Adverse events following immunization reported with COVID-19 vaccines in Burkina Faso: Analysis of spontaneous reports / Manifestations post-vaccinales indésirables rapportées avec les vaccins anti-COVID-19 au Burkina Faso : analyse des notifications spontanées

The rapid deployment of COVID-19 vaccines to a large proportion of the population requires a focus on safety. However, few studies have assessed the safety of COVID-19 vaccines in Africa. In Burkina Faso, this issue has not yet been addressed. The objective of this study was to contribute to the description of the characteristics of adverse events following immunization (AEFIs) related to COVID-19 vaccines in Burkina Faso. This was a cross-sectional descriptive retrospective study of spontaneous reports of COVID-19 vaccine-related AEFIs recorded in VigiBase® between June 2021 and November 2022 in Burkina Faso. Individual case safety reports (ICSRs) were extracted from VigiBase® using the Anatomical Therapeutic Chemical level 2 (ATC2) code. The proportion of ICSRs according to the reporter's qualification, the reporting rate, the time taken to submit and record ICSRs, and the completeness score were calculated. A total of 973 ICSRs concerned COVID-19 vaccines and represented 32.6% of all 2,988 reports in VigiBase®. Overall, 82.0% of the reporters were nurses/midwives, 7.8% were physicians, 6.7% were pharmacists, and 3.4% were patients. The median time between the onset of AEFIs and the submission of the report to the Pharmacovigilance Center was 180 days (IQR: 136; 281). The median registration time was 188 days (IQR: 149; 286). The mean ICSR completeness score was 0.8 (standard deviation = 0.1). The overall AEFI reporting rate was 27.8 per 100,000 vaccine doses. The AEFI reporting rates for the ChAdOx1-nCoV-19, JNJ 78436735, Elasomeran, Tozinameran, and HB02 vaccines were 454.2, 17.4, 11.0, 10.2, and 0.4 per 100,000 vaccine doses, respectively. The majority of AEFIs were systemic in nature (90.1%). Headache (21.2%), fever (19.4%), and myalgia (11.0%) were the most frequently reported AEFIs. Eighteen cases (1.8%) of serious AEFIs (9 hospitalizations, 4 life threatening, 3 temporary disabilities, and 2 others unspecified) were reported. The majority of AEFIs reported were systemic in nature and mild. However, there have been reports of serious AEFIs. The overall AEFI reporting rate was low. There is a need to strengthen the monitoring of these vaccines to better organize strategies to optimize the adherence of the population of Burkina Faso.

Le déploiement rapide des vaccins anti COVID-19 sur une grande partie de la population nécessite de mettre l'accent sur la sécurité. Cependant, peu d'études ont évalué la sécurité des vaccins anti COVID-19 en Afrique. Au Burkina Faso, cette question n'a pas encore été abordée. La présente étude avait pour objectif de contribuer à la description des caractéristiques des manifestations post-vaccinales indésirables (MAPI) liées aux vaccins anti COVID-19 au Burkina Faso. Il s'est agi d'une étude transversale rétrospective ayant porté sur les notifications de MAPI liées aux vaccins anti COVID-19 enregistrées dans VigiBase® entre juin 2021 et novembre 2022 au Burkina Faso. Les cas individuels de rapports de sécurité (CIRS) ont été extraits de VigiBase® à l'aide du code Anatomical Therapeutic Chemical niveau 2 (ATC2). La proportion de CIRS selon la qualification du notificateur, le taux de notification, le délai de transmission et d'enregistrement des CIRS et le score d'exhaustivité ont été calculés. Au total 973 CIRS concernaient les vaccins anti COVID-19 et représentaient 32,6 % des 2 988 rapports enregistrés dans VigiBase®. La répartition des notifications en fonction de la qualification du notificateur a montré que 82,0 % étaient des infirmiers/sage femmes, 7,8 % des médecins, 6,7 % des pharmaciens et 3,4 % des patients. Le délai médian entre l'apparition des MAPI et la transmission du rapport au Centre de pharmacovigilance était de 180 jours (IQR : 136 ; 281). Le délai médian d'enregistrement était de 188 jours (IQR : 149 ; 286). Le score d'exhaustivité moyen des CIRS était de 0,8 (écart type = 0,1). Le taux global de notifications des MAPI était de 27,8 pour 100 000 doses de vaccins. Les taux de notification des MAPI pour les vaccins ChAdOx1-nCoV-19, JNJ 78436735, Elasomeran, Tozinameran et HB02 étaient de 454,2 ; 17,4 ; 11,0 ; 10,2 et 0,4 pour 100 000 doses, respectivement. La majorité des MAPI était de manifestation systémique (90,1 %). Les céphalées (21,2 %), la fièvre (19,4 %) et les myalgies (11,0 %) étaient les MAPI les plus fréquemment notifiés. Dix-huit cas (1,8 %) de MAPI graves (9 hospitalisations, 4 mises en jeu du pronostic vital, 3 incapacités temporaires et 2 autres non précisés) ont été rapportés. La majorité des cas notifiés dans le cadre de la surveillance des MAPI était de manifestation systémique et de nature bénigne. Néanmoins, des cas de MAPI graves ont été notifiés. Le taux global de notification des MAPI était faible. Il est nécessaire de renforcer la surveillance de ces vaccins pour mieux organiser les stratégies visant à optimiser l'adhésion de la population burkinabé.

Cholera and COVID-19 pandemic prevention in multiple hotspot districts of Uganda: vaccine coverage, adverse events following immunization and WASH conditions survey.

BACKGROUND: Between March, 2020 and December, 2021 due to cholera and coronavirus disease 2019 (COVID-19) pandemics, there were 1,534 cholera cases with 14 deaths and 136,065 COVID-19 cases with 3,285 deaths reported respectively in Uganda. This study investigated mass vaccination campaigns for the prevention of the two pandemics namely: oral cholera vaccine (OCV) and COVID-19 vaccine coverage; adverse events following immunization (AEFI); barriers and enablers for the vaccine uptake and assessed water, sanitation and hygiene (WASH) conditions in the six cholera and COVID-19 hotspot districts of Uganda. METHODS: A household survey was conducted between January and February, 2022 in the six cholera hotspot districts of Uganda which had recently conducted OCV mass vaccination campaigns and had ongoing COVID-19 mass vaccination campaigns. The survey randomly enrolled 900 households with 4,315 persons of whom 2,085 were above 18 years. Data were collected using a data entry application designed in KoBoToolbox and analysed using STATA version 14. Frequencies, percentages, odds ratios, means, confidence intervals and maps were generated and interpreted. RESULTS: The OCV coverage for dose one and two were 85% (95% CI: 84.2-86.4) and 67% (95% CI: 65.6-68.4) respectively. Among the 4,315 OCV recipients, 2% reported mild AEFI, 0.16% reported moderate AEFI and none reported severe AEFI. The COVID-19 vaccination coverage for dose one and two were 69.8% (95% CI: 67.8-71.8) and 18.8% (95% CI: 17.1-20.5) respectively. Approximately, 23% (478/2,085) of COVID-19 vaccine recipient reported AEFI; most 94% were mild, 0.6% were moderate and 2 cases were severe. The commonest reason for missing COVID-19 vaccine was fear of the side effects. For most districts (5/6), sanitation (latrine/toilet) coverage were low at 7.4%-37.4%. CONCLUSION: There is high OCV coverage but low COVID-19 vaccine and sanitation coverage with high number of moderate cases of AEFI recorded due to COVID-19 vaccines. The low COVID-19 vaccine coverage could indicate vaccine hesitancy for COVID-19 vaccines. Furthermore, incorporation of WASH conditions assessment in the OCV coverage surveys is recommended for similar settings to generate data for better planning. However, more studies are required on COVID-19 vaccine hesitancy.

A systematic review on mucocutaneous presentations after COVID-19 vaccination and expert recommendations about vaccination of important immune-mediated dermatologic disorders.

With dermatologic side effects being fairly prevalent following vaccination against COVID-19, and the multitude of studies aiming to report and analyze these adverse events, the need for an extensive investigation on previous studies seemed urgent, in order to provide a thorough body of information about these post-COVID-19 immunization mucocutaneous reactions. To achieve this goal, a comprehensive electronic search was performed through the international databases including Medline (PubMed), Scopus, Cochrane, Web of science, and Google scholar on July 12, 2021, and all articles regarding mucocutaneous manifestations and considerations after COVID-19 vaccine administration were retrieved using the following keywords: COVID-19 vaccine, dermatology considerations and mucocutaneous manifestations. A total of 917 records were retrieved and a final number of 180 articles were included in data extraction. Mild, moderate, severe and potentially life-threatening adverse events have been reported following immunization with COVID vaccines, through case reports, case series, observational studies, randomized clinical trials, and further recommendations and consensus position papers regarding vaccination. In this systematic review, we categorized these results in detail into five elaborate tables, making what we believe to be an extensively informative, unprecedented set of data on this topic. Based on our findings, in the viewpoint of the pros and cons of vaccination, mucocutaneous adverse events were mostly non-significant, self-limiting reactions, and for the more uncommon moderate to severe reactions, guidelines and consensus position papers could be of great importance to provide those at higher risks and those with specific worries of flare-ups or inefficient immunization, with sufficient recommendations to safely schedule their vaccine doses, or avoid vaccination if they have the discussed contra-indications.

Adverse reactions to the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines in Japan.

INTRODUCTION: The BNT162b2 and mRNA-1273 COVID-19 vaccines are the main vaccines that have been used for mass vaccination in Japan. Information on adverse reactions to COVID-19 vaccines in the Japanese population is limited. METHODS: We conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 or mRNA-1273 vaccine. The incidence of adverse events after each dose of vaccine was investigated. Propensity score matching was used to compare the incidence of adverse reactions after the second dose of the BNT162b2 and mRNA-1273 vaccines. RESULTS: After the first and second doses of the BNT162b2 vaccine, and the first and second doses of the mRNA-1273 vaccine, 890, 853, 6401, and 3965 individuals, respectively, provided complete responses. Systemic reactions, including fever, fatigue, headache, muscle/joint pain, and nausea were significantly more common in females, individuals aged <50 years, and after the second dose. The incidence of injection site pain did not differ significantly according to the dose. The incidence of delayed injection site reactions after the first dose of mRNA-1273 vaccine was 3.9% and 0.8% among females and males, respectively, and 10.6% among females aged 40-69 years. Local and systemic reactions after the second dose, including fever, fatigue, headache, muscle/joint pain, nausea, and skin rash were more common in individuals who had received the mRNA-1273 vaccine. CONCLUSIONS: Adverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine.

Understanding and experience of adverse event following immunization (AEFI) and its consequences among healthcare providers in Kebbi State, Nigeria: a qualitative study.

BACKGROUND: Vaccines used in the national immunization program are relatively safe and effective. However, no vaccine is perfectly safe. Therefore, adverse reactions may occur. This study aimed to investigate the understanding and experience of Adverse Event Following Immunization (AEFI) among healthcare workers and Routine Immunization (RI) officers. METHODS: Phenomenological qualitative study was conducted between June and September 2019, using a semi-structured question guide in Kebbi State, Northwest Nigeria. Face-to-face interviews were conducted with 12 RI providers, eight Expanded Program on Immunization (EPI) officers, and eight Disease Surveillance and Notification Officers. Thematic analysis was used to analyze the data. The interviews were transcribed and translated, then manually analyzed thematically. RESULTS: The knowledge level of healthcare providers on AEFI definition and classification varied and was suboptimal. Error during vaccination was the study participants' most frequently mentioned possible cause of AEFI. Persistent crying, fever, fainting, and swelling and tenderness at injection sites were the AEFI experienced by the healthcare providers in their careers. Block rejection, lower immunization uptake, loss of confidence in RI, attack on RI providers, discrimination of RI providers and divorce threats among spouses were the consequences of AEFI. Supportive supervision of the RI sessions, refresher training on safe injection for RI providers, and symptomatic treatment of clients with AEFI would prevent AEFI consequences. Also, educating caregivers, community sensitization, and dialogue would minimize the consequences of AEFI. CONCLUSIONS: Evidence of a sub-optimal understanding of AEFI was established in this study. Hence, policymakers should consider regular refresher training on AEFI to ensure all RI providers have an optimal understanding of AEFI. Health education of caregivers and parents during RI sessions and community engagement should be considered to minimise AEFI consequences on the immunization program and the society.

Dermatomyositis Following BNT162b2 mRNA COVID-19 Vaccination.

Dermatomyositis (DM) is one of the uncommon multi-organ idiopathic inflammatory myopathies that has been reported following the hepatitis B, Influenza, tetanus toxoid, H1N1, and BCG vaccines. However, an association with the coronavirus disease 2019 (COVID-19) vaccine is yet to be reported. In this case, we present the case of a 43-year-old Asian Indian female who was diagnosed with DM 10 days after receiving the second dosage of BNT162b2 mRNA COVID-19 vaccination, in the absence of any additional triggering factors. The diagnosis was established based on physical examination, serological antibodies, magnetic resonance imaging of the muscles, skin biopsy, and electromyography. She received standard treatment for DM, including oral high doses of prednisolone, hydroxychloroquine, mycophenolate, and physiotherapy. The treatment successfully reversed skin changes and muscle weakness. This is the first reported case of classic DM complicated by interstitial lung disease following COVID-19 vaccination. More clinical and functional studies are needed to elucidate this association. Clinicians should be aware of this unexpected adverse event following COVID-19 vaccination and arrange for appropriate management.

Myocarditis-induced Sudden Death after BNT162b2 mRNA COVID-19 Vaccination in Korea: Case Report Focusing on Histopathological Findings.

We present autopsy findings of a 22-year-old man who developed chest pain 5 days after the first dose of the BNT162b2 mRNA vaccine and died 7 hours later. Histological examination of the heart revealed isolated atrial myocarditis, with neutrophil and histiocyte predominance. Immunohistochemical C4d staining revealed scattered single-cell necrosis of myocytes which was not accompanied by inflammatory infiltrates. Extensive contraction band necrosis was observed in the atria and ventricles. There was no evidence of microthrombosis or infection in the heart and other organs. The primary cause of death was determined to be myocarditis, causally-associated with the BNT162b2 vaccine.

Necrotizing fasciitis following measles vaccine administration: a case report.

BACKGROUND: The occurrence of adverse events following immunization (AEFI) in national immunization programmes is very rare; however, if they occur causality assessment is conducted to identify the associated cause. In the report, we describe a case of severe necrotizing fasciitis in the left arm of a 9-month old boy following administration of the measles vaccine. CASE PRESENTATION: A 9-month old boy presented with swelling on the left upper arm and adjoining the chest area, low-grade continuous fever, frequent passage of loose watery stool and persistent cries 24 h after measles vaccine was administered on the left upper arm. On examination, he was mildly pale, febrile, anicteric. Extensive erythema of the left upper arm occurred thereafter with extensive scalded skin lesions involving the deltoid area, the upper chest wall and arm. This was followed by desquamation of the affected areas and severe necrosis. A diagnosis of severe necrotizing fasciitis was made. A causality assessment was conducted by the state AEFI committee using the detailed AEFI investigation forms to identify the cause of the incidence. CONCLUSION: Here we present a rare case of necrotizing fasciitis which could have been caused by incorrect use of reconstituted measles vaccine. Hence we recommend training of routine immunization service providers on proper vaccine management as well as intensified supervision of immunization sessions.

[Develop the active surveillance system for vaccine safety in China].

Post-marketing surveillance of vaccine safety is an important measure to detect adverse events following immunization and therefore reduce the harms to public health. The conventional method for safety surveillance is a passive way through spontaneous reporting, which suffer from under-reporting and incomplete. While active surveillance, a newly proposed surveillance method in developed countries, is capable to make up the deficiencies of passive surveillance. The surveillance system of vaccine safety in China is currently using passive surveillance, and facing many problems and challenges. This arouses a need to promote development of an active surveillance system for vaccine safety in China, learning from the experience world-wide. This commentary aims to throw out suggestions for establishing the active surveillance system, according to the specific situation in China and based on a scoping review of literature.

[Analysis on the characteristics of suspected vaccine-related deaths in Fujian Province, 2012-2017].

Objective: To analyze the characterisitics of the death cases suspected to be related to vaccination in Fujian Province from 2012 to 2017. Methods: A total of 33 death cases information which was suspected to be related to the vaccinations from 2012 to 2017 were extracted from Chinese Adverse Events Following Immunization Information System (AEFI). The autopsy reports and the conclusions made by AEFI investigation diagnosis expert committee were collected at the same time. The inoculation data were obtained through the Fujian province Immunization Program Information System. The AEFI incidence, rare vaccine reaction incidences and mortality rates following immunization were figured out to analyze the characterisitics of the death cases associated with vaccination. Results: The age of deuths cases was from 26 days to 52 months. Among 33 cases, 23 were males, and 8 were due to vaccine-related reaction, and the others were due to coincidental events. The number of rare vaccine reaction cases from 2012 to 2017 were 2,3,6,8,7 and 7, respectively. The highest AEFI incidence was measles and rubella combined attenuated live vaccine [38.88 (95%CI: 36.85-40.91)/100 000 dose], and the lowest was trivalent oral poliomyelitis attenuated live vaccine [2.01 (95%CI: 1.73-2.30)/100 000 dose]. The highest rare vaccine reaction incidence was measles and rubella combined attenuated live vaccine [15.04 (95%CI: 13.78-16.30)/100 000 dose], and the lowest was trivalent oral poliomyelitis attenuated live vaccine [0.38 (95%CI: 0.25-0.50)/100 000]. The highest mortality rate was inactivated poliomyelitis vaccine [0.26 (95%CI: 0.04-0.54)/100 000 doses], and the lowest mortality rate was measles, mumps and rubella combined attenuated live vaccine [0.01 (95%CI: 0.00-0.08)/100 000 doses]. The Spearman correlation analysis showed that there were correlations between AEFI incidence and rare vaccine reaction incidence (r=0.64, P=0.048), there were no correlations between AEFI incidence and mortality rate (r=-0.34, P=0.329), and there were no correlations between rare vaccine reaction incidence and mortality rate (r=-0.25, P=0.484). Conclusion: Neither AEFI incidence nor rare vaccine reaction incidence was correlation with mortality rate. The main causes of death following vaccination were coincidental events.

[Scoping review of active surveillance systems for vaccine safety world-wide].

Objective: To identify post-marketing active surveillance systems for vaccine safety around the world and understand their features and mechanisms, in order to provide guidance for vaccine administration activities in China. Methods: Following the steps of scoping review, literature about active surveillance system for vaccine safety and published by 30 June 2018 were identified by searching electronic databases, including PubMed, Scopus, and Cochrane Library. Grey literature were also sought by exploring relevant websites. Identified literature were screened according to eligibility criteria, and informative data from included literature were then charted. Framework Synthesis and Thematic Analysis were performed to integrate the charted data. Results: 97 pieces of literature were included for review, and 11 active surveillance systems for vaccine safety were identified, mostly located in developed countries. These systems were constructed by 3 types of organizations: administration departments, academic or research institutions, and health care providers. Their data sources included immunization registries, electronic medical records, claims data, case reports of adverse events following immunization electronic questionnaires, and epidemiologic study data. According to their operation procedures, these systems were grouped into 4 modes of active surveillance: Data Linkage, Investigator Network, Automatic Follow-up System, Studies Consortium. Conclusion: Practice of active surveillance for vaccine safety greatly varies across countries, with different conditions and advantages. It is suggested that developing countries should choose suitable mode of active surveillance considering their local situations.

Risk of seizures after immunization in children with epilepsy: a risk interval analysis.

BACKGROUND: In children with epilepsy, fever and infection can trigger seizures. Immunization can also induce inflammation and fever, which could theoretically trigger a seizure. The risk of seizure after immunization in children with pre-existing epilepsy is not known. The study objective was to determine the risk of medically attended seizure after immunization in children with epilepsy < 7 years of age. METHODS: We conducted a retrospective study of children < 7 years of age with epilepsy in Nova Scotia, Canada from 2010 to 2014. Hospitalizations, emergency visits, unscheduled clinic visits, and telephone calls for seizures were extracted from medical records. Immunization records were obtained from family physicians and Public Health with informed consent. We conducted a risk interval analysis to estimate the relative risk (RR) of seizure during risk periods 0-14, 0-2, and 5-14 days post-immunization versus a control period 21-83 days post-immunization. RESULTS: There were 302 children with epilepsy who were eligible for the study. Immunization records were retrieved on 147 patients (49%), of whom 80 (54%) had one or more immunizations between the epilepsy diagnosis date and age 7 years. These 80 children had 161 immunization visits and 197 medically attended seizures. Children with immunizations had more seizures than either those with no immunizations or those with no records (mean 2.5 versus 0.7 versus 0.9, p < 0.001). The risk of medically attended seizure was not increased 0-14 days after any vaccine (RR = 1.1, 95% confidence interval (CI): 0.5-2.8) or 0-2 days after inactivated vaccines (RR = 0.9, 95% CI: 0.1-7.1) versus 21-83 days post-immunization. No seizure events occurred 5-14 days after live vaccines. CONCLUSIONS: Children with epilepsy do not appear to be at increased risk of medically attended seizure following immunization. These findings suggest that immunization is safe in children with epilepsy, with benefits outweighing risks.

What information can change the attitude of teachers toward the human papillomavirus vaccine?

AIM: We conducted a self-administered survey on the perception of teachers toward human papillomavirus (HPV) vaccine to determine the ways to increase their willingness to encourage its use. METHODS: Answers were obtained both prior to and after having the teachers read five brief information articles: (i) cervical cancer knowledge, (ii) vaccine knowledge, (iii) result of a survey in Nagoya, (iv) news report of the World Health Organization statement and (v) articles written by Dr Muranaka, a journalist. RESULTS: Most of the respondents (180/247) did not know about the natural history of cervical cancer. Only 36% knew that HPV is the cause of cervical cancer, although 63% knew that HPV vaccine would prevent cervical cancer. Few respondents had knowledge regarding adverse events following immunization and the survey results from Nagoya. Among those who were initially negative for the HPV vaccine, only 43% revealed that they fully understood its safety and only 29% reversed their opinion to recommend vaccination to their daughters and/or students, even after reading our informational material. The most useful information for changing their attitudes was to increase their understanding of vaccines and informing them about Nagoya city survey results. They mostly wanted a proof of the preventive effects of the vaccine on cervical cancer in Japan. CONCLUSION: Gynecologists and pediatricians must proactively communicate accurate scientific information to the government and the media to spread awareness among people in Japan. Also, we must try to demonstrate the capabilities of this vaccine to prevent cervical cancer and/or its precancerous lesions.

[Analysis on death from adverse event following immunization surveillance system of Shandong Province during 2011-2016].

Objective: To analyze the occurrence and death of Adverse Event Following Immunization (AEFI) in Shandong province. Methods: Collecting the information of AEFI cases from 2011 to 2016, which were reported through the National AEFI Management System in Shandong province up to January 15, 2017. The autopsy reports of death following immunization were issued by the qualified institutions. The inoculation data from 2011 to 2016 was obtained through Immunization Information Management System of Shandong province. Chi-square test was used to compare the incidence rate of AEFI and mortality related to immunization among different time and age groups. Results: A total of 189 864 512 doses of vaccine were administered in Shandong province during 2011-2016, the total number of AEFI cases was 89 973 and the incidence rate of AEFI was 473.88/1 000 000. The number of death cases was 52 and the mortality rate was 0.27/1 000 000. The incidence rate of AEFI from 2011 to 2016 respectively was 273.63/1 000 000, 405.22/1 000 000, 479.88/1 000 000, 545.13/1 000 000, 500.66/1 000 000, and 627.09/1 000 000 (P<0.001), respectively. The mortality rate from 2011 to 2016 was 0.17/1 000 000, 0.16/1 000 000, 0.25/1 000 000, 0.39/1 000 000, 0.26/1 000 000, and 0.40/1 000 000 (P=0.285), respectively.The mortality rates of HepB, BCG and IPV were the top three. There was statistical significance of the mortality rate among different month-old children (P<0.001). The highest mortality rate was<2 month-old (1.09/1 000 000), and the next was 4-5 month-old (0.54/1 000 000), and the lowest was ≥10 month-old (0.06/1 000 000). The mortality rate of spring (from February to April), summer (from May to July), autumn (from August to October) and winter (from November to January of next year) was 0.41/1 000 000, 0.16/1 000 000, 0.08/1 000 000 and 0.48/1 000 000 (P<0.001), respectively. Among 52 death cases, 26 cases were anatomized, including 3 rare vaccine reaction following immunization and 23 coincidental events; 26 cases were not anatomized, including 17 coincidental events and 9 unknown causes. Conclusion: The AEFI mortality rate of<2 month-old, spring and winter, and the second dose was higher than else, which was similar to normal child mortality. Immunization did not increase the risk of death, and the most deaths following immunization were coincidental events.

No-Fault Compensation for Adverse Events Following Immunization: A Review of Chinese Law And Practice.

In 2005, China introduced an administrative no-fault one-time compensation scheme for adverse events following immunization (AEFI). The scheme aims to ensure fair compensation for those injured by adverse reactions following immunization. These individuals bear a significant burden for the benefits of widespread immunization. However, there is little empirical evidence of how the scheme has been implemented and how it functions in practice. The article aims to fill this gap. Based on an analysis of the legal basis of the scheme and of practical compensation cases, this article examines the structuring, function, and effects of the scheme; evaluates loopholes in the scheme; evaluates the extent to which the scheme has achieved its intended objectives; and discusses further development of the scheme.

Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.

OBJECTIVES: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. STUDY DESIGN: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. METHODS: Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out. RESULTS: More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events. CONCLUSIONS: SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.

Adverse event following immunization surveillance systems for pregnant women and their infants: a systematic review.

BACKGROUND: The World Health Organization's Strategic Advisory Group of Experts on Immunization has declared that maternal immunization is a key priority. Robust adverse event following immunization (AEFI) surveillance systems that capture outcomes in pregnant women and their infants are needed to ensure the safety of maternal immunization programs. We sought to identify the active and passive AEFI surveillance systems for pregnant women and their offspring described in the literature. METHODS: A systematic literature review was conducted of the MEDLINE, CINAHL, and EMBASE databases from 1990 to 2014. English-language articles were reviewed if they included pregnant women as the population of interest and described the surveillance method used. RESULTS: Of 619 articles retrieved from the search, 16 met the criteria for review. These included reports of AEFI surveillance for pregnant women, their offspring, or both. The majority of reports (11/16) came from the USA and described findings on two active and four passive AEFI surveillance systems, only three of which specifically targeted pregnant women. The remaining five articles described one-time AEFI surveillance programs, all in high-income countries. CONCLUSION: There are no published reports outside of the USA of ongoing AEFI surveillance systems that specifically target pregnant women or their offspring. There may be AEFI surveillance systems that capture events in these populations that have not been reported in the literature. A survey of immunization program managers and national regulatory authorities is needed to determine the current status of AEFI surveillance for pregnant women and their offspring globally.

Adverse events following Covaxin administration among adolescents (15-18 years) - A pharmacovigilance study in a district in Northern India.

Introduction: The study was undertaken to observe the adverse event following immunization (AEFI) to the Covaxin vaccine in young adolescents in the age group of 15-18 years in a district in Northern India. The study was conducted to assess the safety profile of the COVAXIN vaccine. Methodology: This was a prospective observational study conducted at rural and urban health centers of a district in Northern India. We included the beneficiaries of the COVAXIN between the age of 15 and 18 years. The administration of the COVAXIN occurred in our district from January 2022. Periodic visits were conducted to the urban and rural health centers of the city to record any suspected adverse drug reaction following immunization in the defined population. The study was conducted for a period of 1 year (January 2022 to December 2022). Results: A total of 72,771 adolescents (15-18 years) received the first dose of Covaxin and 49,046 received the second dose. No adverse drug event following immunization was reported during the study. Conclusion: Thus, it can be concluded that Covaxin was found to be safe in adolescents (15-18 years).

Revaccination outcomes among adolescents and adults with suspected hypersensitivity reactions following COVID-19 vaccination: A Canadian immunization research network study.

BACKGROUND: COVID-19 vaccination has been associated with anaphylaxis and hypersensitivity reactions. Infectious disease physicians and allergists in the Canadian Special Immunization Clinic (SIC) Network developed guidance for evaluating patients with adverse events following immunization (AEFI) including suspected hypersensitivity. This study evaluated management and adverse event recurrence following subsequent COVID-19 vaccinations. METHODS: Individuals aged 12 years and older enrolled at participating SICs before February 28, 2023 who were referred for suspected or diagnosed hypersensitivity reaction following COVID-19 vaccination, or for prevaccination assessment of suspected allergy to a COVID-19 vaccine component were included. De-identified clinical assessments and revaccination data, captured in a centralized database, were analyzed. The Brighton Collaboration case definition (BCCD) for anaphylaxis (2023 version) was applied. RESULTS: The analysis included 206 participants from 13 sites: 26 participants referred for pre-vaccination assessment and 180 participants referred for adverse events following COVID-19 vaccination (15/180 [8.3%] with BCCD confirmed anaphylaxis, 84 [46.7%] with immediate hypersensitivity symptoms not meeting BCCD, 33 [18.3%] with other diagnosed hypersensitivity reactions, and 48 [26.7%] participants with a final diagnosis of non-hypersensitivity AEFI). Among participants referred for AEFIs following COVID-19 vaccination, 166/180 (92.2%) were recommended for COVID-19 revaccination after risk assessment, of whom 158/166 (95.2%) were revaccinated (all with a COVID-19 mRNA vaccine). After revaccination, 1/15 (6.7%) participants with prior anaphylaxis, 1/77 (1.3%) with immediate hypersensitivity not meeting criteria for anaphylaxis and 1/24 (4.2%) with other physician diagnosed hypersensitivity developed recurrent AEFI symptoms that met the BCCD for anaphylaxis. All 26 participants referred pre-vaccination, including 9 (34.6%) with history of polyethylene glycol-asparaginase reactions, were vaccinated without occurrence of immediate hypersensitivity symptoms. CONCLUSIONS: Most individuals in this national cohort who experienced a hypersensitivity event following COVID-19 vaccination and were referred for specialist review were revaccinated without AEFI recurrence, suggesting that specialist evaluation can facilitate safe revaccination.

Canadian vaccine safety surveillance reports following immunization with seasonal influenza vaccines, 2021-2022.

Background: Seasonal influenza vaccines (SIV) authorized for use in Canada have all undergone rigorous regulatory assessments for safety and effectiveness. Serious adverse events following immunization (AEFI) can occur, though they are rare. Continuous safety surveillance of vaccines during the post-marketing phase is a critical component of vaccination programs. This enables the detection of rare, late onset, or unexpected adverse events. An updated safety summary following the introduction of any new vaccines and/or formulations to immunization programs is necessary for refining the risk-benefit profile of a specific vaccine and maintaining public confidence. Here we provide an updated safety summary for SIVs distributed during the 2021/2022 influenza season from AEFI reports submitted to the Canadian Adverse Event Following Immunization Surveillance System (CAEFISS) and the Canadian Vigilance Database (CVD). Methods: We searched CAEFISS and CVD for individuals who were vaccinated with a SIV between October 1, 2021, and March 31, 2022. Descriptive statistics were calculated, including median age of vaccinated individuals, vaccines co-administered with SIV, and the most frequently reported AEFIs. Crude AEFI reporting rates were calculated by severity of the AEFI report, and SIV-type using doses distributed data. Medical reviews were conducted for reports including death, serious events (or outcomes) after SIV were administered alone, and selected adverse events (i.e., anaphylaxis, Guillain-Barré syndrome, febrile seizures, oculo-respiratory syndrome). Disproportionality analysis was used to identify potential safety signals among SIV and AEFI pairs. Results: There were 448 AEFI reports, with most AEFI classified as non-serious events (84.2%). The majority of reports described vaccination in adults at least 65 years of age (38.6%). The most frequently reported AEFIs were vaccination site pain, urticaria, pyrexia and rash. Medical review of AEFI reports did not find any evidence that reported deaths were related to vaccination with SIV. Among serious reports, nervous system disorders were the most commonly reported medical conditions. A higher number of events related to vaccination errors were also identified using disproportionality analysis. Conclusion: Findings from our analysis of reports to CAEFISS and CVD following vaccination with SIV are consistent with the known safety profile of SIVs distributed during the 2021/2022 influenza season. The majority of reports were non-serious with the most common AEFI symptoms occurring at the vaccination site or systemic symptoms that were self-limiting. The majority of vaccination error reports involved the administration of the vaccine at an inappropriate site, although no serious AEFIs were reported.