Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: a systematic review and meta-analysis
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SUBMITTER: Liu Q
PROVIDER: S-EPMC8590867 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The development of COVID-19 vaccines has been a triumph of biomedical research. However, there are still challenges, including assessment of their immunogenicity in high-risk populations, including PLWH. In the present study, we enrolled 121 PLWH aged >18 years, that were vaccinated against COVID-19 in the Polish National Vaccination Program. Patients filled in questionnaires regarding the side effects of vaccination. Epidemiological, clinical, and laboratory data were collected. The efficacy of COVID-19 vaccines was evaluated with an ELISA that detects IgG antibodies using a recombinant S1 viral protein antigen. The interferon-gamma release assay (IGRA) was applied to quantitate interferon-gamma (IFN-γ) to assess cellular immunity to SARS-CoV-2. In total, 87 patients (71.9%) received mRNA vaccines (BNT162b2-76 (59.5%), mRNA-1273- 11 (9.1%)). A total of 34 patients (28.09%) were vaccinated with vector-based vaccines (ChAdOx Vaxzevria- 20 (16.52%), Ad26.COV2.S- 14 (11.6%)). A total of 95 (78.5%) of all vaccinated patients developed a protective level of IgG antibodies. Only eight PLWH (6.6%) did not develop cellular immune response. There were six patients (4.95%) that did not develop a cellular and humoral response. Analysis of variance proved that the best humoral and cellular response related to the administration of the mRNA-1273 vaccine. COVID-19 vaccines were found to be immunogenic and safe in PLWH. Vaccination with mRNA vaccines were related to better humoral and cellular responses.
| S-EPMC10222990 | biostudies-literature
Project description:ObjectiveThe Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce. Bell's palsy, herpes zoster, Guillain-Barré syndrome (GBS) and other neurological complaints in proximity to vaccination have received special public attention. We compared their rates among vaccinated and unvaccinated individuals.MethodsIndividuals ≥16 years vaccinated with at least one dose of BNT162b2 were eligible for this historical cohort study in a health maintenance organization insuring 1.2 million citizens. Each vaccinee was matched to a non-vaccinated control by sex, age, population sector (general Jewish, Arab, ultra-orthodox Jewish) and comorbidities. Diagnosis of Covid-19 before or after vaccination was an exclusion criterion. The outcome was a diagnosis of Bell's palsy, GBS, herpes zoster or symptoms of numbness or tingling, coded in the visit diagnosis field using ICD-9 codes. Diagnoses of Bell's palsy and GBS were verified by individual file review.ResultsOf 406 148 individuals vaccinated during the study period, 394 609 (97.2%) were eligible (11 539 excluded). A total of 233 159 (59.1%) were matched with unvaccinated controls. Mean follow was 43 ± 15.14 days. In vaccinated and unvaccinated individuals there were 23 versus 24 cases of Bell's palsy (RR 0.96, CI 0.54-1.70), one versus zero cases of GBS, 151 versus 141 cases of herpes zoster (RR 1.07, CI 0.85-1.35) and 605 versus 497 cases of numbness or tingling (RR 1.22, CI 1.08-1.37), respectively.DiscussionNo association was found between vaccination, Bell's palsy, herpes zoster or GBS. Symptoms of numbness or tingling were more common among vaccinees. This study adds reassuring data regarding the safety of the BNT162b2 vaccine.
| S-EPMC8479307 | biostudies-literature
Project description:IntroductionThere are concerns regarding the effectiveness and safety of SARS-CoV-2 vaccine in inflammatory Bowel Disease (IBD) patients. This systematic review and meta-analysis comprehensively summarises the available literature regarding the safety and effectiveness of SARS-CoV-2 vaccine in IBD.MethodsThree independent reviewers performed a comprehensive review of all original articles describing the response of SARS-CoV-2 vaccines in patients with IBD. Primary outcomes were (1) pooled seroconversion rate SARS-CoV-2 vaccination in IBD patients (2) comparison of breakthrough COVID-19 infection rate SARS-CoV-2 vaccination in IBD patients with control cohort and (3) pooled adverse event rate of SARS-CoV-2 vaccine. All outcomes were evaluated for one and two doses of SARS-CoV-2 vaccine. Meta-regression was performed. Probability of publication bias was assessed using funnel plots and with Egger's test.ResultsTwenty-one studies yielded a pooled seroconversion rate of 73.7% and 96.8% in IBD patients after one and two doses of SARS-CoV-2 vaccine respectively. Sub-group analysis revealed non-statistically significant differences between different immunosuppressive regimens for seroconversion. Meta-regression revealed that the vaccine type and study location independently influenced seroconversion rates. There was no statistically significant difference in breakthrough infection in IBD patients as compared to control after vaccination.ConclusionIn summary, the systematic review and meta-analysis suggest that SARS-CoV-2 vaccine is safe and effective in IBD patients.
| S-EPMC9111455 | biostudies-literature
Project description:ObjectiveTo systematically evaluate the effectiveness and safety of the SARS-CoV-2 vaccines currently undergoing clinical trials.MethodsPubMed, EMBASE, and Cochrane Library databases were searched to collect open human COVID-19 vaccines randomized controlled trials, without limiting the search time and language. The research papers collected in the above-mentioned databases were initially screened according to the title and abstract content and merged, and the repeated ones were removed. After reading the full text of the remaining research, the studies that did not meet the inclusion criteria were excluded, and finally, nine studies were obtained. After extracting the statistical data of adverse events in the study, load them into Review Manager for heterogeneity analysis.ResultsThe incidence of adverse reactions of inactivated virus vaccines, RNA vaccines, and adenovirus vector vaccines was higher than that of placebo. Common adverse reactions included pain, swelling, and fever at the injection site.ConclusionFrom the perspective of effectiveness, RNA vaccine > adenovirus vector vaccine > inactivated virus vaccine. From the perspective of safety, the incidence of adverse reactions of the three vaccines is higher than that of a placebo, and the incidence of adverse reactions of the adenovirus vector vaccine is higher.
| S-EPMC8426880 | biostudies-literature
Project description:IntroductionCausal inference helps researchers and policy-makers to evaluate public health interventions. When comparing interventions or public health programs by leveraging observational sensitive individual-level data from populations crossing jurisdictional borders, a federated approach (as opposed to a pooling data approach) can be used. Approaching causal inference by re-using routinely collected observational data across different regions in a federated manner, is challenging and guidance is currently lacking. With the aim of filling this gap and allowing a rapid response in the case of a next pandemic, a methodological framework to develop studies attempting causal inference using federated cross-national sensitive observational data, is described and showcased within the European BeYond-COVID project.MethodsA framework for approaching federated causal inference by re-using routinely collected observational data across different regions, based on principles of legal, organizational, semantic and technical interoperability, is proposed. The framework includes step-by-step guidance, from defining a research question, to establishing a causal model, identifying and specifying data requirements in a common data model, generating synthetic data, and developing an interoperable and reproducible analytical pipeline for distributed deployment. The conceptual and instrumental phase of the framework was demonstrated and an analytical pipeline implementing federated causal inference was prototyped using open-source software in preparation for the assessment of real-world effectiveness of SARS-CoV-2 primary vaccination in preventing infection in populations spanning different countries, integrating a data quality assessment, imputation of missing values, matching of exposed to unexposed individuals based on confounders identified in the causal model and a survival analysis within the matched population.ResultsThe conceptual and instrumental phase of the proposed methodological framework was successfully demonstrated within the BY-COVID project. Different Findable, Accessible, Interoperable and Reusable (FAIR) research objects were produced, such as a study protocol, a data management plan, a common data model, a synthetic dataset and an interoperable analytical pipeline.ConclusionsThe framework provides a systematic approach to address federated cross-national policy-relevant causal research questions based on sensitive population, health and care data in a privacy-preserving and interoperable way. The methodology and derived research objects can be re-used and contribute to pandemic preparedness.
| S-EPMC10594731 | biostudies-literature
Project description:(1) Background: Evidence on the outcomes of ustekinumab treatment in real-world Crohn's disease (CD) patients is needed. Our aim was to evaluate the effectiveness and safety of ustekinumab in CD, reported by observational studies. (2) Methods: bibliographical searches were performed (PubMed, EMBASE).Selectionobservational studies assessing the effectiveness and safety of ustekinumab in CD.Exclusion criteriastudies using ustekinumab as a prophylaxis for postoperative recurrence or perianal disease.Data synthesiseffectiveness by intention-to-treat (random-effects model). Data were stratified by study design, population included, administered dose, and prior biologic exposure. (3) Results: A total of 63 studies (8529 patients) were included. Response was achieved in 60% (95% CI, 54-67%) in the short term (8-14 weeks); 64% (57-71%) in the medium term (16-24 weeks); and 64% (52-74%) in the long term (48-52 weeks). Remission was achieved in 37% (28-46%) in the short term; 42% (36-49%) in the medium term; and 45% (37-53%) in the long term. The endoscopic remission rate was 33% (25-40%) in the long term. Eighteen percent of patients lost response during follow-up. Nearly one-third of the patients needed dose optimisation, and in 59% of them it was effective. Twenty-five percent of patients developed adverse events, leading to treatment withdrawal in seven percent of the cases. (4) Conclusions: Ustekinumab is an effective and safe therapy in real-world refractory CD patients. Dose optimisation is frequently required, being effective in a high percentage of cases.
| S-EPMC9317084 | biostudies-literature
Project description:BackgroundSelective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness.MethodsA systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC) or Crohn's disease (CD). MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with UC/CD reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, 2014-June 22, 2017. Response and remission rates were combined in random-effects meta-analyses.ResultsAt treatment week 14, 32% of UC patients [95% confidence interval (CI) 27-39%] and 30% of CD patients (95% CI 25-34%) were in remission; and at month 12, 46% for UC (95% CI 37-56%) and 30% for CD (95% CI 20-42%). For UC, the rates of corticosteroid-free remission were 26% at week 14 (95% CI 20-34%) and 42% at month 12 (95% CI 31-53%); for CD they were 25% at week 14 (95%, CI 20-31%) and 31% at month 12 (95%, CI 20-45%). At month 12, 33-77% of UC and 6-63% of CD patients had mucosal healing. Nine percent of patients reported serious adverse events.ConclusionsVedolizumab demonstrated real-world effectiveness in patients with moderate-to-severely active UC or CD, with approximately one-half and one-third of patients, respectively, in remission at treatment month 12. These findings are consistent with clinical trial data and support the long-term benefit-risk profile of vedolizumab.
| S-EPMC6132930 | biostudies-literature
Project description:ObjectivesIn this study, we aimed to investigate vaccine effectiveness (VE) against SARS-CoV-2 infections among adolescents aged 12 to 17 years in Malaysia and examine potential VE differences after full vaccination.MethodsWe consolidated data on COVID-19 testing, vaccination, and outcomes for all public school-going adolescents in Malaysia from September 1, 2021, to December 31, 2021, and estimated the VE against SARS-CoV-2 infections during this period. Cases were defined as positive tests, either by reverse transcriptase- PCR (RT-PCR) or rapid antigen (RTK-Ag) testing, while controls were negative tests. Secondarily, we restricted the analysis to all tests performed in December 2021 and compared VE by month of full vaccination.ResultsA total of 175,880 eligible tests (53.4% or 93,995 RT-PCR tests) were included. After full vaccination with BNT162b2, VE against SARS-CoV-2 infections was 65.7% (95% confidence interval [CI] 64.4, 66.9) over the study period. When restricted to tests in December 2021, VEs for those fully vaccinated in September 2021, October 2021, and November 2021 were comparable (60.6% [95% CI 23.7, 81.5], 56.9% [95% CI 51.1, 62.0], and 65.7% [95% CI 59.8, 70.7] respectively).ConclusionsAmong adolescents, full vaccination with BNT162b2 offered considerable protection against SARS-CoV-2 infections over at least three months without substantial evidence of waning.
| S-EPMC9055416 | biostudies-literature
Project description:The SARS-CoV-2 Omicron variant has demonstrated enhanced transmissibility and escape of vaccine-derived immunity. Although first-generation vaccines remain effective against severe disease and death, robust evidence on vaccine effectiveness (VE) against all Omicron infections, irrespective of symptoms, remains sparse. We used a community-wide serosurvey with 5,310 subjects to estimate how vaccination histories modulated risk of infection in infection-naive Hong Kong during a large wave of Omicron BA.2 epidemic in January-July 2022. We estimated that Omicron infected 45% (41-48%) of the local population. Three and four doses of BNT162b2 or CoronaVac were effective against Omicron infection 7 days after vaccination (VE of 48% (95% credible interval 34-64%) and 69% (46-98%) for three and four doses of BNT162b2, respectively; VE of 30% (1-66%) and 56% (6-97%) for three and four doses of CoronaVac, respectively). At 100 days after immunization, VE waned to 26% (7-41%) and 35% (10-71%) for three and four doses of BNT162b2, and to 6% (0-29%) and 11% (0-54%) for three and four doses of CoronaVac. The rapid waning of VE against infection conferred by first-generation vaccines and an increasingly complex viral evolutionary landscape highlight the necessity for rapidly deploying updated vaccines followed by vigilant monitoring of VE.
| S-EPMC9941049 | biostudies-literature
Project description:BACKGROUND:The promise of real-world evidence (RWE) is especially relevant to pediatrics, where medicines prescribed for children are often used without evidence derived from randomized clinical trials. OBJECTIVES:The aim of this systematic review was to describe the state of RWE in pediatrics by identifying observational studies published during 2016 that used RWE to assess medication safety or effectiveness in children. METHODS:An electronic search of PubMed was combined with an extended search of references within systematic reviews and expert suggestions. Studies were included if they reported on an infant or child under 18 years with exposure to medications; assessed safety or effectiveness; specified a comparison or control group, and were published in English in 2016. Data extraction was conducted by one team member using a standardized form and reviewed by a second team member. Study quality was assessed using the GRACE checklist for rating the quality of observational studies. RESULTS:After removing duplicates, 915 citations were screened and 29 studies met the eligibility criteria. Most of the eligible studies relied on primary data collection or chart review at a single institution and did not use the growing number of administrative or electronic health record databases available. One-quarter of the studies did not use well-established statistical methods to control for confounders. No single disease group or medication predominated, and age groups ranged from infants to adolescents. CONCLUSIONS:A small body of observational studies published in 2016 were categorized by the study team as using real-world data to assess medication safety or effectiveness in children. Studies varied in age groups, diseases or conditions, and methods, and may not have fully met the FDA definition of RWE. Our review indicates that the use of RWE is not fully developed in pediatrics, and suggests an opportunity to further develop capabilities and more fully leverage administrative and electronic health record databases to study medication safety and effectiveness in children. Our systematic review appears generalizable to pediatrics broadly, and documents that the high level of activity in RWE in general has had less of an impact on pediatrics.
| S-EPMC7221095 | biostudies-literature