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1.
Med Sci Monit ; 28: e935952, 2022 Jan 01.
Article in English | MEDLINE | ID: covidwho-1596813

ABSTRACT

On 4th November 2021, the first oral antiviral drug for COVID-19, molnupiravir (Lagevrio®), received full regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. Molnupiravir is an orally bioavailable antiviral drug for use at home when a SARS-CoV-2 test is positive. On 22nd December 2022, the FDA granted emergency use authorization (EUA) for the oral antiviral drug, nirmatrelvir/ritonavir (Paxlovid®) for adults and children with mild and moderate COVID-19 at increased risk of progression to severe COVID-19. These regulatory drug approvals come at a crucial time when new variants of concern of the SARS-CoV-2 virus are spreading rapidly. Although the FDA approved remdesivir (Veklury®) on 22nd October 2020 for use in adults and children for the treatment of COVID-19 requiring hospitalization, its use has been limited by the requirement for intravenous administration in a healthcare facility. The four FDA-approved therapeutic neutralizing monoclonal antibodies, imdevimab, bamlanivimab, etesevimab, and casirivimab are costly and also require medically-supervised intravenous administration. The availability of effective, low-cost oral antiviral drugs available in a community setting that can be used at an early stage of SARS-CoV-2 infection is now a priority in controlling COVID-19. An increasing number of repurposed antiviral drugs are currently under investigation or in the early stages of regulatory approval. This Editorial aims to present an update on the current status of orally bioavailable antiviral drug treatments for SARS-CoV-2 infection.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Cytidine/analogs & derivatives , Hydroxylamines/therapeutic use , Administration, Oral , Antibodies, Monoclonal/therapeutic use , Cytidine/therapeutic use , Drug Approval , Drug Repositioning/trends , Humans , Lactams/therapeutic use , Leucine/therapeutic use , Nitriles/therapeutic use , Proline/therapeutic use , Ritonavir/therapeutic use , SARS-CoV-2/drug effects , SARS-CoV-2/pathogenicity , United States , United States Food and Drug Administration
2.
Med Sci Monit ; 27: e935624, 2021 Dec 01.
Article in English | MEDLINE | ID: covidwho-1547798

ABSTRACT

In 2021, data from global disease monitoring and infection surveillance programs have shown that vaccination programs have reduced the incidence of SARS-CoV-2 infection and hospitalization and mortality rates. Currently, the US Centers for Disease Control and Prevention (CDC) identifies a fully vaccinated individual as being ≥14 days after the completion of all the recommended doses of a COVID-19 vaccine that has been authorized by the US Food and Drug Administration (FDA). A partially vaccinated individual is <14 days following primary vaccination or has not completed the vaccination program. Clinical studies and data on the vaccine status of populations have identified breakthrough COVID-19 cases in fully vaccinated individuals at 14 or more days after completing the recommended dose of an authorized SARS-CoV-2 vaccine. This Editorial presents an update on what has been learned in the past year on SARS-CoV-2 vaccine responses and breakthrough COVID-19.

3.
Med Sci Monit ; 28: e935299, 2021 Nov 01.
Article in English | MEDLINE | ID: covidwho-1497922

ABSTRACT

Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant national reporting agencies as part of the process of post-marketing drug safety monitoring. In the US, the Vaccine Adverse Event Reporting System (VAERS) is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Data from VAERS and other national and global reporting systems show very low rates of adverse events related to currently approved SARS-CoV-2 vaccines. Populations studies have supported the findings from adverse event reporting systems. The presentation, monitoring, and reporting of adverse events related to SARS-CoV-2 vaccines may have future applications in vaccine monitoring for several other potential pandemic zoonotic infections. This editorial aims to summarize the current understanding of adverse events from current COVID-19 vaccines from global adverse event reporting systems, rather than individual case reports or anecdotal reporting in the media.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , COVID-19 Vaccines/adverse effects , COVID-19/drug therapy , SARS-CoV-2/drug effects , Vaccination/adverse effects , COVID-19/immunology , COVID-19/virology , Humans , International Agencies
4.
Med Sci Monit ; 27: e935123, 2021 Oct 18.
Article in English | MEDLINE | ID: covidwho-1478478

ABSTRACT

The development and use of digital health technology have increased during the global COVID-19 pandemic. Artificial intelligence (AI)-powered digital tools have been increasingly used to diagnose and screen for SARS-CoV-2 infection. Digital technology, in the form of mobile phone applications (apps), has been adopted by several countries to track infected individuals as infection prevention and surveillance measures. Global best practice guidelines, technology approvals, and patient care models have only recently begun to catch up with the developments in digital technology. In 2021, the WHO published a global strategy on digital health (eHealth) and mobile health (mHealth) for 2020 to 2025. The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) now evaluates software as a medical device (SaMD) and software that is in a medical device (SiMD) through the International Medical Device Regulators Forum (IMDRF). This Editorial aims to discuss how the COVID-19 pandemic has driven global initiatives to support the use and regulation of digital health technology and the requirements for digital health evidence frameworks and new approaches to regulatory approvals.


Subject(s)
COVID-19 , Telemedicine/methods , Artificial Intelligence , COVID-19/epidemiology , Humans , Mobile Applications , Pandemics , Smartphone
5.
Med Sci Monit ; 27: e935005, 2021 Oct 11.
Article in English | MEDLINE | ID: covidwho-1464039

ABSTRACT

Recent studies on the pathogenesis and clinical spectrum of human disease following infection with the new human pathogen, SARS-CoV-2, have identified the varied presentations and sequelae of COVID-19. Acute 'cytokine storm' in severe COVID-19 results in multiorgan damage due to vascular hyperpermeability, edema, and hypercoagulation. The long-term consequences of infection from SARS-CoV-2 include long COVID. or post-COVID syndrome, and multisystem inflammatory syndrome in children (MIS-C). Several case reports of multisystem inflammatory syndrome in adults (MIS-A) have shown the presentation at more than four weeks after initial infection with SARS-CoV-2 in adults more than 21 years of age. In September 2021, a published systematic review of the literature identified 221 patients with MIS-A, representing the most comprehensive clinical study to date. MIS-A occurs in the post-acute COVID-19 period. The pathogenesis may involve a dysregulated antibody-mediated immune response, similar to MIS-C. Therefore, patients with MIS-A may respond to supportive therapies that control hyperinflammation. This Editorial aims to describe MIS-A and discuss COVID-19 as a spectrum of hyperinflammatory disease in terms of severity, extent, duration, and patient age.


Subject(s)
COVID-19/complications , Systemic Inflammatory Response Syndrome/etiology , COVID-19/genetics , COVID-19/immunology , Cytokine Release Syndrome/etiology , Cytokine Release Syndrome/genetics , Cytokine Release Syndrome/immunology , Humans , Systemic Inflammatory Response Syndrome/genetics , Systemic Inflammatory Response Syndrome/immunology
6.
Med Sci Monit ; 27: e934949, 2021 Oct 04.
Article in English | MEDLINE | ID: covidwho-1450987

ABSTRACT

There have been five viral pandemics in the past century, four were due to influenza, and the ongoing COVID-19 pandemic is due to SARS-CoV-2 infection. During the COVID-19 pandemic, there has been a 99% global reduction in the diagnosis of influenza. Also, from 2020, global mortality rates from influenza fell to record levels during the influenza seasons in the southern and northern hemispheres. However, as social restrictions become lifted and the winter season begins in the northern hemisphere, it is expected that influenza will re-emerge. The World Health Organization (WHO) FluNet surveillance platform provides global surveillance data on influenza, and the US Centers for Disease Control and Prevention (CDC) records national weekly infection rates. Both surveillance programs have identified zoonotic avian and swine influenza variants in humans. The WHO Pandemic Influenza Preparedness (PIP) Framework requires WHO Member States to share data on cases of emerging influenza viruses with pandemic potential in a regular and timely way. The WHO PIP Framework organizes the Global Influenza Surveillance and Response System (GISRS), a global network of public health laboratories developing candidate virus vaccines. This Editorial aims to present the reasons for concern regarding the emergence of pandemic influenza viruses driven by the social and public health responses to the COVID-19 pandemic and highlights the importance of global influenza surveillance at this time.


Subject(s)
COVID-19/epidemiology , Influenza, Human/epidemiology , Orthomyxoviridae/immunology , Pandemics , COVID-19/immunology , Humans , Influenza, Human/immunology , SARS-CoV-2
7.
Med Sci Monit ; 27: e934854, 2021 Sep 27.
Article in English | MEDLINE | ID: covidwho-1441381

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has affected the number of completed clinical trials, particularly in oncology. Between 80-85% of all lung cancers are non-small cell lung cancer (NSCLC), and of these, between 2-3% have an EGFR exon 20 insertion, which is associated with increased cell proliferation, metastasis, and a lack of response to chemotherapy and epidermal growth factor receptor (EGFR) inhibitors. Until this year, there were no available targeted therapies for advanced NSCLC with this genetic subtype. However, in May 2021, the US Food and Drug Administration (FDA) granted accelerated approval for amivantamab-vmjw (Rybrevant®), a bispecific monoclonal antibody, targeting activating and resistant EGFR and MET mutations and amplifications. This FDA approval was for adult patients with locally advanced metastatic NSCLC, with disease progression on or following platinum-based chemotherapy. The FDA also approved the Guardant360® companion diagnostic, a next-generation sequencing platform for circulating tumor DNA (ctDNA), which is a liquid biopsy assay. In 2019, Project Orbis was launched by the FDA Oncology Center of Excellence as a global collaborative review program to facilitate rapid global access for patients to innovative cancer therapies. This Editorial aims to highlight how global regulatory initiatives from the FDA have delivered accelerated approval of the first bispecific therapeutic monoclonal antibody, amivantamab-vmjw (Rybrevant®), and a companion diagnostic for patients with advanced NSCLC with an EGFR exon 20 insertion.


Subject(s)
Antibodies, Bispecific/administration & dosage , Carcinoma, Non-Small-Cell Lung/drug therapy , Drug Approval , Lung Neoplasms/drug therapy , Carcinoma, Non-Small-Cell Lung/diagnosis , Carcinoma, Non-Small-Cell Lung/genetics , Carcinoma, Non-Small-Cell Lung/metabolism , ErbB Receptors/genetics , ErbB Receptors/metabolism , High-Throughput Nucleotide Sequencing , Humans , Mutation , Proto-Oncogene Proteins c-met/genetics , Proto-Oncogene Proteins c-met/metabolism , United States , United States Food and Drug Administration
8.
Med Sci Monit ; 27: e934766, 2021 Sep 20.
Article in English | MEDLINE | ID: covidwho-1431155

ABSTRACT

During the past two years, clinical studies have attempted to identify risk factors to predict clinical outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In July 2021, a study using a high-throughput technique detected autoantibodies to chemokines, cytokines, and complement components in patients with symptomatic coronavirus disease 2019 (COVID-19). In August 2021, a study identified pre-existing autoantibodies to type 1 interferons (IFNs) in 10% of patients with severe COVID-19 but not asymptomatic individuals. Autoantibodies may be the long-awaited markers of clinical risk for severe COVID-19 in patients with SARS-CoV-2 infection. This Editorial aims to present some recent findings of autoantibodies to components of the immune system, including type 1 IFNs, and the risk of severe COVID-19.


Subject(s)
Autoantibodies/immunology , COVID-19/immunology , Interferon Type I/immunology , SARS-CoV-2/immunology , COVID-19/virology , Humans , Interferon Type I/genetics , SARS-CoV-2/genetics
9.
Med Sci Monit ; 27: e934625, 2021 Sep 06.
Article in English | MEDLINE | ID: covidwho-1395313

ABSTRACT

In the past 18 months, accelerated vaccine development to prevent or reduce the severity of coronavirus disease 2019 (COVID-19) has resulted in rapid global emergency regulatory approvals, including the US Food and Drug Administration (FDA) emergency use authorization (EUA) approvals. On August 23, 2021, the US FDA gave the first full regulatory approval for a COVID-19 vaccine and approved the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) for individuals 16 years and older. In the US, there is a continued EUA for individuals aged 12-15 years of age. Also, the EUA includes the administration of a third or booster dose in immunocompromised individuals at increased risk for severe COVID-19. This Editorial aims to present an update on the first COVID-19 vaccine to receive full regulatory approval, the Pfizer-BioNTech vaccine, and the implications for real-world public health during the global COVID-19 pandemic and increasing concerns for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern.


Subject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Health Policy , Immunization , Pandemics/prevention & control , Humans
10.
Med Sci Monit ; 27: e934514, 2021 Aug 30.
Article in English | MEDLINE | ID: covidwho-1378498

ABSTRACT

During 2020 and 2021, the COVID-19 pandemic has resulted in interruptions and cancellations of clinical trials and has delayed drug development in all areas except SARS-CoV-2 vaccine development. A further concern is the need to rapidly share anonymized datasets and improve opportunities to conduct randomized clinical trials (RCTs) in low-resource developing countries, particularly for oncology trials and for other infectious diseases. The Consolidated Standards of Reporting Trials (CONSORT) 2010 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 currently guide the reporting of trial protocols and completed RCTs, respectively. Extenuating circumstances or unavoidable situations may occur that are beyond the control of study sponsors and investigators. On June 21, 2021, the CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance (CONSERVE) was published. The scope of CONSERVE 2021 includes modifications that have substantive implications for the feasibility, ethical conduct, scientific content, and study analysis. This Editorial aims to provide the background to CONSERVE 2021 and show how these guidelines may reduce the number of clinical trials currently being paused or discontinued due to the COVID-19 pandemic, particularly in poorly resourced and developing countries.


Subject(s)
COVID-19/epidemiology , Clinical Protocols/standards , Guidelines as Topic , Publishing/standards , Randomized Controlled Trials as Topic/standards , Research Report/standards , SARS-CoV-2/physiology , COVID-19/virology , Humans , United States/epidemiology
11.
Med Sci Monit ; 27: e934393, 2021 Aug 16.
Article in English | MEDLINE | ID: covidwho-1359432

ABSTRACT

Regulatory authorities, including the US Food and Drug Administration (FDA), have accelerated diagnostic and therapeutic approvals during the coronavirus disease 2019 (COVID-19) pandemic. Accelerated clinical development and approvals have resulted in vaccine programs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, some individuals remain at high risk for the progression of COVID-19. In the US, the FDA has given Emergency Use Authorization (EUA) for two neutralizing therapeutic monoclonal antibody 'cocktails,' casirivimab and imdevimab (REGEN-COV), bamlanivimab and etesevimab, and one monotherapy, bamlanivimab, for prophylactic post-exposure therapy in individuals at high risk of progressing to severe COVID-19. Preclinical and clinical studies showed consistent effectiveness of REGEN-COV against current variants of SARS-CoV-2. On 21st November 2020, the FDA approved an initial EUA for REGEN-COV to treat mild to moderate COVID-19 in adults and in children 12 years or older with exposure to SARS-CoV-2 at high risk for progression to severe COVID-19. On 30th July 2021, the FDA updated its EUA for REGEN-COV for emergency use as post-exposure prophylactic to prevent COVID-19 progression in adults and children aged 12 years or older. This Editorial aims to provide an update on accelerated regulatory authorization for post-exposure prophylactic neutralizing monoclonal antibodies to SARS-CoV-2 for individuals at high risk for COVID-19.


Subject(s)
Antibodies, Monoclonal/therapeutic use , COVID-19/drug therapy , Humans , Risk , SARS-CoV-2 , United States , United States Food and Drug Administration
12.
Med Sci Monit ; 27: e934292, 2021 Aug 09.
Article in English | MEDLINE | ID: covidwho-1348802

ABSTRACT

The World Health Organization (WHO) estimated that in 2019, 10.0 million people worldwide developed tuberculosis (TB), with 1.4 million deaths from TB in that year. Infection with Mycobacterium tuberculosis that is resistant to at least isoniazid and rifampin and an additional chemotherapeutic agent is known as multidrug-resistant TB (MDR TB). Until recently, the prevalence of drug resistance in patients with TB has been poorly understood due to a lack of infection surveillance and molecular testing. Countries with the highest prevalence of TB, including MDR TB, are also those most affected by the COVID-19 pandemic. The identification of MDR TB requires careful monitoring and resources for molecular testing. Previous treatment regimens have required intravenous treatments of long duration and high cost. The 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB have included oral treatment regimens and reduced treatment duration. This Editorial aims to present the rationale for the 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB.


Subject(s)
Tuberculosis, Multidrug-Resistant/drug therapy , Tuberculosis, Pulmonary/drug therapy , Tuberculosis/drug therapy , Antitubercular Agents/therapeutic use , Clinical Protocols/standards , Global Health , Humans , Mycobacterium tuberculosis/isolation & purification , Tuberculosis/epidemiology , Tuberculosis, Multidrug-Resistant/epidemiology , Tuberculosis, Pulmonary/epidemiology , World Health Organization
13.
Med Sci Monit ; 27: e934171, 2021 Aug 02.
Article in English | MEDLINE | ID: covidwho-1337822

ABSTRACT

Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19) commonly presents with pneumonia. However, COVID-19 is now recognized to involve multiple organ systems with varying severity and duration. In July 2021, the findings from a retrospective population study from the National COVID Cohort Collaborative (N3C) Consortium were published that included analysis by machine learning methods of 174,568 adults with SARS-CoV-2 infection from 34 medical centers in the US. The study stratified patients for COVID-19 according to the World Health Organization (WHO) Clinical Progression Scale (CPS). Severe clinical outcomes were identified as the requirement for invasive ventilatory support, or extracorporeal membrane oxygenation (ECMO), and patient mortality. Machine learning analysis showed that the factor most strongly associated with severity of clinical course in patients with COVID-19 was pH. A separate multivariable logistic regression model showed that independent factors associated with more severe clinical outcomes included age, dementia, male gender, liver disease, and obesity. This Editorial aims to present the rationale and findings of the largest population cohort of adult patients with COVID-19 to date and highlights the importance of using large population studies with sophisticated analytical methods, including machine learning.


Subject(s)
COVID-19 , Machine Learning , Adult , COVID-19/classification , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/mortality , Diagnosis, Computer-Assisted , Female , Humans , Male , Middle Aged , Models, Statistical , Population Health , Risk Factors , SARS-CoV-2 , Severity of Illness Index
14.
Med Sci Monit ; 27: e934077, 2021 Jul 26.
Article in English | MEDLINE | ID: covidwho-1326004

ABSTRACT

Current treatments for patients with Alzheimer's disease aim to improve behavioral, cognitive, and non-cognitive symptoms. There have been no new drug approvals for preventing or treating Alzheimer's disease for more than two decades. Drug development in Alzheimer's disease aims to identify disease-modifying therapies that will delay or slow the clinical course of this disease. More than 50% of the current Alzheimer's disease drug pipeline now involves immunotherapies or oral small molecule agents. The most promising disease-modifying drug targets are amyloid ß and tau protein. In June 2021, aducanumab, a humanized recombinant monoclonal antibody to amyloid ß, was the first potential disease-modifying therapy approved by the US Food and Drug Administration (FDA) to treat Alzheimer's disease and mild cognitive impairment. Accelerated approval of aducanumab was based on the results of only one of two phase 3 clinical trials. Several clinical trials of targeted disease-modifying immunotherapies to the tau protein and amyloid ß that commenced before the current COVID-19 pandemic have been delayed. This Editorial aims to provide an update on past, present, and future disease-modifying therapies in Alzheimer's disease, including targeted therapies for amyloid ß and tau protein.


Subject(s)
Alzheimer Disease/drug therapy , Alzheimer Disease/metabolism , Amyloid beta-Peptides/metabolism , tau Proteins/metabolism , Antibodies, Monoclonal, Humanized/therapeutic use , Cognitive Dysfunction/drug therapy , Cognitive Dysfunction/immunology , Humans , Immunotherapy/methods , Immunotherapy/trends , Tauopathies/drug therapy
15.
Med Sci Monit ; 27: e933446, 2021 Jun 07.
Article in English | MEDLINE | ID: covidwho-1323453

ABSTRACT

During 2020, increasing numbers of case reports, case series, and small observational studies reported long-term complications of coronavirus disease 2019 (COVID-19) in patients who had recovered from acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Long COVID has a prevalence of between 10-30% in patients with a recent history of SARS-CoV-2 infection. Pulmonary, hematologic, cardiovascular, neuropsychiatric, renal, endocrine, gastrointestinal and hepatobiliary, and dermatologic involvement, and chronic multisystem inflammatory syndrome in children (MIS-C) highlights the requirement for a multidisciplinary approach to the management of patients with long COVID. This Editorial aims to present the current status of long COVID, or post-COVID syndrome, and its global impact on health and the provision of health care.


Subject(s)
COVID-19/complications , COVID-19/epidemiology , COVID-19/economics , COVID-19/metabolism , COVID-19/therapy , Convalescence , Delivery of Health Care , Humans , Pandemics , Recovery of Function , SARS-CoV-2/isolation & purification
16.
Med Sci Monit ; 27: e933973, 2021 Jul 19.
Article in English | MEDLINE | ID: covidwho-1317347

ABSTRACT

Vaccinated, non-vaccinated, and immunosuppressed individuals will continue to be infected with SARS-CoV-2. Therefore, there is a priority to develop treatments that reduce the severity of COVID-19 in patients who require hospital admission. Interleukin-6 (IL-6) is a proinflammatory cytokine. In 2011, a humanized monoclonal antibody to the IL-6 receptor (IL-6R), tocilizumab, was approved by the US Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, and Castleman's disease. In 2017, tocilizumab was approved to treat chimeric antigen receptor (CAR) T-cell therapy-induced cytokine release syndrome (CRS). In 2021, the results of the REMAP-CAP clinical trial (NCT02735707) and the COVID-19 Therapy (RECOVERY) clinical trial (NCT04381936) supported FDA Emergency Use Authorization (EUA) for tocilizumab to treat hospitalized patients with moderate and severe COVID-19. Monoclonal antibodies are currently in clinical development or undergoing clinical trials to treat COVID-19. Further clinical trials will provide safety and efficacy data on targeting IL-6 and IL-6R and provide rationales for more personalized combination treatments to control the systemic effects of SARS-CoV-2 infection in hospitalized patients with moderate and severe COVID-19. This Editorial aims to present the background to the recent authorization of tocilizumab, a humanized therapeutic monoclonal antibody to the IL-6 receptor (IL-6R), for hospitalized patients with moderate and severe COVID-19 and future combination therapies.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/therapy , Interleukin-6/immunology , Combined Modality Therapy , Humans
17.
Med Sci Monit ; 27: e933088, 2021 05 17.
Article in English | MEDLINE | ID: covidwho-1314975

ABSTRACT

Synthetic mRNA and the expression of therapeutic proteins have accelerated vaccine development to prevent infection and heralds a new era in targeted immunotherapy in oncology. Therapeutic mRNA vaccines rely on available tumor tissue for gene sequencing analysis to compare the patient's normal cellular DNA sequences and those of the tumor. Carrier-based mRNA vaccines for cancer immunotherapy are now in development that use delivery systems based on peptides, lipids, polymers, and cationic nano-emulsions. There have also been recent developments in dendritic cell-based mRNA vaccines. For patients with available tumor tissue samples, it is possible to develop mRNA vaccines that result in the expression of tumor antigens by antigen-presenting cells (APCs), resulting in innate and adaptive immune responses. Ongoing developments in mRNA immunotherapy include modifications in the route of administration and combined delivery of multiple mRNA vaccines with checkpoint inhibitors. This Editorial aims to present a brief overview of how mRNA immunotherapy may change the therapeutic landscape of personalized medicine for patients with solid malignant tumors.


Subject(s)
Cancer Vaccines/immunology , Neoplasms/immunology , Neoplasms/therapy , RNA, Messenger/immunology , Vaccines, Synthetic/immunology , Humans , Immunotherapy/methods , Medical Oncology/methods , Precision Medicine/methods
18.
Med Sci Monit ; 27: e933831, 2021 Jul 05.
Article in English | MEDLINE | ID: covidwho-1296218

ABSTRACT

During the global COVID-19 pandemic, data from clinical studies, systematic review, and population registry data have shown that when compared with non-pregnant women, SARS-CoV-2 infection in pregnancy is associated with a small increase in risk to the mother. Large cohort studies and registry data collected from 2020 have included the US Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET), COVI-PREG, the UK and Global Pregnancy and Neonatal Outcomes in COVID-19 (PAN-COVID) study, the American Academy of Pediatrics (AAP) Section on Neonatal-Perinatal Medicine (SONPM) National Perinatal COVID-19 Registry, the Swedish Pregnancy Register, and the Canadian Surveillance of COVID-19 in Pregnancy (CANCOVID-Preg) registry. Recently published data have shown that most maternal infections with SARS-CoV-2 occur during the third trimester and result in a small increase in hospital admission, admission to the intensive care unit (ICU), mechanical ventilation, preterm birth, and increased cesarean sections in mothers infected with SARS-CoV-2. However, currently approved vaccines given in pregnancy result in an immune response to current SARS-CoV-2 variants. Transplacental transmission of SARS-CoV-2 to the fetus can occur, but the immediate and long-term effects on the newborn infant remain unclear. Therefore, women who are pregnant or planning a pregnancy should be managed according to current clinical guidelines with timely vaccination to prevent infection with SARS-CoV-2. This Editorial summarizes what is currently known about maternal SARS-CoV-2 infection and pregnancy outcomes from multinational studies.


Subject(s)
COVID-19/epidemiology , Pregnancy Complications, Infectious/epidemiology , Premature Birth/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Cesarean Section/statistics & numerical data , Female , Hospitalization/statistics & numerical data , Humans , Infectious Disease Transmission, Vertical , Intensive Care Units/statistics & numerical data , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Pregnancy Outcome , Respiration, Artificial/statistics & numerical data , SARS-CoV-2
19.
Med Sci Monit ; 27: e932899, 2021 04 26.
Article in English | MEDLINE | ID: covidwho-1261462

ABSTRACT

During 2020 and 2021, the global pandemic of coronavirus disease 2019 (COVID-19) due to severe acute respi- ratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in high death rates and acute and chronic morbidity in all countries. The rapid development of new mRNA vaccines to SARS-CoV-2 brings hope that the spread of this virus can be controlled. The ChAdOx1 nCoV-19 vaccine developed by a collaboration between the University of Oxford and AstraZeneca showed efficacy in clinical trials, with a good safety profile. However, there have been recent reports of the rare development of thrombotic events in young women following vaccination with ChAdOx1 nCoV-19, particularly of the rare condition of cavernous sinus thrombosis. Studies have begun to in- vestigate whether antibodies to the SARS-CoV-2 spike cross-react with platelet factor 4 (PF4/CXLC4) and mim- ic autoimmune heparin-induced thrombocytopenia. This Medical Science Monitor Editorial aims to briefly update the current status of studies on a possible rare complication of using new mRNA vaccines to prevent COVID-19.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/complications , Purpura, Thrombocytopenic, Idiopathic/etiology , RNA, Messenger , SARS-CoV-2 , COVID-19/prevention & control , COVID-19 Vaccines/genetics , COVID-19 Vaccines/immunology , Clinical Trials as Topic , Humans , RNA, Messenger/genetics , RNA, Messenger/immunology , SARS-CoV-2/genetics , SARS-CoV-2/immunology
20.
Med Sci Monit ; 27: e933446, 2021 Jun 07.
Article in English | MEDLINE | ID: covidwho-1259746

ABSTRACT

During 2020, increasing numbers of case reports, case series, and small observational studies reported long-term complications of coronavirus disease 2019 (COVID-19) in patients who had recovered from acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Long COVID has a prevalence of between 10-30% in patients with a recent history of SARS-CoV-2 infection. Pulmonary, hematologic, cardiovascular, neuropsychiatric, renal, endocrine, gastrointestinal and hepatobiliary, and dermatologic involvement, and chronic multisystem inflammatory syndrome in children (MIS-C) highlights the requirement for a multidisciplinary approach to the management of patients with long COVID. This Editorial aims to present the current status of long COVID, or post-COVID syndrome, and its global impact on health and the provision of health care.


Subject(s)
COVID-19/complications , COVID-19/epidemiology , COVID-19/economics , COVID-19/metabolism , COVID-19/therapy , Convalescence , Delivery of Health Care , Humans , Pandemics , Recovery of Function , SARS-CoV-2/isolation & purification
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