10 June 2026, Volume 49 Issue 3
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International Journal of Biologicals. 2026, 49(3): 143-150. https://doi.org/10.3760/cma.j.cn311962-20251226-00095With the increasing frequency of emerging infectious diseases globally in recent years, the response practices to previous public health crises indicate that a rapid vaccine response is crucial to effective threats containing from pathogens with large-scale epidemic potential. In 2021, the Coalition for Epidemic Preparedness Innovations (CEPI) proposed the strategic plan CEPI 2.0, also known as the 100 Days Mission. The six pillars of the plan, namely establishing a prototype vaccine library, building a global clinical trial network, identifying early immune biomarkers, developing rapid manufacturing and validation capabilities, deploying early outbreak surveillance systems, and strengthening biosafety and biosecurity capacity, aim to achieve preliminary authorization and mass production readiness for target vaccines within 100 days after confirmation of a pandemic pathogen.This paper provides a systematic review and interpretation of the scientific framework of the plan, seeking to offer reference and insights for China to better respond to potential epidemic risks and pandemic occurrences.
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International Journal of Biologicals. 2026, 49(3): 151-155. https://doi.org/10.3760/cma.j.cn311962-20260320-00018Objective To analyze the characteristics of adverse events following immunization (AEFIs) with varicella live attenuated vaccine (VarV) in Anhui Province from 2016 to 2025.Methods Data on VarV AEFI cases in Anhui Province from 2016 to 2025 were collected through the China Disease Control and Prevention Information System, and the number of VarV vaccination doses were collected through the Anhui Immunization Program Information System. Descriptive epidemiological methods were used to analyze the incidence and distribution characteristics of AEFIs.Results A total of 2 408 VarV AEFIs were reported in Anhui Province from 2016 to 2025, with an average annual incidence of 329.46 per million doses. The incidence of common reactions and rare adverse reactions were 308.46 per million doses and 17.80 per million doses, respectively. Among all cases, 53.74% were male, 64.70% were ≤1 year old, 61.17% were from northern Anhui Province, 78.15% occurred within 24 h, and 77.24% were from the first dose. Among rare adverse reactions, anaphylactic rash accounted for 90.77%, with an average annual reported incidence of 16.16 per million doses.Conclusion VarV AEFIs are mainly common reactions in Anhui Province, with extremely rare adverse reactions, which shows an overall good safety profile of VarV.
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International Journal of Biologicals. 2026, 49(3): 156-160. https://doi.org/10.3760/cma.j.cn311962-20250331-00018Objective To analyze the epidemiological characteristics of varicella in Qingpu District, Shanghai, from 2020 to 2024, and to provide a basis for improving varicella prevention and control measures.Methods Varicella cases in Qingpu District, Shanghai, from 2020 to 2024 were collected from the Immunization Program Information Management System of the Chinese Center for Disease Prevention and Control. Descriptive research methods were used to analyze the temporal, regional, and population distribution of varicella cases. Data were organized and analyzed using SPSS 26.0 software, and the chi-square test was used to compare rates among multiple groups.Results A total of 1 225 varicella cases were reported in Qingpu District from 2020 to 2024, showing an overall downward trend in incidence (χ2 trend = 110.73, P < 0.001). The 2 high-incidence periods for varicella were from May to July and from November to January of the following year, respectively. Cases were reported in all subdistricts and towns, with a concentration in central urban areas including Xiayang Subdistrict and Xujing Town. Cases were distributed across multiple age groups, with the highest number of cases occurring in the < 5-year-old group, although its proportion showed a declining trend with constituent ratio among all cases decreasing from 22.34% in 2020 to 13.46% in 2024. Among all occupations, students accounted for the majority of cases (38.04%), followed by scattered children (15.10%).Conclusions The incidence of varicella in Qingpu District has declined during 2020-2024, but attention should be paid to key institutions and populations, and standardized outbreak response measures should be implemented promptly. Meanwhile, the coverage rate of varicella vaccine should be steadily increased.
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International Journal of Biologicals. 2026, 49(3): 161-167. https://doi.org/10.3760/cma.j.cn311962-20250716-00052Objective To analyze the epidemiological and spatio-temporal characteristics of varicella in Susong County from 2019 to 2024, in order to provide scientific basis for varicella surveillance, prevention and control.Methods Case data of varicella reported in Susong County from January 1, 2019 to December 31, 2024 were obtained from the China Disease Control and Prevention Information System . Descriptive epidemiological methods were used to analyze the epidemiological characteristics (temporal, population, and geographical distribution). SaTScan software (version 10.1) was employed to perform retrospective space-time scan statistics, with township as geographical unit and month as time unit, to identify spatio-temporal clusters of varicella incidence.Results A total of 1 091 varicella cases were reported in Susong County from 2019 to 2024. The annual reported incidence rate fluctuated between 14.23/100 000 and 35.39/100 000, with average annual incidence rate at 21.06/100 000. Based on chi-squared test for trend, a significant decreasing trend in the annual reported incidence was observed (χ² = 28.76, P < 0.01). The incidence exhibited a bimodal seasonal pattern, with primary peak occurring from October to January (autumn and winter) and secondary peak from May to July (late spring and early summer). Spatio-temporal scan analysis identified 4 statistically significant clusters (P<0.05), covering 10 townships. High-risk areas were mainly concentrated in the central and northern parts of the county, particularly in townships surrounding the central Fuyu Town. More cases were male (n=615, 56.37%) than female (n=476, 43.63%). Cases were predominantly observed in children and adolescents (<15 years old, 64.54%), with the highest incidence in the 5-9 age group (30.26%), followed by the 10-14 age group (23.46%). By occupation, students constituted the majority of cases (n=723，66.27%), followed by preschool children. A significant portion of the cases (78.00%) had no history of varicella vaccination.Conclusions From 2019 to 2024, the reported incidence of varicella in Susong County shows a significant declining trend. Students are the most affected population, and the disease distribution exhibits spatio-temporal clustering. To further control varicella outbreaks, it is recommended to continuously strengthen varicella surveillance, with a particular focus on cluster outbreaks in schools and childcare institutions, and to implement and improve the coverage of the 2-dose varicella vaccine schedule, especially for age-appropriate children and individuals with no prior immunization history.
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International Journal of Biologicals. 2026, 49(3): 168-172. https://doi.org/10.3760/cma.j.cn311962-20251120-00088Objective To evaluate the safety of combination vaccines containing diphtheria, tetanus, and acellular pertussis (DTaP) components in Nan’an District, Chongqing.Methods Data on adverse events following immunization (AEFI) reported for DTaP-containing combination vaccines and corresponding vaccination data in Nan’an District, Chongqing from 2020 to 2024 were collected through the Immunization Program Information Management System of the Chinese Center for Disease Control and Prevention and the Chongqing Immunization Program Information Management System.Results From 2020 to 2024, a total of 191 299 doses of DTaP-containing combination vaccines were administered in Nan’an District, Chongqing, with 296 AEFI cases reported. The reported AEFI rate was 154.73 per 100 000 doses. Among these, 291 cases were general reactions (152.12 per 100 000 doses) and 5 cases were abnormal reactions (2.61 per 100 000 doses). The male-to-female ratio was 1.33∶1.00. Children aged 18-24 months accounted for 70.95% of cases. Cases were reported throughout the year, with the majority (78.38%) occurring from April to September. The reported AEFI incidence rate for booster doses was higher than that for primary immunization, and the difference was statistically significant (χ²trend = 266.21, P < 0.01).Conclusion From 2020 to 2024, AEFI reports for DTaP-containing vaccines in Nan’an District, Chongqing are predominantly general reactions, with rare abnormal reactions, indicating that these vaccines have a favorable safety profile.
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International Journal of Biologicals. 2026, 49(3): 173-179. https://doi.org/10.3760/cma.j.cn311962-20260305-00011Objective To analyze the incidence and distribution characteristics of adverse events following immunization (AEFIs) associated with diphtheria-tetanus-acellular pertussis vaccine (DTaP) before and after the implementation of new immunization strategy under the National Immunization Program in Anhui Province, and to provide evidence for evaluating the safety of the new strategy.Methods AEFI surveillance data in Anhui Province during 2024（before strategy adjustment） to 2025（after the new strategy implemention on January 1, 2025） were collected through the Immunization Program Information Management System of the Chinese Center for Disease Control and Prevention, and concurrent vaccination data were obtained from Anhui Immunization Program Information Management System. Descriptive epidemiological methods were used to analyze the distribution and incidence of AEFI. The Chi-square test or Fisher’s precision probability test were used to compare the data before and after the policy adjustment.Results From 2024 to 2025, a total of 2 375 028 doses of DTaP were administered in Anhui Province, with 4 958 AEFI cases reported. The overall incidence was 208.76/100 000 doses. Following the strategy adjustment, the incidence of general reactions increased from 186.69/100 000 doses to 221.37/100 000 doses (χ2=32.50, P<0.001)，while the incidence of adverse reactions (rare/serious) decreased from 0.66/100 000 doses to 0.20/100 000 doses, representing a reduction of approximately 69.70%. After advancing the first dose to 2 months of age, the AEFI incidence decreased from 170.57/100 000 doses to 119.65/100 000 doses (χ2=24.76, P<0.001). For the 6-year-old dose switched from the diphtheria and tetanus vaccine to DTaP, no adverse reactions were observed, with incidence of 0.00/100 000 doses (95% confidence interval: 0.00-0.83/100 000 doses ).Conclusions DTaP AEFIs in Anhui Province are predominantly general reactions, with extremely low adverse reaction rates. Advancing the first dose to 2 months of age significantly reduces the AEFI incidence, facilitating the early establishment of immune barrier. With no new safety risks monitored during this surveillance period after switching to DTaP for the 6-year-old booster, core safety indicators perform well during the study period. The new 5-dose DTaP strategy (at 2, 4, 6, 18 months and 6 years of age) demonstrates a good safety profile within the observation period.
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International Journal of Biologicals. 2026, 49(3): 180-184. https://doi.org/10.3760/cma.j.cn311962-20251028-00078Objective To analyze the distribution of adverse events following immunization (AEFIs) in Zhaoxiang Town, Qingpu District, Shanghai from 2019 to 2023, and provide a basis for evaluating the safety of vaccination and improving the quality of vaccination services.Methods AEFI and vaccination data in Zhaoxiang Town, Qingpu District, Shanghai from 2019 to 2023 were collected through China Disease Control and Prevention Information System and Shanghai Integrated Vaccine Management and Vaccination Service Information System, respectively, and analyzed using descriptive epidemiological methods.Results From 2019 to 2023, a total of 504 AEFI cases were reported in Zhaoxiang Town, Qingpu District, Shanghai, with an average annual reported incidence of 355.18/100 000 doses. General reactions (99.01%) were mainly fever (45.24%) and local reactions (42.86%). Abnormal reactions (0.99%) were all allergic rash. There were slightly more males than females (1.20∶1.00), and children < 1 year old accounted for the highest proportion (53.77%). Among all AEFIs，83.73% occurred within 1 d after vaccination. Herpes zoster vaccine accounted for the highest reported incidence, followed by diphtheria, tetanus and acellular pertussis combined vaccine (DTaP), and DTaP-Haemophilus influenzae type b conjugate vaccine (quadruple vaccine) and 13-valent pneumococcal vaccine (conjugate) were also reported at a higher incidence.Conclusions AEFI in Zhaoxiang Town is dominated by general reactions, with a low incidence of abnormal reactions， which shows good safety of vaccination.It is recommended to focus on strengthening AEFI monitoring in children under 1 year old and within 24 h after vaccination.
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International Journal of Biologicals. 2026, 49(3): 185-192. https://doi.org/10.3760/cma.j.cn311962-20250512-00031Objective To analyze adverse events associated with rabies vaccine for human use (RVFHU) based on data from the US Vaccine Adverse Event Reporting System (VAERS) and to evaluate the safety profile of RVFHU.Methods RVFHU-related reports were retrieved from the VAERS database for the period from January 1, 2019 to September 15, 2023. Descriptive statistical analysis was employed to characterize the distribution of adverse events, and disproportionality analysis was applied to detect vaccine safety signals.Results A total of 794 adverse event reports (comprising 2 606 clinical symptoms) were included. Product use issues were the most frequently reported clinical symptoms. In terms of System Organ Class, symptoms related to general disorders and administration site conditions accounted for the highest proportion. Regarding the composition ratios of general adverse events and serious adverse events by vaccination dose, the difference was statistically significant (χ²=10.25, P<0.05), whereas no statistically significant differences were observed for gender, age, or time of occurrence (χ²=0.32, 2.58, 2.02, respectively; P>0.05). Disproportionality analysis identified 59 positive safety signals, involving product use issues, immune system disorders, psychiatric disorders, and other aspects.Conclusions Adverse events associated with RVFHU are predominantly product use issues or transient and mild reactions. The positive safety signals detected are limited in number and require further investigation and validation.
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International Journal of Biologicals. 2026, 49(3): 193-199. https://doi.org/10.3760/cma.j.cn311962-20250525-00038Objective To validate a size-exclusion high-performance liquid chromatography (SEC-HPLC) method for determining the purity of recombinant human coagulation factor Ⅶa (rFⅦa) for injection, and apply it to stability analysis of the purity of rFⅦa finished products.Methods The SEC-HPLC method was validated for the system suitability and specificity, sample loading robustness, accuracy, repeatability, intermediate precision, and column durability using rFⅦa standard， bulk and finished product. The stability of rFⅦa stored at 2-8 °C and 40 °C for 6 months was analyzed using this method.Results The peak-to-valley ratio of dimer in the rFⅦa international standard was 1.43, and the tailing factor of monomer was 1.08. An excipient peak accounting for up to 0.4% at the monomer position in the formulation buffer. Within the protein loading range of 10-50 μg, the relative standard deviations (RSDs) of the monomer peak area percentage for rFⅦa bulk and finished product were 0.03% and 0.07%, respectively. Accuracy was evaluated through forced thermal degradation testing, which demonstrated recovery rates of 97.5%- 100.0% for percentage changes in the peak areas of polymers, dimers/oligomers, and monomers, and 98.5%-100.6% for the total peak area. The RSDs for the monomer peak area percentages in the repeatability verification of rFⅦa bulk and finished product were 0.03% and 0.02%, respectively. Intermediate precision verification showed no statistically significant differences across operators, analytical equipments, or testing dates (F=0.13-2.09,P all＞0.05), with RSDs of 0.2% for bulk and 0.9% for finished products. Column durability results showed no statistically significant differences among column batches (F=0.01, P＞0.05). After 6 months of storage at 2-8 °C, the molecular size distribution of rFⅦa finished product remained stable. Following 6 months of accelerated stability conditions at 40 °C, the monomer decreased by 3.1%-4.0%, dimer/oligomer increased by 1.9%-2.3%, and polymer increased by 1.2%-1.7%.Conclusions The validated SEC-HPLC method is efficient, accurate, and reproducible for purity determination of rFⅦa for injection. The finished product of rFⅦa for injection exhibits good stability when stored at 2–8 °C or 40 °C for 6 months.
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International Journal of Biologicals. 2026, 49(3): 200-205. https://doi.org/10.3760/cma.j.cn311962-20250421-00025Objective To develop and validate the isoelectric point (pI) detection method for recombinant human interferon α1b (rhIFNα1b) by imaging capillary isoelectric focusing electrophoresis (iCIEF).Methods Based on The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q2 (R2) requirement, iCIEF was used to detect the pI of rhIFNα1b, and the concentration of urea added to sample and isoelectric focus time were determined.The developed method was verified for specificity, accuracy, repeatability, intermediate precision and durability.Results In iCIEF, the focusing was performed at 3 000 V for 3 min, and 1 mol/L urea was added to treat samples. Blank control (acetate buffer) showed no interference to the determination of pI of rhIFNα1b. Isoelectric focusing of rhIFNα1b generated 2 peaks. The pIs of peak 1 and 2 were approximately 5.4 and 5.5, respectively. The method had good specificity, accuracy, repeatability, intermediate precision, and durability.Conclusion This established iCIEF method can be used for the detection of the pI of rhIFNα1b, providing a reference for the quality control of this product.
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International Journal of Biologicals. 2026, 49(3): 206-213. https://doi.org/10.3760/cma.j.cn311962-20250625-00047The large-scale animal cell culture technology for production of influenza virus vaccines offers advantages such as high efficiency, stability, scalability, and safety, making it a promising alternative to traditional embryonated egg-based method. This approach is expected to become the prevailing method for manufacturing influenza virus vaccines. Gaining an in-depth understanding of the viral amplification and cellular stress responses of influenza viruses in vaccine production cell lines is pivotal for the development of production cell strains and the rational design and optimization of virus production processes. This review provides an overview of the production workflow for cell-based influenza vaccines, summarizes recent advancements in research on the viral amplification process and cellular stress responses following influenza virus infection in production cell lines, and highlights the application of mathematical modeling in influenza virus production. The aim is to offer insights and references to guide the rational optimization of cell-based influenza vaccine production processes.
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International Journal of Biologicals. 2026, 49(3): 214-222. https://doi.org/10.3760/cma.j.cn311962-20250818-00066The treatment of infectious bone defects faces great challenges due to the “infection-repair” vicious cycle. Antibacterial-osteogenic bifunctional hydrogels provide an innovative strategy to solve this problem by synergistically integrating antibacterial and osteogenic functions. This article reviews the latest research progress on the synergistic effect of this type of hydrogel in bone repair of bone marrow mesenchymal stem cells (BMSCs), focuses on design strategy giving the material intelligent function, and analyzes its core synergy mechanism including temporal synergy, microenvironment remodeling and spatial collaboration. The function of BMSCs is coordinated through multi-dimensional mechanisms such as physical antibacterial, immunomodulation, and intelligent drug release, effectively breaking the vicious circle of infection inhibiting bone regeneration. Although preclinical studies have shown significant efficacy, its clinical translation still faces challenges such as insufficient microenvironment response, function synergy contradiction, and biosafety. Future research needs to focus on the development of intelligent carriers and the construction of spatiotemporal sequential release systems, so as to promote bone regeneration strategies to be more intelligent and precise.
创刊：1978年10月
主管：中华人民共和国国家卫生健康委员会
主办：中华医学会
上海生物制品研究所有限责任公司
编辑：《国际生物制品学杂志》编辑委员会
出版：《中华医学杂志》社有限责任公司
ISSN 1673-4211
CN 31-1962/R
主管：中华人民共和国国家卫生健康委员会
主办：中华医学会
上海生物制品研究所有限责任公司
编辑：《国际生物制品学杂志》编辑委员会
出版：《中华医学杂志》社有限责任公司
ISSN 1673-4211
CN 31-1962/R
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