☆ 4.7 Review

Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

VACCINES (2021)

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Article Infectious Diseases

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial

Shengli Xia et al.

Summary: The inactivated SARS-CoV-2 vaccine, BBIBP-CorV, demonstrated safety and immunogenicity in two age groups. Humoral responses against SARS-CoV-2 were induced in all vaccine recipients by day 42. A two-dose immunisation with 4 mu g vaccine on days 0 and 21 or days 0 and 28 achieved higher neutralising antibody titres compared to other dosing schedules.

LANCET INFECTIOUS DISEASES (2021)

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Article Medicine, General & Internal

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Merryn Voysey et al.

Summary: The ChAdOx1 nCoV-19 vaccine has been shown to have an acceptable safety profile and effectiveness against symptomatic COVID-19, with higher efficacy observed in the group that received a low dose followed by a standard dose.

LANCET (2021)

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Article Infectious Diseases

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial

Raches Ella et al.

Summary: The BBV152 vaccine demonstrated tolerable safety outcomes and enhanced immune responses in this clinical trial, leading to selection of both Algel-IMDG formulations for phase 2 immunogenicity trials. Further efficacy trials are warranted to validate the vaccine's effectiveness.

LANCET INFECTIOUS DISEASES (2021)

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Article Biochemistry & Molecular Biology

Looking beyond COVID-19 vaccine phase 3 trials

Jerome H. Kim et al.

Summary: Following the announcement of COVID-19 vaccine efficacy in clinical trials, a comprehensive strategy is needed for global vaccination, including manufacturing, support, supply coordination, equitable distribution, and logistics. Additionally, addressing scientific questions to improve vaccine efficacy is crucial for ending the pandemic effectively and efficiently.

NATURE MEDICINE (2021)

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Review Pharmacology & Pharmacy

Advances in gene-based vaccine platforms to address the COVID-19 pandemic

Deborah Pushparajah et al.

Summary: The global scientific community is actively developing gene-based vaccines to combat the novel coronavirus, including platforms based on viral vectors, DNA, and RNA. The U.S. FDA has recently authorized the emergency use of two RNA-based COVID-19 vaccines, with more gene-based vaccine candidates proceeding through clinical trials in the future.

ADVANCED DRUG DELIVERY REVIEWS (2021)

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Article Medicine, General & Internal

Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

Denis Y. Logunov et al.

Summary: The Gam-COVID-Vac vaccine showed 91.6% efficacy against COVID-19 in the phase 3 trial, with good safety and tolerability in a large cohort of participants.

LANCET (2021)

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Article Medicine, General & Internal

Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial

Peter Richmond et al.

Summary: A study in Australia evaluated the dose-finding and adjuvant justification of the SCB-2019 vaccine against SARS-CoV-2. The vaccine, which contains a stabilised trimeric form of the spike protein (S-Trimer) combined with AS03 or CpG/Alum adjuvants, elicited robust humoral and cellular immune responses in both younger and older adults.

LANCET (2021)

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Article Infectious Diseases

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial

Zhiwei Wu et al.

Summary: The study showed that CoronaVac vaccine is safe and well tolerated in older adults, and is able to induce neutralizing antibody levels. The highest dose of 3 μg of the vaccine can generate neutralizing antibody levels similar to the 6 μg dose, supporting the use of the 3 μg dose CoronaVac in phase 3 trials.

LANCET INFECTIOUS DISEASES (2021)

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Article Infectious Diseases

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial

Yanjun Zhang et al.

Summary: This study investigated the safety, tolerability, and immunogenicity of the COVID-19 vaccine candidate CoronaVac, and found that the 3 μg dose showed higher seroconversion rates in the phase 2 trial.

LANCET INFECTIOUS DISEASES (2021)

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Article Infectious Diseases

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial

Raches Ella et al.

Summary: BBV152 vaccine, consisting of whole-virion inactivated SARS-CoV-2 with Algel and IMDG, showed high neutralizing antibody responses in phase 1 trial and better reactogenicity in phase 2 trial. The 6 mu g with Algel-IMDG formulation has been chosen for phase 3 efficacy trial.

LANCET INFECTIOUS DISEASES (2021)

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Article Immunology

A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine

Laurence Chu et al.

Summary: The study evaluated the safety and immunogenicity of the mRNA-1273 vaccine in healthy adults, showing significant immune responses to SARS-CoV-2 with acceptable safety profile. This vaccine induced higher antibody levels at a 100 mg dose, confirming its immunogenicity and safety for use in a 2-dose regimen.

VACCINE (2021)

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Article Biotechnology & Applied Microbiology

An online survey of the attitude and willingness of Chinese adults to receive COVID-19 vaccination

Musha Chen et al.

Summary: The study found that the majority of Chinese adults were willing to receive a COVID-19 vaccine, with concerns about potential adverse effects. Domestic vaccines were preferred. Lack of confidence, complacency about health, vaccine risk, and attention frequency were the main factors influencing vaccine acceptance.

HUMAN VACCINES & IMMUNOTHERAPEUTICS (2021)

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Letter Clinical Neurology

Longitudinally extensive transverse myelitis following acute COVID-19 infection

Thibault Fumery et al.

Summary: COVID-19 can lead to a variety of neurological complications, including longitudinally extensive transverse myelitis.

MULTIPLE SCLEROSIS AND RELATED DISORDERS (2021)

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Article Immunology

COVID-19 Vaccine Acceptance among Health Care Workers in the United States

Rahul Shekhar et al.

Summary: In the survey, only 36% of respondents were willing to take the vaccine as soon as it became available, while 56% were undecided. Only 8% of healthcare workers do not plan to get vaccinated. Vaccine acceptance increased with age, education, and income level, with direct medical care providers showing higher acceptance rates.

VACCINES (2021)

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Article Medicine, General & Internal

US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021

Isaac See et al.

Summary: Cases of CVST with thrombocytopenia following Ad26.COV2.S vaccination have been reported in the US, leading to serious outcomes. This case series may provide guidance for clinical management and further investigation into the potential relationship between Ad26.COV2.S vaccine and CVST with thrombocytopenia.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2021)

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Article Hematology

Thrombocytopenia with acute ischemic stroke and bleeding in a patient newly vaccinated with an adenoviral vector-based COVID-19 vaccine

Rolf Ankerlund Blauenfeldt et al.

Summary: This study reported the first Danish case of presumed inflammatory and thrombotic response following vaccination with the AZD1222 COVID-19 vaccine. The patient, a 60-year-old woman, experienced abdominal pain 7 days after vaccination, along with adrenal hemorrhages, ischemic stroke, and ultimately death. Blood tests revealed significant drops in platelet counts and increased D-dimer levels, suggesting a novel immune-mediated response to the vaccine.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2021)

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Article Infectious Diseases

Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials

Shilong Yang et al.

Summary: The results from Phase 1 and Phase 2 trials of the COVID-19 vaccine ZF2001 show that the vaccine is well tolerated and immunogenic, supporting the use of a 25 microgram dose in a three-dose schedule for large-scale evaluation in a Phase 3 trial.

LANCET INFECTIOUS DISEASES (2021)

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Article Infectious Diseases

Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial

Keith J. Chappell et al.

Summary: The study evaluated the safety and immunogenicity of a novel COVID-19 vaccine, showing promising results in both aspects. Adverse reactions were minimal, and the vaccine elicited antigen-specific responses regardless of the dosage.

LANCET INFECTIOUS DISEASES (2021)

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Editorial Material Medicine, General & Internal

COVID-19 vaccination-associated myelitis

Hardeep Singh Malhotra et al.

QJM-AN INTERNATIONAL JOURNAL OF MEDICINE (2021)

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Article Public, Environmental & Occupational Health

Rapid Emergence and Epidemiologic Characteristics of the SARS-CoV-2 B.1.526 Variant - New York City, New York, January 1-April 5, 2021

Corinne N. Thompson et al.

MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT (2021)

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Article Immunology

Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine Reported to EudraVigilance Database

Mansour Tobaiqy et al.

Summary: The development of safe and effective vaccines against COVID-19 is crucial in the fight against the pandemic. Although some thrombotic adverse reactions were associated with the Oxford-AstraZeneca vaccine, the European Medicines Agency affirmed the vaccine's safety and effectiveness, with the benefits outweighing the risks. Conducting further analyses based on more detailed thrombotic adverse event reports may help evaluate causality with higher specificity.

VACCINES (2021)

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Review Immunology

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Ali Pormohammad et al.

Summary: This study systematically reviewed the clinical features of COVID-19 vaccines in clinical trials, finding that mRNA-based and adenovirus-vectored vaccines exhibited different efficacy and side effect profiles. Both types of vaccines showed high efficacy after the first and second doses, with mRNA-based vaccines having higher reported side effects.

VACCINES (2021)

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Review Medicine, General & Internal

Evaluation of the safety profile of COVID-19 vaccines: a rapid review

Qianhui Wu et al.

Summary: Meta-analysis of safety profiles of COVID-19 vaccines showed that different platforms of vaccines have different safety outcomes, with age groups of vaccine recipients also playing a role in safety profiles. Long-term population-level surveillance is needed to further define the safety profile of COVID-19 vaccines.

BMC MEDICINE (2021)

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Article Infectious Diseases

An outbreak caused by the SARS-CoV-2 Delta (B.1.617.2) variant in a care home after partial vaccination with a single dose of the COVID-19 vaccine Vaxzevria, London, England, April 2021

Sarah V. Williams et al.

Summary: An outbreak of the SARS-CoV-2 Delta variant occurred in a London care home, where most infected individuals had received a single dose of the Vaxzevria vaccine. Despite the high vaccination rate, the attack rate was still significant, though there were no fatalities.

EUROSURVEILLANCE (2021)

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Article Medicine, General & Internal

Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults A Randomized Clinical Trial

Nawal Al Kaabi et al.

Summary: This interim analysis of an ongoing randomized trial in the UAE and Bahrain evaluated the efficacy of two inactivated COVID-19 vaccines in preventing symptomatic cases and adverse events in healthy adults. The study found that both vaccines significantly reduced the risk of symptomatic COVID-19 compared to the control group, with efficacy rates of 72.8% and 78.1%. Serious adverse events were rare across all groups.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2021)

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Article Neurosciences

Cerebral Venous Thrombosis after BNT162b2 mRNA SARS-CoV-2 vaccine

Leonor Dias et al.

Summary: Concerns have been raised about venous thromboembolism, specifically cerebral venous thrombosis, following the development of SARS-CoV-2 vaccines. While cases of cerebral venous thrombosis have been reported after viral vector vaccine administration, two cases of cerebral venous thrombosis following mRNA vaccine administration did not exhibit thrombocytopenia or anti platelet antibodies. This suggests that the pathophysiology of these cases may not differ significantly from cerebral venous thrombosis not associated with SARS-CoV-2 vaccination.

JOURNAL OF STROKE & CEREBROVASCULAR DISEASES (2021)

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Editorial Material Virology

Epidemic Spread of SARS-CoV-2 Lineage B.1.1.7 in Brazil

Filipe R. R. Moreira et al.

VIRUSES-BASEL (2021)

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Review Infectious Diseases

Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trials

Musha Chen et al.

Summary: A systematic review and meta-analysis found that the safety and tolerance of current COVID-19 vaccine candidates are acceptable for mass vaccination, with inactivated COVID-19 vaccines candidates having the lowest reported adverse events following immunization (AEFI). Long-term surveillance of vaccine safety is required, especially among elderly people with underlying medical conditions.

INFECTIOUS DISEASES OF POVERTY (2021)

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Article Public, Environmental & Occupational Health

Willingness of Greek general population to get a COVID-19 vaccine

Georgia Kourlaba et al.

Summary: The study examined the willingness of adult residents in Greece to receive a COVID-19 vaccine, with only 57.7% of respondents stating they would get vaccinated. Factors such as age, vulnerability to the virus, beliefs about its origins, perceptions of its severity compared to other viruses, and knowledge score on COVID-19 were significantly associated with willingness to get vaccinated.

GLOBAL HEALTH RESEARCH AND POLICY (2021)

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Article Medicine, General & Internal

Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study

Nanshan Chen et al.

LANCET (2020)

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Article Medicine, General & Internal

Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial

Feng-Cai Zhu et al.

LANCET (2020)

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Article Medicine, General & Internal

Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

Fei Zhou et al.

LANCET (2020)

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Article Clinical Neurology

Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of cerebral venous sinus thrombosis

Yuhua Fan et al.

STROKE AND VASCULAR NEUROLOGY (2020)

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Article Medicine, General & Internal

Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes Interim Analysis of 2 Randomized Clinical Trials

Shengli Xia et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2020)

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Article Medicine, General & Internal

Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial

Feng-Cai Zhu et al.

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Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial

Pedro M. Folegatti et al.

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Article Multidisciplinary Sciences

Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults

Mark J. Mulligan et al.

NATURE (2020)

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Article Medicine, General & Internal

An mRNA Vaccine against SARS-CoV-2-Preliminary Report

L. A. Jackson et al.

NEW ENGLAND JOURNAL OF MEDICINE (2020)

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Article Medicine, General & Internal

Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia

Denis Y. Logunov et al.

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Review Multidisciplinary Sciences

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NATURE (2020)

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Edward E. Walsh et al.

NEW ENGLAND JOURNAL OF MEDICINE (2020)

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Article Medicine, General & Internal

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E. J. Anderson et al.

NEW ENGLAND JOURNAL OF MEDICINE (2020)

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Article Medicine, General & Internal

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Cheryl Keech et al.

NEW ENGLAND JOURNAL OF MEDICINE (2020)

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Neurotropism of SARS-CoV-2 and its neuropathological alterations: Similarities with other coronaviruses

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Rebecca E. Chandler

NATURE REVIEWS IMMUNOLOGY (2020)

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A West Nile Virus DNA Vaccine Utilizing a Modified Promoter Induces Neutralizing Antibody in Younger and Older Healthy Adults in a Phase I Clinical Trial

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BMJ-BRITISH MEDICAL JOURNAL (2011)

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