scholarly journals An Overview of COVID-19 Vaccine Safety and Post-marketing Surveillance Systems

2021 ◽  
Vol 12 (4) ◽  
pp. 8
Author(s):  
Manal Mohammed Younus ◽  
Ali Azeez Al-Jumaili
Keyword(s):  
Safety Monitoring ◽  
Vaccine Safety ◽  
Lessons Learned ◽  
Surveillance Systems ◽  
Real World Data ◽  
Post Marketing Surveillance ◽  
The World ◽  
Post Marketing ◽  
Data Surveillance ◽  
Tools And Methods

The need for the safety monitoring of the COVID-19 vaccine is unprecedented. It is an ongoing process starting from different phases of clinical trials and continued to post-marketing to tackle the emergency used authorized COVID-19 vaccines across the world. Rapid detection, exchange, prioritization, and assessment of safety signals based on available real-world data, surveillance of Adverse events following immunization (AEFI), and adverse event of special interest (AESI) by studying the observed/expected cases. Enhanced collaboration, and availability of resources, tools, and methods will add to the lessons learned from previous experiences.

scholarly journals Case Report: ANCA-Associated Vasculitis Presenting With Rhabdomyolysis and Pauci-Immune Crescentic Glomerulonephritis After Pfizer-BioNTech COVID-19 mRNA Vaccination

2021 ◽  
Vol 12 ◽  
Author(s):  
Samy Hakroush ◽  
Björn Tampe
Keyword(s):  
Crescentic Glomerulonephritis ◽  
Current Knowledge ◽  
Herd Immunity ◽  
Disease Outbreaks ◽  
Vaccine Safety ◽  
Surveillance Systems ◽  
Vaccination Programs ◽  
Anca Associated Vasculitis ◽  
Post Marketing Surveillance ◽  
Post Marketing

As the coronavirus disease 2019 (COVID-19) pandemic is ongoing and new variants of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) are emerging, there is an urgent need for COVID-19 vaccines to control disease outbreaks by herd immunity. Surveillance of rare safety issues related to these vaccines is progressing, since more granular data emerge with regard to adverse events of COVID-19 vaccines during post-marketing surveillance. Interestingly, four cases of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) presenting with pauci-immune crescentic glomerulonephritis (GN) after COVID-19 mRNA vaccination have already been reported. We here expand our current knowledge of this rare but important association and report a case of AAV presenting with massive rhabdomyolysis and pauci-immune crescentic GN after Pfizer-BioNTech COVID-19 mRNA vaccination. As huge vaccination programs are ongoing worldwide, post-marketing surveillance systems must continue to assess vaccine safety important for the detection of any events associated with COVID-19 vaccination. This is especially relevant in complex diseases where diagnosis is often challenging, as in our patient with AAV presenting with massive rhabdomyolysis and pauci-immune crescentic GN.

Current status and future directions of post-marketing vaccine safety monitoring with focus on USA and Europe

Biologicals ◽  
2012 ◽  
Vol 40 (5) ◽  
pp. 393-397 ◽  
Author(s):  
Jan Bonhoeffer ◽  
Steve Black ◽  
Hector Izurieta ◽  
Patrick Zuber ◽  
Miriam Sturkenboom
Keyword(s):  
Safety Monitoring ◽  
Vaccine Safety ◽  
Current Status ◽  
Future Directions ◽  
Post Marketing

Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China

Vaccine ◽  
2014 ◽  
Vol 32 (44) ◽  
pp. 5875-5879 ◽  
Author(s):  
Yali Wang ◽  
Duo Dong ◽  
Gang Cheng ◽  
Shuyan Zuo ◽  
Dawei Liu ◽  
...  
Keyword(s):  
Japanese Encephalitis ◽  
Vaccine Safety ◽  
Japanese Encephalitis Vaccine ◽  
Post Marketing Surveillance ◽  
Post Marketing

The method to detect the adverse drug events through the chronological relationship between the medication period and the presence of adverse reactions from electronic medical record systems. (Preprint)

2021 ◽  
Author(s):  
Kei Teramoto ◽  
Toshihiro Takeda ◽  
Naoki Mihara ◽  
Yoshie Shimai ◽  
Shirou Manabe ◽  
...  
Keyword(s):  
Medical Records ◽  
Adverse Reactions ◽  
Adverse Drug Events ◽  
Assessment Method ◽  
Medication History ◽  
Real World Data ◽  
Drug Induced ◽  
Drug Induced Liver Injury ◽  
Post Marketing Surveillance ◽  
Post Marketing

BACKGROUND Taking medicine may cause a variety of adverse reactions. An enormous amount of money and effort are spent investigating adverse drug events (ADEs) in clinical trials and post-marketing surveillance. Real world data from multiple electronic medical records (EMRs) can make it easy to understand the ADEs that occur in actual patients. OBJECTIVE In this study, we generated a database of the patients’ medication history from the records of physician orders of EMR, which allowed the period of medication to be clearly identified. METHODS We developed the method to detect the ADE based on the chronological relationship between the presence of the adverse event and the medication period. To verify our method, we detected the ADE with alanine aminotransferase (ALT) elevation for aspirin, clopidogrel and ticlopidine. The accuracy of detecting ADE were examined by chart review and by the comparison with Roussel Uclaf Causality Assessment Method (RUCAM) which was known as standard method for detecting drug induced liver injury. RESULTS The calculated rates of ADE with ALT elevation for aspirin, clopidogrel and ticlopidine were 3.33%, 3.70% and 5.69%, respectively, which were in line with the rates of previous reports. We reviewed the medical records of the patients in whom ADE were detected. Our method accurately predicted ADE in 90%, 100% and 100%, of patients with ALT elevation from aspirin, clopidogrel, and ticlopidine, respectively. With the comparison of the RUCAM, only 3 patients were not detected as ADE by our method. CONCLUSIONS These findings demonstrate that the present method is effective for detecting ADE from EMR data.

Treatment status and safety of crizotinib in 2028 Japanese patients with ALK-positive NSCLC in clinical settings

2019 ◽  
Vol 49 (7) ◽  
pp. 676-686 ◽  
Author(s):  
Naomi Ueno ◽  
Shigeo Banno ◽  
Yutaka Endo ◽  
Motoko Tamura ◽  
Katsuko Sugaya ◽  
...  
Keyword(s):  
Japanese Patients ◽  
Real World Data ◽  
Anaplastic Lymphoma ◽  
Treatment Status ◽  
Post Marketing Surveillance ◽  
The Status ◽  
Post Marketing ◽  
Alk Positive ◽  
Almost All ◽  
Ecog Ps

AbstractObjectivePost-marketing surveillance (PMS) was performed in Japan to obtain information on the safety and efficacy of crizotinib.MethodsTarget patients included almost all patients with anaplastic lymphoma kinase-positive non-small cell lung cancer who were administered crizotinib. The observation period was 52 weeks. In the present study, we focused on the treatment status and safety of crizotinib therapy and analyzed the real-world data obtained by this PMS (ClinicalTrials.gov: NCT01597258).ResultsThe safety analysis set included 2028 Japanese patients, and more than half of the patients (56.4%) were nonsmokers. The incidence of adverse drug reactions (ADRs) was 91.6%, and common ADRs (incidence ≥15%) were nausea (32.2%), diarrhea (24.3%), photopsia (18.9%), vomiting (17.5%) and dysgeusia (16.8%). Many patients (623 patients) discontinued treatment of crizotinib because of adverse events within 12 weeks after therapy initiation, which tended to frequently occur in the following cases: (1) elderly, (2) body weight <40 kg, (3) body surface area <1.2 m2 (4) ECOG PS 2–4, (5) higher Brinkman index and (6) history of occupational/environmental exposure such as asbestos/pneumoconiosis. The proportions of patients remaining on crizotinib therapy were 68.2% for 3 months, 55.2% for 6 months and 36.1% for 12 months, with a median duration of 7.9 months. Multivariate analysis with a Cox proportional hazard model identified 10 statistically significant patient background factors influencing the duration of crizotinib therapy.ConclusionsNo new safety concerns were observed in this PMS study. Our results provide useful information regarding the status of crizotinib therapy in the clinical setting.

scholarly journals Safety Profile of Biologics Used in Rheumatology: An Italian Prospective Pharmacovigilance Study

2020 ◽  
Vol 9 (4) ◽  
pp. 1227 ◽  
Author(s):  
Maria Antonietta Barbieri ◽  
Giuseppe Cicala ◽  
Paola Maria Cutroneo ◽  
Elisabetta Gerratana ◽  
Caterina Palleria ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Inflammatory Arthritis ◽  
Gastrointestinal Disease ◽  
Risk Profile ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Real World Data ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Disease Modifying

Post-marketing surveillance activities are essential to detect the risk/benefit profile of biologic disease-modifying antirheumatic drugs (bDMARDs) in inflammatory arthritis. The aim of this study was to evaluate adverse events (AEs) in patients treated with bDMARDs in rheumatology during a prospective pharmacovigilance study from 2016 to 2018. Descriptive statistical analyses were performed to evaluate bDMARDs-related variables of patients without AEs/failures vs patients with AEs and failures. The risk profile among biologics was assessed by comparing patients treated with each bDMARD to patients treated with etanercept. A total of 1155 patients were enrolled, mostly affected by rheumatoid arthritis (46.0%). AEs and failures were experienced by 8.7% and 23.3%, respectively. The number of comorbidities significantly influenced the onset of AEs, while anxiety-depressive, gastrointestinal disease, and fibromyalgia influenced onset of failures. The probability of developing an AE was significantly lower in patients treated with secukinumab, while the probability of developing treatment failure was significantly lower in patients treated with golimumab, secukinumab and tocilizumab. A total of 216 AEs were reported (25.5% serious), mostly regarding infections (21.8%), musculoskeletal (17.6%) and skin (16.2%) disorders. Serious AEs included neutropenia (12.7%), lymphocytosis (9.1%) and uveitis (7.3%). The obtained results revealed known AEs but real-world data should be endorsed for undetected safety concerns.

scholarly journals Thrombotic events and COVID-19 vaccines

2021 ◽  
Vol 25 (9) ◽  
pp. 701-707
Author(s):  
C. Brazete ◽  
A. Aguiar ◽  
I. Furtado ◽  
R. Duarte
Keyword(s):  
Immune Thrombocytopenia ◽  
Large Scale ◽  
Viral Vector ◽  
Vaccine Safety ◽  
Severe Thrombocytopenia ◽  
The European Union ◽  
Vein Thrombosis ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Vaccination Campaigns

COVID-19 vaccines are considered promising agents in the control of the pandemic. Although their safety was assessed in randomised clinical trials, severe adverse events (AEs) have been reported after large-scale administration. This study aims to evaluate thromboembolic AEs reported after vaccination in a real-world context and how they led to the interruption of vaccination campaigns. We also review the benefits and risks of the vaccines approved in the European Union and provide recommendations. A review of the literature was performed using Medline/PubMed electronic database as well as institutional and pharmacovigilance official reports. Our findings show that vaccine-induced prothrombotic immune thrombocytopenia has been suggested as a very rare AE associated with viral vector vaccines. Unusual thrombotic events combined with moderate-to-severe thrombocytopenia were reported mainly in women under 60 years of age. As safety signals emerged, Vaxzevria and Janssen´s COVID-19 vaccine campaigns have been paused while investigations proceed. On the other hand, the number of deep vein thrombosis and pulmonary embolism reports have not increased. Post-marketing surveillance indicated that mRNA vaccines are safe and should continue to be used. The thrombotic events report rate is not increased in people over 60 years. As they are at greater risk for COVID-19 complications and death, no vaccine restrictions are recommended in this group. Risk factors for vaccine-induced prothrombotic immune thrombocytopenia should be established so that evidence-based decisions can be made. Systematic monitoring of COVID-19 vaccine safety is essential to ensure that the benefits of vaccination outweigh the risks.

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