scholarly journals Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities

Pharmaceutics ◽  
2013 ◽  
Vol 5 (4) ◽  
pp. 168-178 ◽  
Author(s):  
Robert Davis
Keyword(s):  
Vaccine Safety ◽  
Lessons Learned ◽  
Surveillance Systems ◽  
Critical Elements ◽  
Safety Surveillance ◽  
The Us

scholarly journals Active vaccine safety surveillance via a scalable, integrated system in Australian pharmacies.

2020 ◽  
Author(s):  
Sandra M Salter ◽  
Gurkamal Singh ◽  
Lisa Nissen ◽  
Kevin Trentino ◽  
Kevin Murray ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Active Surveillance ◽  
Odds Ratio ◽  
Surveillance System ◽  
Adjusted Odds Ratio ◽  
Vaccine Safety ◽  
Integrated System ◽  
Surveillance Systems ◽  
Participant Engagement ◽  
Safety Surveillance

ABSTRACT Introduction: Active vaccine safety surveillance will be critical to COVID-19 vaccine deployment. Pharmacists have been identified as potential immunisers in COVID-19 policies, yet there are no reported active surveillance systems operating in pharmacies. We integrated an established participant-centred active vaccine safety surveillance system with a cloud-based pharmacy immunisation-recording program. We measured adverse events following immunisation (AEFI) reported via the new surveillance system in pharmacies, and compared these to AEFI reported via an existing surveillance system in non-pharmacy sites (general practice and other clinics). Methods: A prospective cohort study of individuals>10 years receiving influenza immunisations from 22 pharmacies and 90 non-pharmacy sites between March and October, 2020, in Australia. Active surveillance was conducted using SMS and smartphone technology, via an opt-out system. Multivariable logistic regression (including a subgroup analysis of participants over 65 years) was used to assess differences in proportions of AEFI between participants immunised in pharmacies compared to non-pharmacy sites, adjusting for confounders of age, sex, and influenza vaccine brand. Results: Of 101,440 influenza immunisation participants (6,992 from pharmacies; 94,448 from non-pharmacy sites), 77,498 (76.4%) responded; 96.1% (n=74,448) within 24 hours. Overall, 4.8% (n=247) pharmacy participants reported an AEFI, compared with 6.0% (n=4,356) non-pharmacy participants (adjusted odds ratio: 0.87; 95% confidence interval: 0.76 to 0.99; p=0.039). Similar proportions of AEFIs were reported in pharmacy (5.8%; n=31) and non-pharmacy participants (6.0; n=1617) aged over 65 years (adjusted odds ratio: 0.94, 95% confidence interval: 0.65 to 1.35; p=0.725). Conclusion: High and rapid response rates demonstrate good participant engagement with active surveillance in both pharmacy and non-pharmacy participants. Significantly fewer AEFIs reported after pharmacist immunisations compared to non-pharmacy immunisations, with no difference in older adults, suggests different cohorts attend pharmacy and non-pharmacy immunisers. The integrated pharmacy system is rapidly scalable across Australia with global potential.

scholarly journals A Case History in Cooperative Biological Research: Compendium of Studies and Program Analyses in Kazakhstan

2019 ◽  
Vol 4 (4) ◽  
pp. 136
Author(s):  
Yeh ◽  
Parekh ◽  
Musralina ◽  
Sansyzbai ◽  
Tabynov ◽  
...  
Keyword(s):  
Disease Outbreaks ◽  
The United States ◽  
Lessons Learned ◽  
Biological Weapons ◽  
Biological Research ◽  
Future Research ◽  
Surveillance Systems ◽  
Infectious Disease Outbreaks ◽  
The Us ◽  
Funding Opportunities

Kazakhstan and the United States have partnered since 2003 to counter the proliferation of weapons of mass destruction. The US Department of Defense (US DoD) has funded threat reduction programs to eliminate biological weapons, secure material in repositories that could be targeted for theft, and enhance surveillance systems to monitor infectious disease outbreaks that would affect national security. The cooperative biological research (CBR) program of the US DoD’s Biological Threat Reduction Program has provided financing, mentorship, infrastructure, and biologic research support to Kazakhstani scientists and research institutes since 2005. The objective of this paper is to provide a historical perspective for the CBR involvement in Kazakhstan, including project chronology, successes and challenges to allow lessons learned to be applied to future CBR endeavors. A project compendium from open source data and interviews with partner country Kazakhstani participants, project collaborators, and stakeholders was developed utilizing studies from 2004 to the present. An earlier project map was used as a basis to determine project linkages and continuations during the evolution of the CBR program. It was determined that consistent and effective networking increases the chances to collaborate especially for competitive funding opportunities. Overall, the CBR program has increased scientific capabilities in Kazakhstan while reducing their risk of biological threats. However, there is still need for increased scientific transparency and an overall strategy to develop a capability-based model to better enhance and sustain future research. Finally, we offer a living perspective that can be applied to further link related studies especially those related to One Health and zoonoses and the assessment of similar capability-building programs.

scholarly journals Postapproval Vaccine Safety Surveillance for COVID-19 Vaccines in the US

JAMA ◽  
2020 ◽  
Vol 324 (19) ◽  
pp. 1937
Author(s):  
Grace M. Lee ◽  
José R. Romero ◽  
Beth P. Bell
Keyword(s):  
Vaccine Safety ◽  
Safety Surveillance ◽  
The Us

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 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 Faster than warp speed: early attention to COVD-19 by anti-vaccine groups on Facebook

2021 ◽  
Author(s):  
Seth C Kalichman ◽  
Lisa A Eaton ◽  
Valerie A Earnshaw ◽  
Natalie Brousseau
Keyword(s):  
Social Media ◽  
Vaccine Development ◽  
Rapid Development ◽  
Development Program ◽  
Vaccine Safety ◽  
Vaccine Hesitancy ◽  
Conspiracy Theories ◽  
The Us ◽  
Us Government ◽  
Vaccine Information

Abstract Background The unprecedented rapid development of COVID-19 vaccines has faced SARS-CoV- (COVID-19) vaccine hesitancy, which is partially fueled by the misinformation and conspiracy theories propagated by anti-vaccine groups on social media. Research is needed to better understand the early COVID-19 anti-vaccine activities on social media. Methods This study chronicles the social media posts concerning COVID-19 and COVID-19 vaccines by leading anti-vaccine groups (Dr Tenpenny on Vaccines, the National Vaccine Information Center [NVIC] the Vaccination Information Network [VINE]) and Vaccine Machine in the early months of the COVID-19 pandemic (February–May 2020). Results Analysis of 2060 Facebook posts showed that anti-vaccine groups were discussing COVID-19 in the first week of February 2020 and were specifically discussing COVID-19 vaccines by mid-February 2020. COVID-19 posts by NVIC were more widely disseminated and showed greater influence than non-COVID-19 posts. Early COVID-19 posts concerned mistrust of vaccine safety and conspiracy theories. Conclusion Major anti-vaccine groups were sowing seeds of doubt on Facebook weeks before the US government launched its vaccine development program ‘Operation Warp Speed’. Early anti-vaccine misinformation campaigns outpaced public health messaging and hampered the rollout of COVID-19 vaccines.

scholarly journals Psychodynamics of imagination failures: Reflections on the 20th anniversary of 9/11

2021 ◽  
pp. 135050762110097
Author(s):  
Amy L Fraher
Keyword(s):  
Lessons Learned ◽  
Macro Level ◽  
Future Research ◽  
September 11Th ◽  
Empire Building ◽  
Public Inquiry ◽  
The Us ◽  
New Type ◽  
20Th Anniversary ◽  
Psychodynamic Understanding

This article aims to advance the psychodynamic understanding of imagination failures by studying lessons learned in the US government’s public inquiry into September 11th, 2001 (9/11). Analyzing the findings of The 9/11 Report, I theorize that two forms of macro-level hubris—America’s “hubris of empire-building” and Al Qaeda’s “hubris-nemesis complex”—amalgamated in a uniquely generative manner leading to events on 9/11. Previous studies of public inquiries often demonstrate that inquiry reports are monological story-telling performances used to create sense-making narratives that function hegemonically to impose a simplified version of reality to assign blame and depoliticize events in order to facilitate closure after shocking events. In contrast, findings here suggest that by constructing a critical narrative, The 9/11 Report may serve as a new type of public inquiry report that invites learning about the complex factors that underpin crisis. The article concludes by identifying fruitful areas of future research and ways to theorize further about the collective psychodynamics of macro-level hubris and the psychodynamic factors that hinder learning and contribute to imagination failures.

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
Sign in / Sign up

Export Citation Format

Share Document