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
2021 ◽  
Vol 12 (4) ◽  
pp. 8
Author(s):  
Manal Mohammed Younus ◽  
Ali Azeez Al-Jumaili

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.


2016 ◽  
Vol 17 (8) ◽  
pp. 755-762 ◽  
Author(s):  
Xu Zhou ◽  
Renhe Liu ◽  
Shuo Qin ◽  
Ruilian Yu ◽  
Yao Fu

2020 ◽  
Vol 11 ◽  
Author(s):  
Nathaniel Edward Bennett Saidu ◽  
Chiara Bonini ◽  
Anne Dickinson ◽  
Magdalena Grce ◽  
Marit Inngjerdingen ◽  
...  

2021 ◽  
Author(s):  
Haoru Dong ◽  
Xinhua Shu ◽  
Qiang Xu ◽  
Chen Zhu ◽  
Andreas M. Kaufmann ◽  
...  

AbstractHuman papillomavirus (HPV) infection identified as a definitive human carcinogen is increasingly being recognized for its role in carcinogenesis of human cancers. Up to 38%–80% of head and neck squamous cell carcinoma (HNSCC) in oropharyngeal location (OPSCC) and nearly all cervical cancers contain the HPV genome which is implicated in causing cancer through its oncoproteins E6 and E7. Given by the biologically distinct HPV-related OPSCC and a more favorable prognosis compared to HPV-negative tumors, clinical trials on de-escalation treatment strategies for these patients have been studied. It is therefore raised the questions for the patient stratification if treatment de-escalation is feasible. Moreover, understanding the crosstalk of HPV-mediated malignancy and immunity with clinical insights from the proportional response rate to immune checkpoint blockade treatments in patients with HNSCC is of importance to substantially improve the treatment efficacy. This review discusses the biology of HPV-related HNSCC as well as successful clinically findings with promising candidates in the pipeline for future directions. With the advent of various sequencing technologies, further biomolecules associated with HPV-related HNSCC progression are currently being identified to be used as potential biomarkers or targets for clinical decisions throughout the continuum of cancer care.


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