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1.
JMIR Mhealth Uhealth ; 12: e58991, 2024 Oct 11.
Article in English | MEDLINE | ID: mdl-39393058

ABSTRACT

BACKGROUND: SMS text messaging- and internet-based self-reporting systems can supplement existing vaccine safety surveillance systems, but real-world participation patterns have not been assessed at scale. OBJECTIVE: This study aimed to describe the participation rates of a new SMS text messaging- and internet-based self-reporting system called the Kaiser Permanente Side Effect Monitor (KPSEM) within a large integrated health care system. METHODS: We conducted a prospective cohort study of Kaiser Permanente Southern California (KPSC) patients receiving a COVID-19 vaccination from April 23, 2021, to July 31, 2023. Patients received invitations through flyers, SMS text messages, emails, or patient health care portals. After consenting, patients received regular surveys to assess adverse events up to 5 weeks after each dose. Linkage with medical records provided demographic and clinical data. In this study, we describe KPSEM participation rates, defined as providing consent and completing at least 1 survey within 35 days of COVID-19 vaccination. RESULTS: Approximately, 8% (164,636/2,091,975) of all vaccinated patients provided consent and completed at least 1 survey within 35 days. The lowest participation rates were observed for parents of children aged 12-17 years (1349/152,928, 0.9% participation rate), and the highest participation was observed among older adults aged 61-70 years (39,844/329,487, 12.1%). Persons of non-Hispanic White race were more likely to participate compared with other races and ethnicities (13.1% vs 3.9%-7.5%, respectively; P<.001). In addition, patients residing in areas with a higher neighborhood deprivation index were less likely to participate (5.1%, 16,503/323,122 vs 10.8%, 38,084/352,939 in the highest vs lowest deprivation quintiles, respectively; P<.001). Invitations through the individual's Kaiser Permanente health care portal account and by SMS text message were associated with the highest participation rate (19.2%, 70,248/366,377 and 10.5%, 96,169/914,793, respectively), followed by email (19,464/396,912, 4.9%) and then QR codes on flyers (25,882/2,091,975, 1.2%). SMS text messaging-based surveys demonstrated the highest sustained daily response rates compared with internet-based surveys. CONCLUSIONS: This real-world prospective study demonstrated that a novel digital vaccine safety self-reporting system implemented through an integrated health care system can achieve high participation rates. Linkage with participants' electronic health records is another unique benefit of this surveillance system. We also identified lower participation among selected vulnerable populations, which may have implications when interpreting data collected from similar digital systems.


Subject(s)
Internet , Self Report , Text Messaging , Humans , Prospective Studies , Male , Female , Middle Aged , Text Messaging/statistics & numerical data , Text Messaging/standards , Text Messaging/instrumentation , Adult , Self Report/statistics & numerical data , Aged , Delivery of Health Care, Integrated/standards , Delivery of Health Care, Integrated/statistics & numerical data , COVID-19 Vaccines/administration & dosage , United States , Cohort Studies , California , COVID-19/prevention & control , Adolescent , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Adverse Drug Reaction Reporting Systems/standards
2.
Health Sci Rep ; 7(10): e70119, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39377025

ABSTRACT

Background: The appearance of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) initiated the COVID-19 pandemic, resulting in millions of confirmed cases and numerous fatalities. In response, rapid vaccine development efforts were launched to mitigate the pandemic's impact. Despite the high efficacy of COVID-19 vaccines, they are also associated with several common side effects/complications, some of them specific to the multiple sclerosis population. Our goal is to review various types of COVID-19 vaccines, assessing their efficacy, adverse events, their association with an MS relapse following vaccination, and the influence of disease modifying therapies (DMTs) on vaccines' efficacy. Methods: The review was based on a database search that included PubMed/Medline, Embase, Scopus, and the Web of Science conducted from January 2020 to July 2024 using the following MeSH terms: MS, COVID-19, COVID-19 vaccination, vaccine side effects, and vaccine hesitancy. Results: Receiving any type of COVID-19 vaccine is a safer and more reliable approach to building immunity compared to becoming infected with the virus. Complications tend to be mild to moderate, occasionally severe. DMTs could affect the humoral response to the COVID-19 vaccine. Among all DMTs, a notable reduction in the humoral response has been observed in patients who received anti-CD20 and sphingosine-1-phosphate (S1P) receptor modulator drugs after their COVID-19 vaccination. Conclusion: Despite certain drawbacks, the benefits of the COVID-19 vaccine significantly outweigh the associated risks, making it a recommended course of action for people with multiple sclerosis (pwMS). However, physicians need to be mindful of potential complications especially in patients undergoing anti CD20 and manage them appropriately.

3.
S Afr Fam Pract (2004) ; 66(1): e1-e9, 2024 Sep 23.
Article in English | MEDLINE | ID: mdl-39354787

ABSTRACT

BACKGROUND:  South Africa faced challenges while implementing coronavirus disease 2019 (COVID-19) measures such as mass vaccination. Some people rejected or were hesitant to receive government-recommended vaccines. This study explored COVID-19 vaccination hesitancy among unvaccinated individuals in a primary care setting in Pretoria, South Africa. METHODS:  This was an exploratory phenomenological study that included one-on-one interviews with 12 individuals at Temba Community Health Centre in Pretoria, South Africa. RESULTS:  The research revealed five themes: perceptions of COVID-19 disease, perceptions of COVID-19 vaccine, factors related to non-vaccination, information sources about the COVID-19 vaccine, and long-term vaccination decisions. There were seven linked sub-themes. CONCLUSION:  Overall, participants had a good understanding of COVID-19 disease, but limited knowledge about the vaccine, causing hesitancy to get vaccinated. Reasons for not getting vaccinated included health-related concerns, safety concerns, personal experiences, and social and political factors. Safety and health-related concerns were prevalent, with adverse vaccine outcomes being the most common concern. Most participants had experienced a historic encounter with a vaccine-related death or illness.Contribution: Vaccine hesitancy should be viewed as a powerful concern from the community, and a key source of worry for the health authorities over any vaccine-related doubt.


Subject(s)
COVID-19 Vaccines , COVID-19 , Primary Health Care , Vaccination Hesitancy , Humans , South Africa/epidemiology , Vaccination Hesitancy/psychology , COVID-19 Vaccines/administration & dosage , Male , Female , COVID-19/prevention & control , Adult , Middle Aged , SARS-CoV-2 , Health Knowledge, Attitudes, Practice , Patient Acceptance of Health Care/psychology , Vaccination/psychology , Interviews as Topic
4.
J Transl Med ; 22(1): 903, 2024 Oct 04.
Article in English | MEDLINE | ID: mdl-39367499

ABSTRACT

Although vaccination is considered the most effective weapon against influenza, coverage rates, national vaccination policies, and funding vary largely around the globe. Despite their huge potential for achieving herd immunity, child-focused national vaccination strategies that favor pain-free nasal vaccines are uncommon. CENTRAL, Embase, and MEDLINE were last searched on November 13, 2023. Active-controlled randomized controlled trials comparing the live-attenuated intranasal vaccine with the inactivated intramuscular influenza vaccine in children were included. Event rates of laboratory-confirmed influenza virus infection, all-cause mortality, hospitalization, serious adverse events, adverse events, and financial outcomes were extracted based on the PRISMA 2020 Guideline. PROSPERO: CRD42021285412. Pooled odds ratios (ORs) with 95% confidence intervals (CI) were calculated using the random-effects model when at least three comparable outcomes were available. We found no significant difference between quadrivalent live-attenuated intranasal and trivalent inactivated intramuscular (OR = 1.48; 95% CI 0.49-4.45) or between trivalent live-attenuated intranasal and inactivated intramuscular vaccines (OR = 0.77, CI = 0.44-1.34) regarding their efficacy. However, the subgroup analysis of large, multi-center trials indicated that the trivalent live attenuated intranasal influenza vaccine was superior to the trivalent inactivated intramuscular influenza vaccine (12,154 people, OR = 0.50, CI = 0.28-0.88). Only 23 "vaccine-related serious adverse events" were recorded among 17 833 individuals, with no significant difference between methods. The widespread initiation of pediatric national flu vaccination programs prioritizing the live-attenuated intranasal influenza vaccine would be beneficial. Multi-continent, high-quality studies that include children younger than two years old and those living in subtropical and tropical regions are needed to further enhance our understanding.


Subject(s)
Influenza Vaccines , Influenza, Human , Humans , Influenza Vaccines/immunology , Influenza Vaccines/administration & dosage , Child , Influenza, Human/prevention & control , Influenza, Human/immunology , Vaccination , Administration, Intranasal , Child, Preschool , Publication Bias , Vaccines, Inactivated/immunology
5.
Cureus ; 16(9): e68936, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39381449

ABSTRACT

Cutaneous adverse reactions to mRNA COVID-19 vaccines in patients with preexisting dermatologic disease include bullous eruptions, pityriasis rubra pilaris, dermatomyositis, and granuloma annulare. Erythroderma is a rare but severe adverse reaction not previously seen. This case report describes the development of erythroderma in a 73-year-old male with a history of atopic dermatitis, with widespread erythema and scaling covering 95% of his body surface area, which developed sequentially after receiving each dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccination. The patient's condition improved significantly with appropriate dermatologic treatment, including systemic and topical corticosteroids and dupilumab. Thus, it is imperative to recognize erythroderma as a potential side effect of the Pfizer-BioNTech COVID-19 vaccine, particularly in patients with preexisting dermatologic conditions. Early diagnosis and treatment are vital for managing this potentially life-threatening reaction and preventing severe complications.

6.
Hum Vaccin Immunother ; 20(1): 2411824, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-39396824

ABSTRACT

Hepatitis B vaccination is the most effective means of interrupting HBV transmission. Although the hepatitis B vaccine is very effective and safe, adverse events following immunization do occur and need to be reported so that problems can be identified and appropriate corrective action can be taken. Most of the research on AEFI focuses on the safety observation of newly used vaccines, and there are few long-term studies on AEFI of the hepatitis B vaccine. This study retrospectively analyzes the reporting rate, clinical symptoms, and onset time of AEFI of the hepatitis B vaccine in Quzhou from 2011 to 2023, and compares the differences in AEFI reporting rates between different types of hepatitis B vaccines, different vaccination ages, and different doses. The surveillance results show that from 2011 to 2023, the AEFI reporting rate of hepatitis B Vaccines in Quzhou was 17.55/100,000 doses. 98.73% of reported AEFI were non-serious. The types of AEFI reported were vaccine product-related reactions, immunization anxiety-related reactions, and coincidental events. 94.12% of vaccine product-related reactions occurred within 3 days, and the main symptoms were fever, local reactions at the injection site, and rash. The AEFI reporting rate of the CHO vaccine was higher than that of the yeast vaccines, and the probability of AEFI in children under 1 year of age receiving the hepatitis B vaccine was higher in the latter dose than in the previous dose. The 13-year-long AEFI surveillance provides reliable evidence of the safety of the hepatitis B vaccine.


Subject(s)
Adverse Drug Reaction Reporting Systems , Hepatitis B Vaccines , Hepatitis B , Humans , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/immunology , Retrospective Studies , Adolescent , Child , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Hepatitis B/prevention & control , Infant , Child, Preschool , Adult , Young Adult , Female , China/epidemiology , Male , Middle Aged , Vaccination/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology
7.
Clin Microbiol Rev ; : e0002524, 2024 Oct 03.
Article in English | MEDLINE | ID: mdl-39360831

ABSTRACT

SUMMARYIn the United Kingdom (UK) in 2022/23, influenza virus infections returned to the levels recorded before the COVID-19 pandemic, exerting a substantial burden on an already stretched National Health Service (NHS) through increased primary and emergency care visits and subsequent hospitalizations. Population groups ≤4 years and ≥65 years of age, and those with underlying health conditions, are at the greatest risk of influenza-related hospitalization. Recent advances in influenza virus vaccine technologies may help to mitigate this burden. This review aims to summarize advances in the influenza virus vaccine landscape by describing the different technologies that are currently in use in the UK and more widely. The review also describes vaccine technologies that are under development, including mRNA, and universal influenza virus vaccines which aim to provide broader or increased protection. This is an exciting and important era for influenza virus vaccinations, and advances are critical to protect against a disease that still exerts a substantial burden across all populations and disproportionately impacts the most vulnerable, despite it being over 80 years since the first influenza virus vaccines were deployed.

8.
J Pharm Bioallied Sci ; 16(Suppl 3): S2818-S2820, 2024 Jul.
Article in English | MEDLINE | ID: mdl-39346240

ABSTRACT

Background: Vaccination of neonates is crucial for preventing infectious diseases and ensuring public health. However, understanding the attitudes of healthcare providers and parents towards neonatal vaccination and the challenges in implementing vaccination schedules is essential for optimizing vaccination strategies. Materials and Methods: A clinical study was conducted involving healthcare providers and parents of neonates. Surveys were administered to assess attitudes towards neonatal vaccination, perceived barriers, and adherence to vaccination schedules. Data analysis was performed using statistical methods to identify trends and associations. Results: Among healthcare providers (n = 200), 85% expressed strong support for neonatal vaccination, citing its importance in disease prevention. However, concerns regarding vaccine safety (62%) and parental hesitancy (48%) were identified as significant barriers. Among parents (n = 500), 78% reported willingness to vaccinate their neonates, with 60% adhering strictly to vaccination schedules. Common reasons for non-adherence included fear of adverse reactions (42%) and misinformation (28%). Challenges in vaccine administration, such as access issues (20%) and vaccine shortages (15%), were also reported. Conclusion: Healthcare providers generally endorse neonatal vaccination, recognizing its benefits in preventing infectious diseases. However, addressing concerns about vaccine safety and parental hesitancy is crucial for improving vaccination rates. Strategies aimed at enhancing education, promoting vaccine confidence, and addressing logistical challenges are essential for the successful implementation of neonatal vaccination schedules.

9.
Vaccines (Basel) ; 12(9)2024 Aug 27.
Article in English | MEDLINE | ID: mdl-39340001

ABSTRACT

Several vaccines against chikungunya fever have been developed and tested, and one has been recently licensed. We performed a meta-analysis to estimate the immunogenicity and safety of all chikungunya vaccines that have been progressed to clinical trial evaluation (VLA1553; mRNA-1388/VAL-181388; PXVX0317/VRC-CHKVLP059-00-VP; ChAdOx1 Chik; MV-CHIK). We included trials retrieved from MedLine, Scopus, and ClinicalTrials.gov. The outcomes were the rates of seroconversion/seroresponse and serious adverse events (SAEs) after the primary immunization course. We retrieved a total of 14 datasets, including >4000 participants. All candidate chikungunya vaccines were able to elicit an immunogenic response in ≥96% of vaccinated subjects, regardless of the vaccination schedule and platform used, and the seroconversion/seroresponse rates remained high 6 to 12 months after vaccination for most vaccines. Four of the five candidate vaccines showed a good overall safety profile (no data were available for ChAdOx1 Chik), with no significant increase in the risk of SAEs among the vaccinated, and a low absolute risk of product-related SAEs. Overall, the present findings support the potential use of the candidate vaccines for the prevention of chikungunya and the current indication for use in adult travelers to endemic regions of the licensed VLA 1553 vaccine. In order to extend chikungunya vaccination to a wider audience, further studies are needed on individuals from endemic countries and frail populations.

10.
Vaccines (Basel) ; 12(9)2024 Sep 08.
Article in English | MEDLINE | ID: mdl-39340057

ABSTRACT

We were tasked by Canada's COVID-19 Immunity Task Force to describe severe adverse events (SAEs) associated with emergency department (ED) visits and/or hospitalizations in individuals with immune-mediated inflammatory diseases (IMIDs). At eight Canadian centres, data were collected from adults with rheumatoid arthritis (RA), axial spondyloarthritis (AxS), systemic lupus (SLE), psoriatic arthritis (PsA), and inflammatory bowel disease (IBD). We administered questionnaires, analyzing SAEs experienced within 31 days following SARS-CoV-2 vaccination. About two-thirds (63%) of 1556 participants were female; the mean age was 52.5 years. The BNT162b2 (Pfizer) vaccine was the most common, with mRNA-1273 (Moderna) being second. A total of 49% of participants had IBD, 27.4% had RA, 14.3% had PsA, 5.3% had SpA, and 4% had SLE. Twelve (0.77% of 1556 participants) SAEs leading to an ED visit or hospitalization were self-reported, occurring in 11 participants. SAEs included six (0.39% of 1556 participants) ED visits (including one due to Bell's Palsy 31 days after first vaccination) and six (0.39% of 1556 participants) hospitalizations (including one due to Guillain-Barré syndrome 15 days after the first vaccination). Two SAEs included pericarditis, one involved SLE (considered a serious disease flare), and one involved RA. Thus, in the 31 days after SARS-CoV-2 vaccination in our IMID sample, very few serious adverse events occurred. As SARS-CoV2 continues to be a common cause of death, our findings may help optimize vaccination acceptance.

11.
Vaccines (Basel) ; 12(9)2024 Sep 14.
Article in English | MEDLINE | ID: mdl-39340082

ABSTRACT

In Canada, vaccine safety studies are often conducted at the provincial/territorial level where the primary data on vaccination reside. Combining health services data from multiple jurisdictions using a pooled data analytic approach would reduce the amount of time needed to detect vaccine safety signals. To determine the difference in the time it would take to identify safety signals using different proportions of the Canadian population, we conducted power and sample size calculations for a hypothetical self-controlled case series-based surveillance analysis. We used scenarios modeled after the real-world examples of myocarditis and vaccine-induced immune thrombotic thrombocytopenia (VITT) following COVID-19 vaccination as our base cases. Our calculations demonstrated that in the case of a myocarditis-type event, a pooled analysis would reduce the time needed to detect a safety signal by over 60% compared to using Ontario data alone. In the case of a VITT-type event, a pooled analysis could detect a safety signal 49 days sooner than using Ontario data alone, potentially averting as many as 30 events. Our analysis demonstrates that there is substantial value in using pan-Canadian health services data to evaluate the safety of vaccines. Efforts should be made to develop a pan-Canadian vaccine data source to allow for an earlier evaluation of suspected adverse events following immunization.

12.
Vaccines (Basel) ; 12(9)2024 Sep 20.
Article in English | MEDLINE | ID: mdl-39340106

ABSTRACT

Underreporting is the main limitation of spontaneous reporting systems. This cohort-event monitoring study aims to examine the potential of short message service (SMS)-based surveillance compared to traditional surveillance systems. Using VigiVax software, parents of vaccinated children aged two years or younger, in the period March 2021-May 2022, received a single SMS inquiry about adverse events following immunization (AEFI). Responses were collected, validated by health operators and integrated with the information on electronic immunization registries. AEFI reports were automatically submitted to the Italian Pharmacovigilance system. Among 254,160 SMS messages sent, corresponding to 451,656 administered doses (AD), 71,643 responses were collected (28.2% response rate), and 21,231 of them (8.3%) reported AEFI. After a seriousness assessment based on clinical criteria, 50 reports (0.24%) were classified as serious. Among these, a causality assessment identified 31 reports at least potentially related to the vaccination (RR: 6.86/100,000 AD). Febrile seizures following MMRV (measles, mumps, rubella, varicella) vaccination accounted for 11 of these 31 cases, with an incidence of 32 per 100,000 AD. No fatal outcomes were reported. Our findings support the highly favorable risk profile of pediatric vaccinations and the possibility to improve spontaneous reporting through the integration of digital technologies.

13.
Disaster Med Public Health Prep ; 18: e137, 2024 Sep 03.
Article in English | MEDLINE | ID: mdl-39225231

ABSTRACT

Safe vaccines are critical for biosecurity protection, yet adverse events-rightly or wrongly attributed to immunization-potentially cause rapid loss of confidence, reduced vaccine uptake, and resurgence of preventable disease. Effective vaccine safety incident management is essential to provide assessment and lead appropriate actions to ensure vaccination programs are safe and mitigate unwarranted crisis escalation that could damage vaccine programs and the effective control of vaccine preventable disease outbreaks or pandemics. Incident management systems (IMS) are used globally to direct emergency management response, particularly for natural disasters of fire, flood, and storm. Public health is equally an emergency response and can therefore benefit from these command control constructs. While examples of IMS for outbreak response and mass immunization logistics exist, there is little to no information on their use in vaccine safety. We describe Australia's vaccine safety Alert Advisory Group establishment in Victoria during the COVID-19 pandemic and onward embedding into routine practice, anticipant of new vaccines, and the next biosecurity threat.


Subject(s)
Pandemics , Vaccines , Humans , Victoria/epidemiology , Vaccines/adverse effects , Pandemics/prevention & control , COVID-19/prevention & control , COVID-19/epidemiology , Advisory Committees
14.
Infect Chemother ; 2024 Aug 08.
Article in English | MEDLINE | ID: mdl-39231505

ABSTRACT

Since its Fast-Track approval by the Federal Drug Administration, the human papillomavirus (HPV) vaccine has been marked by controversies. Unconfirmed reports of adverse events in both Japan and Denmark led to suspensions of national vaccination programs, which setback the fight against cervical cancer and associated mortality and morbidity. Despite follow-up studies of vaccine adverse reports, additional randomized control trials, and review reports from both the World Health Organization and the European Commission, there is still a great deal of hesitancy around the vaccine. While all three version of the HPV vaccine have been shown to be efficacious and safe, additional ethical dilemmas deserve to be considered as well.

15.
BJOG ; 2024 Sep 16.
Article in English | MEDLINE | ID: mdl-39279662

ABSTRACT

OBJECTIVE: Assessment of COVID-19 vaccine safety in pregnancy using population-based data. DESIGN: Matched case-control study nested in a retrospective cohort. SETTING: April 2021-March 2022, England. POPULATION OR SAMPLE: All pregnant individuals aged between 18 and 50 years with valid health records. METHODS: Individuals identified from the national Maternity Services Data Set (MSDS) had their records linked to hospital admission, national COVID-19 vaccine and COVID-19 testing databases. Matching included participant's age and estimated week of conception. We compared outcomes across multiple COVID-19 vaccine exposures using conditional multivariable logistic regression, adjusting for demographic and health characteristics. MAIN OUTCOME MEASURES: Adverse pregnancy, maternal and neonatal outcomes. RESULTS: 514 013 individuals were included. We found lower odds of giving birth to a baby who was low birthweight (aOR = 0.86, 95% CI: 0.79-0.93), preterm (aOR = 0.89, 95% CI: 0.85-0.92) or who had an Apgar score < 7 at 5 min of age (aOR = 0.89, 95% CI: 0.80-0.98) for individuals who received at least one dose of COVID-19 vaccine during pregnancy. The odds of admission to intensive care unit during pregnancy were lower in those vaccinated (aOR = 0.85, 95% CI: 0.76-0.95). There was no association between vaccination in pregnancy and stillbirth, neonatal death, perinatal death and maternal venous thromboembolism in pregnancy. CONCLUSIONS: COVID-19 vaccines are safe to use in pregnancy. Our findings generated important information to communicate to pregnant individuals and health professionals to support COVID-19 maternal vaccination programmes.

16.
Vaccine ; 42(26): 126256, 2024 Sep 10.
Article in English | MEDLINE | ID: mdl-39260053

ABSTRACT

BACKGROUND: Although numerous studies support the safety of influenza vaccination during pregnancy, fewer studies have evaluated the risk of miscarriage or considered the effect of prior immunization. METHODS: Using national de-identified administrative claims data from the Optum Labs Data Warehouse, we conducted a claims-based cohort study of 117,626 pregnancies between January 2009 and December 2018. We identified pandemic A(H1N1)pdm09 and seasonal influenza vaccinations using CPT codes. Fetal loss was defined as miscarriage, medical termination, or stillbirth as identified by ICD-10-CM diagnostic codes. Cox proportional hazard models treating influenza vaccination as a time-varying exposure, weighted for loss-to-follow-up and stratified by baseline probability of vaccination, were used to model the risk of fetal loss by exposure to influenza vaccine. RESULTS: About 31.4 % of the cohort had a record of influenza vaccination; 10.0 % were vaccinated before pregnancy only, 17.8 % during pregnancy only, and 3.6 % before and during pregnancy. The risk of miscarriage was 39 % lower among those vaccinated during pregnancy compared to unvaccinated (adjusted hazard ratio, aHR 0.61; 95 % CI 0.50, 0.74) and was similar for medical termination or stillbirth (HR 0.69; 95 % CI 0.45, 1.03 and aHR 0.99; 95 % CI 0.76, 1.30, respectively). Similar results were observed for women who received the vaccine before and during pregnancy. We observed little to no association between vaccination before pregnancy and risk of miscarriage (HR 0.98; 95 % CI 0.76, 1.26), medical termination (HR 1.02; 95 % CI 0.46, 2.24), or stillbirth (HR 1.14, 95 % CI 0.77, 1.69). DISCUSSION: Influenza vaccination was not associated with an increased risk of fetal loss. These results support the safety of influenza vaccine administration even when administered before or early during pregnancy.

17.
Aust N Z J Public Health ; 48(5): 100188, 2024 Sep 10.
Article in English | MEDLINE | ID: mdl-39260065

ABSTRACT

OBJECTIVE: Post-licensure vaccine safety surveillance of adverse events following immunisation is critical to ensure public safety and confidence in vaccines. This paper aims to describe the governance structure and data linkage methodology behind the establishment of the largest linked vaccine safety surveillance data resource in Australia - The Vaccine Safety Health Link (VSHL). METHODS: The Vaccine Safety Health Link contains linked records from the Australian Immunisation Register with records from hospital, perinatal, mortality, and notifiable disease datasets in near real-time. Linkage is done by the Centre for Victorian Data Linkage who receive the datasets in an identifiable format which then undergo standardisation, enrichment, linkage, quality assurance and de-identification, prior to being supplied for analysis. RESULTS: The VSHL data resource allows sensitive and rapid analysis of a broad spectrum of suspected adverse events to ensure the safety of all vaccines administered. It is also used to refute spurious concerns where no associations are found, upholding trust, and maintaining vaccine confidence. CONCLUSIONS: The Vaccine Safety Health Link's surveillance design complements existing vaccine safety surveillance methods. Challenges encountered and lessons learnt using Vaccine Safety Health Link would benefit linkage projects globally. IMPLICATIONS FOR PUBLIC HEALTH: In its first two years, The Vaccine Safety Health Link has been used for 14 vaccine safety investigations. Studies into these conditions would not have otherwise been possible. The Vaccine Safety Health Link also partners with the Global Vaccine Data Network™ for approved collaborative studies with a combined population of over 300 million people.

18.
Animals (Basel) ; 14(17)2024 Aug 25.
Article in English | MEDLINE | ID: mdl-39272258

ABSTRACT

This paper explores the significance of quality vaccines in managing ASF in Asia, where it poses a substantial threat to the pork industry. It emphasizes the risks associated with substandard vaccines, including the emergence of new virus strains that complicate disease control. Highlighting recent advancements in vaccine deployment in Vietnam, the paper calls for rigorous testing and regulations to guarantee vaccine effectiveness and safety. The authors advocate for the implementation of vaccines with the inclusion of differentiating infected from vaccinated animals (DIVA), which enhances disease management strategies in both endemic and non-endemic regions. The conclusion underscores the necessity of stringent standards in vaccine development and strict adherence to regulatory guidelines to ensure successful ASF management and maintain public trust in the vaccines.

19.
Stud Health Technol Inform ; 318: 30-35, 2024 Sep 24.
Article in English | MEDLINE | ID: mdl-39320177

ABSTRACT

Social media offers a rich source of real-time health data, including potential vaccine reactions. However, extracting meaningful insights is challenging due to the noisy nature of social media content. This paper explores using large language models (LLMs) and prompt engineering to detect personal mentions of vaccine reactions. Different prompting strategies were evaluated on two LLM models (GPT-3.5 and GPT-4) using Reddit data focused on shingles (zoster) vaccines. Zero-shot and few-shot learning approaches with both standard and chain-of-thought prompts were compared. The findings demonstrate that GPT-based models with carefully crafted chain-of-thought prompts could identify the relevant social media posts. Few-shot learning helped GPT4 models to identify more of the marginal cases, although less precisely. The use of LLMs for classification with lightweight supervised pretrained language models (PLMs) found that PLMs outperform LLMs. However, a potential benefit in using LLMs to help identify records for training PLMs was revealed, especially to eliminate false negatives, and LLMs could be used as classifiers when insufficient data exists to train a PLM.


Subject(s)
Social Media , Humans , Natural Language Processing , Vaccines , Machine Learning
20.
Acta Obstet Gynecol Scand ; 103(10): 1943-1954, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39106178

ABSTRACT

INTRODUCTION: The human papillomavirus (HPV) vaccine is crucial in preventing cervical cancer, and a significant number of women in 135 countries worldwide may have unknowingly received the vaccine during peri-pregnancy or pregnancy due to a lack of regular pregnancy testing. Previous studies on the safety of pregnancy outcomes with vaccination before and after pregnancy have not reached definitive conclusions. Thus, we subdivided the vaccination time frame and conducted an updated study to further examine whether exposure to the HPV vaccine during pregnancy or the periconceptional period increases the likelihood of adverse pregnancy outcomes. MATERIAL AND METHODS: The clinical trials and cohort studies published before August 1, 2023, were retrieved from PubMed, Embase, Web of Science, and Cochrane Central Register of Controlled Trials. The Newcastle-Ottawa Scale and Cochrane risk of bias assessment tool were adopted to evaluate the risk of bias in the included studies. In addition, the quality assessment was carried out using the Review Manager 5.4 Software, and a meta-analysis was conducted using the Stata 16 Software. RESULTS: Eleven studies were located. The results showed that receiving 4vHPV during the periconceptional or gestational period had no relationship with an increased risk of spontaneous abortion, stillbirth, preterm birth, birth defects, small for gestational age, and ectopic pregnancy. Neither receiving 2vHPV nor 9vHPV was associated with a higher risk of stillbirth, preterm birth, birth defects, small for gestational age, and ectopic pregnancy; however, receiving 2vHPV during the period from 45 days before last menstrual period (LMP) to LMP and 9vHPV during the period from 90 days before LMP to 45 days after LMP seemed to be related to an increased risk of spontaneous abortion (RR = 1.59, 95% CI: 1.04-2.45, RR = 2.04, 95% CI: 1.28-3.24). CONCLUSIONS: In conclusion, the likelihood of an elevated risk of spontaneous abortion caused by HPV vaccination during the periconceptional or gestational period could not be completely ruled out. Given the lack of evidence, further research is needed to examine the effect of HPV vaccination on spontaneous abortion.


Subject(s)
Papillomavirus Infections , Papillomavirus Vaccines , Pregnancy Outcome , Humans , Female , Pregnancy , Papillomavirus Vaccines/administration & dosage , Papillomavirus Infections/prevention & control , Vaccination , Uterine Cervical Neoplasms/prevention & control
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