23,628 results match your criteria vaccine safety

Feasibility and safety of rVSV-ZEBOV vaccination of humanitarian health workers against Ebola virus disease: an observational study.

J Travel Med 2021 Jun 15. Epub 2021 Jun 15.

Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland.

Background And Rationale: Geneva University Hospitals were granted a temporary authorization to administer the recombinant live vesicular stomatitis virus rVSV-ZEBOV (Ervebo®) vaccine to expatriate humanitarian frontline workers (FLWs) prior to mission deployment.

Objectives: Our aims were to assess the feasibility of FLW vaccination before deployment and to report adverse events (AEs).

Methods: FLWs received a single injection of rVSV-ZEBOV (>7. Read More

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Prevention and management of herpes zoster in patients with rheumatoid arthritis and psoriatic arthritis: a clinical review.

Clin Exp Rheumatol 2021 May 28. Epub 2021 May 28.

Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.

The risk of herpes zoster (HZ) and HZ-related complications is increased in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) relative to the general population; therefore, HZ vaccination is recommended in these patient groups. In this literature-based review, we summarise the available evidence on the use of HZ vaccines in patients with RA and PsA, and discuss strategies for managing breakthrough infection. Currently available data show suboptimal rates of HZ vaccination among these patients and highlight a need for strategies to improve HZ vaccination programmes in clinical practice. Read More

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Use of M-M-R II outside of the routinely recommended age range - a systematic literature review.

Hum Vaccin Immunother 2021 Jun 15:1-7. Epub 2021 Jun 15.

Former Employee of Merck & Co., Inc., Kenilworth, NJ, USA.

M-M-R® (M-M-R II) is routinely used in many countries at 12-15 months with a second dose at 4 to 6 years of age. However, the vaccine may need to be administered at other ages due to delays in the immunization schedule or in certain situations such as outbreaks or international travel. A systematic literature review was conducted to evaluate efficacy, immunogenicity and safety of M-M-R II among 6- to 11-month-olds and persons ≥7 years of age. Read More

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American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 2.

Arthritis Rheumatol 2021 Jun 15. Epub 2021 Jun 15.

University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha.

Objective: To provide guidance to rheumatology providers on the use of coronavirus disease 2019 (COVID-19) vaccines for patients with rheumatic and musculoskeletal diseases (RMDs).

Methods: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Read More

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Safety of COVID-19 vaccines, their components or their platforms for pregnant women: A rapid review.

medRxiv 2021 Jun 6. Epub 2021 Jun 6.

Background: Pregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed. Read More

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Vaccination with BCGΔBCG1419c protects against pulmonary and extrapulmonary TB and is safer than BCG.

Sci Rep 2021 Jun 14;11(1):12417. Epub 2021 Jun 14.

Biotecnología Médica y Farmacéutica, Centro de Investigación y Asistencia en Tecnología y diseño del Estado de Jalisco, Av. Normalistas 800, Col. Colinas de la Normal, 44270, Guadalajara, Jalisco, Mexico.

A single intradermal vaccination with an antibiotic-less version of BCGΔBCG1419c given to guinea pigs conferred a significant improvement in outcome following a low dose aerosol exposure to M. tuberculosis compared to that provided by a single dose of BCG Pasteur. BCGΔBCG1419c was more attenuated than BCG in murine macrophages, athymic, BALB/c, and C57BL/6 mice. Read More

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Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study.

Ann Rheum Dis 2021 Jun 14. Epub 2021 Jun 14.

Rheumatology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Introduction: Vaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited.

Methods: A multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Read More

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Post-vaccination HPV seroprevalence among female sexual health clinic attenders in England.

Vaccine 2021 Jun 11. Epub 2021 Jun 11.

Blood Safety, Hepatitis, Sexually Transmitted Infections (STI) and HIV Service, Public Health England, London, UK.

Background: The National HPV Immunisation Programme was introduced in England in September 2008 using the HPV16/18 bivalent vaccine. We conducted serological surveillance to explore vaccination coverage levels. We also conducted a case-control study to investigate a hypothesised cross-protective effect of the HPV16/18 vaccine against genital warts. Read More

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N-acetylgalactosamine-decorated nanoliposomes for targeted delivery of paclitaxel to hepatocellular carcinoma.

Eur J Med Chem 2021 Jun 5;222:113605. Epub 2021 Jun 5.

China International Science and Technology Cooperation Base of Food Nutrition/Safety and Medicinal Chemistry, College of Biotechnology, Tianjin University of Science and Technology, Sino-French Joint Lab of Food Nutrition/Safety and Medicinal Chemistry, Key Laboratory of Industrial Fermentation Microbiology of Ministry of Education, Tianjin, 300457, China. Electronic address:

In this study, we designed and developed a novel asialoglycoprotein receptor (ASGPR)-targeted PEGylated paclitaxel (PTX) nanoliposome for hepatocellular carcinoma (HCC). N-acetylgalactosamine with α configuration (Tn) was synthesized and used as the active targeting ligand. Notably, Tn modified nanoliposomes loaded with PTX (Tn-Lipo-PTX) showed a narrow distribution (PDI = 0. Read More

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Pharmacological mechanisms underlying the efficacy of antibodies generated by a vaccine to treat oxycodone use disorder.

Neuropharmacology 2021 Jun 11:108653. Epub 2021 Jun 11.

University of Minnesota Medical School, Department of Pharmacology; Hennepin Healthcare Research Institute; University of Minnesota Medical School, Department of Medicine; University of Minnesota Center for Immunology.

Therapeutic vaccines offer a viable strategy to treat opioid use disorders (OUD) complementary to current pharmacotherapies. The candidate Oxy(Gly)-sKLH vaccine targeting oxycodone displayed pre-clinical proof of efficacy, selectivity and safety, and it is now undergoing clinical evaluation. To further support its implementation in the clinic, this study tested critical in vivo neuropsychopharmacological properties of the Oxy(Gly)-sKLH vaccine in rats. Read More

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Safety and Immunogenicity of a Third Dose of SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series.

Ann Intern Med 2021 Jun 15. Epub 2021 Jun 15.

Johns Hopkins University School of Medicine, Baltimore, Maryland (W.A.W., B.J.B., M.T.O., A.B.M., A.A.T., J.M.G., D.L.S.).

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Mandatory Infant Vaccinations in France During the COVID-19 Pandemic in 2020.

Front Pediatr 2021 28;9:666848. Epub 2021 May 28.

EPI-PHARE (French National Agency for Medicines and Health Products Safety, ANSM; and French National Health Insurance, CNAM), Saint-Denis, France.

To describe changes in the dispensation of 11 mandatory vaccines to infants in France during the COVID-19 pandemic in 2020, considering the priming doses and boosters separately. With data from the French national health database, all dispensations of priming doses and boosters of 11 mandatory vaccines [penta/hexavalent, measles mumps rubella (MMR), meningococcal conjugate type-C (Men-C-C), 13-valent pneumococcal conjugate (PCV13)] for infants ≤24 months old were aggregated by 4-week periods in 2020. Expected counts in 2020 were estimated according to counts in 2019 weighted by a ratio considering the level of vaccine dispensation before the pandemic onset in 2020. Read More

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Safety and Efficacy of Personalized Cancer Vaccines in Combination With Immune Checkpoint Inhibitors in Cancer Treatment.

Front Oncol 2021 28;11:663264. Epub 2021 May 28.

Department of Biotherapy, Cancer Center, West China Hospital of Sichuan University, Chengdu, China.

Cancer immunotherapy can induce sustained responses in patients with cancers in a broad range of tissues, however, these treatments require the optimized combined therapeutic strategies. Despite immune checkpoint inhibitors (ICIs) have lasting clinical benefit, researchers are trying to combine them with other treatment modalities, and among them the combination with personalized cancer vaccines is attractive. Neoantigens, arising from mutations in cancer cells, can elicit strong immune response without central tolerance and out-target effects, which is a truly personalized method. Read More

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Next steps for efficacy evaluation in clinical trials of COVID-19 vaccines.

Engineering (Beijing) 2021 May 19. Epub 2021 May 19.

School of Public Health, Southeast University, Nanjing 210009, China.

There are currently ten COVID-19 vaccines being announced their preliminary efficacies from phase 3 clinical trial, and nine of them have been authorized for emergency use or conditional licensed, which brings some issues to present placebocontrolled efficacy trial of other COVID-19 vaccines. The approval of "first wave" COVID-19 vaccines raises concerns about the administration of a placebo in ongoing and future phase 3 trials of COVID-19 vaccine candidates. Comprehensive efficacy assessment strategy for the next steps is now required. Read More

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Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.

Front Pharmacol 2021 28;12:671498. Epub 2021 May 28.

Pharmacology Department, Medical Faculty, Universiti Kebangsaan Malaysia (The National University of Malaysia), Kuala Lumpur, Malaysia.

SARS-CoV-2 is the latest worldwide pandemic declared by the World Health Organization and there is no established anti-COVID-19 drug to combat this notorious situation except some recently approved vaccines. By affecting the global public health sector, this viral infection has created a disastrous situation associated with high morbidity and mortality rates along with remarkable cases of hospitalization because of its tendency to be high infective. These challenges forced researchers and leading pharmaceutical companies to find and develop cures for this novel strain of coronavirus. Read More

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Tinnitus following COVID-19 vaccination: report of three cases.

Int J Audiol 2021 Jun 13:1-4. Epub 2021 Jun 13.

Department of Neuroscience DNS, Audiology and Phoniatrics Unit, University of Padova, Treviso, Italy.

Objective: To ensure the safety and quality of vaccines, especially the newest RNA-vaccines against COVID-19, is one of the World Health Organization's current highest priorities.

Design: Case description.

Study Sample: We report three cases of sudden unilateral tinnitus following BNT162b2 mRNA-vaccine injection, which rapidly resolved in 2 out of 3 cases. Read More

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COVID Arm: Delayed Hypersensitivity Reactions to SARS-CoV-2 Vaccines Misdiagnosed as Cellulitis.

J Prim Care Community Health 2021 Jan-Dec;12:21501327211024431

Bay Area Cosmetic Dermatology, San Francisco, CA, USA.

The term "COVID arm" has been coined to describe a harmless delayed hypersensitivity reaction occurring approximately a week after administration of the novel SARS-CoV-2 mRNA vaccine. It appears as a red, warm, pruritic, indurated, or swollen area in the vicinity of the vaccine site. These reactions, especially if accompanied by systemic symptoms, have been mistaken for cellulitis. Read More

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Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary data.

Stat Med 2021 Jun 13. Epub 2021 Jun 13.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts, USA.

In sequential analysis, hypothesis testing is performed repeatedly in a prospective manner as data accrue over time to quickly arrive at an accurate conclusion or decision. In this tutorial paper, detailed explanations are given for both designing and operating sequential testing. We describe the calculation of exact thresholds for stopping or signaling, statistical power, expected time to signal, and expected sample sizes for sequential analysis with Poisson and binary type data. Read More

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Novel corona virus (COVID-19); Global efforts and effective investigational medicines: A review.

J Infect Public Health 2021 May 1;14(7):910-921. Epub 2021 May 1.

Department of Chemistry, Hindu College, University of Delhi, Delhi 110007,India.

Coronavirus disease-2019 (COVID-19), associated with the outbreak of deadly virus originating in Wuhan, China, is now a global health emergency and a matter of serious concern. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is rapidly spreading worldwide, and WHO declared the outbreak of this disease a pandemic on March 11, 2020. Though some of the countries have succeeded in slowing down the rate of the spread of this pandemic, most the countries across the globe are still continuing to experience an increasing trend in the growth and spread of this deadly disease. Read More

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Safety and immunological proof-of-concept following treatment with tolerance-inducing cell products in patients with autoimmune diseases or receiving organ transplantation: A systematic review and meta-analysis of clinical trials.

Autoimmun Rev 2021 Jun 10:102873. Epub 2021 Jun 10.

Laboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium; Center for Cell Therapy and Regenerative Medicine, Antwerp University Hospital, Edegem, Belgium.

In the past years, translational approaches have led to early-stage clinical trials assessing safety and efficacy of tolerance-inducing cell-based treatments in patients. This review aims to determine if tolerance-inducing cell-based therapies, including dendritic cells, regulatory T cells and mesenchymal stem cells, are safe in adult patients who underwent organ transplantation or in those with autoimmune diseases, including multiple sclerosis, diabetes mellitus type 1, Crohn's disease and rheumatoid arthritis. Immunological and clinical outcomes were reviewed, to provide evidence for proof-of-concept and efficacy. Read More

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Evaluation of post-introduction COVID-19 vaccine effectiveness: Summary of interim guidance of the World Health Organization.

Vaccine 2021 Jun 1. Epub 2021 Jun 1.

World Health Organization, 20 Avenue Appia, Geneva 1211, Switzerland.

Phase 3 randomized-controlled trials have provided promising results of COVID-19 vaccine efficacy, ranging from 50 to 95% against symptomatic disease as the primary endpoints, resulting in emergency use authorization/listing for several vaccines. However, given the short duration of follow-up during the clinical trials, strict eligibility criteria, emerging variants of concern, and the changing epidemiology of the pandemic, many questions still remain unanswered regarding vaccine performance. Post-introduction vaccine effectiveness evaluations can help us to understand the vaccine's effect on reducing infection and disease when used in real-world conditions. Read More

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Systematic review of M. Bovis BCG and other candidate vaccines for Buruli ulcer prophylaxis.

Vaccine 2021 Jun 9. Epub 2021 Jun 9.

Department of Microbiology and Immunology, Peter Doherty Institute at the University of Melbourne, Melbourne, Australia. Electronic address:

Buruli ulcer, caused by Mycobacterium ulcerans, is a neglected tropical disease endemic to over 30 countries, with increasing incidence in temperate, coastal Victoria, Australia. Strategies to control transmission are urgently required. This study systematically reviews the literature to identify and describe candidate prophylactic Buruli ulcer vaccines. Read More

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Efficacy and safety of SARS-CoV-2 vaccine in patients with giant cell arteritis.

Med Clin (Barc) 2021 May 27. Epub 2021 May 27.

Unidad de Enfermedades Sistémicas. Servicio de Medicina Interna. Hospital Clínico Universitario San Cecilio, Granada, España.

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Evaluation of Covid-19 vaccines: Pharmacoepidemiological aspects.

Therapie 2021 May 7. Epub 2021 May 7.

University Bordeaux, Inserm, BPH, U1219, Team Pharmacoepidemiology, 33000 Bordeaux, France; CHU de Bordeaux, pôle de santé publique, service de pharmacologie médicale, unité de pharmaco-épidémiologie et bon usage du médicament, 33000 Bordeaux, France.

The marketing authorization granted to SARS-Cov-2 vaccines was accompanied by reinforced safety monitoring plans. These plans' implementation was part of the usual logic of post-marketing surveillance of new and innovative health products. It was especially adapted to the context of post-marketing monitoring of drugs developed according to the usual scientific quality standards but in an accelerated schedule. Read More

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A survey on COVID-19 vaccine acceptance and concern among Malaysians.

BMC Public Health 2021 Jun 12;21(1):1129. Epub 2021 Jun 12.

Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, 94300, Kota Samarahan, Sarawak, Malaysia.

Background: Vaccination is an effective way to curtail the burden of COVID-19 in which success depends on a high acceptance of the vaccine. However, addressing concerns among vaccine-hesitant individuals is essential to avoid failure of the immunisation programme. This study sought to assess the concerns and acceptance rates regarding the COVID-19 vaccine among Malaysians. Read More

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Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States.

J Int AIDS Soc 2021 Jun;24(6):e25747

Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Introduction: Vaginal rings are a promising approach to provide a woman-centred, long-acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV-1 infection. Extended duration rings replaced every three months may encourage user adherence, improve health service efficiency and reduce cost overall. Read More

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Emerging Infection, Vaccination, and Guillain-Barré Syndrome: A Review.

Neurol Ther 2021 Jun 12. Epub 2021 Jun 12.

Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, 466-8550, Japan.

Guillain-Barré syndrome (GBS) is an autoimmune disorder of the peripheral nervous system that typically develops within 4 weeks after infection. In addition to conventional infectious diseases with which we are familiar, emerging infectious diseases, such as Zika virus infection and coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), have also been suggested to be associated with GBS. GBS is mainly categorized into a demyelinating subtype known as acute inflammatory demyelinating polyneuropathy (AIDP) and an axonal subtype known as acute motor axonal neuropathy (AMAN). Read More

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Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Tdap Vaccine: Randomized Phase IIIb Trial in Healthy Participants 9-60 Years of Age in the Philippines.

Pediatr Infect Dis J 2021 Jun 10. Epub 2021 Jun 10.

From the Philippine Children's Medical Center, Quezon City, The Philippines Far Eastern University Nicanor Reyes Medical Foundation, Quezon City, The Philippines Medical Center Manila, Manila, The Philippines Research Institute for Tropical Medicine, Alabang Muntinlupa City, The Philippines Sanofi Pasteur, France Sanofi Pasteur, Mexico City, Mexico.

Background: Incorporating dengue vaccination into existing childhood vaccination programs could increase vaccine coverage. This study assessed the safety and immunogenicity of concomitant versus sequential administration of the combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and the tetravalent dengue vaccine (CYD-TDV).

Methods: This phase IIIb, randomized, open-label, multicenter study was conducted in the Philippines in individuals 9-≤60 years of age (NCT02992418). Read More

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