1.Progress in research of safety, efficiency and vaccination status of influenza vaccine in populations at high risk.
Hai Tian SUI ; Yang GUO ; Jie ZHAO ; Zhong Nan YANG ; Jin Feng SU ; Yuan YANG ; Qing WANG ; Lu Zhao FENG
Chinese Journal of Epidemiology 2022;43(3):436-439
This paper reviews the domestic and foreign studies published in 2020 on the application of influenza vaccine in populations at high risk. The importance of influenza vaccination in population at high risk has been proved by larger sample, multicentre, high-quality evidence-based studies. Influenza vaccination is the most cost-effective measure to prevent influenza. However, the coverage rate of influenza vaccine is very low in China, it is necessary to strengthen the health education to promote influenza vaccination in different populations. It is recommended to give influenza vaccination to the population in whom influenza vaccination has been proven safe and effective before influenza season. Research of the safety, efficiency and cost-effectiveness of influenza vaccine should be accelerated for the populations in whom such data are lacking or insufficient.
China
;
Costs and Cost Analysis
;
Humans
;
Influenza Vaccines/adverse effects*
;
Influenza, Human/prevention & control*
;
Vaccination
2.Immunogenicity of inacitivated quadrivalent influenza vaccine in adults aged 18-64 years: A systematic review and Meta-analysis.
Z Y MENG ; J Y ZHANG ; Z G ZHANG ; D LUO ; X M YANG
Chinese Journal of Epidemiology 2018;39(12):1636-1641
Objective: To evaluate the immunogenicity of inactivated quadrivalent influenza vaccine (QIV) in adults aged 18-64 years, through a Meta-analysis. Methods: Literature was retrieved by searching the Medline, Cochrane Library, Science Direct in the past decade. All the studies were under random control trial (RCT) and including data related to immunogenicity which involving sero-protection rate (SPR) and sero-conversion rate (SCR) of the QIV, versus inactivated trivalent influenza vaccine (TIV) in the population aged 18 to 64. Revman 5.3 software was employed to manipulate the pooled date of the included literature. Result: A total of 8 studies for the SPR and SCR of the shared strains (two A lineage and one B lineage) were included. There appeared no significant differences in the response rates between the two vaccines. As for QIV versus TIV (B/Yamagata), the pooled RR of the SPR for B/Victoria was 1.28 (95%CI: 1.08-1.51, P<0.05), with the pooled RR of the SCR for B/Victoria as 1.94 (95%CI: 1.50-2.50, P<0.05). For QIV versus TIV (B/Victoria), the pooled RR of the SPR for B/Yamagata as 1.10 (95%CI: 1.02-1.18, P<0.05), and the pooled RR of SCR for B/Yamagata as 1.99 (95%CI: 1.34-2.97, P<0.05). Conclusion: In the population aged 18-64 years, inactivated QIV was equivalently immunogenic against the shared three strains included in the activated TIV while a superior immunogenic effect was noticed in the vaccine strain which did not include the inactivated QIV.
Adolescent
;
Adult
;
Antibodies, Viral/blood*
;
Drug-Related Side Effects and Adverse Reactions
;
Hemagglutination Inhibition Tests
;
Humans
;
Influenza A virus/immunology*
;
Influenza B virus/immunology*
;
Influenza Vaccines/immunology*
;
Influenza, Human/prevention & control*
;
Middle Aged
;
Vaccines, Inactivated/immunology*
;
Young Adult
3.Surveillance and compensation claims for adverse events following immunization from 2011 to 2016 in the Republic of Korea.
Min Kyung KIM ; Yeon Kyeong LEE ; Tae Eun KIM ; Insik KONG ; Hyeon Jong YANG ; Eun Sook SUH
Clinical and Experimental Vaccine Research 2017;6(2):146-155
PURPOSE: In recent years, research on reported adverse events following immunization (AEFI) and claims filed for compensation has been lacking. We reviewed reported AEFIs and compensation claims in Korea from 2011 to 2016. MATERIALS AND METHODS: We listed all of the AEFI registered in the Integrated Management System of Disease and Public Health and reviewed the list of claims filed and serious AEFIs reported from 2011 to 2016. RESULTS: An average of 278 AEFI cases was reported annually from 2011 to 2016. Of these, 31 deaths were reported. However, there was no association found between these deaths and vaccinations when evaluating vaccine lot, reviewing autopsies, and considering underlying diseases. AEFI reporting rate was as high as 20.8 cases for bacillus Calmette–Guérin (BCG) vaccine, 7.3 cases for 23-valent pneumococcal polysaccharide vaccine (PPV23), and 5.4 cases for human papillomavirus vaccine per 100,000 vaccination doses in 2016. Of the 469 total cases that claimed vaccine injury compensation from 2011 to 2016, the BCG vaccine was most commonly involved, with 235 cases (50%), followed by influenza vaccine and PPV23, with 90 and 55 cases, respectively. Of these cases, 96% of BCG-related AEFI were compensated, while only 31% and 49% of AEFI following influenza and PPV23 vaccination, respectively, were compensated. Common characteristics of uncompensated cases included the elderly subjects, receiving influenza vaccine, having underlying disease, or a very short time interval between vaccination and symptoms. CONCLUSION: We have maintained vaccine safety management system through both rapid response to serious AEFI and vaccine injury compensation in order to sustain public trust in the National Immunization Program.
Aged
;
Autopsy
;
Bacillus
;
BCG Vaccine
;
Compensation and Redress*
;
Drug-Related Side Effects and Adverse Reactions
;
Government Programs
;
Humans
;
Immunization Programs
;
Immunization*
;
Influenza Vaccines
;
Influenza, Human
;
Korea
;
Pneumococcal Vaccines
;
Public Health
;
Public Health Surveillance
;
Republic of Korea*
;
Safety Management
;
Vaccination
4.Evaluation of safety of haemophilus influenza type b(Hib) conjugate vaccine in postmarketing based on the immunization information management system.
Zhiguo WANG ; Email: NJWANG1718@163.COM. ; Fubao MA ; Jinlin ZHANG ; Jing YU ; Guodong KANG ; Jun GAO
Chinese Journal of Preventive Medicine 2015;49(6):475-480
OBJECTIVETo analyze the occurrence feature of adverse events following immunization (AEFI) of Hib conjugate vaccine (HibCV) and to evaluate the safety of HibCV in postmarketing.
METHODS2008-2013 HibCV AEFI data were collected through national AEFI information management system, which were downloaded in March 18, 2014.The demographic information and inoculation quantity of HibCV were from Immunization information management system in Jiangsu province. The incidence rate and 95% CI value of AEFI, common vaccine reaction and rare vaccine reaction following immunization of HibCV were calculated. The differences in the incidence rate of common vaccine reaction and rare vaccine reaction among sex, months of age, and number of injections were compared by means of (χ² tests.
RESULTSA total of 6.16 million doses of vaccine were administered in Jiangsu province during 2008-2013, and 4 718 vaccinees reported having adverse event, for a rate of 76.60/100 000 (95% CI: 74.42/100 000-78.79/100 000). The incidence rate of common vaccine reaction and rare vaccine reaction was 71.10/100 000 (95% CI: 68.99/100 000-73.20/100 000) and 5.16/100 000 (95% CI: 4.60/100 000-5.73/100 000), respectively. The main symptoms of common vaccine reactions were fever, swelling, indurations and gastrointestinal reactions. The incidence rates of them were 40.54/100 000, 35.09/100 000, 12.94/100 000 and 0.36/100 000 in turn. The main symptoms of rare vaccine reactions were anaphylactic rashes and angioedema, the incidence rates of which were 4.77/100 000 and 0.15/100 000 respectively. 91.39% (4 002/4 379) of common vaccine reactions and 88.36% (281/318) of rare vaccine reactions happened within 1 d after vaccination. Anaphylactic shock (3 cases) and laryngeal edema (1 case) all happened within 1 d after vaccination. The incidence rate of common vaccine reactions among boys (79.72/100 000, 2 641/3 313 071) was higher than that of girls (61.07/100 000, 1 738/2 846 001) (χ² = 74.92, P < 0.001). The incidence rate of common vaccine reactions among children aged ≥ 12 month-old (86.82/100 000, 2 200/2 533 949) was higher than that among children aged 2-11 month-old (60.11/100 000, 2 179/3 625 123) (χ² = 149.79, P < 0.001). The incidence rate of common vaccine reactions in children vaccinated the first dose (78.93/100 000, 2 666/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (61.59/100 000, 1 713/2 781 458) (χ² = 64.59, P < 0.001). The incidence rate of rare vaccine reactions in children vaccinated the first dose (6.69/100 000, 226/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (3.31/100 000, 92/2 781 458) (χ² = 33.82, P < 0.001).
CONCLUSIONThe safety of HibCV among children was relative good. However, the surveillance should still focus on the anaphylactoid reactions of anaphylactic shock and laryngeal edema after HibCV immunization.
Angioedema ; Bacterial Capsules ; Child ; Female ; Fever ; Haemophilus Infections ; Haemophilus Vaccines ; adverse effects ; Haemophilus influenzae type b ; Humans ; Hypersensitivity ; Immunization ; Influenza, Human ; Male ; Safety ; Vaccination ; Vaccines, Conjugate
5.Prolonged pruritic rash following influenza A (H1N1) vaccination.
Singapore medical journal 2013;54(5):e117-9
In Singapore, the approved influenza A (H1N1) vaccines are Panvax® and Pandemrix®. An estimated 425,000 doses of Panvax and less than 100 doses of Pandemrix had been distributed in Singapore from November 2009 to February 2010. Reviews on the H1N1 vaccine have concluded that it has a safety profile similar to that of seasonal influenza vaccines. From the time the H1N1 vaccination was implemented in Singapore on November 3, 2009, up to October 11, 2010, the Health Sciences Authority had received 173 adverse event reports from healthcare professionals. We report a case of prolonged illness after H1N1 vaccination.
Adult
;
Exanthema
;
chemically induced
;
diagnosis
;
Female
;
Humans
;
Influenza A Virus, H1N1 Subtype
;
Influenza Vaccines
;
adverse effects
;
Prednisolone
;
therapeutic use
;
Pruritus
;
chemically induced
;
diagnosis
;
Singapore
;
Treatment Outcome
;
Vaccination
;
adverse effects
6.False-Positive Hypermetabolic Lesions on Post-Treatment PET-CT after Influenza Vaccination.
Jeong Eun KIM ; Eun Kyoung KIM ; Dae Ho LEE ; Sang We KIM ; Cheolwon SUH ; Jung Shin LEE
The Korean Journal of Internal Medicine 2011;26(2):210-212
We report a case of a 59-year-old man with testicular germ cell tumor who showed new hypermetabolic lesions at the left axillary lymph nodes on a post-treatment positron emission tomography-computed tomography (PET-CT) scan. The hypermetabolic lesions were found to be caused by an influenza vaccination 10 days prior to the PET-CT scan and disappeared without additional treatment. To date, he is alive with complete remission.
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
;
False Positive Reactions
;
Humans
;
Influenza Vaccines/*administration & dosage/adverse effects
;
Injections, Intramuscular
;
Lymph Nodes/drug effects/*radiography/*radionuclide imaging
;
Male
;
Middle Aged
;
*Positron-Emission Tomography
;
Predictive Value of Tests
;
Seminoma/*diagnosis/drug therapy/pathology/radiography/radionuclide imaging
;
Testicular Neoplasms/*diagnosis/drug therapy/pathology/radiography/radionuclide imaging
;
*Tomography, X-Ray Computed
;
Treatment Outcome
;
*Whole Body Imaging
7.Effect of aluminum hydroxide adjuvant on the immunogenicity of the 2009 pandemic influenza A/H1N1 vaccine: multi-level modeling of data with repeated measures.
Da Peng YIN ; Bao Ping ZHU ; Hua Qing WANG ; Lei CAO ; Wen Di WU ; Ke Yu JIANG ; Wei XIA ; Guo Min ZHANG ; Jing Shan ZHENG ; Ling Sheng CAO ; Xiao Feng LIANG
Biomedical and Environmental Sciences 2011;24(6):624-629
OBJECTIVETo evaluate the effect of the aluminum hydroxide (Al-OH) adjuvant on the 2009 pandemic influenza A/H1N1 (pH1N1) vaccine.
METHODSIn a multicenter, double-blind, randomized, placebo-controlled trial, participants received two doses of split-virion formulation containing 15 μg hemagglutinin antigen, with or without aluminum hydroxide (Al-OH). We classified the participants into six age categories (>61 years, 41-60 years, 19-40 years, 13-18 years, 8-12 years, and 3-7 years) and obtained four blood samples from each participant on days 0, 21, 35, and 42 following the first dose of immunization. We assessed vaccine immunogenicity by measuring the geometric mean titer (GMT) of hemagglutination inhibiting antibody. We used a two-level model to evaluate the fixed effect of aluminum Al-OH and other factors, accounting for repeated measures.
RESULTSThe predictions of repeated measurement on GMTs of formulations with or without Al-OH, were 80.35 and 112.72, respectively. Al-OH significantly reduced immunogenicity after controlling for time post immunization, age-group and gender.
CONCLUSIONThe Al-OH adjuvant does not increase but actually reduces the immunogenicity of the split-virion pH1N1 vaccine.
Adjuvants, Pharmaceutic ; chemistry ; Adolescent ; Adult ; Aluminum Hydroxide ; chemistry ; Antibodies, Viral ; blood ; Child ; Child, Preschool ; China ; Data Interpretation, Statistical ; Double-Blind Method ; Female ; Hemagglutination Inhibition Tests ; Humans ; Influenza A Virus, H1N1 Subtype ; immunology ; Influenza Vaccines ; adverse effects ; chemistry ; immunology ; Influenza, Human ; epidemiology ; immunology ; prevention & control ; virology ; Male ; Middle Aged ; Models, Statistical ; Pandemics ; Young Adult
8.Immunogenicity and Safety of Trivalent Inactivated Influenza Vaccine: A Randomized, Double-Blind, Multi-Center, Phase 3 Clinical Trial in a Vaccine-Limited Country.
Joon Young SONG ; Hee Jin CHEONG ; Heung Jeong WOO ; Seong Heon WIE ; Jin Soo LEE ; Moon Hyun CHUNG ; Yang Ree KIM ; Sook In JUNG ; Kyung Hwa PARK ; Tae Hyong KIM ; Soo Taek UH ; Woo Joo KIM
Journal of Korean Medical Science 2011;26(2):191-195
Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with > or = 80% of subjects achieving post-vaccination titers > or = 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.
Adolescent
;
Adult
;
Aged
;
Aged, 80 and over
;
Double-Blind Method
;
Humans
;
Influenza Vaccines/administration & dosage/*adverse effects/*immunology
;
Influenza, Human/*prevention & control
;
Male
;
Middle Aged
;
Republic of Korea
;
Vaccination
;
Vaccines, Inactivated/administration & dosage/adverse effects/immunology
;
Young Adult
9.Two cases of exudative retina detachment and uveitis following H1N1 influenza vaccination.
Yong TAO ; Li-Bing CHANG ; Min ZHAO ; Xiao-Xin LI
Chinese Medical Journal 2011;124(22):3838-3840
Uveitis was a rare adverse event of vaccination. We met two cases of acute uveitis with exudative retinal detachment following vaccination of H1N1 influenza. Case 1 was a 10-year-old boy who was admitted for bilateral blurred vision at 10 days after vaccination of H1N1 influenza. Vitreous opacity was obvious in both eyes. Broad exudative retinal detachment was observed in the right eye. Case 2 was a 47-year-old female who suffered from an acute high fever at 2 days after the vaccination of H1N1 influenza. Later, she encountered bilateral headache and decreasing vision. In both eyes, mutton fat keratic precipitates, positive Tyndall phenomenon, congestion of optic disc and exudative retinal detachment were observed.
Child
;
Female
;
Humans
;
Influenza A Virus, H1N1 Subtype
;
pathogenicity
;
Influenza Vaccines
;
adverse effects
;
therapeutic use
;
Influenza, Human
;
immunology
;
prevention & control
;
Male
;
Middle Aged
;
Retinal Detachment
;
diagnosis
;
etiology
;
Uveitis
;
diagnosis
;
etiology
10.Safety and Immunogenicity of a New Trivalent Inactivated Split-virus Influenza Vaccine in Healthy Korean Children: A Randomized, Double-blinded, Active-controlled, Phase III Study.
Jin Han KANG ; Chi Eun OH ; Jina LEE ; Soo Young LEE ; Sung Ho CHA ; Dong Soo KIM ; Hyun Hee KIM ; Jung Hyun LEE ; Jin Tack KIM ; Sang Hyuk MA ; Young Jin HONG ; Hee Jin CHEONG ; Hoan Jong LEE
Journal of Korean Medical Science 2011;26(11):1421-1427
We report results of a randomized, double-blinded, active-controlled, phase III study conducted to evaluate the immunogenicity and safety of a new trivalent inactivated split-virus influenza vaccine (GC501) manufactured by the Green Cross Corporation in Korea. A total of 283 healthy children aged 6 months to < 18 yr were randomized to receive either GC501 or control. Of the GC501 recipients, seroconversion occurred in 48.5% for A/H1N1, 67.7% for A/H3N2 and 52% for influenza B. The proportion of subjects who had post-vaccination hemagglutination-inhibition titers of 1:40 or greater was 90.7% for A/H1N1, 86.8% for A/H3N2 and 82.4% for influenza B in the GC501 recipients. No serious adverse events related to vaccination, or withdrawals because of adverse events were reported. The majority of solicited adverse events were mild in intensity. GC501 vaccine has good tolerability and favorable immunogenicity in children aged 6 months to < 18 yr. The addition of one more brand of influenza vaccine may allow for better global accessibility of vaccine for epidemics or future pandemics.
Adolescent
;
Antibodies, Viral/*blood
;
Child
;
Child, Preschool
;
Double-Blind Method
;
Female
;
Humans
;
Infant
;
Influenza A Virus, H1N1 Subtype/*immunology
;
Influenza A Virus, H3N2 Subtype/*immunology
;
Influenza B virus/*immunology
;
Influenza Vaccines/*adverse effects/*immunology
;
Male
;
Republic of Korea
;
Vaccination
;
Vaccines, Inactivated/adverse effects/immunology

Result Analysis
Print
Save
E-mail