Prior Vaccination Against Diphtheria And Tetanus Associated With Less Severe Covid-19
▫️Older Individuals Who Have Gotten A Diphtheria Or Tetanus Vaccine Booster Shot In The Last 10 Years May Be At Lower Risk For Severe Covid-19, A New Study Suggests.
▫️Using A Large UK Registry, Researchers Looked Back At 10 Years of Immunization Records from 103,409 Participants With An Average Age of 71.
▫️They Saw A Trend Toward A Lower Risk of A Positive Covid-19 Test In People Who Had Gotten A Tetanus Or Diphtheria Booster Shot During The Study Period, Although The Difference Was Small And Might Have Been Due To Chance.
▫️There Was, However, A Statistically Significant Association Between The Booster Shots And The Odds of Severe Covid-19, According To A Report Posted on medRxiv on Saturday Ahead of Peer Review.
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▫️Older Individuals Who Have Gotten A Diphtheria Or Tetanus Vaccine Booster Shot In The Last 10 Years May Be At Lower Risk For Severe Covid-19, A New Study Suggests.
▫️Using A Large UK Registry, Researchers Looked Back At 10 Years of Immunization Records from 103,409 Participants With An Average Age of 71.
▫️They Saw A Trend Toward A Lower Risk of A Positive Covid-19 Test In People Who Had Gotten A Tetanus Or Diphtheria Booster Shot During The Study Period, Although The Difference Was Small And Might Have Been Due To Chance.
▫️There Was, However, A Statistically Significant Association Between The Booster Shots And The Odds of Severe Covid-19, According To A Report Posted on medRxiv on Saturday Ahead of Peer Review.
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medRxiv
Vaccination history for diphtheria and tetanus is associated with less severe COVID-19
Background COVID-19 is characterized by strikingly large, mostly unexplained, interindividual variation in symptom severity. While some individuals remain nearly asymptomatic, others suffer from severe respiratory failure. It has been hypothesized that previous…
Humanigen Starts Rolling Submission For Covid-19 Drug In The UK
▫️Humanigen Has Commenced A Rolling Review Submission To The UK Medicines And Healthcare Products Regulatory Agency (MHRA), Seeking Marketing Approval For Its Drug Candidate, Lenzilumab.
▫️A Monoclonal Antibody, Lenzilumab Is Designed To Neutralize Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).
▫️This Development Comes After The Company Applied for Emergency Use Authorization (EUA) of The Drug by The US Food And Drug Administration (FDA).
▫️The Latest Application To The MHRA Is Based on Favourable Results from The Phase III LIVE-AIR Clinical Study.
▫️Data from This Trial Showed That Lenzilumab Met The Primary Goal With A 54% Relative Improvement In The Chances of Survival Without Ventilation (SWOV) Versus Placebo.
▫️In Participants Receiving Both Corticosteroids And Remdesivir, Lenzilumab Provided A 92% Improvement In Relative Chances of SWOV. This Improvement Was Found To Be Three-fold In Participants With A CRP<150mg/L And Aged Below 85 Years.
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▫️Humanigen Has Commenced A Rolling Review Submission To The UK Medicines And Healthcare Products Regulatory Agency (MHRA), Seeking Marketing Approval For Its Drug Candidate, Lenzilumab.
▫️A Monoclonal Antibody, Lenzilumab Is Designed To Neutralize Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).
▫️This Development Comes After The Company Applied for Emergency Use Authorization (EUA) of The Drug by The US Food And Drug Administration (FDA).
▫️The Latest Application To The MHRA Is Based on Favourable Results from The Phase III LIVE-AIR Clinical Study.
▫️Data from This Trial Showed That Lenzilumab Met The Primary Goal With A 54% Relative Improvement In The Chances of Survival Without Ventilation (SWOV) Versus Placebo.
▫️In Participants Receiving Both Corticosteroids And Remdesivir, Lenzilumab Provided A 92% Improvement In Relative Chances of SWOV. This Improvement Was Found To Be Three-fold In Participants With A CRP<150mg/L And Aged Below 85 Years.
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FDA Declines To Approve Avenue’s Intravenous Use of Tramadol
▫️The US Food And Drug Administration (FDA) Has Declined To Approve Avenue Therapeutics’ New Drug Application (NDA) For Intravenous (IV) Use of Analgesic Tramadol for A Second Time.
▫️In Its Second Complete Response Letter (CRL) To The Company, The FDA Said That The Delayed And Unpredictable Onset of Analgesia With IV Tramadol Did Not Support Its Use As A Monotherapy For Treating Patients In Acute Pain.
▫️The FDA Also Noted The Inadequate Data Supporting The Usage of IV Tramadol With Other Analgesics As A Safe And Effective Option To Treat The Intended Patient Population.
- The Agency Did Not Notify Any Chemistry, Manufacturing And Controls (CMC) Issues In The Latest CRL.
▫️Avenue Does Not Agree With The FDA’s Interpretation of The Data Provided In The NDA And Plans To Seek Regulatory Approval For IV Tramadol.
▫️A Speciality Pharmaceutical Company, Avenue Focuses on Developing IV Tramadol As A Probable Substitute To Lower The Use of Standard Opioids for Treating People With Acute Pain In The US.
▫️According To The FDA, If A Patient With Acute Pain Needs An Analgesic Between The First IV Tramadol dose And The Onset of Analgesia, A Rescue Analgesic Would Be Required.
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▫️The US Food And Drug Administration (FDA) Has Declined To Approve Avenue Therapeutics’ New Drug Application (NDA) For Intravenous (IV) Use of Analgesic Tramadol for A Second Time.
▫️In Its Second Complete Response Letter (CRL) To The Company, The FDA Said That The Delayed And Unpredictable Onset of Analgesia With IV Tramadol Did Not Support Its Use As A Monotherapy For Treating Patients In Acute Pain.
▫️The FDA Also Noted The Inadequate Data Supporting The Usage of IV Tramadol With Other Analgesics As A Safe And Effective Option To Treat The Intended Patient Population.
- The Agency Did Not Notify Any Chemistry, Manufacturing And Controls (CMC) Issues In The Latest CRL.
▫️Avenue Does Not Agree With The FDA’s Interpretation of The Data Provided In The NDA And Plans To Seek Regulatory Approval For IV Tramadol.
▫️A Speciality Pharmaceutical Company, Avenue Focuses on Developing IV Tramadol As A Probable Substitute To Lower The Use of Standard Opioids for Treating People With Acute Pain In The US.
▫️According To The FDA, If A Patient With Acute Pain Needs An Analgesic Between The First IV Tramadol dose And The Onset of Analgesia, A Rescue Analgesic Would Be Required.
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Researchers Identify Why Covid-19 Patients Develop Life-Threatening Clots
▫️Previous Research Has Established That Blood Clotting Is A Significant Cause Of Death In Patients With Covid-19. To Understand Why That Clotting Happens, The Researchers Analyzed Blood Samples That Were Taken from Patients With Covid-19 In The Beaumont Hospital Intensive Care Unit In Dublin.
▫️They Found That The Balance Between A Molecule That Causes Clotting, Called Von Willebrand Factor (VWF), And Its Regulator, Called ADAMTS13, Is Severely Disrupted In Patients With Severe Covid-19.
▫️When Compared To Control Groups, The Blood of Covid-19 Patients Had Higher Levels of The Pro-Clotting VWF Molecules And Lower Levels of The Anti-Clotting ADAMTS13.
▫️The Work, Led by Researchers from RCSI University of Medicine And Health Sciences, Is Published In The Journal of Thrombosis And Haemostasis.
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▫️Previous Research Has Established That Blood Clotting Is A Significant Cause Of Death In Patients With Covid-19. To Understand Why That Clotting Happens, The Researchers Analyzed Blood Samples That Were Taken from Patients With Covid-19 In The Beaumont Hospital Intensive Care Unit In Dublin.
▫️They Found That The Balance Between A Molecule That Causes Clotting, Called Von Willebrand Factor (VWF), And Its Regulator, Called ADAMTS13, Is Severely Disrupted In Patients With Severe Covid-19.
▫️When Compared To Control Groups, The Blood of Covid-19 Patients Had Higher Levels of The Pro-Clotting VWF Molecules And Lower Levels of The Anti-Clotting ADAMTS13.
▫️The Work, Led by Researchers from RCSI University of Medicine And Health Sciences, Is Published In The Journal of Thrombosis And Haemostasis.
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Wiley Online Library
ADAMTS13 regulation of VWF multimer distribution in severe COVID‐19
Background
Consistent with fulminant endothelial cell activation, elevated plasma von Willebrand factor (VWF) antigen levels have been reported in patients with COVID-19. The multimeric size and fun...
Consistent with fulminant endothelial cell activation, elevated plasma von Willebrand factor (VWF) antigen levels have been reported in patients with COVID-19. The multimeric size and fun...
Cholesterol-Lowering Drugs Appear To Boost Cancer Immunotherapies
▫️Based on The Findings, Human Studies Are Already Being Proposed To Determine Whether Cholesterol Drugs Such As Evolocumab (Sold As Repatha) Or Alirocumab (Praluent) Might Bolster The Effect of Immune Checkpoint Inhibitors. These Cancer Immunotherapies Have Held Great Promise, But Still Only Result In Long-Term Survival Benefits For A Third of Cancer Patients, At Most.
▫️The Study Appears Online Nov. 11 In The Journal Nature.
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▫️Based on The Findings, Human Studies Are Already Being Proposed To Determine Whether Cholesterol Drugs Such As Evolocumab (Sold As Repatha) Or Alirocumab (Praluent) Might Bolster The Effect of Immune Checkpoint Inhibitors. These Cancer Immunotherapies Have Held Great Promise, But Still Only Result In Long-Term Survival Benefits For A Third of Cancer Patients, At Most.
▫️The Study Appears Online Nov. 11 In The Journal Nature.
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Nature
Inhibition of PCSK9 potentiates immune checkpoint therapy for cancer
Inhibiting the PCSK9 protein, a regulator of cholesterol metabolism, enhances immune checkpoint therapy in mouse models of cancer, in a manner that depends on the regulation of antigen-presenting MHC I molecules.
CureVac Preliminary Data Shows Covid-19 Vaccine Is Only 47% Effective
▫️German Biotech CureVac Said on Wednesday Its Covid-19 Vaccine Was Only 47% Effective In A Late-Stage Trial, Missing The Study’s Main Goal And Throwing In Doubt The Potential Delivery of Hundreds of Millions of doses To The European Union.
▫️In Its Study of 40,000 People, CureVac Said 13 Variants Were Found In Volunteers, With More Than Half of The Coronavirus Cases Caused by Variants of Concern.
▫️The Disappointing Efficacy of The Shot Known As CVnCoV Emerged from An Interim Analysis Based on 134 Covid-19 Cases In The Study With About 40,000 Volunteers In Europe And Latin America.
▫️Out of The Reported Covid-19 Cases In The Trial, 124 Were Sequenced To Identify The Variant Causing The Infection, It Said. One Case Was Attributable To The Original Version of The SARS-CoV-2 Coronavirus That Emerged In Chinese City of Wuhan In Late 2019, While 57% of The Cases Were Caused by More Highly Transmissible So-Called "Variants of Concern".
▫️CureVac's U.S. Traded Shares Fell 50.6% To $46.81 In After-Hours Trading Following Publication of The Data.
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▫️German Biotech CureVac Said on Wednesday Its Covid-19 Vaccine Was Only 47% Effective In A Late-Stage Trial, Missing The Study’s Main Goal And Throwing In Doubt The Potential Delivery of Hundreds of Millions of doses To The European Union.
▫️In Its Study of 40,000 People, CureVac Said 13 Variants Were Found In Volunteers, With More Than Half of The Coronavirus Cases Caused by Variants of Concern.
▫️The Disappointing Efficacy of The Shot Known As CVnCoV Emerged from An Interim Analysis Based on 134 Covid-19 Cases In The Study With About 40,000 Volunteers In Europe And Latin America.
▫️Out of The Reported Covid-19 Cases In The Trial, 124 Were Sequenced To Identify The Variant Causing The Infection, It Said. One Case Was Attributable To The Original Version of The SARS-CoV-2 Coronavirus That Emerged In Chinese City of Wuhan In Late 2019, While 57% of The Cases Were Caused by More Highly Transmissible So-Called "Variants of Concern".
▫️CureVac's U.S. Traded Shares Fell 50.6% To $46.81 In After-Hours Trading Following Publication of The Data.
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Ibuprofen Kills Pain Better Than Codeine With Fewer Side Effects, Study Finds
▫️Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Such As Ibuprofen Provide Better Pain Control And Have Fewer Adverse Effects Than Codeine, a Commonly Prescribed Opioid, When Prescribed After Outpatient Surgery, According To New Research Published In CMAJ (Canadian Medical Association Journal).
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▫️Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Such As Ibuprofen Provide Better Pain Control And Have Fewer Adverse Effects Than Codeine, a Commonly Prescribed Opioid, When Prescribed After Outpatient Surgery, According To New Research Published In CMAJ (Canadian Medical Association Journal).
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Oxford Covid-19 Vaccine Shows Effectiveness Against Delta Variant
▫️AstraZeneca Has Reported New Data Showing That Its Covid-19 Vaccine Provided Increased Levels of Protection Against The Delta Variant, B.1.617.2, Formerly Known As The "Indian Variant".
▫️The Vaccine Shows 92% And 86% Efficiency Against Hospitalization In Delta And Alpha Variant Cases, Respectively.
▫️Developed by The University of Oxford, Along With Vaccitech, The Vaccine Utilizes A Weakened Adenovirus And Has The SARS-CoV-2 Virus Spike Protein Genetic Material.
- On Vaccination, The Surface Spike Protein Is Generated, Which Prepares The Immune System To Fight SARS-CoV-2 on Contracting Covid-19.
▫️The New Real-World Data from Public Health England (PHE) Showed That Two doses of Covid-19 Vaccine Oxford-AstraZeneca Had 92% Efficiency Against Hospitalization In Delta Variant Cases.
▫️No Deaths Were Reported Among Those Inoculated With The Vaccine, The Company Noted.
▫️The Analysis Was Conducted on 14,019 Cases of The Delta Variant Observed Between 12 April And 4 June This Year In England.
▫️Furthermore, The Vaccine Was Effective Against The Alpha Variant Or B.1.1.7 And Decreased Hospitalisation by 86% With No Deaths Observed.
▫️The Data Also Showed That The Vaccine Had Lower Effectiveness Against Milder Symptomatic Covid-19. The Effectiveness Was 74% And 64% Against Symptomatic Disease by The Alpha And Delta Variants, Respectively.
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▫️AstraZeneca Has Reported New Data Showing That Its Covid-19 Vaccine Provided Increased Levels of Protection Against The Delta Variant, B.1.617.2, Formerly Known As The "Indian Variant".
▫️The Vaccine Shows 92% And 86% Efficiency Against Hospitalization In Delta And Alpha Variant Cases, Respectively.
▫️Developed by The University of Oxford, Along With Vaccitech, The Vaccine Utilizes A Weakened Adenovirus And Has The SARS-CoV-2 Virus Spike Protein Genetic Material.
- On Vaccination, The Surface Spike Protein Is Generated, Which Prepares The Immune System To Fight SARS-CoV-2 on Contracting Covid-19.
▫️The New Real-World Data from Public Health England (PHE) Showed That Two doses of Covid-19 Vaccine Oxford-AstraZeneca Had 92% Efficiency Against Hospitalization In Delta Variant Cases.
▫️No Deaths Were Reported Among Those Inoculated With The Vaccine, The Company Noted.
▫️The Analysis Was Conducted on 14,019 Cases of The Delta Variant Observed Between 12 April And 4 June This Year In England.
▫️Furthermore, The Vaccine Was Effective Against The Alpha Variant Or B.1.1.7 And Decreased Hospitalisation by 86% With No Deaths Observed.
▫️The Data Also Showed That The Vaccine Had Lower Effectiveness Against Milder Symptomatic Covid-19. The Effectiveness Was 74% And 64% Against Symptomatic Disease by The Alpha And Delta Variants, Respectively.
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Regeneron's Antibody Cocktail Saves Lives In Hospitalised Covid-19 Patients
▫️A Covid-19 Antibody Cocktail Developed by Regeneron Pharmaceuticals Inc And Roche Reduced Deaths In Hospitalised Patients Whose Own Immune Systems Had Failed To Produce A Response, A Large British Study At The University of Oxford Found on Wednesday.
▫️The Researchers Found That Regeneron’s REGEN-COV Reduced The Risk of 28-day Mortality by 20% In Patients Hospitalised With Covid-19 Who Had Not Mounted Their Own Immune Response And Tested Negative for Antibodies. These Patients Are Known As Seronegative.
▫️The Study Involved 9,785 Patients Hospitalised With Covid-19 In Hospitals Across The UK. One-Third Showed No Trace of Producing Their Own Antibodies. In This Seronegative Group, Mortality Was 30% Among Those Who Received Standard Clinical Care But Dropped to 24% Among Those Given An Intravenous Infusion of 8,000mg of REGEN-COV.
▫️REGEN-COV Is A Cocktail of Two Monoclonal Antibodies, Casirivimab With Imdevimab, Designed To Block The Infectivity of SARS-CoV-2. The Two Antibodies Work by Binding To Two Different Points on The Coronavirus Spike Protein, Neutralising The Ability of The Virus To Infect Cells.
▫️Previous Phase III Trials In Non-Hospitalised Covid-19 Patients Demonstrated That REGEN-COV “Reduced Viral Levels, Shortened The Time To Resolution of Symptoms And Significantly Reduced The Risk of Hospitalisation Or Death.”
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▫️A Covid-19 Antibody Cocktail Developed by Regeneron Pharmaceuticals Inc And Roche Reduced Deaths In Hospitalised Patients Whose Own Immune Systems Had Failed To Produce A Response, A Large British Study At The University of Oxford Found on Wednesday.
▫️The Researchers Found That Regeneron’s REGEN-COV Reduced The Risk of 28-day Mortality by 20% In Patients Hospitalised With Covid-19 Who Had Not Mounted Their Own Immune Response And Tested Negative for Antibodies. These Patients Are Known As Seronegative.
▫️The Study Involved 9,785 Patients Hospitalised With Covid-19 In Hospitals Across The UK. One-Third Showed No Trace of Producing Their Own Antibodies. In This Seronegative Group, Mortality Was 30% Among Those Who Received Standard Clinical Care But Dropped to 24% Among Those Given An Intravenous Infusion of 8,000mg of REGEN-COV.
▫️REGEN-COV Is A Cocktail of Two Monoclonal Antibodies, Casirivimab With Imdevimab, Designed To Block The Infectivity of SARS-CoV-2. The Two Antibodies Work by Binding To Two Different Points on The Coronavirus Spike Protein, Neutralising The Ability of The Virus To Infect Cells.
▫️Previous Phase III Trials In Non-Hospitalised Covid-19 Patients Demonstrated That REGEN-COV “Reduced Viral Levels, Shortened The Time To Resolution of Symptoms And Significantly Reduced The Risk of Hospitalisation Or Death.”
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FDA Approves Mallinckrodt’s StrataGraft For Thermal Burns Treatment
▫️The US Food And Drug Administration (FDA) Has Approved Mallinckrodt’s StrataGraft To Treat Adults With Thermal Burns Comprising Intact Dermal Elements.
▫️StrataGraft Is Made from Two Types of Human Skin Cells, Keratinocytes And Dermal Fibroblasts, Cultured Together To Create A Bi-Layered Construct Or A Cellularised Scaffold.
▫️The FDA Approval Is Backed by Data from The Phase III STRATA2016 Clinical Trial of A Single StrataGraft Application In Patients With Deep Partial-Thickness Burns.
▫️According To The Trial Results, A Significantly Lesser Area of Burn Wounds Treated With StrataGraft Needed Autografting by Three Months Versus The Area Of Wounds Treated Only With Autograft.
▫️Furthermore, 96% Of The Burn Sites Treated With The Product Did Not Need Autografting In All Subjects.
- A Difference of 98% Was Noted In The Per cent Area of StrataGraft Versus Control Autograft Treatment Sites That Needed Autografting by Three Months.
- In Addition, Nearly 83% of The Patients Had Durable Closure of The StrataGraft Treatment Site At Three Months Without Needing An Autograft Placement.
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▫️The US Food And Drug Administration (FDA) Has Approved Mallinckrodt’s StrataGraft To Treat Adults With Thermal Burns Comprising Intact Dermal Elements.
▫️StrataGraft Is Made from Two Types of Human Skin Cells, Keratinocytes And Dermal Fibroblasts, Cultured Together To Create A Bi-Layered Construct Or A Cellularised Scaffold.
▫️The FDA Approval Is Backed by Data from The Phase III STRATA2016 Clinical Trial of A Single StrataGraft Application In Patients With Deep Partial-Thickness Burns.
▫️According To The Trial Results, A Significantly Lesser Area of Burn Wounds Treated With StrataGraft Needed Autografting by Three Months Versus The Area Of Wounds Treated Only With Autograft.
▫️Furthermore, 96% Of The Burn Sites Treated With The Product Did Not Need Autografting In All Subjects.
- A Difference of 98% Was Noted In The Per cent Area of StrataGraft Versus Control Autograft Treatment Sites That Needed Autografting by Three Months.
- In Addition, Nearly 83% of The Patients Had Durable Closure of The StrataGraft Treatment Site At Three Months Without Needing An Autograft Placement.
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Alzheimer’s Vaccine Shows Promise In Phase II Trial
▫️New Phase II Data Suggests AXON Neuroscience’s "Tau Vaccine", AADvac1, Was Safe, Well Tolerated And Generated An Exceptional Tau Antibody Response In Alzheimer’s Disease (AD) Patients.
▫️Hyper-Phosphorylated Tau Accumulated In Neurofibrillary Tangles (NFT) Is One of The Hallmarks of AD, Alongside Amyloid beta Plaques. NFT Has Been Shown To Be Linked To Neuronal Loss And Brain Atrophy.
▫️The Phase II ADAMANT Trial Was A 24-Month Placebo-Controlled, Randomised, Parallel Group, Double-Blinded, MultiCentre Study of AADvac1, An Active Immunotherapy Against Pathological Tau, In AD Patients With Mild Disease.
▫️The Trial Met Its Primary Endpoint, With The Vaccine Being Safe And Well Tolerated. Serious Adverse Events Occurred In 17.1% of AADvac1-Treated Individuals And 24.1% of Placebo-Treated Individuals; And Adverse Events Were Observed In 84.6 Percent of The AADvac1 Arm And 81 Percent of Placebo Arm.
▫️In Terms of Its Secondary Endpoints; The Vaccine Was Found To Induced High Levels of Immunoglobulin G (IgG) Antibodies; Significantly Reduce The Accumulation of Neurofilament Light Chain (NfL), An Important Biomarker of Neurodegeneration, In The Blood by 58 Percent; And Diminish Other Core AD Cerebrospinal Fluid (CSF) Biomarkers of Tau Pathology And Tau Neurodegeneration, Including The Most Specific CSF Biomarker Phosphotau-T217.
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▫️New Phase II Data Suggests AXON Neuroscience’s "Tau Vaccine", AADvac1, Was Safe, Well Tolerated And Generated An Exceptional Tau Antibody Response In Alzheimer’s Disease (AD) Patients.
▫️Hyper-Phosphorylated Tau Accumulated In Neurofibrillary Tangles (NFT) Is One of The Hallmarks of AD, Alongside Amyloid beta Plaques. NFT Has Been Shown To Be Linked To Neuronal Loss And Brain Atrophy.
▫️The Phase II ADAMANT Trial Was A 24-Month Placebo-Controlled, Randomised, Parallel Group, Double-Blinded, MultiCentre Study of AADvac1, An Active Immunotherapy Against Pathological Tau, In AD Patients With Mild Disease.
▫️The Trial Met Its Primary Endpoint, With The Vaccine Being Safe And Well Tolerated. Serious Adverse Events Occurred In 17.1% of AADvac1-Treated Individuals And 24.1% of Placebo-Treated Individuals; And Adverse Events Were Observed In 84.6 Percent of The AADvac1 Arm And 81 Percent of Placebo Arm.
▫️In Terms of Its Secondary Endpoints; The Vaccine Was Found To Induced High Levels of Immunoglobulin G (IgG) Antibodies; Significantly Reduce The Accumulation of Neurofilament Light Chain (NfL), An Important Biomarker of Neurodegeneration, In The Blood by 58 Percent; And Diminish Other Core AD Cerebrospinal Fluid (CSF) Biomarkers of Tau Pathology And Tau Neurodegeneration, Including The Most Specific CSF Biomarker Phosphotau-T217.
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New Oxford-AstraZeneca B.1.351 Vaccine AZD2816 Strongly Immunogenic Against Multiple SARS-CoV-2 Variants of Concern
▫️A New Study, Released on The
▫️When AZD2816 Was Given As A Third Booster dose To Mice That Had Received Two doses of AZD1222 4 Weeks Apart, The T Cell Response Remained Unchanged In Magnitude And Profile.
▫️These Variants Are Called Variants of Concern (VOCs), The Best-Known Being B.1.1.7 (Alpha), First Identified In The UK; B.1.351 (Beta), In South Africa; And P.1 (Gamma), In Brazil, Besides The Most Recently Reported Variants, B.1.617.1 (Kappa) And B.1.617.2 (Delta).
▫️All VOCs Identified So Far Contain The D614G Mutation That Increases Infectivity, Possibly by Increasing The Expression of The Spike Protein on The Surface of The Viral Particle.
▫️The Third dose Did Enhance The Number of Variants Recognized by The T Cells. One dose of AZD2816 Also Generated T Cells Reactive To Both The Spike Variant In The Original Vaccine, That In The New Vaccine, And That Present In B.1.351.
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▫️A New Study, Released on The
bioRxiv Preprint Server, Supports The Efficacy of The Wildtype ChAdOx1 nCoV-19 (AZD1222) Vaccine Against B.1.351, B.1.617.1 And B.1.617.2, While Showing That A Booster dose of Vaccine Based on The B.1.351 Spike Induces Further Increase In Antibody Titers.▫️When AZD2816 Was Given As A Third Booster dose To Mice That Had Received Two doses of AZD1222 4 Weeks Apart, The T Cell Response Remained Unchanged In Magnitude And Profile.
▫️These Variants Are Called Variants of Concern (VOCs), The Best-Known Being B.1.1.7 (Alpha), First Identified In The UK; B.1.351 (Beta), In South Africa; And P.1 (Gamma), In Brazil, Besides The Most Recently Reported Variants, B.1.617.1 (Kappa) And B.1.617.2 (Delta).
▫️All VOCs Identified So Far Contain The D614G Mutation That Increases Infectivity, Possibly by Increasing The Expression of The Spike Protein on The Surface of The Viral Particle.
▫️The Third dose Did Enhance The Number of Variants Recognized by The T Cells. One dose of AZD2816 Also Generated T Cells Reactive To Both The Spike Variant In The Original Vaccine, That In The New Vaccine, And That Present In B.1.351.
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bioRxiv
The ChAdOx1 vectored vaccine, AZD2816, induces strong immunogenicity against SARS-CoV-2 B.1.351 and other variants of concern in…
There is an ongoing global effort, to design, manufacture, and clinically assess vaccines against SARS-CoV-2. Over the course of the ongoing pandemic a number of new SARS-CoV-2 virus isolates or variants of concern (VoC) have been identified containing mutations…
Flu Shots, Covid-19 Vaccine Can Be Given Together
▫️People May Be Able To Get An Annual Flu Shot And A Covid-19 Vaccine At The Same Time, A UK Study Suggests. The 431 Study Participants All Received Influenza Vaccines Manufactured by Seqirus, A Unit of CSL Ltd.
▫️They Also Received Either The Not-Yet Approved Covid-19 Vaccine from Novavax Inc, Which Has Been Highly Effective In Clinical Trials, Or A Placebo.
▫️The Results, Posted on Sunday on
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▫️People May Be Able To Get An Annual Flu Shot And A Covid-19 Vaccine At The Same Time, A UK Study Suggests. The 431 Study Participants All Received Influenza Vaccines Manufactured by Seqirus, A Unit of CSL Ltd.
▫️They Also Received Either The Not-Yet Approved Covid-19 Vaccine from Novavax Inc, Which Has Been Highly Effective In Clinical Trials, Or A Placebo.
▫️The Results, Posted on Sunday on
medRxiv And Submitted For Review to The Lancet, Suggest The Two Vaccines Do Not Interfere With Each Other. @MedicalNoteBook
medRxiv
Safety, Immunogenicity, and Efficacy of a COVID-19 Vaccine (NVX-CoV2373) Co-administered With Seasonal Influenza Vaccines
Background The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines has not yet been reported.
Methods A sub-study on influenza vaccine co-administration was conducted as part of the phase…
Methods A sub-study on influenza vaccine co-administration was conducted as part of the phase…
Convalescent Plasma Associated With Better Survival In Blood Cancer Patients With Covid-19
▫️Convalescent Plasma Therapy Was Associated With Better Survival In Blood Cancer Patients Hospitalized With Covid-19, Especially In Sicker Patients. The Findings by The Covid-19 And Cancer Consortium (CCC19) Are Newly Published In The Peer-Reviewed Journal JAMA Oncology.
▫️The Analysis Compared The 30-Day Death Rates of Hospitalized Adults With Both Blood Cancer And Covid-19 From Patient Data Supplied by The CCC19 Consortium Institutions. The Analysis Compared Treatment Data from 143 Patients Who Received Convalescent Plasma And 823 Who Did Not.
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▫️Convalescent Plasma Therapy Was Associated With Better Survival In Blood Cancer Patients Hospitalized With Covid-19, Especially In Sicker Patients. The Findings by The Covid-19 And Cancer Consortium (CCC19) Are Newly Published In The Peer-Reviewed Journal JAMA Oncology.
▫️The Analysis Compared The 30-Day Death Rates of Hospitalized Adults With Both Blood Cancer And Covid-19 From Patient Data Supplied by The CCC19 Consortium Institutions. The Analysis Compared Treatment Data from 143 Patients Who Received Convalescent Plasma And 823 Who Did Not.
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Blocking IL-11 Signaling Can Promote Liver Regeneration After Paracetamol-Induced Damage
▫️Scientists At Duke-NUS Medical School And National Heart Center Singapore (NHCS), In Collaboration With Colleagues In Singapore And The UK, Have Shown That The Human Form of The Signaling Protein Interleukin 11 (IL-11) Has A Damaging Effect on Human Liver Cells - Overturning A Prior Hypothesis That It Could Help Livers Damaged By Paracetamol Poisoning.
▫️The Finding, Published Last Week In Science Translational Medicine, Suggests That Blocking IL-11 Signaling Could Have A Restorative Effect.
▫️Paracetamol, Also Called Acetaminophen, Is A Widely Available Over-The-Counter Painkiller, And An Overdose Can Lead To Serious Liver Damage And Even Death.
- They Can be Treated With A Drug Called N-Acetylcysteine If Administered Within Eight Hours of Overdose. Any Longer, However, And The Only Recourse May Be A Liver Transplant.
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▫️Scientists At Duke-NUS Medical School And National Heart Center Singapore (NHCS), In Collaboration With Colleagues In Singapore And The UK, Have Shown That The Human Form of The Signaling Protein Interleukin 11 (IL-11) Has A Damaging Effect on Human Liver Cells - Overturning A Prior Hypothesis That It Could Help Livers Damaged By Paracetamol Poisoning.
▫️The Finding, Published Last Week In Science Translational Medicine, Suggests That Blocking IL-11 Signaling Could Have A Restorative Effect.
▫️Paracetamol, Also Called Acetaminophen, Is A Widely Available Over-The-Counter Painkiller, And An Overdose Can Lead To Serious Liver Damage And Even Death.
- They Can be Treated With A Drug Called N-Acetylcysteine If Administered Within Eight Hours of Overdose. Any Longer, However, And The Only Recourse May Be A Liver Transplant.
@MedicalNoteBook
Heart Inflammation Condition Looked Like Heart Attack In Kids, Pediatrician Says
▫️The CDC Has Received Reports of More Than 300 Cases of Heart Inflammation In Young People Following Vaccination With The Pfizer-BioNTech And Moderna Covid-19 Vaccine, According To NBC News.
▫️The Teenaged Boys All Looked Like They Were Having Heart Attacks.
▫️They Complained of Chest Pain And General Discomfort, And Tests Looked At First As If They Were Suffering An Acute Myocardial Infarction, Or Heart Attack.
- But They Weren't. Instead, The Seven Youths Ages 14 To 19 Were Suffering from A Very Rare Type of Heart Inflammation. It's One That Public Health Officials Are Beginning To Link To mRNA Covid-19 Vaccines.
▫️Doctors In Virginia And Texas Reported Similar Findings Wednesday In A Case Series of Seven Men Ages 19 To 39. They, Too, Had Alarming Symptoms Including Chest Pain. They Were Diagnosed With Myocarditis, And Were Treated And Released, The Doctors Reported In The Journal Circulation.
▫️A Different Group of Vaccine Advisers, The Centers for Disease Control (CDC) And Prevention's Advisory Committee on Immunization Practices, Will Meet Next Week To Review The Cases. During Its Regularly Scheduled June 23-25 Meeting, The Committee Will To Discuss Whether Myocarditis Might Be Clearly Linked To mRNA Vaccines.
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▫️The CDC Has Received Reports of More Than 300 Cases of Heart Inflammation In Young People Following Vaccination With The Pfizer-BioNTech And Moderna Covid-19 Vaccine, According To NBC News.
▫️The Teenaged Boys All Looked Like They Were Having Heart Attacks.
▫️They Complained of Chest Pain And General Discomfort, And Tests Looked At First As If They Were Suffering An Acute Myocardial Infarction, Or Heart Attack.
- But They Weren't. Instead, The Seven Youths Ages 14 To 19 Were Suffering from A Very Rare Type of Heart Inflammation. It's One That Public Health Officials Are Beginning To Link To mRNA Covid-19 Vaccines.
▫️Doctors In Virginia And Texas Reported Similar Findings Wednesday In A Case Series of Seven Men Ages 19 To 39. They, Too, Had Alarming Symptoms Including Chest Pain. They Were Diagnosed With Myocarditis, And Were Treated And Released, The Doctors Reported In The Journal Circulation.
▫️A Different Group of Vaccine Advisers, The Centers for Disease Control (CDC) And Prevention's Advisory Committee on Immunization Practices, Will Meet Next Week To Review The Cases. During Its Regularly Scheduled June 23-25 Meeting, The Committee Will To Discuss Whether Myocarditis Might Be Clearly Linked To mRNA Vaccines.
@MedicalNoteBook
Covid-19 May Cause Long-Term Brain Loss, Study Says
▫️A New Study from Researchers In The United Kingdom Has Found That The Coronavirus May Cause Long-Term Brain Loss And Could be The Reason Some Covid-19 Patients Lose Their Sense of Smell And Taste.
▫️According To The Study, Researchers In The United Kingdom Had Access To Brain Image Testing on About 40,000 People That Was done Before The Start of The Coronavirus Pandemic.
▫️Loss of Smell And Taste Is One of The Hallmarks of A Covid-19 Infection. Research Shows It Can Continue Up To 5 Months After The Virus First Strikes.
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▫️A New Study from Researchers In The United Kingdom Has Found That The Coronavirus May Cause Long-Term Brain Loss And Could be The Reason Some Covid-19 Patients Lose Their Sense of Smell And Taste.
▫️According To The Study, Researchers In The United Kingdom Had Access To Brain Image Testing on About 40,000 People That Was done Before The Start of The Coronavirus Pandemic.
▫️Loss of Smell And Taste Is One of The Hallmarks of A Covid-19 Infection. Research Shows It Can Continue Up To 5 Months After The Virus First Strikes.
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Covid-19 May Damage Blood Vessels In The Brain
▫️Until Now, The Neurological Manifestations of Covid-19 Have Been Believed To Be A Result of Direct Damage To Nerve Cells. However, A New Study Suggests That The Virus Might Actually Damage The Brain's Small Blood Vessels Rather Than Nerve Cells Themselves.
▫️A Postmortem Analysis Found Abnormalities In The Brains of A Small Sample Of Patients With Covid-19, Suggesting Inflammation And Vascular Damage To The Brain Stem And Olfactory Bulb.
▫️The Research Was Published Online Jan. 12 In The New England Journal of Medicine.
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▫️Until Now, The Neurological Manifestations of Covid-19 Have Been Believed To Be A Result of Direct Damage To Nerve Cells. However, A New Study Suggests That The Virus Might Actually Damage The Brain's Small Blood Vessels Rather Than Nerve Cells Themselves.
▫️A Postmortem Analysis Found Abnormalities In The Brains of A Small Sample Of Patients With Covid-19, Suggesting Inflammation And Vascular Damage To The Brain Stem And Olfactory Bulb.
▫️The Research Was Published Online Jan. 12 In The New England Journal of Medicine.
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The New England Journal of Medicine
Microvascular Injury in the Brains of Patients with Covid-19 | NEJM
High-resolution MRI and histopathological study of the brains of patients who had
died from Covid-19 showed punctate hyperintensities and punctate or linear hypointensities,
which represented vario...
died from Covid-19 showed punctate hyperintensities and punctate or linear hypointensities,
which represented vario...
Study Confirms GSK-Vir Antibody Drug Reduces Hospitalization, Death In Covid-19 Patients
▫️GlaxoSmithKline And Vir Biotechnology Said on Monday Final Results from A Late-Stage Study of Their Monoclonal Antibody Confirmed It Significantly Reduced Hospitalization And Death Among High-Risk Covid-19 Patients When Given Early In The Disease.
▫️The Treatment, Sotrovimab, Received An Emergency Use Authorization from The U.S. Food And Drug Administration (FDA) In May, While The European Union’s Drug Regulator Has Also Backed It.
▫️The Drugmakers Also Said on Monday The U.S. National Institutes of Health (NIH) Has Recommended Sotrovimab To Treat High-Risk, Non-Hospitalized Patients With Mild-To-Moderate Covid-19.
▫️The Treatment Appeared To “Retain Activity” Against Current Variants of Concern And Interest, The Agency Said In Its Updated Guidelines.
▫️In A Study of 1,057 Patients, Sotrovimab Resulted In A 79% Reduction In Risk of Hospitalization for More Than 24 Hours Or Death Due To Any Cause, The Companies Said on Monday.
▫️Sotrovimab Belongs To A Class of Drugs Called Monoclonal Antibodies That Mimic The Natural Antibodies The Body Generates To Fight off Infection.
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▫️GlaxoSmithKline And Vir Biotechnology Said on Monday Final Results from A Late-Stage Study of Their Monoclonal Antibody Confirmed It Significantly Reduced Hospitalization And Death Among High-Risk Covid-19 Patients When Given Early In The Disease.
▫️The Treatment, Sotrovimab, Received An Emergency Use Authorization from The U.S. Food And Drug Administration (FDA) In May, While The European Union’s Drug Regulator Has Also Backed It.
▫️The Drugmakers Also Said on Monday The U.S. National Institutes of Health (NIH) Has Recommended Sotrovimab To Treat High-Risk, Non-Hospitalized Patients With Mild-To-Moderate Covid-19.
▫️The Treatment Appeared To “Retain Activity” Against Current Variants of Concern And Interest, The Agency Said In Its Updated Guidelines.
▫️In A Study of 1,057 Patients, Sotrovimab Resulted In A 79% Reduction In Risk of Hospitalization for More Than 24 Hours Or Death Due To Any Cause, The Companies Said on Monday.
▫️Sotrovimab Belongs To A Class of Drugs Called Monoclonal Antibodies That Mimic The Natural Antibodies The Body Generates To Fight off Infection.
@MedicalNoteBook
Gilead's Remdesivir Reduces Covid-19 Mortality Risk: Data
▫️Gilead Sciences Inc Said An Analysis Showed Its Antiviral Remdesivir Reduced Mortality Rates In Hospitalized Patients With Covid-19 And Increased The Likelihood of Being Discharged By Day 28 After A Five-day Course of The Treatment.
▫️The Drugmaker Said on Monday It Analyzed Data from 98,654 Patients from Three Retrospective Studies of The Real-World Treatment of Hospitalized CovId-19 Patients.
▫️Remdesivir Achieved Statistically Significant 54% And 23% Reduction In Risk of Mortality Among The Analyzed Patients In Two of The Studies, The Company Said. The Data Was Presented At The World Microbe Forum (WMF) This Week.
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▫️Gilead Sciences Inc Said An Analysis Showed Its Antiviral Remdesivir Reduced Mortality Rates In Hospitalized Patients With Covid-19 And Increased The Likelihood of Being Discharged By Day 28 After A Five-day Course of The Treatment.
▫️The Drugmaker Said on Monday It Analyzed Data from 98,654 Patients from Three Retrospective Studies of The Real-World Treatment of Hospitalized CovId-19 Patients.
▫️Remdesivir Achieved Statistically Significant 54% And 23% Reduction In Risk of Mortality Among The Analyzed Patients In Two of The Studies, The Company Said. The Data Was Presented At The World Microbe Forum (WMF) This Week.
@MedicalNoteBook
Sanofi’s Aubagio Obtains EC Approval For Pediatric Multiple Sclerosis
▫️Sanofi Has Obtained Approval from The European Commission (EC) for Its Aubagio (Teriflunomide) To Treat Pediatric Patients Aged 10 To 17 Years With Relapsing-Remitting Multiple Sclerosis (RRMS).
▫️Currently Approved In About 80 Countries for RRMS Treatment, Aubagio Received Approval for Use In Adults In The EU in 2013.
▫️Pediatric MS Is A Rare, Chronic Neurodegenerative Disease. In 98% of Pediatric Patients, The Onset of MS Is followed by The Development of A Relapsing-Remitting Disease.
▫️Sanofi Noted That Aubagiois Is The First Oral MS Treatment To Receive Approval As First-Line Therapy for Children And Adolescents With RRMS.
▫️The EC Based Its Latest Approval on Results from The Phase III TERIKIDS Trial of Aubagio.
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▫️Sanofi Has Obtained Approval from The European Commission (EC) for Its Aubagio (Teriflunomide) To Treat Pediatric Patients Aged 10 To 17 Years With Relapsing-Remitting Multiple Sclerosis (RRMS).
▫️Currently Approved In About 80 Countries for RRMS Treatment, Aubagio Received Approval for Use In Adults In The EU in 2013.
▫️Pediatric MS Is A Rare, Chronic Neurodegenerative Disease. In 98% of Pediatric Patients, The Onset of MS Is followed by The Development of A Relapsing-Remitting Disease.
▫️Sanofi Noted That Aubagiois Is The First Oral MS Treatment To Receive Approval As First-Line Therapy for Children And Adolescents With RRMS.
▫️The EC Based Its Latest Approval on Results from The Phase III TERIKIDS Trial of Aubagio.
@MedicalNoteBook