scholarly journals Exact sequential test for clinical trials and post‐market drug and vaccine safety surveillance with Poisson and binary data

2021 ◽  
Author(s):  
Ivair R. Silva ◽  
Judith Maro ◽  
Martin Kulldorff
Keyword(s):  
Clinical Trials ◽  
Binary Data ◽  
Vaccine Safety ◽  
Sequential Test ◽  
Safety Surveillance ◽  
Post Market

scholarly journals Active Vaccine Safety Surveillance: Global Trends and Challenges in China

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Zhike Liu ◽  
Ruogu Meng ◽  
Yu Yang ◽  
Keli Li ◽  
Zundong Yin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Active Surveillance ◽  
Vaccine Safety ◽  
Population Based ◽  
Vaccine Hesitancy ◽  
Great Success ◽  
Surveillance Systems ◽  
Global Trends ◽  
Safety Concerns ◽  
Safety Surveillance

Importance. The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns. This has caused vaccine hesitancy to be the top 10 in threats to global health. The comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval surveillance. It has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical trials. Highlights. In the present study, the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety concerns. Then, the global progress of active surveillance systems was reviewed, mainly focusing on population-based or hospital-based active surveillance. With these successful paradigms, the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases, methodology challenges, policy supports, and ethical considerations. Conclusion. In the inevitable trend of the global vaccine safety ecosystem, the establishment of an active surveillance system for vaccine safety in China is urgent and feasible. This process can be accelerated with the consensus and cooperation of regulatory departments, research institutions, and data owners.

scholarly journals Informing selection of drugs for COVID-19 treatment through adverse events analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Wenjing Guo ◽  
Bohu Pan ◽  
Sugunadevi Sakkiah ◽  
Zuowei Ji ◽  
Gokhan Yavas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Safety Concern ◽  
Clinical Practices ◽  
Safety Concerns ◽  
Post Market ◽  
Z Scores ◽  
Favorable Safety ◽  
Effective Drugs ◽  
Selection Of

AbstractCoronavirus disease 2019 (COVID-19) is an ongoing pandemic and there is an urgent need for safe and effective drugs for COVID-19 treatment. Since developing a new drug is time consuming, many approved or investigational drugs have been repurposed for COVID-19 treatment in clinical trials. Therefore, selection of safe drugs for COVID-19 patients is vital for combating this pandemic. Our goal was to evaluate the safety concerns of drugs by analyzing adverse events reported in post-market surveillance. We collected 296 drugs that have been evaluated in clinical trials for COVID-19 and identified 28,597,464 associated adverse events at the system organ classes (SOCs) level in the FDA adverse events report systems (FAERS). We calculated Z-scores of SOCs that statistically quantify the relative frequency of adverse events of drugs in FAERS to quantitatively measure safety concerns for the drugs. Analyzing the Z-scores revealed that these drugs are associated with different significantly frequent adverse events. Our results suggest that this safety concern metric may serve as a tool to inform selection of drugs with favorable safety profiles for COVID-19 patients in clinical practices. Caution is advised when administering drugs with high Z-scores to patients who are vulnerable to associated adverse events.

scholarly journals Recombinant Zoster Vaccine (Shingrix) real-world effectiveness in the first two years post-licensure

2021 ◽  
Author(s):  
Hector S Izurieta ◽  
Xiyuan Wu ◽  
Richard Forshee ◽  
Yun Lu ◽  
Heng-Ming Sung ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Herpes Zoster ◽  
Real World ◽  
Postherpetic Neuralgia ◽  
Vaccine Effectiveness ◽  
Community Dwelling ◽  
Zoster Vaccine ◽  
Post Market ◽  
Recombinant Zoster Vaccine ◽  
Dose Vaccine

Abstract Background Shingrix™ (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as two doses given 2–6 months apart, among adults ages ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster,but post-market vaccine performance has not been evaluated. Efficacy of a single dose, delayed second dose, or among persons with autoimmune or general immunosuppressive conditions have also not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix. Methods We conducted a cohort study among vaccinated and unvaccinated Medicare Part D community dwelling beneficiaries ages >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance, and marginal structural models to estimate hazard ratios. Results We found a vaccine effectiveness of 70.1% (95% CI, 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for two and one doses, respectively. The two-dose vaccine effectiveness was not significantly lower for beneficiaries 80+ years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4-81.8). Conclusions This large real-world observational study of effectiveness of Shingrix demonstrates the benefit of completing the two-dose regimen. Second doses administered beyond the recommended 6 months did not impair vaccine effectiveness.Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.

Myocarditis after Smallpox/Vaccinia Immunization: Passive Vaccine Safety Surveillance Compared to Prospective Studies

2009 ◽  
Vol 123 (2) ◽  
pp. S264-S264 ◽  
Author(s):  
R.J.M. Engler ◽  
L.C. Collins ◽  
B.T. Gibbs ◽  
B.A. Hemann ◽  
D.G. Gates ◽  
...  
Keyword(s):  
Prospective Studies ◽  
Vaccine Safety ◽  
Safety Surveillance

scholarly journals SARS-CoV-2 mass vaccination: Urgent questions on vaccine safety that demand answers from international health agencies, regulatory authorities, governments and vaccine developers                  

2021 ◽  
Author(s):  
Roxana Bruno ◽  
Peter A Mccullough ◽  
Teresa Forcades I Vila ◽  
Alexandra Henrion-Caude ◽  
Teresa García-Gasca ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Risk Mitigation ◽  
Safety Data ◽  
Vaccine Safety ◽  
Endothelial Damage ◽  
Mass Vaccination ◽  
High Rate ◽  
Public Confidence ◽  
World Population

Since the start of the COVID-19 outbreak, the race for testing new platforms designed to confer immunity against SARS-CoV-2, has been rampant and unprecedented, leading to conditional emergency authorization of various vaccines. Despite progress on early multidrug therapy for COVID-19 patients, the current mandate is to immunize the world population as quickly as possible. The lack of thorough testing in animals prior to clinical trials, and authorization based on safety data generated during trials that lasted less than 3.5 months, raise questions regarding vaccine safety. The recently identified role of SARS-CoV-2 Spike glycoprotein for inducing endothelial damage characteristic of COVID-19, even in absence of infection, is extremely relevant given that most of the authorized vaccines induce endogenous production of Spike. Given the high rate of occurrence of adverse effects that have been reported to date, as well as the potential for vaccine-driven disease enhancement, Th2-immunopathology, autoimmunity, and immune evasion, there is a need for a better understanding of the benefits and risks of mass vaccination, particularly in groups excluded from clinical trials. Despite calls for caution, the risks of SARS-CoV-2 vaccination have been minimized or ignored by health organizations and government authorities. As for any investigational biomedical program, data safety monitoring boards (DSMB) and event adjudication committees (EAC), should be enacting risk mitigation. If DSMBs and EACs do not do so, we will call for a pause in mass vaccination. If DSMBs and EACs do not exist, then vaccination should be halted immediately, in particular for demographic groups at highest risk of vaccine-associated death or serious adverse effects, during such time as it takes to assemble these boards and commence critical and independent assessments. We urge for pluralistic dialogue in the context of health policies, emphasizing critical questions that require urgent answers, particularly if we wish to avoid a global erosion of public confidence in science and public health.

A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation

2010 ◽  
Vol 1 (1) ◽  
pp. 93-106 ◽  
Author(s):  
T. Tompkins ◽  
X. Xu ◽  
J. Ahmarani
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Clinical Findings ◽  
Chronic Diarrhoea ◽  
Helicobacter Pylori Eradication ◽  
Asian Populations ◽  
Post Market ◽  
Improve Compliance ◽  
Irritable Bowel ◽  
Study Designs

Probiotics as dietary supplements have been readily accepted by Asian populations. Use of certain probiotic preparations is widespread and the number of clinical trials undertaken with such products is unparalleled in western scientific literature. One such preparation, containing a combination of Enterococcus faecium R0026 and Bacillus subtilis R0179, has 23 publications on post-market clinical studies involving over 1,800 adults. The majority of these publications are printed in Chinese and Korean journals. This review examines the clinical findings with this probiotic combination. As mono-therapy, it has been used to overcome symptoms associated with chronic diarrhoea and irritable bowel syndrome. It has been used as co-adjuvant therapy with sulfasalazine and mesalazine to improve remission times in mild to moderate Ulcerative Colitis and to improve compliance with conventional triple therapy for Helicobacter pylori eradication. While the much of the data is preliminary and the study designs require refinement, the contribution of these trials should not be ignored. The information derived in this review will provide practitioners with practical information on appropriate applications for probiotic supplements, expected outcomes, dosing regimes, safety and reported adverse events. Furthermore, identification of problems in these trials should help researchers design better clinical trials when investigating probiotic products.

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