scholarly journals Vaccine safety surveillance across the globe with a focus on the COVID-19 vaccines

2021 ◽  
Vol 2 (3) ◽  
pp. 1-3
Author(s):  
Arunima Sen
Keyword(s):  
Side Effects ◽  
Best Practices ◽  
Adverse Events ◽  
Vaccine Safety ◽  
Development Stage ◽  
Clinical Development ◽  
Healthy Population ◽  
Global Collaboration ◽  
New Drug ◽  
Safety Surveillance

Taking a bird's eye's view across the globe to understand the different methods to look at vaccine safety surveillance, one thing becomes clear. The commitment to monitor the safety of a vaccine does not stop at the clinical development stage. Rather, awareness, reporting, and research need to be bolstered after the vast population gets exposed to the vaccine. Global collaboration, understanding, and embracing the global best practices will go a long way to ensure safer vaccinations. With the COVID-19 pandemic already creating havoc in minds of all, the panic or unacceptance about the vaccination side effects in the population is undesirable.  Adverse events are the unfortunate yet unavoidable element in the journey of a new drug or a vaccine. But since it is a healthy population who are recipients of vaccines, the researchers and PV professionals need to be more mindful of the risk-benefit profile of the vaccine.

scholarly journals Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

2015 ◽  
Vol 20 (43) ◽  
Author(s):  
Alexis Pillsbury ◽  
Patrick Cashman ◽  
Alan Leeb ◽  
Annette Regan ◽  
Darren Westphal ◽  
...  
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Real Time ◽  
Surveillance System ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Influenza Vaccines ◽  
Safety Surveillance ◽  
Medical Attendance

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination.

scholarly journals Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031851 ◽  
Author(s):  
Peter Jacoby ◽  
Catherine Glover ◽  
Chloe Damon ◽  
Parveen Fathima ◽  
Alexis Pillsbury ◽  
...  
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Influenza Vaccination ◽  
Vaccination Programme ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Public Confidence ◽  
Safety Signal ◽  
Seasonal Influenza Vaccination ◽  
Safety Surveillance

ObjectivesTo determine how soon after commencement of the seasonal influenza vaccination programme, the AusVaxSafety active vaccine safety surveillance system, currently in use across Australia, would have detected a safety signal had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies).DesignSimulation study.SettingWestern Australian vaccine influenza coverage and adverse event surveillance data.Outcome measuresSimulated solicited responses from caregivers who would have received an SMS survey about adverse events experienced following seasonal influenza vaccination of their children aged 6 months to <5 years.ParticipantsNone.ResultsWe estimated a >90% probability of a safety signal being detected by AusVaxSafety based on solicited reports for either fever or medical attendance at or before the week ending 28 March 2010, 3 weeks after the start of vaccine distribution. Suspension of the national paediatric influenza vaccination programme as a result of the passive adverse events surveillance operating at the time did not occur until 23 April 2010.ConclusionsActive vaccine safety surveillance leading to rapid detection of a safety signal would likely have resulted in earlier suspension of Fluvax from the vaccination programme, prevention of many febrile convulsions and maintenance of public confidence in influenza vaccination for young children.

scholarly journals Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring

2021 ◽  
Author(s):  
Winston E. Abara ◽  
Julianne Gee ◽  
Yi Mu ◽  
Mark J Delorey ◽  
Tun Ye ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Monitoring ◽  
Vaccine Safety ◽  
Risk Assessments ◽  
Temporal Association ◽  
Safety Signal ◽  
Public Health Communication ◽  
Health Events ◽  
Safety Surveillance ◽  
Adverse Health Events

Background: Knowledge of expected rates of potential adverse events of special interest (AESI) that may occur coincidentally following COVID-19 vaccination is essential for vaccine safety surveillance and assessment. We calculated the expected rates of 21 potential AESI following COVID-19 vaccination among vaccinated persons within 1 day, 7 days, and 42 days of vaccination. Methods: We used meta-analytic methods to estimate background rates of 21 medical conditions considered potential AESI and calculated expected rates of each potential AESI within 1 day, 7 days, and 42 days of vaccination. Results: Background rates of three commonly monitored AESI, Guillain-Barre syndrome (GBS), myopericarditis, and all-cause deaths were 2.0 GBS cases/100,000 person-years, 1.3 myopericarditis cases/100,000 person-years, and 863.8 all-cause deaths/100,000 person-years, respectively. Based on these background rates, if 10,000,000 persons are vaccinated, we would expect 0.5, 3.7, and 22.5 GBS cases; 0.3, 2.4, and 14.3 myopericarditis cases; and 236.5, 1655.5, and 9932.8 all-cause deaths to occur in coincident temporal association (i.e., as a result of background incidence) within 1 day, 7 days, and 42 days of vaccination, respectively. Conclusion: Knowledge of expected rates of potential AESI can help contextualize adverse health events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine public health communication, and inform benefit-risk assessments of COVID-19 vaccines.

scholarly journals Immune Myocarditis Overlapping With Myasthenia Gravis Due to Anti-PD-1 Treatment for a Chordoma Patient: A Case Report and Literature Review

2021 ◽  
Vol 12 ◽  
Author(s):  
Shujing Liang ◽  
Jingxian Yang ◽  
Yun Lin ◽  
Tong Li ◽  
Wenrong Zhao ◽  
...  
Keyword(s):  
Case Report ◽  
Survival Rate ◽  
Side Effects ◽  
Literature Review ◽  
Best Practices ◽  
Adverse Events ◽  
Myasthenia Gravis ◽  
Effective Treatment ◽  
Malignant Tumor ◽  
Clinical Benefit

Immunotherapy begins to be widely used due to the increasing exploration and gratifying effects in multiple cancers. Chordoma, as a rare bone malignant tumor, often recurs and metastasizes after undergoing surgery and radiotherapy. Therefore, immunotherapy can be explored as an emerging, potentially effective treatment to improve the survival rate and clinical benefit of patients. However, a variety of immune-related adverse events (irAEs) cannot be avoided completely. And the immunotherapy-induced myocarditis, as a rare but fatal irAE, has been increasingly reported. Understanding the mechanism involved in irAEs can inform best practices for side effects management. Here, we firstly reported a case of immune myocarditis and subsequent myasthenia gravis (MG) following anti-PD-1 treatment for chordoma.

scholarly journals Use of a new global indicator for vaccine safety surveillance and trends in adverse events following immunization reporting 2000–2015

Vaccine ◽  
2018 ◽  
Vol 36 (12) ◽  
pp. 1577-1582 ◽  
Author(s):  
Jiayao Lei ◽  
Madhava Ram Balakrishnan ◽  
Jane F. Gidudu ◽  
Patrick L.F. Zuber
Keyword(s):  
Adverse Events ◽  
Vaccine Safety ◽  
Safety Surveillance ◽  
Global Indicator

Real-Time Vaccine Safety Surveillance for the Early Detection of Adverse Events

Medical Care ◽  
2007 ◽  
Vol 45 (Suppl 2) ◽  
pp. S89-S95 ◽  
Author(s):  
Tracy A. Lieu ◽  
Martin Kulldorff ◽  
Robert L. Davis ◽  
Edwin M. Lewis ◽  
Eric Weintraub ◽  
...  
Keyword(s):  
Early Detection ◽  
Adverse Events ◽  
Real Time ◽  
Vaccine Safety ◽  
Safety Surveillance

scholarly journals Adverse Events After Pandemic Flu A/H1N1 Vaccination In Children: Concern About Vaccine Safety

2016 ◽  
Vol 26 (5) ◽  
pp. 54-62
Author(s):  
Birutė Strukčinskienė ◽  
Sigitas Griškonis
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Vaccine Safety ◽  
Swine Flu ◽  
Sudden Increase ◽  
Rapid Spread ◽  
Flu Virus ◽  
Pandemic Flu ◽  
And Control ◽  
Vaccination Period

Vaccination is essential tool for the management and control of infectious diseases. However, it can cause adverse events. After novel Pandemic (“swine”) flu virus A H1N1 rapid spread in 2009 all over the world and mass vaccination initiatives, the sudden increase in childhood narcolepsy with cataplexy in some countries has occurred. It stunned medical and public health society, and general population, what increased awareness of recorded side effects and vaccine safety. An integrative review of the literature was conducted and extra search of reports and documents was performed. Despite adverse events were recorded after vaccination against pandemic flu, side effects bear very small proportion of all vaccinated. Vaccination against swine flu can cause generalized, flu-like, neurological, gastrointestinal, and allergic-type symptoms. A more serious complication, which has been identified, is narcolepsy with cataplexy. The incidence of narcolepsy with cataplexy in children and adolescents in European countries increased during the pandemic and vaccination period. The use of adjuvants has been shown to provoke some adverse events. Vaccination safety remains a priority issue in vaccination science. It is of high importance to devout finances, to form vaccine policy, to coordinate vaccine research, and to promote vaccine investigation, creation, and improvements. Safe vaccination will encourage population and empower societies for wider usage of vaccination as the mean for flu control, especially in children.

Sending out Biased Signals: an Appropriate Proposition for Pain?

2019 ◽  
Vol 32 (2) ◽  
pp. 108-110 ◽  
Author(s):  
E. Besserer-Offroy ◽  
P. Sarret
Keyword(s):  
Side Effects ◽  
Acute Pain ◽  
Gold Standard ◽  
Pain Treatment ◽  
Opioid Analgesics ◽  
Mu Opioid Receptor ◽  
Clinical Development ◽  
Mu Opioid ◽  
Development Stages ◽  
The Past

In the past few years, several biased ligands acting at the mu-opioid receptor were reported in the literature. These agonists are aimed at reducing pain while having fewer side effects than morphine, the gold standard of opioid analgesics. In this mini-review, we describe and discuss the recent advances in mu-biased ligands actually in preclinical and clinical development stages, including the latest U.S. Food and Drug Administration review of oliceridine, a biased mu-agonist for moderate to severe acute pain treatment developed by the company Trevena.

Proton Pump Inhibitors in 2021: Pros, Cons, and Everything in Between

2021 ◽  
pp. 263451612110217
Author(s):  
Joshua A. Sloan ◽  
Philip O. Katz
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Adverse Events ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Drug Class ◽  
Life Threatening

The medical and lay literature has exploded with reports of adverse events associated with proton pump inhibitors over the last 10 to 15 years. The dissemination of these reports to patients and clinicians have created substantial concerns regarding what has been an exceptionally valuable drug class, dramatically improving patient quality of life, and in many cases preventing life threatening side effects of other medication. Patients are more frequently seeking to avoid these medications, and practitioners are reducing or discontinuing them to the patient’s detriment due to a misunderstanding of the data. This review will discuss the data regarding the most commonly publicized adverse events and attempt to put them in perspective.

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