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1.
Hum Vaccin Immunother ; 18(1): 2039017, 2022 12 31.
Article in English | MEDLINE | ID: covidwho-1730547

ABSTRACT

Assessment of safety of COVID-19 vaccines is an ongoing process. This study aims to explore long-term adverse events reported by physicians and dentists who received at least two COVID-19 vaccine doses. A group of physicians and dentists were invited to complete a validated questionnaire that was composed of items on: socio-demographics, medical history, administered vaccines, and long-term adverse events (LTAE). Data of a total of 498 practitioners were included. Age ranged from 22 to 71 years (mean age= 35.75 ± 11.74) with a female majority (N = 348, 69.9%). The most frequently administered vaccines were Pfizer-BioNtech, Sinopharm and AstraZeneca vaccines. A total of 80 (16.0%) participants reported LTAEs which were mainly fatigue, menstrual disturbances, myalgia, arthralgia, dizziness, and headache (N = 32, 15, 8, 6, 4, and 4, respectively). There was no statistically significant association between LTAEs and: age, gender, or medical history (P > .05). The collective symptoms of fatigue, myalgia, arthralgia, dizziness, and headache were significantly associated with Sinopharm vaccine (P = .04). This was further confirmed by general linear multivariate model analysis. Less than 20% of COVID-19 vaccine recipients may complain of LTAEs that are mostly fatigue-related. It seems that factors such as age, gender, and medical status play a negligible role in development of these AEs. On the other hand, Sinopharm vaccine showed the highest significant association with these AEs followed by AstraZeneca vaccine.


Subject(s)
COVID-19 , Physicians , Adult , Aged , Arthralgia/chemically induced , Arthralgia/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Dentists , Dizziness , Fatigue/chemically induced , Fatigue/epidemiology , Female , Headache/chemically induced , Headache/epidemiology , Humans , Jordan , Middle Aged , Myalgia/chemically induced , Myalgia/epidemiology , SARS-CoV-2 , Saudi Arabia , Young Adult
2.
Biomed Pharmacother ; 147: 112650, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1635955

ABSTRACT

BACKGROUND: The objective of the present work was to assess the reactogenicity and immunogenicity of heterologous COVID-19 vaccination regimens in clinical trials and observational studies. METHODS: PubMed, Cochrane Library, Embase, MedRxiv, BioRxiv databases were searched in September 29, 2021. The PRISMA instruction for systemic review was followed. Two reviewers independently selected the studies, extracted the data and assessed risk of bias. The quality of studies was evaluated using the New Castle-Ottawa and Cochrane risk of instrument. The characteristics and study outcome (e.g., adverse events, immune response, and variant of concern) were extracted. RESULTS: Nineteen studies were included in the final data synthesis with 5 clinical trials and 14 observational studies. Heterologous vaccine administration showed a trend toward more frequent systemic reactions. However, the total reactogenicity was tolerable and manageable. Importantly, the heterologous prime-boost vaccination regimens provided higher immunogenic effect either vector/ mRNA-based vaccine or vector/ inactivated vaccine in both humoral and cellular immune response. Notably, the heterologous regimens induced the potential protection against the variant of concern, even to the Delta variant. CONCLUSIONS: The current findings provided evidence about the higher induction of robust immunogenicity and tolerated reactogenicity of heterologous vaccination regimens (vector-based/mRNA vaccine or vector-based/inactivated vaccine). Also, this study supports the application of heterologous regimens against COVID-19 which may provide more opportunities to speed up the global vaccination campaign and maximize the capacity to control the pandemic.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Immunogenicity, Vaccine , /therapeutic use , Arthralgia/chemically induced , /therapeutic use , Diarrhea/chemically induced , Fatigue/chemically induced , Fever/chemically induced , Headache/chemically induced , Humans , Immunization, Secondary , Injection Site Reaction/etiology , Myalgia/chemically induced , SARS-CoV-2 , Vaccination , Vaccines, Subunit/therapeutic use
4.
Clin Pharmacol Ther ; 110(6): 1467-1477, 2021 12.
Article in English | MEDLINE | ID: covidwho-1372711

ABSTRACT

Therapeutics for patients hospitalized with coronavirus disease 2019 (COVID-19) are urgently needed during the pandemic. Bamlanivimab is a potent neutralizing monoclonal antibody that blocks severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) attachment and entry into human cells, which could potentially lead to therapeutic benefit. J2W-MC-PYAA was a randomized, double-blind, sponsor unblinded, placebo-controlled, single ascending dose first-in-human trial (NCT04411628) in hospitalized patients with COVID-19. A total of 24 patients received either placebo or a single dose of bamlanivimab (700 mg, 2,800 mg, or 7,000 mg). The primary objective was assessment of safety and tolerability, including adverse events and serious adverse events, with secondary objectives of pharmacokinetic (PK) and pharmacodynamic analyses. Treatment-emergent adverse event (TEAE) rates were identical in the placebo and pooled bamlanivimab groups (66.7%). There were no apparent dose-related increases in the number or severity of TEAEs. There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events. PKs of bamlanivimab is linear and exposure increased proportionally with dose following single i.v. administration. The half-life was ~ 17 days. These results demonstrate the favorable safety profile of bamlanivimab, and provided the initial critical evaluation of safety, tolerability, and PKs in support of the development of bamlanivimab in several ongoing clinical trials.


Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , Antiviral Agents/administration & dosage , COVID-19/diagnosis , COVID-19/drug therapy , Hospitalization/trends , Administration, Intravenous , Adult , Aged , Antibodies, Monoclonal, Humanized/adverse effects , Antiviral Agents/adverse effects , COVID-19/immunology , Dose-Response Relationship, Drug , Double-Blind Method , Fatigue/chemically induced , Female , Headache/chemically induced , Humans , Male , Middle Aged
5.
Nat Commun ; 12(1): 4636, 2021 07 30.
Article in English | MEDLINE | ID: covidwho-1347938

ABSTRACT

Chikungunya virus (CHIKV) is a reemerging mosquito-borne virus that causes swift outbreaks. Major concerns are the persistent and disabling polyarthralgia in infected individuals. Here we present the results from a first-in-human trial of the candidate simian adenovirus vectored vaccine ChAdOx1 Chik, expressing the CHIKV full-length structural polyprotein (Capsid, E3, E2, 6k and E1). 24 adult healthy volunteers aged 18-50 years, were recruited in a dose escalation, open-label, nonrandomized and uncontrolled phase 1 trial (registry NCT03590392). Participants received a single intramuscular injection of ChAdOx1 Chik at one of the three preestablished dosages and were followed-up for 6 months. The primary objective was to assess safety and tolerability of ChAdOx1 Chik. The secondary objective was to assess the humoral and cellular immunogenicity. ChAdOx1 Chik was safe at all doses tested with no serious adverse reactions reported. The vast majority of solicited adverse events were mild or moderate, and self-limiting in nature. A single dose induced IgG and T-cell responses against the CHIKV structural antigens. Broadly neutralizing antibodies against the four CHIKV lineages were found in all participants and as early as 2 weeks after vaccination. In summary, ChAdOx1 Chik showed excellent safety, tolerability and 100% PRNT50 seroconversion after a single dose.


Subject(s)
Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , Chikungunya Fever/immunology , Chikungunya virus/immunology , Viral Vaccines/immunology , Adolescent , Adult , Chikungunya Fever/prevention & control , Chikungunya Fever/virology , Chikungunya virus/classification , Chikungunya virus/physiology , Cytokines/immunology , Cytokines/metabolism , Enzyme-Linked Immunosorbent Assay , Fatigue/chemically induced , Female , Headache/chemically induced , Humans , Immunoglobulin G/immunology , Injections, Intramuscular , Male , Middle Aged , T-Lymphocytes/immunology , T-Lymphocytes/metabolism , Vaccination/methods , Viral Vaccines/administration & dosage , Viral Vaccines/adverse effects , Young Adult
6.
Expert Rev Vaccines ; 20(8): 1013-1025, 2021 08.
Article in English | MEDLINE | ID: covidwho-1284827

ABSTRACT

INTRODUCTION: Several vaccine candidates have been developed using different platforms, including nucleic acids (DNA and RNA), viral vectors (replicating and non-replicating), virus-like particles, peptide-based, recombinant proteins, live attenuated, and inactivated virus modalities. Although many of these vaccines are undergoing pre-clinical trials, several large clinical trials investigating the clinical efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines have produced promising findings. AREAS COVERED: In this review, we provide a status update on COVID-19 vaccines currently undergoing clinical trials and discuss issues of concern beyond vaccine efficacy and safety, including dosing regimens, the mixed vaccine strategy, prior severe acute respiratory syndrome coronavirus-2 infection, antibody levels, cellular immunity and protection, variants of concern, COVID-19 vaccine distribution, vaccination willingness, herd immunity, immunity passports, and vaccine indications. EXPERT OPINION: Four vaccines have obtained emergency use authorization, 87 are at the clinical development stage, and 186 are in pre-clinical development. While the knowledge and development of COVID-19 vaccines is rapidly expanding, the benefits of COVID-19 vaccines must outweigh the potential risks of adverse events. To combat the COVID-19 pandemic, clinicians should consistently update COVID-19-associated information, and healthcare authorities and manufacturers should work together to provide adequate and appropriate vaccinations for the prevention of COVID-19. PLAIN LANGUAGE SUMMARY: What is the context?Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) caused a global pandemic: the coronavirus disease 2019 (COVID-19) outbreak. The development and implementation of the COVID-19 vaccine could be an important measure to control the COVID-19 pandemic.What is new?Several phase 3 clinical trials have demonstrated the effectiveness and safety of COVID-19 vaccines for the prevention of SARS-CoV-2 infections. Several COVID-19 vaccines have obtained emergency use authorization and been implemented in many countries. Although concerns regarding unusual blood clots and low platelet counts have been raised, the benefits of COVID-19 vaccines outweigh the potential risks of adverse events.What is the impact?Except for children, the COVID-19 vaccine is recommended for all people, including those pregnant or immunocompromised. Healthcare authorities should advise people receiving the vaccine that they must seek medical attention if they have associated thromboembolism and thrombocytopenia symptoms. More studies are necessary to determine the appropriate vaccine dose and regimen strategy, as well as the effectiveness of COVID-19 vaccines against variants of concerns. A global effort must be made to achieve widespread vaccination and herd immunity.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Patient Safety , Animals , COVID-19/epidemiology , Clinical Trials, Phase III as Topic/methods , Fatigue/chemically induced , Female , Fever/chemically induced , Headache/chemically induced , Humans , Immunocompromised Host/drug effects , Immunocompromised Host/physiology , Male , Pregnancy , Randomized Controlled Trials as Topic/methods , Treatment Outcome
7.
Postgrad Med ; 133(5): 548-551, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1082103

ABSTRACT

Objective: Hypoglycemia is a serious adverse effect of hydroxychloroquine (HCQ) which is very rare in non-diabetic patients. This case report describes a non-diabetic patient without any other chronic diseases, who experienced mild hypoglycemia related to HCQ used for COVID-19 treatment.Methods: All etiologies causing hypoglycemia were investigated and a 72-hour fast test was performed.Results: A 34-year-old male patient was admitted to our hospital with a high fever, cough, and chest pain. The result of his COVID-19 PCR test was positive. He received HCQ for 10 days for the treatment of COVID-19 infection. He experienced fatigue, dizziness, severe headache, weakness and feeling of hunger after discontinuation of HCQ during his isolation at home. Before COVID-19 infection, he never experienced hypoglycemia symptoms. He did not have a history of chronic diseases, drug use, alcohol consumption, or smoking. A 72-hour fasting test was performed. He complained about headache and weakness during the 72-hour test period. The PG level was determined as 49 mg/dl during these symptoms. Concurrent insulin and C-peptide levels were <2 mU/mL and 0.553 ng/mL, respectively. ACTH, cortisol, growth hormones, liver and kidney function tests were normal. HbA1c level was 4.7% (28 mmol/mol) (Normal Range %4,5-5,7).Conclusion: Hypoglycemia may be observed as an adverse effect of HCQ used for COVID-19 infection even in patients without chronic diseases and comorbidities. We must be careful while using HCQ for these patients and must warn them about this effect. The warning about hypoglycemia effect of HCQ must be added to COVID-19 treatment guidelines.


Subject(s)
Antiviral Agents/adverse effects , COVID-19/drug therapy , Hydroxychloroquine/adverse effects , Hypoglycemia/chemically induced , Hypoglycemia/diagnosis , Adult , Antiviral Agents/therapeutic use , Dizziness/chemically induced , Fatigue/chemically induced , Humans , Hydroxychloroquine/therapeutic use , Male , Treatment Outcome
8.
Travel Med Infect Dis ; 36: 101812, 2020.
Article in English | MEDLINE | ID: covidwho-633889

ABSTRACT

BACKGROUND: Hydroxychloroquine (HCQ) is currently being examined for COVID-19. No previous meta-analysis has evaluated its side effects versus placebo. We conducted this meta-analysis to compare the safety of HCQ versus placebo. METHODS: Two authors independently searched PubMed and EMBASE databases for randomized controlled trials (RCTs) of adults comparing the adverse events (AEs) of HCQ versus placebo for any indication. Peto odds ratios (Peto ORs) and 95% confidence intervals (CIs) were calculated based on random-effects models. The heterogeneity (I2) was assessed using Cochran's Q test. RESULTS: Nine RCTs (eight were double-blind) with a total of 916 patients were included. HCQ caused significantly more skin pigmentation than placebo (Peto OR, 4.64; 95% CI, 1.13 to 19.00; P-value = 0.033; I2 = 0%). The increase in other AEs did not reach statistical significance: rash (Peto OR, 1.11; 95% CI, 0.3 to 3.77; P-value = 0.03; I2 = 0%); gastrointestinal AEs (Peto OR, 1.43; 95% CI, 0.55 to 3.72; P-value = 0.46; I2 = 15.17%); headache (Peto OR, 1.94; 95% CI, 0.65 to 5.78; P-value = 0.23; I2 = 9.99%); dizziness (Peto OR, 1.32; 95% CI, 0.49 to 3.52; P-value = 0.58; I2 = 0%); fatigue (Peto OR, 2.13; 95% CI, 0.76 to 5.98; P-value = 0.15; I2 = 0%); and visual AEs (Peto OR, 1.61; 95% CI, 0.76 to 3.41; P-value = 0.22; I2 = 0%). Cardiac toxicity was not reported. CONCLUSIONS: This meta-analysis of RCTs found a significantly higher risk of skin pigmentation in HCQ users versus placebo. More data are needed to evaluate HCQ in the context of COVID-19 treatment.


Subject(s)
Alzheimer Disease/drug therapy , Antirheumatic Agents/adverse effects , Chronic Urticaria/drug therapy , Glomerulonephritis, IGA/drug therapy , HIV Infections/drug therapy , Hydroxychloroquine/adverse effects , Hyperpigmentation/chemically induced , Rheumatic Diseases/drug therapy , Arthritis, Rheumatoid/drug therapy , Asymptomatic Infections , Betacoronavirus , COVID-19 , Coronavirus Infections/drug therapy , Dizziness/chemically induced , Exanthema/chemically induced , Fatigue/chemically induced , Gastrointestinal Diseases/chemically induced , Headache/chemically induced , Humans , Lupus Erythematosus, Cutaneous/drug therapy , Lupus Erythematosus, Systemic/drug therapy , Osteoarthritis/drug therapy , Pandemics , Pneumonia, Viral/drug therapy , Randomized Controlled Trials as Topic , SARS-CoV-2
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