scholarly journals 14. Postmarketing Safety Experience With MenACWY-TT

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S131-S131
Author(s):  
Lidia Serra ◽  
Susan Mather ◽  
Cindy Burman ◽  
Chris Webber
Keyword(s):  
Safety Data ◽  
The United States ◽  
System Organ Class ◽  
Vaccination Site ◽  
Safety Database ◽  
Periodic Safety ◽  
Periodic Safety Update Report ◽  
Procedural Complications ◽  
Site Pain ◽  
Effectiveness Data

Abstract Background MenACWY-TT (Nimenrix®), a quadrivalent meningococcal tetanus toxoid conjugate vaccine, was first licensed in 2012 and is available in 82 countries but not in the United States. MenACWY-TT is administered in infants as a 2 + 1 (6 weeks to < 6 months of age) or 1 + 1 (6 to < 12 months of age) schedule with the booster dose at 12 months of age, and from 12 months of age as a single dose. In addition to its widespread use to protect against meningococcal serogroups A, C, W, and Y, MenACWY-TT is a constituent of an investigational pentavalent meningococcal (MenABCWY) vaccine currently undergoing clinical development. Methods Using the MenACWY-TT Periodic Safety Update Report (PSUR) with format and content in accordance with Good Pharmacovigilance Practice Module VII and International Council for Harmonisation Guideline E2C, for data up to April 19, 2020, postmarketing safety experience with MenACWY-TT is considered. The PSUR data included herein are spontaneous adverse events (AEs) from the Pfizer safety database. AEs were coded by system organ class (SOC) and preferred term (PT) using MedDRA v.22.1J. Results The cumulative estimated exposure of MenACWY-TT was nearly 26 million doses, with the majority administered in 0- to 16-year-olds and in the Western European Union (Figure 1). Over the reporting period, 13,301 cumulative AEs occurred. The most common SOCs in the reporting period were general disorders and administration site conditions (n=5169; 39%); nervous system disorders (n=1986; 15%); injury, poisoning and procedural complications (n=1266; 10%); and gastrointestinal disorders (n=1031; 8%) (Figure 2). By PT, the most common AEs were pyrexia (n=1613; 12%), headache (n=738; 6%), and vaccination site pain (n=394; 3%) (Figure 3). Of the 3299 serious AEs reported, the most common were pyrexia (n=317; 10%) and headache (n=209; 6%). Conclusion Based on cumulative safety data in conjunction with existing efficacy and effectiveness data, the benefit-risk profile of MenACWY-TT remains favorable and is consistent with the safety profile of MenACWY-TT established in clinical studies. Disclosures Lidia Serra, MS, Pfizer Inc (Employee, Shareholder) Susan Mather, MD, Pfizer Inc (Employee, Shareholder) Cindy Burman, PharmD, Pfizer Inc (Employee, Shareholder) Chris Webber, MD, Pfizer (Employee, Shareholder)

Power, Conflict, and Effectiveness

2000 ◽  
Vol 5 (1) ◽  
pp. 28-33 ◽  
Author(s):  
M. Afzalur Rahim ◽  
David Antonioni ◽  
Krum Krumov ◽  
Snejana Ilieva
Keyword(s):  
United States ◽  
Regression Analysis ◽  
Interpersonal Conflict ◽  
The United States ◽  
Hierarchical Regression ◽  
Hierarchical Regression Analysis ◽  
Referent Power ◽  
Legitimate Power ◽  
Power Base ◽  
Effectiveness Data

This study investigated the relationships of bases of leader power (coercive, reward, legitimate, expert, and referent) and styles of handling interpersonal conflict (integrating, obliging, dominating, avoiding, and compromising) to subordinates' effectiveness. Data for this study were collected with questionnaires from the United States and Bulgaria and analyzed with hierarchical regression analysis for each country. Results indicated that in the United States referent power base of supervisors and integrating style of handling conflict of subordinates were positively associated with effectiveness. In Bulgaria, legitimate power base of supervisors was positively associated with effectiveness, but the subordinates' conflict styles were not associated with effectiveness.

scholarly journals Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273

2021 ◽  
pp. 089719002110096
Author(s):  
Shyh Poh Teo
Keyword(s):  
Vaccine Development ◽  
Safety Data ◽  
The United States ◽  
Virus Infections ◽  
Phase 3 ◽  
Vaccination Programs ◽  
Safety Surveillance ◽  
Mass Immunization ◽  
United States Food ◽  
States Food

The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer-BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb the pandemic.

DEFINING THE RISK OF RETREATMENT FOR ANEURYSM RECURRENCE OR RESIDUAL AFTER INITIAL TREATMENT BY ENDOVASCULAR COILING

Neurosurgery ◽  
2009 ◽  
Vol 65 (2) ◽  
pp. 311-315 ◽  
Author(s):  
Andrew J. Ringer ◽  
Rafael Rodriguez-Mercado ◽  
Erol Veznedaroglu ◽  
Elad I. Levy ◽  
Ricardo A. Hanel ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Surgical Repair ◽  
The United States ◽  
Patient Treatment ◽  
Endovascular Coiling ◽  
Total Risk ◽  
Clinical Recurrence ◽  
Choice Of Treatment ◽  
Procedural Complications

Abstract OBJECTIVE Endovascular treatment of intracranial aneurysms is less invasive than surgical repair but poses a higher risk for aneurysm recurrence, which may necessitate retreatment, thus adding to the long-term risk. Cerebrovascular neurosurgeons from 8 institutions in the United States and Puerto Rico collaborated to assess the risk of retreatment for residual or recurrent aneurysms after the initial endovascular coiling. METHODS Data were prospectively recorded for 311 patients with coiled intracranial aneurysms who underwent 352 retreatment procedures after angiographic or clinical recurrence (hemorrhage after initial coiling). Results analyzed included procedural complications and procedure-related morbidity. Morbidity was classified as major (modified Rankin scale score > 3) or minor, and temporary (<30 days) or permanent (>30 days). RESULTS Retreatment mortality was 0.85% per procedure and 0.96% per patient. Treatment-related rates were 0.32% per patient (0.28% per procedure) for permanent or temporary major disability; 1.29% for permanent minor disability (1.14% per procedure); and 1.61% for temporary minor disability (1.42% per procedure). Total risk for death or permanent major disability was 1.28% per patient and 1.13% per procedure. CONCLUSION Retreatment poses a low risk for patients with recurrences of intracranial aneurysms after initial coiling; this risk is smaller than that posed by the initial endovascular therapy. The risk of disability associated with retreatment for aneurysm recurrence after coiling must be considered prospectively in the choice of treatment but with the recognition that its effects are low in the overall management risk.

iGlarLixi: A Fixed-Ratio Combination of Insulin Glargine 100 U/mL and Lixisenatide for the Treatment of Type 2 Diabetes

2017 ◽  
Vol 51 (11) ◽  
pp. 990-999 ◽  
Author(s):  
Jennifer Goldman ◽  
Jennifer M. Trujillo
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
English Language ◽  
Data Extraction ◽  
Safety Data ◽  
Fixed Ratio ◽  
Postprandial Glucose ◽  
The United States ◽  
Glucagon Like Peptide 1

Objective: To review the safety and efficacy of iGlarLixi, a titratable fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, a glucagon-like peptide-1 receptor agonist. Data Sources: A literature search of MEDLINE for all English-language primary articles through June 2016, using the terms LixiLan, iGlarLixi and insulin glargine and lixisenatide, and a search of abstracts presented at the 2016 Scientific Sessions of the American Diabetes Association were performed. Study Selection and Data Extraction: All studies assessing the efficacy and/or safety of iGlarLixi were evaluated. Data Synthesis: iGlarLixi has been approved in the United States for glycemic control in people with type 2 diabetes (T2D) inadequately controlled with basal insulin (<60 U/d) or lixisenatide. In clinical trials, iGlarLixi was associated with significantly greater reductions from baseline in glycated hemoglobin A1C (A1C) than iGlar or lixisenatide alone. Reductions in postprandial glucose were also greater with iGlarLixi than with iGlar or lixisenatide. iGlarLixi was weight neutral compared with the weight gain with iGlar and loss with lixisenatide alone, and there was no increase in hypoglycemia with iGlarLixi compared with iGlar despite the greater A1C reduction. Gastrointestinal events, frequently associated with lixisenatide, were less common with iGlarLixi. Potential drawbacks of iGlarLixi include reduced flexibility in dosing and the absence of long-term efficacy and safety data. Conclusions: iGlarLixi is a titratable fixed-ratio combination that shows improved efficacy and comparable or improved safety outcomes relative to its separate constituents, offering an alternative approach to intensification of therapy in T2D.

Update From the Advisory Committee on Immunization Practices

2019 ◽  
Vol 8 (6) ◽  
pp. 495-500
Author(s):  
Sean T O’leary ◽  
Yvonne A Maldonado ◽  
David W Kimberlin
Keyword(s):  
Advisory Committee ◽  
Hepatitis A Virus ◽  
Safety Data ◽  
The United States ◽  
Vaccine Research ◽  
Vaccine Preventable Diseases ◽  
American Academy Of Pediatrics ◽  
Control And Prevention ◽  
Clinical Trial Results ◽  
Health Experts

Abstract The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. There usually are 15 voting members, but at the June 2019 meeting, only 14 were present; each member’s term is 4 years. ACIP members and Centers for Disease Control and Prevention (CDC) staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from the American Academy of Pediatrics (AAP) (Y. A. M. and D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met on June 26 to 27, 2019, to discuss the use of human papillomavirus (HPV) vaccine in adults, pneumococcal vaccines in adults, measles updates, zoster vaccine, influenza vaccines, hepatitis A virus (HAV) vaccines, meningococcal vaccines, and dengue vaccine.

Efficacy of naxitamab in patients with refractory/relapse (R/R) high-risk neuroblastoma (HR-NB) by bone/bone marrow (BM) evaluation, potential sites of residual disease.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 10022-10022
Author(s):  
Brian H. Kushner ◽  
Daniel A. Morgenstern ◽  
Karsten Nysom ◽  
Melissa K. Bear ◽  
Karen Tornøe ◽  
...  
Keyword(s):  
High Risk ◽  
Residual Disease ◽  
Safety Data ◽  
The United States ◽  
Outpatient Setting ◽  
Minor Response ◽  
Overall Response ◽  
Gm Csf ◽  
Prior Therapy ◽  
Meaningful Activity

10022 Background: NB is the most common extracranial solid tumor in children and half of patients present with high-risk disease. Bone and BM are frequent sites of metastatic disease and can serve as a reservoir for residual disease driving relapse. Naxitamab, a GD2-binding monoclonal antibody, was recently approved in the United States in combination with GM-CSF for the treatment of pediatric patients ≥1 year of age and adult patients with R/R HR-NB in the bone/BM who have demonstrated a partial response (PR), minor response (MR), or stable disease (SD) to prior therapy. Here we describe outcomes from the registrational Trial 201 (NCT03363373) detailed by bone/BM involvement. Methods: HR-NB patients with primary refractory disease or incomplete response to salvage treatment following relapse or progressive disease (PD) (in both cases including SD, MR and PR) with disease limited to bone and/or BM were eligible. Naxitamab was administered over ≥30 min in the outpatient setting on Days 1, 3 and 5 at 3 mg/kg/infusion (9 mg/kg/cycle) in combination with GM-CSF at 250 µg/m2/day on Days -4 to 0 and at 500 µg/m2/day on days 1 to 5. Treatment cycles were repeated every 4 weeks. Response was assessed after Cycle 2 and then every 2-3 months by revised International Neuroblastoma Response Criteria (INRC) using BM biopsies/aspirates and 123I-MIBG scintigraphy or FDG-PET. Effectiveness was concluded if the lower limit of the Clopper-Pearson exact 95% confidence interval (CI) of overall response rate (ORR) was >20%. We report efficacy data on 22 patients and safety data on the first 25 patients enrolled. Results: 13 (59%) patients had NB in bone, 2 (9%) had NB in BM, and 7 (32%) had NB in both bone and BM. Summary of overall response and response by compartment. Conclusions: Naxitamab provided clinically meaningful activity in both bone and BM with ORR of 68% and had a manageable AE profile. Clinical trial information: NCT03363373. [Table: see text]

How I Treat Chronic Phase Chronic Myelogenous Leukemia

Blood ◽  
2021 ◽  
Author(s):  
Ellin Berman
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Clinical Care ◽  
Treatment Algorithm ◽  
Safety Data ◽  
Specific Treatment ◽  
Chronic Phase ◽  
The United States ◽  
Myelogenous Leukemia ◽  
Individual Response ◽  
Number Of Patients

When imatinib, the first tyrosine kinase inhibitor (TKI) developed for use in chronic myelogenous leukemia (CML) was approved in 2001, the treatment of this disease was forever changed. Significant reductions in the molecular burden of disease were seen with the first generation TKI imatinib and with the addition of dasatinib (2006), nilotinib (2007), bosutinib (2012) and ponatinib (2013), deeper and more rapid reductions were noted. Physicians could begin to tailor TKI therapy to individual patients, and patients who did not respond to or could not tolerate first line therapy now had options. Importantly, the number of patients who developed accelerated or blast phase disease decreased dramatically. Research in CML continues to evolve and by presenting illustrative cases, this article will review some of the newer aspects of clinical care in this disease. Updated information regarding bosutinib and asciminib, the latter currently in clinical trials, will be presented; bosutinib is of particular interest as the drug's transit through the United States Food and Drug Administration (FDA) highlights the question of what is considered optimal response to TKI therapy. The challenge of understanding the cardiac safety data of ponatinib and the unique dosing schedule based on individual response will be discussed. Lastly, two cases will focus on features of TKI treatment that -remarkably- have become part of the treatment algorithm: family planning for women with CML and stopping therapy after meeting a specific treatment milestone.

Lung Volume Reduction in Pulmonary Emphysema

2020 ◽  
Vol 41 (06) ◽  
pp. 874-885 ◽  
Author(s):  
Justin L. Garner ◽  
Pallav L. Shah
Keyword(s):  
Exercise Capacity ◽  
Lung Volume ◽  
Safety Data ◽  
Clinical Excellence ◽  
The United States ◽  
Volume Reduction ◽  
Lung Volume Reduction ◽  
Novel Technologies ◽  
Mechanical Constraints ◽  
Improve Exercise Capacity

AbstractSevere emphysema with hyperinflation presents a therapeutic challenge. Inhaled medication has limited efficacy in individuals with mechanical constraints to the respiratory pump and impaired gas exchange. Lung volume reduction surgery (LVRS) reestablishes some semblance of normal physiology, resecting grossly expanded severely diseased tissue to restore the function of compromised relatively healthy lung, and has been shown to significantly improve exercise capacity, quality of life, and survival, especially in individuals with upper-lobe predominant emphysema and low-baseline exercise capacity, albeit with higher early morbidity and mortality. Bronchoscopic lung volume reduction achieved by deflating nonfunctioning parts of the lung is promoted as a less invasive and safer approach. Endobronchial valve implantation has demonstrated comparable outcomes to LVRS in selected individuals and has recently received approvals by the National Institute of Clinical Excellence in the United Kingdom and the Food and Drug Administration in the United States of America. Endobronchial coils are proving a viable treatment option in severe hyperinflation in the presence of collateral ventilation in selected cases of homogeneous disease. Modalities including vapor and sealant are delivered using a segmental strategy preserving healthier tissue within the same target lobe-efficacy and safety-data are, however, limited. This article will review the data supporting these novel technologies.

scholarly journals Update from the Advisory Committee on Immunization Practices

2020 ◽  
Vol 9 (1) ◽  
pp. 3-5
Author(s):  
Sean T O’Leary ◽  
Yvonne A Maldonado ◽  
David W Kimberlin
Keyword(s):  
Advisory Committee ◽  
Safety Data ◽  
Vaccine Safety ◽  
The United States ◽  
Vaccine Research ◽  
Vaccine Preventable Diseases ◽  
American Academy Of Pediatrics ◽  
Control And Prevention ◽  
Adult Immunization ◽  
Health Experts

Abstract The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. There are usually 15 voting members; members’ terms are for 4 years. ACIP members and Centers for Disease Control and Prevention staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and results from clinical trials. Representatives from the American Academy of Pediatrics (Y. A. M., D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met on 23–24 October 2019 to discuss pertussis vaccines, the child/adolescent and adult immunization schedule, influenza vaccine effectiveness and safety, Ebola vaccine, orthopoxvirus vaccines, Dengue vaccine, rabies vaccine, measles, and vaccine safety update.

Update From the Advisory Committee on Immunization Practices

2019 ◽  
Vol 8 (5) ◽  
pp. 379-383 ◽  
Author(s):  
Sean T O’Leary ◽  
Yvonne A Maldonado ◽  
David W Kimberlin
Keyword(s):  
Advisory Committee ◽  
Safety Data ◽  
Pneumococcal Vaccination ◽  
The United States ◽  
Human Papillomavirus Vaccine ◽  
Vaccine Preventable Diseases ◽  
Japanese Encephalitis Vaccine ◽  
Control And Prevention ◽  
Clinical Trial Results ◽  
Papillomavirus Vaccine

Abstract The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. The group usually has 15 voting members, each of whom is appointed to a 4-year term. ACIP members and Centers for Disease Control and Prevention staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from the American Academy of Pediatrics (Y. A. M. and D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met February 27 to 28, 2019, to discuss hepatitis A (HepA) vaccination of human immunodeficiency virus–infected persons, pneumococcal vaccination among adults aged 65 years or older, influenza vaccine effectiveness and safety, anthrax vaccination in the setting of a mass exposure, human papillomavirus vaccine, zoster vaccines, and Japanese encephalitis vaccine.

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