COVID-19 complications in males and females: recent developments

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Abstract

Aim:

To provide a comprehensive understanding of the varying effects of SARS-CoV-2 infection based on sex.

Methods:

A PubMed search of 470 primary articles was performed, with inclusion based on relevance (sex differences discussed in the target COVID population) and redundancy. PubMed was queried based on title for the keywords “SEX” and “COVID” or “SARS” between 2020 and 2022.

Results:

For COVID-19, males have increased risk for infectivity and intensive care unit admission and worse overall outcomes compared with females. Genetic predispositions, sex hormones, immune system responses and non-biological causes all contribute to the disparity in COVID-19 responses between the sexes. COVID-19 sex-related determinants of morbidity and mortality remain unclear.

Conclusions:

Male sex is a risk factor for several overall worse outcomes related to COVID-19. Investigating the sex impact of COVID-19 is an important part of understanding the behavior of the disease. Future work is needed to further explore these relationships and optimize the management of COVID-19 patients based on sex.

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Most cited references 62

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)

Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)

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Attributes and predictors of long COVID

Carole H. Sudre, Benjamin Murray, Thomas Varsavsky … (2021)

Reports of long-lasting coronavirus disease 2019 (COVID-19) symptoms, the so-called 'long COVID', are rising but little is known about prevalence, risk factors or whether it is possible to predict a protracted course early in the disease. We analyzed data from 4,182 incident cases of COVID-19 in which individuals self-reported their symptoms prospectively in the COVID Symptom Study app1. A total of 558 (13.3%) participants reported symptoms lasting ≥28 days, 189 (4.5%) for ≥8 weeks and 95 (2.3%) for ≥12 weeks. Long COVID was characterized by symptoms of fatigue, headache, dyspnea and anosmia and was more likely with increasing age and body mass index and female sex. Experiencing more than five symptoms during the first week of illness was associated with long COVID (odds ratio = 3.53 (2.76-4.50)). A simple model to distinguish between short COVID and long COVID at 7 days (total sample size, n = 2,149) showed an area under the curve of the receiver operating characteristic curve of 76%, with replication in an independent sample of 2,472 individuals who were positive for severe acute respiratory syndrome coronavirus 2. This model could be used to identify individuals at risk of long COVID for trials of prevention or treatment and to plan education and rehabilitation services.

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Author and article information

Journal

Journal ID (nlm-ta): J Comp Eff Res

Journal ID (iso-abbrev): J Comp Eff Res

Journal ID (publisher-id): CER

Title: Journal of Comparative Effectiveness Research

Publisher: Future Medicine Ltd (London, UK )

ISSN (Print): 2042-6305

ISSN (Electronic): 2042-6313

Publication date (Electronic, pub): 05 May 2022

Publication date (Print, pub): June 2022

Publication date PMC-release: 05 May 2022

Volume: 11

Issue: 9

Pages: 689-698

Affiliations

[1 ]Department of Anesthesiology, Weill Cornell Medicine, 525 East 68th Street, Box 124, New York, NY 10065, USA

[2 ]Weill Cornell Medical College, Weill Cornell Medicine, 1300 York Avenue, New York, NY 10065, USA

Author notes

[* ]Author for correspondence: Tel.: +1 917 693 0464; rsw9006@ 123456med.cornell.edu

Author information

Rahul Chaturvedi https://orcid.org/0000-0001-6324-0771

Article

DOI: 10.2217/cer-2022-0027

PMC ID: 9149780

PubMed ID: 35510532

SO-VID: 55ed63f5-e643-4019-9587-e62abf32047c

License:

This work is licensed under the Creative Commons Attribution 4.0 License

History

Date received : 12 February 2022

Date accepted : 13 April 2022

Date: 05 May 2022

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Pages: 10

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COVID-19 complications in males and females: recent developments

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Most cited references 62

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Attributes and predictors of long COVID

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