individuals aged 50 years and above was merely 0.19%. About 20% of vaccinated individuals (12,821 people) received only the first dose, failing to complete the recommended two-dose regimen. A total of 43 and 217 cases of AEFIs following vaccination were reported after administration of the HZ vaccine during the periods of 2020–2021 and 2022–2023, respectively, resulting in reporting rates (RRs) of 240.7 and 201.2 per 100,000 doses, correspondingly. The majority of AEFIs following vaccination with HZ vaccines were common reactions, while rare reactions and coincidental events accounted for only 1.5% and 0.4% of cases, respectively. Over 55% of AEFIs occurred within 30 minutes post-vaccination , with fever, allergic eruptions, and drowsiness being the most reported systemic symptoms, and redness and induration being the main symptoms at the injection site. Despite the proven safety profile of the HZ vaccine, its coverage remains significantly low among individuals aged 50 years and above in Jiangsu Province, China as of 2023. The majority of AEFIs were mild and commonly observed. To enhance the comprehensiveness of post-marketing safety data, it is imperative to conduct further active surveillance studies.
KEYWORDS: Herpes zoster vaccine, adverse reaction, safety, post-marketing surveillance
Introduction
Herpes zoster (HZ), commonly referred to as shingles, is caused by the reactivation of the varicella-zoster virus that remains latent after primary infection. With advancing age or immune suppression, this dormant virus can reactivate, leading to painful skin rashes and other complications, such as postherpetic neuralgia.1 The global burden of HZ is substantial, particularly among individuals aged 50 years and older.2 Despite the availability of an effective HZ vaccine, vaccination coverage remains low in many settings, including China, due to factors such as cost, awareness, and access.3,4 The overall incidence of HZ has been steadily increasing over time, particularly among individuals aged 50 years and older who are more susceptible to developing this condition.5 By age 85, approximately half of all individuals will have experienced at least one episode of HZ. Elderly individuals and those immunocompromised face the highest risk for developing this disease.6
After completing a full course of vaccination, more than 75% of individuals can achieve protection against HZ, making vaccination the optimal strategy for preventing and controlling this condition.7 It is widely acknowledged that three primary factors impact vaccine coverage: severity of infection, vaccine efficacy, and vaccine safety.8 The most direct criterion for assessing vaccine safety lies in post-vaccination reactions. Therefore, obtaining accurate data on adverse events following immunization (AEFI) plays a crucial role in enhancing awareness about vaccination safety and alleviating concerns among recipients. In China, post-marketing vaccine safety monitoring predominantly relies on the Chinese national reporting system of adverse events after Vaccination (CNAEFIS), which operates as a passive reporting system. Over the past decade, Jiangsu province comprehensive vaccination service management information system (JPCVs) is becoming more reliable. This study aimed to evaluate the coverage rate and safety profile of the HZ vaccine in Jiangsu Province using data from 2020 to 2023, focusing on AEFI reported through passive surveillance systems.
Methods
Study design
This study employed a retrospective descriptive analysis to investigate the vaccine coverage and prevalence of adverse events following immunization (AEFI) associated with herpes zoster (HZ) vaccine use in Jiangsu Province, China. Data were collected from January 2020 to December 2023. The study analyzed vaccination records and AEFI reports obtained from the Jiangsu comprehensive vaccination service management information system (JPCVs) and the Chinese national adverse event following immunization system (CNAEFIS).
Study setting and population
The analysis focused on adults aged 50 years and above who were eligible to receive the HZ vaccine. The inclusion criteria for the study population were as follows: 1.Individuals aged 50 years and older who received at least one dose of the HZ vaccine during the study period. 2.Vaccination records successfully entered into the JPCVs database by licensed vaccination clinics. 3.AEFI cases reported and documented in the CNAEFIS system.
Excluded were: 1. Cases where vaccination records or AEFI reports were incomplete or missing essential information. 2. Individuals vaccinated outside Jiangsu Province.
Data collection and variables
Vaccination records included demographic data, dose information (first or second), and timing of vaccination. AEFI cases included detailed clinical symptoms, onset timing, classification (common reactions, rare reactions, coincidental events), severity, and outcomes. The reporting rate of AEFI was calculated as the number of reported cases per 100,000 doses administered. The denominator for calculating the reporting rate of AEFI was obtained by extracting the number of HZ vaccination doses from the provincial central server database of JPCVs in Jiangsu Province. Whenever an adult receives any type of vaccine at vaccination clinic (VC) in Jiangsu Province, the vaccinator physician submits and automatically uploads their name, date of birth, home address, and vaccination information (including vaccine name, type, batch number, and dose number) to JPCVs on the provincial central server.
The study analyzed vaccination and AEFI data over two distinct periods:
2020–2021: The initial introduction phase of the HZ vaccine in Jiangsu Province.
2022–2023: A period of increased uptake as public awareness of the vaccine grew.
These periods were selected to examine trends in vaccine coverage and the reporting rates of AEFIs over time.
Surveillance of CNAEFIS and JPCVs
AEFI are defined as post-vaccination reactions or events suspected to be associated with vaccine administration.9 Since 2008, the management of CNAEFIS has been entrusted to the chinese center for disease control and prevention in accordance with the chinese national AEFI guidelines. An adverse reaction refers to an unexpected harmful response that occurs following vaccination or is unrelated to the intended purpose of the vaccine. AEFI can be categorized into five types.10 Category I, vaccine product-related reactions, encompasses adverse reactions occurring after routine administration of vaccine products that are not associated with the intended purpose of vaccination, including both common and rare adverse events. Common adverse reactions result from transient impairment of bodily functions due to inherent characteristics of the vaccine post-administration, such as fever, local redness and swelling accompanied by discomfort, fatigue, and loss of appetite. Rare adverse reactions involve impairment of normal tissue or organ function in vaccinated individuals during or after standard immunization procedures. Category 2 pertains to vaccine quality events characterized by tissue and organ damage as well as functional impairment caused by substandard vaccines. Category 3 represents procedural errors resulting in damage to recipient tissues or organs along with impaired normal function due to violations of standardized operating procedures, vaccination protocols, or usage guidelines. The fourth category involves coincidental events where a vaccinated individual experiences disease onset during incubation or preclinical stages which aligns temporally with vaccination administration. Lastly, psychogenic reactions encompass individual or group responses occurring during or after vaccination due to psychological factors affecting recipients’ emotional state. Medical institutions and vaccination units are the responsible reporting units of AEFI and the reporter shall report to the county-level centers for disease control and prevention in the place where the infected person is located in time after finding AEFI within the scope of the report. The latter shall be responsible for verifying the basic information, main clinical manifestations, vaccination and improving relevant data, and completing the case questionnaire. And through the chinese AEFI monitoring information system for direct network reporting, municipal and provincial centers for disease control and prevention responsible for the investigation and review of the case questionnaire.
The adult vaccination clinics in Jiangsu province are equipped with digital systems, ensuring that vaccination information is automatically recorded upon completion of the code scanning process, three checks, and seven verifications. The comprehensive vaccination service management Information system in Jiangsu province is responsible for collecting data on HZ vaccine recipients and their vaccination details.
Statistical analysis
SPSS 24.0 software was used to establish and compile the database. The incidence of AEFI caused by HZ from 2020 to 2023 was calculated, and its epidemiological characteristics were descriptively analyzed. AEFI reported incidence (per 100 000 doses) was determined as the number of AEFI reported cases divided by the number of vaccine doses multiplied by 100 000. HZ vaccine coverage rate of an age group (%) : The numerator is the cumulative number of people in this age group who received 2 doses of HZ vaccine, and the denominator is the total population in this age group. The chi-square test of R software was used to analyze the differences in the incidence of AEFI by gender, dose and reporting year. A difference of 0.05 was considered statistically significant.
Results
HZ vaccine adiministration
From 2020 to 2023, a total of 125,127 doses of the HZ vaccine were administered in Jiangsu Province, including 68,974 first doses and 56,153 second doses. Among the 12,821 individuals who only received the first dose, they accounted for approximately 20% of the total vaccinated population. The overall vaccination rate for individuals aged 50 years and above was 0.2% (12,821 out of 6,749,000 eligible individuals).
Notably, the vaccination rate for men within this age group was lower compared to women. Furthermore, there was a declining trend observed in the vaccination rates across different age brackets: those aged between 50–59 years old, between 60–79 years old, and particularly those aged above 80 years had an alarmingly low vaccination rate of only 0.04% (Table 1).
Table 1.
Statistics of population coverage of herpes zoster vaccine in Jiangsu province, China (%).
| Region | 50–59 age group | 60-79age group | People aged 80 years and older | People aged 50 years and older | People aged 60 years and older | Men aged 50 years and older | Women aged 50 years and older |
|---|---|---|---|---|---|---|---|
| Nanjing | 0.58 | 0.50 | 0.11 | 0.51 | 0.44 | 0.35 | 0.68 |
| Wuxi | 0.33 | 0.21 | 0.04 | 0.25 | 0.18 | 0.18 | 0.32 |
| Xuzhou | 0.19 | 0.23 | 0.05 | 0.20 | 0.20 | 0.15 | 0.26 |
| Changzhou | 0.31 | 0.23 | 0.05 | 0.25 | 0.20 | 0.18 | 0.34 |
| Suzhou | 0.21 | 0.17 | 0.03 | 0.18 | 0.15 | 0.13 | 0.24 |
| Nantong | 0.21 | 0.09 | 0.02 | 0.12 | 0.08 | 0.09 | 0.16 |
| Lianyungang | 0.26 | 0.26 | 0.05 | 0.24 | 0.23 | 0.19 | 0.31 |
| Huaian | 0.15 | 0.07 | 0.02 | 0.10 | 0.06 | 0.08 | 0.13 |
| Yancheng | 0.18 | 0.13 | 0.02 | 0.14 | 0.11 | 0.12 | 0.17 |
| Yangzhou | 0.15 | 0.06 | 0.01 | 0.09 | 0.05 | 0.06 | 0.12 |
| Zhenjiang | 0.16 | 0.09 | 0.04 | 0.11 | 0.08 | 0.08 | 0.15 |
| Taizhou | 0.18 | 0.06 | 0.01 | 0.10 | 0.05 | 0.07 | 0.13 |
| Suqian | 0.07 | 0.04 | 0.01 | 0.05 | 0.04 | 0.04 | 0.07 |
| In total | 0.25 | 0.17 | 0.04 | 0.19 | 0.15 | 0.14 | 0.26 |
The vaccination rate in southern Jiangsu exceeded that in central and northern Jiangsu regions. The elderly population accounted for 21.8% of the total population in Jiangsu province, indicating an aging demographic trend. However, HZ vaccine coverage in older adults over 60 years is only 0.15%. Generally, there was a decline in HZ vaccine uptake with increasing age. Notably, domestic service workers (15.2%), civil servants (10.2%), and medical workers (7.2%) were the top three groups with highest vaccination rates.
AEFI of HZ vaccine
A total of 43 and 217 cases of AEFIs following vaccination were reported after administration of the HZ vaccine during the periods of 2020–2021 and 2022–2023, respectively, resulting in reporting rates (RRs) of 240.7 and 201.2 per 100,000 doses, correspondingly. The IR for AEFIs associated with HZ vaccine was higher in females compared to males, with a sex ratio of IRs at approximately 1:0.7, this difference has statistical significance(χ2 = 8.9, P=.003). There were no statistically significant differences observed in the incidence of AEFI across different years. Among the four age groups, the 50–59 age group had the highest probability of AEFI, which was statistically different from other age groups(χ2 = 32.2，P<.001). Furthermore, a higher number of AEFIs were reported among individuals receiving their first dose compared to those receiving their second dose. The reporting rate for AEFI did not exhibit significant variation across different regions within Jiangsu province (Table 2).
Table 2.
Basic distribution characteristics of herpes zoster vaccine AEFI in Jiangsu Province from 2021 to 2023.
| Variables | Vaccine doses | AEFI cases | IR (per 100,000 Vaccine doses),95% confidence intervals | χ2 | P value | |
|---|---|---|---|---|---|---|
| Sex | Male | 45007 | 70 | 155.5 (122.1–176.6) | 8.9 | .003 |
| Female | 80714 | 190 | 235.4 (197.7–278.1) | |||
| Age | 50–59 | 69328 | 178 | 256.8(222.3–255.4) | 32.2 | <.001 |
| 60–69 | 39148 | 68 | 173.7 (111.8–203.9) | |||
| 70–79 | 13689 | 11 | 80.4 (50.3–109.0) |
|||
| ≥80 | 3556 | 3 | 84.4 (55.0–157.4) |
|||
| Year | 2020–2021 | 17863 | 43 | 240.7 (199.0–289.9) | 1.2 | .281 |
| 2022–2023 | 107858 | 217 | 201.2 (162.3–246.7) |
|||
| Dose | First Dose | 74834 | 196 | 261.9 (203.4–298.4) | 27.2 | <.001 |
| Second Dose | 50887 | 64 | 125.77 (78.9–156.3) |
|||
| Place of residence | Northern Jiangsu | 76437 | 158 | 206.7 (177.6–245.9) | 0.3 | .850 |
| Central Jiangsu | 29389 | 58 | 197.3 (155.2–235.7) | |||
| Southern Jiangsu | 19895 | 44 | 221.2 (166.8–245.6) | |||
| Total | 125721 | 260 | 206.8 (166.9–257.9) |
The majority of AEFIs following vaccination with HZ vaccines were common reactions (The composition ratio was 98.1%), while rare reactions and coincidental events accounted for only 1.5% and 0.4% of cases, respectively. No vaccine quality issues, program errors, psychogenic reactions, or fatalities were reported. In the classification of AEFIs, there was no significant difference in the proportion of AEFIs between the first dose and the second dose. More than 55% of AEFIs occurred within 30 minutes after administration for HZ vaccine.The proportion of AEFIs was very low (2.3%) when the vaccination time was more than 3 days (Table 3). A total of 4 cases of serious adverse reactions were reported respectively, 2 cases of anaphylactoid purpura, 2 cases of immune thrombocytopenia, 4 cases have been cured after treatment. The vast majority of allergic reactions occurred within half an hour of receiving the vaccine. The predominant symptoms occurring within a time interval of less than 30 minutes were allergy-related manifestations, primarily characterized by allergic rash (Table 4). Notably, the longest observed interval between symptoms was 21 days. Remarkably, this particular case exhibited thrombocytopenic purpura as a clinical manifestation subsequent to vaccination.
Table 3.
Herpes zoster vaccine classification and AEFIs time intervals of AEFIs.
| Total |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Dose |
Second Dose |
χ2 | P value | Total |
||||||||
| AEFI cases | Proportion(%) | IR (per 100,000 doses) | AEFI cases | Proportion(%) | IR (per 100,000 doses) | AEFI cases | Proportion(%) | IR (per 100,000 doses) | ||||
| Classification of AEFIs | Common reaction | 192 | 98.0 | 256.6 | 63 | 98.4 | 123.8 | 0.3 | 0.849 | 255 | 98.1 | 202.8 |
| Rare reaction | 3 | 1.5 | 4.0 | 1 | 1.6 | 2.0 | 4 | 1.5 | 3.2 | |||
| Coincidental event | 1 | 0.5 | 1.3 | 0 | 0.0 | 0 | 1 | 0.4 | 0.8 | |||
| AEFIs time intervals | ≤30 min | 113 | 57.7 | 151 | 34 | 53.1 | 66.8 | 4.0 | 0.136 | 147 | 56.5 | 116.9 |
| 30 min-3 days | 77 | 39.23 | 102.9 | 30 | 46.9 | 59.0 | 107 | 41.2 | 85.1 | |||
| >3 days | 6 | 3.1 | 8.0 | 0 | 0.0 | 0 | 6 | 2.3 | 4.8 | |||
| Total | 196 | - | 261.9 | 64 | 100.0 | 125.8 | 260 | - | 206.8 | |||
The denominator of the first dose IR is 74,834; The denominator of the second dose IR is 50,887.
Table 4.
Herpes zoster vaccine systemic reaction and injection site reactions.
| AEFIs symptoms | Herpes zoster vaccine |
|||
|---|---|---|---|---|
| Number | Proportion(%) | IR (per 100,000 doses) | ||
| Systemic reaction | Fever (>38.6 ℃) | 66 | 25.38 | 52.5 |
| Fever (37.6℃ −38.5℃) | 110 | 42.31 | 87.5 | |
| Fever (37.1 ℃−37.6℃) | 22 | 8.46 | 17.5 | |
| Irritability | 4 | 1.54 | 3.2 | |
| Allergic eruption | 12 | 4.62 | 9.5 | |
| Fatigue | 5 | 1.92 | 4.0 | |
| Loss of appetite | 5 | 1.92 | 4.0 | |
| Drowsiness | 6 | 2.31 | 4.8 | |
| Vomiting | 2 | 0.77 | 1.6 | |
| Diarrhea | 1 | 0.38 | 0.8 | |
| Pruritus | 1 | 0.38 | 0.8 | |
| Cough | 2 | 0.77 | 1.6 | |
| Sweat | 3 | 1.15 | 2.4 | |
| Rhinorrhea | 4 | 1.54 | 3.2 | |
| Skin pale | 3 | 1.15 | 2.4 | |
| Abdominal pain | 2 | 0.77 | 1.6 | |
| Injection site reactions | Redness (>5 cm) | 35 | 13.46 | 27.8 |
| Redness (2.6 cm–5 cm) | 61 | 23.46 | 48.5 | |
| Redness (≤2.5 cm) | 30 | 11.54 | 23.9 | |
| Induration (>5 cm) | 13 | 5.00 | 10.3 | |
| Induration (2.6 cm–5 cm) | 25 | 9.62 | 19.9 | |
| Induration (≤2.5 cm) | 16 | 6.15 | 12.7 | |
| Total | 260 | 206.8 | ||
Table 4 summarizes the IRs of different AEFI symptoms, according to the type of the HZ vaccine. The IRs of different symptoms ranged from 0.8 to 87.5 (per 100,000 doses) for HZ vaccine. Among systemic symptoms, fever, allergic eruptions, and drowsiness were the most frequently reported. Redness and induration were the main symptoms at the injection site. All AEFIs resolved spontaneously without necessitating specialized medical intervention.
Discussion
Statistics show that approximately 1.56 million individuals aged 50 and above in China are affected by herpes zoster each year.11 Prevention proves more advantageous than cure for the disease itself.12 Available data indicates that the efficacy of the HZ vaccine is favorable. Global clinical studies demonstrate an efficacy rate of 97.2% for adults aged 50 years and over, and 91.3% for those aged 70 years and over.13 Current clinical research suggests that vaccinated individuals maintain cellular and humoral immune responses against HZ for up to 10 years.14 It should be noted that having had chickenpox does not confer immunity against herpes zoster. Age stands as the most significant risk factor for developing this condition, as immune function gradually declines with age, leading to reactivation of the virus causing HZ symptoms.8,15,16 Over a four-year period from 2020 to 2023, there was a consistent upward trend in the total number of doses administered annually, increasing from 3,680 doses in 2020 to 65,817 doses in 2023. However, it was observed that approximately 20% of individuals only received the initial dose and did not complete the recommended two-dose regimen as vaccination guidelines. The analysis revealed a significantly low coverage rate of the HZ vaccine in Jiangsu Province, with only 0.14% among the people aged 50 and above and merely 0.15% among individuals aged 60 and above. Relevant research indicates that for people over 50 years old, the risk of HZ infection increases with age. However, our research data shows that the older the age, the lower the vaccination rate of the HZ vaccine among the elderly. The HZ vaccine coverage rate in Jiangsu Province of China is much lower than that in Beijing (9.9%),17 and significantly lower than that in developed countries such as the United States, the United Kingdom, Australia and Europe.18,19 Currently, the low coverage rate of HZ vaccine in Jiangsu Province and even nationwide can be attributed to several factors. Firstly, the limited time since the vaccine’s introduction to the market has resulted in insufficient promotion by health authorities, leading to a lack of public awareness and understanding. Many older individuals are unaware of the risks associated with shingles and remain oblivious to its preventability through vaccination. Secondly, the high cost of the HZ vaccine poses a significant barrier for self-funded vaccinations, making it challenging for ordinary families to afford this expense. Lastly, elderly individuals residing in rural areas face difficulties accessing vaccination clinics promptly.
HZ vaccine is part of the routine vaccination recommendations for adults. Under normal circumstances, adults are more sensitive to their own body changes and can report their suspected side effects caused by vaccines in a timely manner. Predominantly observed in individuals aged between 50 and 59 years, this trend may be attributed to age-related variations in immune system response and tolerance, facilitating easier recognition and reporting of certain adverse reactions among younger populations-a finding consistent with previous studies investigating vaccine-induced AEFIs.20 Notably, our study revealed a higher IR of AEFI following the first dose compared to the second dose One possible explanation is that individuals may exhibit refusal to receive the second dose of the vaccine due to physical discomfort experienced after the first dose, thereby indirectly resulting in a significantly lower rate of adverse reactions for the second dose.21 Some researchers posit that this phenomenon could be attributed to an adaptive process within the body following initial inoculation, leading to a relatively reduced probability of adverse reactions. The predominance of AEFIs reported within the first 30 minutes post-vaccination (56.5%) can largely be attributed to the routine practice of observing vaccinees during this period at the clinic, which enhances the likelihood of detecting and reporting AEFIs promptly. Conversely, AEFIs occurring after the individual leaves the medical facility may be underreported due to several reasons, including mild symptoms being overlooked or vaccinees not associating delayed symptoms with vaccination. This limitation is inherent in passive surveillance systems like CNAEFIS and has been noted in similar vaccine safety studies globally. To address this reporting bias, active surveillance methods such as follow-up calls or digital monitoring tools could be implemented to capture delayed or unreported AEFIs, providing a more accurate assessment of their incidence and timeline. Future studies focusing on active surveillance could also help validate our findings and address any gaps in the current reporting framework. There was no statistical difference in the incidence of adverse reactions between different regions and different genders, which was consistent with relevant results.The incidence of adverse reactions of HZ vaccine is much higher than that of other self-funded vaccines, but the incidence of rare reactions is not significantly different from that of other self-funded vaccines, which indicates that the elderly population may be more prone to general reactions after vaccination.12
The primary clinical manifestations of AEFI caused by HZ include general reactions such as pyrexia, erythema, or induration, typically appearing 2–5 days post-vaccination. It has been observed that individuals’ awareness of AEFI tends to wane over time.22 Even if minor adverse reactions occur beyond the initial 5-day period, they are often disregarded by the affected individual due to their perception as insignificant manifestations. This phenomenon is similarly noted in post-marketing surveillance studies conducted on other vaccines.23 Consequently, this represents one of the drawbacks associated with passive monitoring.
One limitation of this study was the utilization of a passive reporting system for analysis of AEFIs24; this system could potentially introduce inconsistencies in data quality, stemming from variations in the expertise of vaccination clinic doctors, the level of awareness among parents or guardians, and perceptions regarding vaccine safety. Another limitation of this paper is that the HZ vaccine is an imported vaccine in China, and the entire vaccination needs about 400 US dollars. Families that can afford to pay for this tend to be wealthier, and this segment of the population is more concerned about changes in their health, so some coincidences may be mistakenly reported as side effects from vaccines. Vaccination coverage in the > 50 and > 60 age groups could be influenced by socioeconomic factors. Younger individuals (50–60 years old) may have greater financial resources, as they are more likely to be employed, compared to older age groups. While our findings indicate that the majority of AEFIs following the HZ vaccine were mild and resolved without medical intervention, it is important to acknowledge that the limited number of vaccine recipients during the study period may have constrained our ability to detect rare adverse events. Consequently, it is possible that certain AEFIs may not have been accurately reported. Therefore, future research should incorporate additional active surveillance studies to confirm and validate our findings.
In conclusion, The current HZ vaccination rate in Jiangsu Province is too low and it is urgent to increase the vaccination rate of HZ vaccine in the future. Our findings demonstrate that the majority of AEFIs caused by the HZ vaccine were mild and categorized as common reactions. No novel or unexpected safety signals were reported during the surveillance period, which is consistent with previous pre- or post-licensure trials. These results have important value in allaying public concerns about the safety of the HZ vaccine and promoting its wider coverage in the elderly population.
Biography
Zhiguo Wang, chief physician and master tutor of Immunization Program of Jiangsu Provincial Center for Disease Control and Prevention, China, mainly engaged in the prevention and control of vaccine-preventable diseases.
Funding Statement
This manuscript was funded by the Opening Foundation of Key Laboratory [JSHD 2022043], the Jiangsu Provincial Geriatric Health Research Project [grant number LKM2023005], Jiangsu Province Capability Improvement Project through Science, Technology and Education [ZDXYS202210].
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
Ethics approval and consent to participate
This study was conducted in accordance with the ethical guidelines for research using administrative data. The data were derived from routine vaccination and adverse event monitoring systems (JPCVs and CNAEFIS), and all identifiable personal information was removed before analysis.
As this study involved retrospective analysis of anonymized data collected during routine public health surveillance activities, it did not require active participant recruitment or direct interaction with individuals. Consequently, ethical approval was waived by the Jiangsu Provincial Center for Disease Control and Prevention Ethics Committee.
Furthermore, the study adhered to principles of confidentiality and data protection, ensuring that all data were securely stored and used solely for the purposes of this research. The authors confirm that the manuscript does not include any personal or sensitive information that could compromise individual privacy.
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The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.