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Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting
Preapproval trials showed that messenger RNA (mRNA)–based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had a good safety profile, yet these trials were subject to size and patient-mix limitations. An evaluation of the safety of the BNT162b2 mRNA vaccine with respect to a broad range of potential adverse events is needed.
SARS-CoV-2 mRNA vaccines induce persistent human germinal centre responses
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA)-based vaccines are ~95% effective in preventing coronavirus disease 20191–5. The dynamics of antibody secreting plasmablasts (PBs) and germinal centre (GC) B cells induced by these vaccines in humans remain unclear. We examined antigen-specific B cell responses in peripheral blood (n=41) and draining lymph nodes (LNs) in 14 individuals who received two doses of BNT162b2, an mRNA-based vaccine encoding full-length SARS-CoV-2 spike (S) gene1. Circulating IgG- and IgA-secreting PBs targeting the S protein peaked one week after the second immunization then declined, becoming undetectable three weeks later. These PB responses preceded maximal levels of serum anti-S binding and neutralizing antibodies to an early circulating SARS-CoV-2 strain as well as emerging variants, especially in individuals previously infected with SARS-CoV-2, who produced the most robust serologic responses. By examining fine needle aspirates (FNAs) of draining axillary LNs, we identified GC B cells that bound S protein in all participants sampled after primary immunization.
SARS-CoV-2 Delta VOC in Scotland: demographics, risk of hospital admission, and vaccine effectiveness
On May 19, 2021, the Delta Variant of Concern (VOC), formerly known as the Indian VOC or B 1.617.2, became the dominant strain of SARS-CoV-2 in Scotland. The Alpha VOC (formerly known as the Kent VOC, B.1.1.7, or S gene negative) had been the dominant strain previously, but it has rapidly been replaced (appendix p 1).
Samples were analysed using ThermoFisher's TaqPath RT-PCR, which tests for the presence of three target genes from SARS-CoV-2. S gene-negative samples had a deletion in S gene of B.1.1.7 (Alpha VOC) at position 69-70, with cycle threshold (Ct) values less than 30 for at least one of the OR and N genes. S gene-positive samples had Ct values less than 30 for the S gene and valid Ct values for the other two genes. In contrast, a weak S gene-positive sample had a Ct of 30 or less for S. Sequencing data from Scotland has found that for April 1 to May 28, 2021, the latest date until which data were available, 97% of S gene positive cases sequenced in Scotland were the Delta variant and that 99% of Delta variants were S gene positive.
Had COVID? You’ll probably make antibodies for a lifetime
Many people who have been infected with SARS-CoV-2 will probably make antibodies against the virus for most of their lives. So suggest researchers who have identified long-lived antibody-producing cells in the bone marrow of people who have recovered from COVID-19.
The study provides evidence that immunity triggered by SARS-CoV-2 infection will be extraordinarily long-lasting. Adding to the good news, “the implications are that vaccines will have the same durable effect”, says Menno van Zelm, an immunologist at Monash University in Melbourne, Australia.
PF4 Immunoassays in Vaccine-Induced Thrombotic Thrombocytopenia
In a recent study, Greinacher et al. reported thrombotic complications, mostly cerebral vein thrombosis, associated with thrombocytopenia in 11 patients after they had been vaccinated with ChAdOx1 nCoV-19 (AstraZeneca). Although none of these patients had received heparin, the authors detected high titers of anti–platelet factor 4 (PF4)–heparin antibodies that strongly activated platelets in vitro without heparin and in the presence of PF4. This syndrome, which resembles autoimmune heparin-induced thrombocytopenia, was called vaccine-induced immune thrombotic thrombocytopenia (VITT), and an algorithm for the management of this syndrome was proposed on the basis of immunoassays detecting anti–PF4–heparin antibodies.
Modeling of Future COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Rates and Nonpharmaceutical Intervention Scenarios
After a period of rapidly declining U.S. COVID-19 incidence during January–March 2021, increases occurred in several jurisdictions (1,2) despite the rapid rollout of a large-scale vaccination program. This increase coincided with the spread of more transmissible variants of SARS-CoV-2, the virus that causes COVID-19, including B.1.1.7 (1,3) and relaxation of COVID-19 prevention strategies such as those for businesses, large-scale gatherings, and educational activities. To provide long-term projections of potential trends in COVID-19 cases, hospitalizations, and deaths, COVID-19 Scenario Modeling Hub teams used a multiple-model approach comprising six models to assess the potential course of COVID-19 in the United States across four scenarios with different vaccination coverage rates and effectiveness estimates and strength and implementation of nonpharmaceutical interventions (NPIs) (public health policies, such as physical distancing and masking) over a 6-month period (April–September 2021) using data available through March 27, 2021 (4).
Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants
The messenger RNA vaccine BNT162b2 (Pfizer–BioNTech) has 95% efficacy against coronavirus disease 2019 (Covid-19).1 Qatar launched a mass immunization campaign with this vaccine on December 21, 2020. As of March 31, 2021, a total of 385,853 persons had received at least one vaccine dose and 265,410 had completed the two doses. Vaccination scale-up occurred as Qatar was undergoing its second and third waves of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, which were triggered by expansion of the B.1.1.7 variant (starting in mid-January 2021) and the B.1.351 variant (starting in mid-February 2021). The B.1.1.7 wave peaked during the first week of March, and the rapid expansion of B.1.351 started in mid-March and continues to the present day. Viral genome sequencing conducted from February 23 through March 18 indicated that 50.0% of cases of Covid-19 in Qatar were caused by B.1.351 and 44.5% were caused by B.1.1.7. Nearly all cases in which virus was sequenced after March 7 were caused by either B.1.351 or B.1.1.7.
COVID-19 vaccination of patients with allergies and type-2 inflammation with concurrent antibody therapy (biologicals) – A Position Paper of the German Society of Allergology and Clinical Immunology (DGAKI) and the German Society for Applied Allergology (AeDA)
After the beginning and during the worldwide pandemic caused by the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), patients with allergic and atopic diseases have felt and still feel insecure. Currently, four vaccines against SARS-CoV-2 have been approved by the Paul Ehrlich Institute in Germany, and vaccination campaigns have been started nationwide. In this respect, it is of utmost importance to give recommendations on possible immunological interactions and potential risks of immunomodulatory substances (monoclonal antibodies, biologicals) during concurrent vaccination with the approved vaccines. Materials and methods: This position paper provides specific recommendations on the use of immunomodulatory drugs in the context of concurrent SARS-CoV-2 vaccinations based on current literature. Results: The recommendations are covering the following conditions in which biologicals are indicated and approved: 1) chronic inflammatory skin diseases (atopic dermatitis, chronic spontaneous urticaria), 2) bronchial asthma, and 3) chronic rhinosinusitis with nasal polyps (CRSwNP).
Successful SARS-CoV-2 vaccine allergy risk-management: the experience of a large Italian University Hospital
Novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines have been recently approved, and public concern regarding the risk of anaphylactic reactions arised after few cases during the first days of mass-vaccination. Polyethylene glycol (PEG) has been suggested as the most probable culprit agent for allergic reactions.
COVID-19 Vaccination in Indonesia
It has been one year since the Coronavirus Disease 2019 (COVID-19) was declared national disaster in Indonesia since April 2020. As March 15, 2021, more than one million people have been confirmed with COVID-19 and 37 thousands have died. COVID-19 increasing cases had negative impact on various sectors in Indonesia, including economy, education and health sectors. In order to prevent more new cases, interventions need to be carried out, by implementing health protocols and vaccinations.
Most COVID-19 hospitalizations due to four conditions
Studies show that certain common medical conditions put people at higher risk for severe illness from COVID-19. These include metabolic disorders like type 2 diabetes and obesity, as well as heart conditions like high blood pressure (hypertension) and heart failure. People with these four conditions are more likely to be hospitalized with COVID-19.
Risk of mortality in patients infected with SARS-CoV-2 variant of concern 202012/1: matched cohort study
A new lineage of the SARS-CoV-2 virus (named B.1.1.7) was identified from genomic sequencing of samples from patients with covid-19 in the south east of England in early October 2020. In December 2020, Public Health England identified this virus as a variant of concern (VOC-202012/1).1 During December this new variant spread from the south east to London and the rest of the UK, with three quarters of infections being attributable to the new variant by 31 December 2020.2 The UK implemented a second national lockdown (5 November to 2 December 2020), which coincided with the relative growth of VOC-202012/1. After the lockdown, additional control measures were implemented as the increased rate of spread of the new variant became apparent and was made public.3 International restrictions on travel from the UK quickly followed, in particular to France and to the rest of Europe late in December 2020 to curb spread of the new variant to other countries, despite evidence that it was already present outside the UK. Since then, the prevalence of VOC-202012/1 has been observed to be increasing in both Europe and the US.
Optimal Management of Hereditary Angioedema: Shared Decision-Making
All patients with hereditary angioedema (HAE) must have access to on-demand therapy to treat attacks and may benefit from prophylactic therapy to reduce the attack frequency. Treatment decisions should be individualized, based on patient preferences and needs. One method for facilitating individualized therapy is shared decision-making (SDM), a widely used methodology for making treatment decisions among multiple therapeutic options. We propose a three-phase “3D” model (Discover, Discuss, Decide) for SDM in HAE. The Discover phase focuses on improving the physician’s understanding of the patient’s needs and understanding of the available therapeutic choices. The Discuss phase considers the alternatives, allowing a collaborative, informed treatment selection in the Decision phase. The 3D model is an ongoing, iterative process based on the patient’s changing needs and response to therapy. Uncovering the patient’s therapy goals through appropriate questions during these phases can help uncover relevant information for treatment selection information. SDM based on the 3D model can be a beneficial tool for optimizing therapy in HAE.
Neutralizing Activity of BNT162b2-Elicited Serum — Preliminary Report
BNT162b2 is a nucleoside-modified RNA vaccine expressing the full-length prefusion spike glycoprotein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In a randomized, placebo-controlled clinical trial involving approximately 44,000 participants, immunization conferred 95% efficacy against coronavirus disease 2019 (Covid-19).
SARS-CoV-2 Vaccines: Much Accomplished, Much to Learn
Over the next weeks and months, physicians will face questions regarding the science, safety, and efficacy of the first wave of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines to be authorized and distributed. In most cases these vaccine platforms will be new technologies that have not previously been administered other than through clinical trials. Although the initial data on efficacy and safety are extraordinarily encouraging, many questions remain regarding who should receive these vaccines and the immediate, intermediate, and long-term impact of the vaccination program on the pandemic. In this article, we provide a perspective on the vaccines furthest along in development in the United States, 2 of which have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and have been recommended for use by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). It is important to note that an EUA by the FDA is a mechanism used during a declared public health emergency to get potentially effective interventions as quickly as possible to those who might benefit and is not the same as formal FDA approval.
SARS-CoV-2 Vaccines and the Growing Threat of Viral Variants
In November 2019, a bat coronavirus made its debut in the human population. Since that time, the virus has continued to adapt, resulting in a series of viral variants. The question that the world faces in early 2021 is whether these new variants will escape recognition by vaccine-induced immunity.
Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine
Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A candidate vaccine, Ad26.COV2.S, is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein.
FDA Briefing Document: Moderna COVID-19 Vaccine
On November 30, 2020, ModernaTX (the Sponsor) submitted an Emergency Use Authorization (EUA) request to FDA for an investigational COVID-19 vaccine (mRNA-1273) intended to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine is based on the SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles (LNPs). The proposed use under an EUA is for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The proposed dosing regimen is 2 doses, 100 μg each, administered 1 month apart.
COVID-19 and asthma, the good or the bad? - Jiu-Yao Wang
Since its first report in Wuhan, China, in December 2019, the novel pandemic COVID-19, caused by SARS-CoV-2 virus, has rampaged throughout the world.1 People with asthma and allergies are usually at greater risk of more severe outcomes with virus infections. However, recent reports have accumulated evidences that the prevalence of allergic diseases and asthma in patients with COVID-19 is lower than expected among other comorbidities and risk factors of the severe form of COVID-19 (Appendix S1 for additional reference 1-3). Why are then allergic diseases and asthma underrepresented as co-morbid risk factors in patients with COVID-19? Is this a sampling bias in the currently published clinical reports or is there a real discrepancy in the prevalence of asthma among COVID-19-infected patients that may glean a light for us to fight this pandemic? Here, we hypothesize the plausible mechanisms in asthmatics based on available publications (Appendix S1) that may have effects in determining their susceptibility to and disease severity with SARS-CoV-2 infection.
Review of immunomodulators as therapeutic interventions for Covid-19 infections (Version 2.0) - PSAAI
The pandemic outbreak of the coronavirus disease continues to spread all over the world. Coronavirus disease 2019 (COVID-19) is a potentially severe acute respiratory infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Majority of patients present with mild symptoms. However, 14% may present with severe disease with a 3% to 5% mortality rate. Drugs or biologics have not been proven to be consistently effective in the treatment of the cytokine storm seen in those presenting with severe disease. Cytokine storm syndrome (CSS) or cytokine release syndrome (CRS) refers to a group of severe hyper-inflammatory disorders which are part of the spectrum of hemophagocytic lymphohistiocytosis (HLH). Primary HLH have a genetic basis, while secondary or acquired HLH are induced by infections, malignancies and autoimmune diseases. In the context of rheumatologic disease, systemic hyperinflammatory states are called macrophage activation syndrome (MAS). Clinically, it commonly presents as systemic inflammation with multiple organ failure, and high inflammatory parameters.
Joint statement on the current epidemics of new Coronavirus SARS-Cov-2 - MSAI x My POPI
Coronaviruses (CoV) are a family of viruses that cause respiratory tract infections. They range from common colds to more serious illnesses like pneumonia. Although coronaviruses commonly cause disease in animals, they can infect people too and spread between them. Recent examples include Severe Acute Respiratory Syndrome (SARS-CoV), and Middle-East Respiratory Syndrome (MERS-CoV).
Artificial intelligence–enabled rapid diagnosis of patients with COVID-19 - Nature Medicine
In this study, we used artificial intelligence (AI) algorithms to integrate chest CT findings with clinical symptoms, exposure history and laboratory testing to rapidly diagnose patients who are positive for COVID-19. Among a total of 905 patients tested by real-time RT–PCR assay and next-generation sequencing RT–PCR, 419 (46.3%) tested positive for SARS-CoV-2. In a test set of 279 patients, the AI system achieved an area under the curve of 0.92 and had equal sensitivity as compared to a senior thoracic radiologist. The AI system also improved the detection of patients who were positive for COVID-19 via RT–PCR who presented with normal CT scans, correctly identifying 17 of 25 (68%) patients, whereas radiologists classified all of these patients as COVID-19 negative. When CT scans and associated clinical history are available, the proposed AI system can help to rapidly diagnose COVID-19 patients.
Related Medical Studies
SARS-CoV-2 Infection in Children
As of March 10, 2020, the 2019 novel coronavirus (SARS-CoV-2) has been responsible for more than 110,000 infections and 4000 deaths worldwide, but data regarding the epidemiologic characteristics and clinical features of infected children are limited.1-3 A recent review of 72,314 cases by the Chinese Center for Disease Control and Prevention showed that less than 1% of the cases were in children younger than 10 years of age.2 In order to determine the spectrum of disease in children, we evaluated children infected with SARS-CoV-2 and treated at the Wuhan Children’s Hospital, the only center assigned by the central government for treating infected children under 16 years of age in Wuhan. Both symptomatic and asymptomatic children with known contact with persons having confirmed or suspected SARS-CoV-2 infection were evaluated. Nasopharyngeal or throat swabs were obtained for detection of SARS-CoV-2 RNA by established methods.4 The clinical outcomes were monitored up to March 8, 2020. Read more here…. -> link to below link
Am I Part of the Cure or Am I Part of the Disease? Keeping Coronavirus Out When a Doctor Comes Home
Last year, after a month of dry cough and shortness of breath while walking up the steep steps of Fillmore Street in San Francisco, Mary, my mother-in-law and housemate, noticed that she was becoming more and more easily winded. When her symptoms didn’t improve over the next several weeks, her doctors at the University of California, San Francisco, ordered a CT scan. They found bronchiolitis obliterans, a chronic, progressive lung condition that leads to gradually worsening lung disease and respiratory collapse. There is no treatment for this disease, whose natural history ends in lung transplantation for patients who are young and healthy enough to undergo it. Mary has spent every day of the past year and a half focused on respiratory physiotherapy, practicing breathing techniques that ease her symptoms but do little to slow disease progression. Read more here…. -> link to below link
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