☆ 3.8 Review

Sex and Gender in COVID-19 Vaccine Research: Substantial Evidence Gaps Remain

FRONTIERS IN GLOBAL WOMENS HEALTH (2021)

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Review Pharmacology & Pharmacy

Sex- or Gender-specific Differences in the Clinical Presentation, Outcome, and Treatment of SARS-CoV-2

Jeannette Wolfe et al.

Summary: This review discusses the sex and gender differences in COVID-19 presentation, treatment, and outcomes, including susceptibility to infection, the role of sex chromosomes on immunologic response, influence of hormones, clinical presentation, complications, and response to treatment and prevention.

CLINICAL THERAPEUTICS (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 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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Article Biotechnology & Applied Microbiology

COVID-19 vaccination intention in the UK: results from the COVID-19 vaccination acceptability study (CoVAccS), a nationally representative cross-sectional survey

Susan M. Sherman et al.

Summary: Most UK adults have a positive attitude towards being vaccinated against COVID-19, with factors such as general vaccine beliefs and attitudes, information sufficiency, and risk perception influencing vaccination intention. Intention to be vaccinated may be influenced by factors such as vaccine safety, perception of COVID-19 risk, among others.

HUMAN VACCINES & IMMUNOTHERAPEUTICS (2021)

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Article Public, Environmental & Occupational Health

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021

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MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT (2021)

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Article Public, Environmental & Occupational Health

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine - United States, December 14-23, 2020

Tom Shimabukuro

MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT (2021)

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Editorial Material Hematology

Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination

Eun-Ju Lee et al.

AMERICAN JOURNAL OF HEMATOLOGY (2021)

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Letter Medicine, General & Internal

Acute Allergic Reactions to mRNA COVID-19 Vaccines

Kimberly G. Blumenthal et al.

Summary: This study investigates the occurrence of acute allergic reactions to mRNA COVID-19 vaccines among healthcare employees in Massachusetts.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2021)

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Letter Medicine, General & Internal

Sex-disaggregated data in COVID-19 vaccine trials

Lavanya Vijayasingham et al.

LANCET (2021)

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Article Medicine, General & Internal

BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

Noa Dagan et al.

Summary: A study conducted in Israel on nearly 600,000 individuals showed that the BNT162b2 mRNA vaccine was effective in reducing the risk of infection, hospitalization, and severe Covid-19. The effectiveness in preventing death was 72% during the period from day 14 through day 20 after the first dose, and hospitalization was reduced by 87% for the period 7 or more days after the second dose, similar to results from a randomized trial.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Letter Medicine, General & Internal

Antibody Responses in Seropositive Persons after a Single Dose of SARS-CoV-2 mRNA Vaccine

Florian Krammer et al.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Editorial Material Clinical Neurology

Under-Enrollment of Women in Stroke Clinical Trials What Are the Causes and What Should Be Done About It?

Cheryl Carcel et al.

Summary: The under-representation of women in clinical trials is a recognized issue that can affect the generalizability of trial outcomes and the utilization of new therapies, with causes including specific trial eligibility criteria, patient attitudes, and potential biases among study personnel. More efforts are needed to address this problem, such as using trial screening logs, conducting qualitative studies to understand patient attitudes, avoiding age-based exclusion criteria, and increasing female leadership in stroke clinical trials.

STROKE (2021)

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Letter Immunology

Safety of the First Dose of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients

Brian J. Boyarsky et al.

TRANSPLANTATION (2021)

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Letter Public, Environmental & Occupational Health

Pregnant women's appetite for risk

Amy Vassallo et al.

LANCET GLOBAL HEALTH (2021)

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Article Public, Environmental & Occupational Health

First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021

Julianne Gee et al.

MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT (2021)

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Article Psychology, Biological

Measuring the impact of COVID-19 vaccine misinformation on vaccination intent in the UK and USA

Sahil Loomba et al.

Summary: Recent online misinformation about COVID-19 vaccines has been found to decrease intent to vaccinate among adults in the UK and the USA, particularly among those who were initially willing to get vaccinated. Certain sociodemographic groups are more negatively impacted by misinformation, and scientifically-sounding misinformation has a stronger effect on reducing vaccination intent.

NATURE HUMAN BEHAVIOUR (2021)

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Article Radiology, Nuclear Medicine & Medical Imaging

Axillary Lymph Nodes Hypermetabolism After BNT162b2 mRNA COVID-19 Vaccination in Cancer Patients Undergoing 18F-FDG PET/CT A Cohort Study

Hanna Bernstine et al.

Summary: This study found that more than half of patients experienced hypermetabolic axillary lymph nodes on FDG PET/CT scans after the second dose of mRNA COVID-19 vaccination, which may lead to misdiagnosis.

CLINICAL NUCLEAR MEDICINE (2021)

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Article Infectious Diseases

Effectiveness of the Comirnaty (BNT162b2, BioNTech/Pfizer) vaccine in preventing SARS-CoV-2 infection among healthcare workers, Treviso province, Veneto region, Italy, 27 December 2020 to 24 March 2021

Massimo Fabiani et al.

Summary: A study conducted in Italy showed that the BioNTech/Pfizer COVID-19 vaccine has an effectiveness of 84% and 95% in preventing SARS-CoV-2 infection within certain time intervals, supporting ongoing vaccination campaigns with targeted communication.

EUROSURVEILLANCE (2021)

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Article Infectious Diseases

Side effects of BNT162b2 mRNA COVID-19 vaccine: A randomized, cross-sectional study with detailed self-reported symptoms from healthcare workers

Renuka A. K. Kadali et al.

Summary: A study on the side effects of the BNT162b2 mRNA vaccine for COVID-19 among healthcare workers revealed that most of the vaccinated individuals experienced some symptoms post vaccination, but the majority still intended to receive the second dose.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2021)

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Article Oncology

Fifth-week immunogenicity and safety of anti-SARS-CoV-2 BNT162b2 vaccine in patients with multiple myeloma and myeloproliferative malignancies on active treatment: preliminary data from a single institution

Fulvia Pimpinelli et al.

Summary: The study assessed the safety and immunogenicity of the BNT162b2 mRNA vaccine in hematological patients, finding lower response rates in multiple myeloma patients. It suggests that these patients should continue to maintain protective measures and monitor vaccine effectiveness post-vaccination.

JOURNAL OF HEMATOLOGY & ONCOLOGY (2021)

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Article Hematology

An observational study to identify the prevalence of thrombocytopenia and anti-PF4/polyanion antibodies in Norwegian health care workers after COVID-19 vaccination

Ingvild Hausberg Sorvoll et al.

Summary: This study investigated the prevalence of thrombocytopenia and anti-PF4/polyanion antibodies in a population recently vaccinated with AZD1222. The results showed a low prevalence of both conditions among Norwegian health care workers after vaccination with AZD1222, with the majority of participants having normal platelet counts and negative immunoassay results.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2021)

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Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial

Katherine R. W. Emary et al.

Summary: A post-hoc analysis was conducted on the efficacy of the ChAdOx1 nCoV-19 vaccine against the B.1.1.7 variant of SARS-CoV-2 in the UK. The vaccine showed reduced neutralisation activity against the B.1.1.7 variant in vitro, but still demonstrated efficacy against the B.1.1.7 variant of the virus.

LANCET (2021)

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Article Infectious Diseases

Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study

Cristina Menni et al.

Summary: This study investigated the safety and effectiveness of the BNT162b2 and ChAdOx1 nCoV-19 vaccines in a UK community setting. The results showed that the frequencies of side effects from these vaccines were lower than reported in clinical trials, and a significant reduction in the risk of SARS-CoV-2 infection was observed starting at 12 days after vaccination.

LANCET INFECTIOUS DISEASES (2021)

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Editorial Material Oncology

Short-term safety of the BNT162b2 mRNA COVID-19 vaccine in patients with cancer treated with immune checkpoint inhibitors

Barliz Waissengrin et al.

LANCET ONCOLOGY (2021)

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Article Clinical Neurology

COVID-19 vaccination in patients with multiple sclerosis: What we have learnt by February 2021

Anat Achiron et al.

Summary: The study shows that the COVID-19 BNT162b2 vaccine is safe for patients with MS, with no increased risk of relapse activity observed after vaccination.

MULTIPLE SCLEROSIS JOURNAL (2021)

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Article Medicine, General & Internal

Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant

S. A. Madhi et al.

Summary: The ChAdOx1 nCoV-19 vaccine did not provide significant protection against mild-to-moderate Covid-19 caused by the B.1.351 variant, with an efficacy of 10.4%. The incidence of serious adverse events was balanced between the vaccine and placebo groups.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Medicine, General & Internal

Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study

Anton Pottegard et al.

Summary: This study assessed rates of cardiovascular and haemostatic events in Denmark and Norway after vaccination with the Oxford-AstraZeneca vaccine ChAdOx1-S, finding increased rates of venous thromboembolic events among recipients. Despite slightly higher rates of thrombocytopenia/coagulation disorders and bleeding, the overall safety outcomes were largely reassuring.

BMJ-BRITISH MEDICAL JOURNAL (2021)

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Article Dermatology

Delayed Localized Hypersensitivity Reactions to the Moderna COVID-19 Vaccine A Case Series

Margaret S. Johnston et al.

Summary: In response to the COVID-19 pandemic, mRNA vaccines from Pfizer-BioNTech and Moderna received emergency use authorization in the US. This study focused on localized cutaneous reactions to the Moderna COVID-19 vaccine, finding them to be delayed hypersensitivity reactions that are self-limited and not associated with serious adverse effects. Most patients who had a reaction to the first vaccine dose also developed a similar reaction to the second dose, typically sooner. The reactions, dubbed COVID arm, are not a contraindication to subsequent vaccination.

JAMA DERMATOLOGY (2021)

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Review Immunology

Acute Transverse Myelitis (ATM):Clinical Review of 43 Patients With COVID-19-Associated ATM and 3 Post-Vaccination ATM Serious Adverse Events With the ChAdOx1 nCoV-19 Vaccine (AZD1222)

Gustavo C. Roman et al.

Summary: Acute transverse myelitis has been unexpectedly found to be a frequent neurological complication of COVID-19, with symptoms including paralysis, sensory deficits, and sphincter dysfunction. The pathogenesis remains unknown, but it is hypothesized that SARS-CoV-2 antigens may induce immune mechanisms leading to myelitis.

FRONTIERS IN IMMUNOLOGY (2021)

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Article Public, Environmental & Occupational Health

Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021

David K. Shay et al.

MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT (2021)

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Article Public, Environmental & Occupational Health

Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers - Eight US Locations, December 2020-March 2021

Mark G. Thompson et al.

MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT (2021)

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Article Medicine, General & Internal

Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic

Abanoub Riad et al.

Summary: The study conducted a survey on the side effects of the Pfizer-BioNTech COVID-19 vaccine among healthcare workers in the Czech Republic, revealing common side effects such as injection site pain, fatigue, and headache. Younger age groups and individuals who received two doses of the vaccine were more likely to experience side effects, with the overall prevalence of side effects higher than reported by the manufacturer.

JOURNAL OF CLINICAL MEDICINE (2021)

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Editorial Material Public, Environmental & Occupational Health

Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines

Alice Palmer-Ross et al.

BMJ GLOBAL HEALTH (2021)

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Article Medicine, General & Internal

Minor to Moderate Side Effects of Pfizer-BioNTech COVID-19 Vaccine Among Saudi Residents: A Retrospective Cross-Sectional Study

Nagla A. El-Shitany et al.

Summary: This study tracked the short-term side effects of the Pfizer vaccine, finding common symptoms to include injection site pain, headaches, and fever. Females and individuals previously infected with the coronavirus were more likely to experience side effects.

INTERNATIONAL JOURNAL OF GENERAL MEDICINE (2021)

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Letter Peripheral Vascular Disease

Stage III Hypertension in Patients After mRNA-Based SARS-CoV-2 Vaccination

Sylvain Meylan et al.

HYPERTENSION (2021)

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Letter Dermatology

Cutaneous adverse reactions after m-RNA COVID-19 vaccine: early reports from Northeast Italy

E. Farinazzo et al.

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY (2021)

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Article Medicine, General & Internal

Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents

Robert W. Frenck et al.

Summary: The BNT162b2 vaccine showed favorable safety profile and a greater immune response in 12-to-15-year-old recipients compared to young adults, and demonstrated high effectiveness against Covid-19.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Multidisciplinary Sciences

Lack of consideration of sex and gender in COVID-19 clinical studies

Emer Brady et al.

Summary: The study found that sex-disaggregated analyses are infrequently presented or planned in COVID-19 studies, with only a small percentage including sex as an analytical variable. This highlights the importance of considering sex and gender differences in research designs for COVID-19 studies.

NATURE COMMUNICATIONS (2021)

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Article Immunology

Pfizer-BioNTech COVID-19 Vaccine Tolerance in Allergic versus Non-Allergic Individuals

Marita Nittner-Marszalska et al.

Summary: The study examined the tolerance of allergic patients to the Pfizer-BioNTech vaccine through an online questionnaire. Results showed that allergic individuals were more likely to experience local and systemic adverse reactions after vaccination, but these reactions were mild and did not prevent successful completion of the vaccination cycle.

VACCINES (2021)

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Article Medicine, General & Internal

Analysis of Female Enrollment and Participant Sex by Burden of Disease in US Clinical Trials Between 2000 and 2020

Jecca R. Steinberg et al.

Summary: This study found that sex differences in clinical trials varied by disease category, with male and female participants underrepresented in different medical fields. Although progress has been made in sex equity, the persistence of sex bias in clinical trials within medical fields has negative consequences for the health of all individuals.

JAMA NETWORK OPEN (2021)

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Article Medicine, General & Internal

Early Safety Monitoring of COVID-19 Vaccines in Healthcare Workers

Joon Young Song et al.

Summary: Hospital-based surveillance found that healthcare workers who received the adenovirus-vectored COVID-19 vaccine experienced higher rates of systemic adverse events compared to mRNA vaccine recipients. Common adverse events among adenovirus-vectored vaccine recipients included fatigue, myalgia, headache, and fever, with most symptoms resolving within 2 days. Both COVID-19 vaccines were generally safe with few serious adverse events reported.

JOURNAL OF KOREAN MEDICAL SCIENCE (2021)

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Article Medicine, General & Internal

Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System

Minji Jeon et al.

Summary: The study focused on investigating adverse events following immunization (AEFIs) for COVID-19 among healthcare workers (HCWs) who received the ChAdOx1 nCoV-19 vaccine. The majority of AEFIs reported were mild-to-moderate in severity, with older age groups experiencing fewer and less severe AEFIs. No serious events requiring hospitalization were reported, and most AEFIs resolved within a few days. The use of the Mobile Vaccine Adverse Events Reporting System (MVAERS) was found to be helpful in monitoring and sharing accurate information about vaccination against COVID-19.

JOURNAL OF KOREAN MEDICAL SCIENCE (2021)

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Article Medicine, General & Internal

Adverse Events in Healthcare Workers after the First Dose of ChAdOx1 nCoV-19 or BNT162b2 mRNA COVID-19 Vaccination: a Single Center Experience

Si Ho Kim et al.

Summary: The study in South Korea on healthcare workers receiving COVID-19 vaccinations showed that more adverse events were reported in ChAdOx1 nCoV-19 recipients compared to BNT162b2 recipients. However, most reported adverse events were mild to moderate in severity, emphasizing the importance of providing sufficient explanation and preparation for expected adverse events to promote widespread vaccination.

JOURNAL OF KOREAN MEDICAL SCIENCE (2021)

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Article Medicine, General & Internal

Adverse Reactions Following the First Dose of ChAdOx1 nCoV-19 Vaccine and BNT162b2 Vaccine for Healthcare Workers in South Korea

Seongman Bae et al.

Summary: A prospective survey conducted in South Korea on healthcare workers who received the first dose of two COVID-19 vaccines showed a higher rate of adverse reactions in the ChAdOx1 group compared to the BNT162b2 group. Females and younger age groups were more likely to experience vaccine-associated adverse reactions.

JOURNAL OF KOREAN MEDICAL SCIENCE (2021)

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Letter Medicine, General & Internal

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Danuta M. Skowronski et al.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Shirin Heidari et al.

BMJ GLOBAL HEALTH (2020)

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Hannah Peckham et al.

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Review Cardiac & Cardiovascular Systems

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Mark Woodward

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Stephanie Fischinger et al.

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Marta Feletto et al.

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Noel T. Brewer et al.

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Mary S. Himmelstein et al.

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