Heart inflammation In Young Men Higher Than Expected After Pfizer, Moderna Covid-19 Vaccines: U.S. CDC
▫️The CDC And Other Health Regulators Have Been Investigating Heart Inflammation Cases After Israel’s Health Ministry Reported That It Had Found A Likely Link To The Condition In Young Men Who Received Pfizer’s Covid-19 Vaccine.
▫️More Than Half of The Cases Reported To The U.S. Vaccine Adverse Event Reporting System (VAERS) After People Had Received Their Second dose of Either The Pfizer-BioNTech Or Moderna Vaccines Were In People Between The Ages of 16 And 24, The CDC Said. Those Age Groups Accounted for Less Than 9% of doses Administered.
▫️The Agency Said It Is Still Assessing The Risk from The Condition And Has Not Yet Concluded That There Was A Causal Relationship Between The Vaccines And Cases of Myocarditis Or Pericarditis.
▫️There Were 283 Observed Cases of Heart Inflammation After The Second Vaccine dose In Those Aged 16 to 24 In The VAERS Data. That Compares With Expectations of 10 To 102 Cases For That Age Range Based on U.S. Population Background Incidence Rates, The CDC Said.
▫️The Median Age of Patients Who Experienced The Inflammation After A Second Vaccine dose Was 24, According To The VAERS Data. Just Under 80% of The Cases Were In Men.
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▫️The CDC And Other Health Regulators Have Been Investigating Heart Inflammation Cases After Israel’s Health Ministry Reported That It Had Found A Likely Link To The Condition In Young Men Who Received Pfizer’s Covid-19 Vaccine.
▫️More Than Half of The Cases Reported To The U.S. Vaccine Adverse Event Reporting System (VAERS) After People Had Received Their Second dose of Either The Pfizer-BioNTech Or Moderna Vaccines Were In People Between The Ages of 16 And 24, The CDC Said. Those Age Groups Accounted for Less Than 9% of doses Administered.
▫️The Agency Said It Is Still Assessing The Risk from The Condition And Has Not Yet Concluded That There Was A Causal Relationship Between The Vaccines And Cases of Myocarditis Or Pericarditis.
▫️There Were 283 Observed Cases of Heart Inflammation After The Second Vaccine dose In Those Aged 16 to 24 In The VAERS Data. That Compares With Expectations of 10 To 102 Cases For That Age Range Based on U.S. Population Background Incidence Rates, The CDC Said.
▫️The Median Age of Patients Who Experienced The Inflammation After A Second Vaccine dose Was 24, According To The VAERS Data. Just Under 80% of The Cases Were In Men.
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Drug Commonly Used As Antidepressant Helps Fight Cancer In Mice
▫️A Class of Drug Called Monoamine Oxidase Inhibitors Is Commonly Prescribed To Treat Depression; The Medications Work by Boosting Levels of Serotonin, The Brain's "Happiness Hormone."
▫️A New Study by UCLA Researchers Suggests That Those Drugs, Commonly Known As MAOIs, Might Have Another Health Benefit: Helping The Immune System Attack Cancer.
▫️Their Findings Are Reported In Two Papers, Which Are Published in The Journals Science Immunology And Nature Communications.
▫️Immune Cells That Had Infiltrated Tumors Had Much Higher Activity of A Gene Called Monoamine Oxidase A, Or MAOA.
- MAOA's Corresponding Protein, Called MAO-A, Controls Levels of Serotonin And Is Targeted by MAOI Drugs.
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▫️A Class of Drug Called Monoamine Oxidase Inhibitors Is Commonly Prescribed To Treat Depression; The Medications Work by Boosting Levels of Serotonin, The Brain's "Happiness Hormone."
▫️A New Study by UCLA Researchers Suggests That Those Drugs, Commonly Known As MAOIs, Might Have Another Health Benefit: Helping The Immune System Attack Cancer.
▫️Their Findings Are Reported In Two Papers, Which Are Published in The Journals Science Immunology And Nature Communications.
▫️Immune Cells That Had Infiltrated Tumors Had Much Higher Activity of A Gene Called Monoamine Oxidase A, Or MAOA.
- MAOA's Corresponding Protein, Called MAO-A, Controls Levels of Serotonin And Is Targeted by MAOI Drugs.
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Nature Communications
Targeting monoamine oxidase A-regulated tumor-associated macrophage polarization for cancer immunotherapy
Monoamine oxidase A (MAO-A) is an outer mitochondrial membrane-bound enzyme best known for its function in the brain, but also linked to cancer progression. Here, the authors show that MAO-A is...
Study Identifies How Covid-19 Linked To Alzheimer's Disease-Like Cognitive Impairment
▫️A New Cleveland Clinic-led Study Has Identified Mechanisms by Which Covid-19 Can Lead To Alzheimer's Disease-Like Dementia.
▫️The Findings, Published In Alzheimer's Research & Therapy, Indicate An Overlap Between Covid-19 And Brain Changes Common In Alzheimer's, And May Help Inform Risk Management And Therapeutic Strategies for Covid-19 Associated Cognitive Impairment.
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▫️A New Cleveland Clinic-led Study Has Identified Mechanisms by Which Covid-19 Can Lead To Alzheimer's Disease-Like Dementia.
▫️The Findings, Published In Alzheimer's Research & Therapy, Indicate An Overlap Between Covid-19 And Brain Changes Common In Alzheimer's, And May Help Inform Risk Management And Therapeutic Strategies for Covid-19 Associated Cognitive Impairment.
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Alzheimer's Research & Therapy
Network medicine links SARS-CoV-2/COVID-19 infection to brain microvascular injury and neuroinflammation in dementia-like cognitive…
Background Dementia-like cognitive impairment is an increasingly reported complication of SARS-CoV-2 infection. However, the underlying mechanisms responsible for this complication remain unclear. A better understanding of causative processes by which COVID…
Metformin Prevents Pulmonary Or Lung Inflammation In Animals Infected With SARS-CoV-2
▫️In A Study Published Online June 8, 2021 In The Journal Immunity, A Multi-Institution Team Led by Researchers At University of California San Diego School of Medicine Identified The Molecular Mechanism for The Anti-Inflammatory Activity of Metformin And, In Mouse Studies, Found That Metformin Prevents Pulmonary Or Lung Inflammation In Animals Infected With SARS-CoV-2, The Virus That Causes Covid-19.
▫️Metformin Also Produced A Marked Reduction In Mortality In Endotoxin-Challenged Mice And Inhibited IL-1β Production And Inflammasome Assembly Within Alveolar Macrophages - Immune Cells Found In The Lungs.
▫️IL-1β, Along With IL-6, Are Small Proteins Called Cytokines That Cause Inflammation As An Early Immune Response. Their Amounts Are Often Highly Elevated In Persons Infected by SARS-CoV-2, Creating "Cytokine Storms" In Which The Body Starts Attacking Its Own Cells And Tissues.
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▫️In A Study Published Online June 8, 2021 In The Journal Immunity, A Multi-Institution Team Led by Researchers At University of California San Diego School of Medicine Identified The Molecular Mechanism for The Anti-Inflammatory Activity of Metformin And, In Mouse Studies, Found That Metformin Prevents Pulmonary Or Lung Inflammation In Animals Infected With SARS-CoV-2, The Virus That Causes Covid-19.
▫️Metformin Also Produced A Marked Reduction In Mortality In Endotoxin-Challenged Mice And Inhibited IL-1β Production And Inflammasome Assembly Within Alveolar Macrophages - Immune Cells Found In The Lungs.
▫️IL-1β, Along With IL-6, Are Small Proteins Called Cytokines That Cause Inflammation As An Early Immune Response. Their Amounts Are Often Highly Elevated In Persons Infected by SARS-CoV-2, Creating "Cytokine Storms" In Which The Body Starts Attacking Its Own Cells And Tissues.
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Vertex’s Trikafta Gets FDA Approval To Treat Cystic Fibrosis In Children
▫️Vertex Pharmaceuticals Has Secured The US Food And Drug Administration (FDA) Approval For Its Trikafta Drug To Treat Cystic Fibrosis In Children Aged Six To 11 Years.
▫️The Approval Is For Children With A Minimum of One F508del Mutation In The Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Or A Mutation In The CFTR Gene That Responds To The Drug Based on In Vitro Data.
▫️Trikafta Is A Combination of Elexacaftor, Tezacaftor And Ivacaftor. With The Latest Approval, A New Dosage Strength of The Drug Is Available, The Company Noted.
▫️In 2019, Trikafta Received The FDA Nod For Use In Cystic Fibrosis Patients Aged 12 Years And Above. It Also Holds Approvals In Other Countries, Including Australia, The UK And The EU.
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▫️Vertex Pharmaceuticals Has Secured The US Food And Drug Administration (FDA) Approval For Its Trikafta Drug To Treat Cystic Fibrosis In Children Aged Six To 11 Years.
▫️The Approval Is For Children With A Minimum of One F508del Mutation In The Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Or A Mutation In The CFTR Gene That Responds To The Drug Based on In Vitro Data.
▫️Trikafta Is A Combination of Elexacaftor, Tezacaftor And Ivacaftor. With The Latest Approval, A New Dosage Strength of The Drug Is Available, The Company Noted.
▫️In 2019, Trikafta Received The FDA Nod For Use In Cystic Fibrosis Patients Aged 12 Years And Above. It Also Holds Approvals In Other Countries, Including Australia, The UK And The EU.
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Glenmark Reports Positive Data of Favipiravir In Covid-19 PMS Study
▫️Glenmark Pharmaceuticals Has Reported Interim Data from Its Post-Marketing Surveillance (PMS) Study In India Where No New Safety Signals Were Observed With Favipiravir Use In Mild-To-Moderate Covid-19 Patients.
▫️Interim Results from 503 Subjects Showed Two-Third of Participants Achieved Clinical Cure on Day Seven.
▫️Favipiravir, Which Holds Approval In Japan Since 2014 To Treat New Or Re-emerging Influenza Virus Infections, Is Marketed Under The Brand Name FabiFlu In India.
▫️The Prospective, Open-Label, Multi-Centre, Single-Arm PMS Study Began In July Last Year And Enrolled A Total of 1,083 Subjects At 13 Centers.
▫️It Analyzed The Safety And Efficacy of Favipiravir In Subjects With Mild-To-Moderate Covid-19.
▫️This Is The First And Large PMS Trial Being Carried Out In The Country To Assess Favipiravir In This Patient Population, Glenmark Noted.
▫️Previously Established Side Effects, Including Weakness, Gastritis, Diarrhoea And Vomiting, Were Observed To Be Mild.
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▫️Glenmark Pharmaceuticals Has Reported Interim Data from Its Post-Marketing Surveillance (PMS) Study In India Where No New Safety Signals Were Observed With Favipiravir Use In Mild-To-Moderate Covid-19 Patients.
▫️Interim Results from 503 Subjects Showed Two-Third of Participants Achieved Clinical Cure on Day Seven.
▫️Favipiravir, Which Holds Approval In Japan Since 2014 To Treat New Or Re-emerging Influenza Virus Infections, Is Marketed Under The Brand Name FabiFlu In India.
▫️The Prospective, Open-Label, Multi-Centre, Single-Arm PMS Study Began In July Last Year And Enrolled A Total of 1,083 Subjects At 13 Centers.
▫️It Analyzed The Safety And Efficacy of Favipiravir In Subjects With Mild-To-Moderate Covid-19.
▫️This Is The First And Large PMS Trial Being Carried Out In The Country To Assess Favipiravir In This Patient Population, Glenmark Noted.
▫️Previously Established Side Effects, Including Weakness, Gastritis, Diarrhoea And Vomiting, Were Observed To Be Mild.
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Novartis' Nuclear Therapy Helps Men With Prostate Cancer Live Longer: Data
▫️Men With A Deadly form of Advanced Prostate Cancer Who Failed Other Treatments Survived Four Months Longer After Getting An Experimental, Tumor-Targeting Radiation Therapy from Swiss Drugmaker Novartis, Data Released on Thursday Showed.
▫️The Company's Lu-PSMA-617 Therapy Boosted Median Overall Survival (OS) To 15.3 Months In Patients With Metastatic Castration-Resistant Prostate Cancer, According To Data Released At The 2021 American Society of Clinical Oncology Annual Meeting.
▫️That Compared With 11.3 Months for Men Who Got Standard Care.
▫️Men Who Got The Treatment Also Lived A Median 8.7 Months Without Their Cancer Progressing, More Than Double The 3.4-Month Progression Free Survival (PFS) of Those Who Did Not Get It, The Data Showed.
▫️The Therapy Attaches A Radioactive Isotope, Lutetium-177, With A Half-Life of Less Than Seven Days To A Small Molecule Drug, PSMA-617, That Binds To An Antigen Expressed In Large Amounts by Prostate Cancer Cells, With The Aim of Killing Them In A Targeted Way While Limiting Damage To Surrounding, Healthy Cells.
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▫️Men With A Deadly form of Advanced Prostate Cancer Who Failed Other Treatments Survived Four Months Longer After Getting An Experimental, Tumor-Targeting Radiation Therapy from Swiss Drugmaker Novartis, Data Released on Thursday Showed.
▫️The Company's Lu-PSMA-617 Therapy Boosted Median Overall Survival (OS) To 15.3 Months In Patients With Metastatic Castration-Resistant Prostate Cancer, According To Data Released At The 2021 American Society of Clinical Oncology Annual Meeting.
▫️That Compared With 11.3 Months for Men Who Got Standard Care.
▫️Men Who Got The Treatment Also Lived A Median 8.7 Months Without Their Cancer Progressing, More Than Double The 3.4-Month Progression Free Survival (PFS) of Those Who Did Not Get It, The Data Showed.
▫️The Therapy Attaches A Radioactive Isotope, Lutetium-177, With A Half-Life of Less Than Seven Days To A Small Molecule Drug, PSMA-617, That Binds To An Antigen Expressed In Large Amounts by Prostate Cancer Cells, With The Aim of Killing Them In A Targeted Way While Limiting Damage To Surrounding, Healthy Cells.
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FDA Extends Shelf Life of Johnson & Johnson Covid-19 Vaccine
▫️Johnson & Johnson (J&J) Said on Thursday The U.S. Food And Drug Administration (FDA) Has Extended The Shelf Life of Its Single-Shot Covid-19 Vaccine from Three Months To Four-And-A-Half Months, As Millions of Unused doses Nationwide Near Expiration.
▫️Safety Concerns About J&J’s Shot And Flagging Demand for Vaccinations Have Left Close To Half of The 21 Million doses The Company Has Produced for The United States Sitting Unused.
▫️The Health Regulator’s Decision Was Based on Data from Ongoing Studies, Which Demonstrated That The Vaccine Is Stable at 4.5 Months When Refrigerated At Temperatures of 36 To 46 Degrees Fahrenheit (2 To 8 Degrees Celsius), The Drugmaker Said.
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▫️Johnson & Johnson (J&J) Said on Thursday The U.S. Food And Drug Administration (FDA) Has Extended The Shelf Life of Its Single-Shot Covid-19 Vaccine from Three Months To Four-And-A-Half Months, As Millions of Unused doses Nationwide Near Expiration.
▫️Safety Concerns About J&J’s Shot And Flagging Demand for Vaccinations Have Left Close To Half of The 21 Million doses The Company Has Produced for The United States Sitting Unused.
▫️The Health Regulator’s Decision Was Based on Data from Ongoing Studies, Which Demonstrated That The Vaccine Is Stable at 4.5 Months When Refrigerated At Temperatures of 36 To 46 Degrees Fahrenheit (2 To 8 Degrees Celsius), The Drugmaker Said.
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Aspirin Does Not Improve Survival In Covid-19 Patients: UK Study
▫️Aspirin Does Not Improve The Chances of Survival In Severely ill Covid-19 Patients, Early Results from One of Britain's Biggest Trials Studying The Commonly Used Painkiller And Blood Thinner Showed on Tuesday.
▫️The Scientists Behind The Trial, Which Is Looking Into A Range of Potential Treatments For Covid-19, Evaluated Aspirin's Effects on Nearly 15,000 Hospitalized Patients Infected With The Novel Coronavirus.
- Since The Drug Helps Reduce Blood Clots In Other Diseases, It Was Tested In Covid-19 Patients Who Are At A Higher Risk of Clotting Issues.
▫️The Trial, Run by The University of Oxford, Is Also Looking At The Effectiveness of Several Other Treatments, And Was The First To Show That The Widely Available Steroid Dexamethasone, Could Save Lives of People Severely ill With Covid-19.
▫️The Aspirin Study Did Not Show Any Significant Change To The Risk of Patients Progressing To Invasive Mechanical Ventilation. For Every 1,000 Patients Treated With The Medicine, About Six More Patients Experienced A Major Bleeding Event And About Six Fewer Experienced A Clotting Event, Oxford Said.
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▫️Aspirin Does Not Improve The Chances of Survival In Severely ill Covid-19 Patients, Early Results from One of Britain's Biggest Trials Studying The Commonly Used Painkiller And Blood Thinner Showed on Tuesday.
▫️The Scientists Behind The Trial, Which Is Looking Into A Range of Potential Treatments For Covid-19, Evaluated Aspirin's Effects on Nearly 15,000 Hospitalized Patients Infected With The Novel Coronavirus.
- Since The Drug Helps Reduce Blood Clots In Other Diseases, It Was Tested In Covid-19 Patients Who Are At A Higher Risk of Clotting Issues.
▫️The Trial, Run by The University of Oxford, Is Also Looking At The Effectiveness of Several Other Treatments, And Was The First To Show That The Widely Available Steroid Dexamethasone, Could Save Lives of People Severely ill With Covid-19.
▫️The Aspirin Study Did Not Show Any Significant Change To The Risk of Patients Progressing To Invasive Mechanical Ventilation. For Every 1,000 Patients Treated With The Medicine, About Six More Patients Experienced A Major Bleeding Event And About Six Fewer Experienced A Clotting Event, Oxford Said.
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Unusual Copper And Iron Found Forming In Brains of Alzheimer's Patients
▫️A Team of Researchers Associated With Several Institutions In The U.K., Germany And The U.S. Has Found Evidence of An Unusual Kind of Copper And Iron in The Brains of Alzheimer's Patients.
▫️In Their Paper Published In The Journal Science Advances, The Group Describes Their Discovery of The Metals In Two Alzheimer's Patients And What It Could Mean for The Study And Treatment of The Disease.
▫️The Researchers Suggest The Metals They found Could Explain How Alzheimer's Harms Cells - Their Surfaces Would Be Highly Reactive, Which Could Lead To Damage When Exposed To Brain Cells.
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▫️A Team of Researchers Associated With Several Institutions In The U.K., Germany And The U.S. Has Found Evidence of An Unusual Kind of Copper And Iron in The Brains of Alzheimer's Patients.
▫️In Their Paper Published In The Journal Science Advances, The Group Describes Their Discovery of The Metals In Two Alzheimer's Patients And What It Could Mean for The Study And Treatment of The Disease.
▫️The Researchers Suggest The Metals They found Could Explain How Alzheimer's Harms Cells - Their Surfaces Would Be Highly Reactive, Which Could Lead To Damage When Exposed To Brain Cells.
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Science
Biogenic metallic elements in the human brain?
The chemistry of copper and iron plays a critical role in normal brain function. A variety of enzymes and proteins containing positively charged Cu+, Cu2+, Fe2+, and Fe3+ control key processes, catalyzing oxidative metabolism and neurotransmitter and neuropeptide…
Oxford Covid-19 Vaccine Inventors Recognised In Queen’s Birthday Honours
▫️The Oxford University Scientists Who Invented The Oxford-AstraZeneca Covid-19 Vaccine Are Among Those To Be Honoured by Queen Elizabeth, Among A Number of Recipients Who Played Key Roles In Britain’s Coronavirus Response, The Government Said on Friday.
▫️Sarah Gilbert, The Oxford Jenner Institute Scientist Who Co-developed The Vaccine, Will be Made A Dame, While Her Colleague, The Institute's Director, Adrian Hill, Is To Receive An Honorary Knighthood.
▫️Andrew Pollard, The Head of The Oxford Vaccine Group Who Ran Trials of The Vaccine, Is To Be Made A Knight Bachelor, An Honor Also Bestowed on Peter Horby And Martin Landray, The Oxford Scientists Behind The Trial Which Showed Dexamethasone Could Be Used To Treat Severely ill Covid-19 Patients.
▫️Kate Bingham, Who Was Praised for Her Work As Head of The Government's Vaccines Taskforce, Which Procured Hundreds of Millions of Covid-19 Vaccines for The British Government, Is Also To Become A Dame.
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▫️The Oxford University Scientists Who Invented The Oxford-AstraZeneca Covid-19 Vaccine Are Among Those To Be Honoured by Queen Elizabeth, Among A Number of Recipients Who Played Key Roles In Britain’s Coronavirus Response, The Government Said on Friday.
▫️Sarah Gilbert, The Oxford Jenner Institute Scientist Who Co-developed The Vaccine, Will be Made A Dame, While Her Colleague, The Institute's Director, Adrian Hill, Is To Receive An Honorary Knighthood.
▫️Andrew Pollard, The Head of The Oxford Vaccine Group Who Ran Trials of The Vaccine, Is To Be Made A Knight Bachelor, An Honor Also Bestowed on Peter Horby And Martin Landray, The Oxford Scientists Behind The Trial Which Showed Dexamethasone Could Be Used To Treat Severely ill Covid-19 Patients.
▫️Kate Bingham, Who Was Praised for Her Work As Head of The Government's Vaccines Taskforce, Which Procured Hundreds of Millions of Covid-19 Vaccines for The British Government, Is Also To Become A Dame.
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Clinical Trial Launched Following Discovery That Psychiatric Drug May Prevent Bowel Cancer
▫️The Study, Published In The Journal Nature, Shows How A Drug Available on The NHS Can Boost Fitness of Healthy Stem Cells In The Gut, Making Them More Resistant To Sabotage from Mutant Stem Cells That Cause Cancer.
▫️Researchers In The Netherlands, Funded by The UK Charity Worldwide Cancer Research, Have Discovered A Way To Boost The fitness of Healthy Cells In The Gut To Prevent The Development of Bowel Cancer.
▫️Lithium, A Commonly Used Drug for The Treatment of Several Psychiatric Disorders, Prevented The Mutant Stem Cells from Taking Over And Forming Tumors In Mice by Rendering The Healthy Stem Cells Insensitive To The Damaging Signals.
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▫️The Study, Published In The Journal Nature, Shows How A Drug Available on The NHS Can Boost Fitness of Healthy Stem Cells In The Gut, Making Them More Resistant To Sabotage from Mutant Stem Cells That Cause Cancer.
▫️Researchers In The Netherlands, Funded by The UK Charity Worldwide Cancer Research, Have Discovered A Way To Boost The fitness of Healthy Cells In The Gut To Prevent The Development of Bowel Cancer.
▫️Lithium, A Commonly Used Drug for The Treatment of Several Psychiatric Disorders, Prevented The Mutant Stem Cells from Taking Over And Forming Tumors In Mice by Rendering The Healthy Stem Cells Insensitive To The Damaging Signals.
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Nature
Apc-mutant cells act as supercompetitors in intestinal tumour initiation
Nature - Using experiments in organoids and in vivo in mice, the authors show that Apc-mutant cells act as supercompetitors to initiate the formation of adenomas.
German Panel Gives Limited Approval For Covid-19 Shot For Adolescents
▫️Germany's Vaccine Advisory Committee, Known As STIKO, Recommended on Thursday That Only Children And Adolescents With Pre-Existing Conditions Should Be Given The Covid-19 Vaccine Produced by Pfizer And BioNTech.
▫️STIKO Said In A Statement That It Recommends A Vaccination Only for Those Youngsters With An illness That Raises Their Risk of A Serious Case of Coronavirus.
▫️It Said It Was Not Currently Recommending The Use of The Vaccine for Those Aged 12-17 Without Pre-Existing Conditions, Although Noted Doctors Were Allowed To Give The Shot If The Individual Accepts The Risk.
▫️The CDC And Other Health Regulators Have Been Investigating Heart Inflammation Cases Had Found A Likely Link To The Condition In Young Men Who Received Pfizer’s Covid-19 Vaccine.
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▫️Germany's Vaccine Advisory Committee, Known As STIKO, Recommended on Thursday That Only Children And Adolescents With Pre-Existing Conditions Should Be Given The Covid-19 Vaccine Produced by Pfizer And BioNTech.
▫️STIKO Said In A Statement That It Recommends A Vaccination Only for Those Youngsters With An illness That Raises Their Risk of A Serious Case of Coronavirus.
▫️It Said It Was Not Currently Recommending The Use of The Vaccine for Those Aged 12-17 Without Pre-Existing Conditions, Although Noted Doctors Were Allowed To Give The Shot If The Individual Accepts The Risk.
▫️The CDC And Other Health Regulators Have Been Investigating Heart Inflammation Cases Had Found A Likely Link To The Condition In Young Men Who Received Pfizer’s Covid-19 Vaccine.
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UK Study Finds Vaccines Offer High Protection Against Hospitalisation from Delta Variant
▫️Covid-19 Vaccines Made by Pfizer And AstraZeneca Offer High Protection of More Than 90% Against Hospitalisation from The Delta Coronavirus Variant, A New Analysis by Public Health England (PHE) Showed on Monday.
▫️PHE Said That The Pfizer-BionTech Covid-19 Vaccine Was 96% Effective Against Hospitalisation from The Delta Variant After Two doses, While AstraZeneca's Offered 92% Protection Against Hospitalisation by Delta.
▫️PHE Said That Those Levels Of Protection Were Comparable To That Against The Alpha Variant, First Identified In Kent, Southeast England.
▫️The Analysis Adds To Evidence That, Although The Delta Variant Reduces The Effectiveness of Vaccines Against Symptomatic Infection, Two doses of Covid-19 Vaccine Still Protect Against Severe Disease.
▫️The PHE Findings Follow A Scottish Study Which Showed That Two doses of A Covid-19 Vaccine Among People Who Tested Positive Cut Their Risk of Hospitalisation by 70%, Although There Were Not Enough Hospital Admissions Reported To Compare The Vaccines.
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▫️Covid-19 Vaccines Made by Pfizer And AstraZeneca Offer High Protection of More Than 90% Against Hospitalisation from The Delta Coronavirus Variant, A New Analysis by Public Health England (PHE) Showed on Monday.
▫️PHE Said That The Pfizer-BionTech Covid-19 Vaccine Was 96% Effective Against Hospitalisation from The Delta Variant After Two doses, While AstraZeneca's Offered 92% Protection Against Hospitalisation by Delta.
▫️PHE Said That Those Levels Of Protection Were Comparable To That Against The Alpha Variant, First Identified In Kent, Southeast England.
▫️The Analysis Adds To Evidence That, Although The Delta Variant Reduces The Effectiveness of Vaccines Against Symptomatic Infection, Two doses of Covid-19 Vaccine Still Protect Against Severe Disease.
▫️The PHE Findings Follow A Scottish Study Which Showed That Two doses of A Covid-19 Vaccine Among People Who Tested Positive Cut Their Risk of Hospitalisation by 70%, Although There Were Not Enough Hospital Admissions Reported To Compare The Vaccines.
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Oxford Covid-19 Shots Have Good Risk-Benefit Profile for Over 60s: EMA Official Says
▫️Oxford-AstraZeneca Shots Have Good Risk-Benefit Profile For Over 60s, Says EMA Official.
▫️The Head of The EU Drug Regulator’s Covid-19 Task Force Said on Sunday That AstraZeneca’s Covid-19 Vaccine Had A Favourable Risk-Benefit Profile For All Age Groups And Particularly For Those Aged Over 60.
▫️Italian Newspaper La Stampa Earlier Quoted European Medicines Agency (EMA) Task Force Chief Marco Cavaleri As Saying Countries Should Avoid Giving The Vaccine To People Aged Over 60 In Addition To Younger Age Groups, Amid Fears Over Very Rare Blood Clotting And As Alternative Vaccines Become Available.
- The AstraZeneca Shot “Maintains A Favourable Benefit Risk Profile In All Ages But Particularly In The Elderly Above 60,” He Said.
▫️The EMA’s Position Is That The AstraZeneca Shot Is Safe And Can Be Used For All Age Groups Over 18.
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▫️Oxford-AstraZeneca Shots Have Good Risk-Benefit Profile For Over 60s, Says EMA Official.
▫️The Head of The EU Drug Regulator’s Covid-19 Task Force Said on Sunday That AstraZeneca’s Covid-19 Vaccine Had A Favourable Risk-Benefit Profile For All Age Groups And Particularly For Those Aged Over 60.
▫️Italian Newspaper La Stampa Earlier Quoted European Medicines Agency (EMA) Task Force Chief Marco Cavaleri As Saying Countries Should Avoid Giving The Vaccine To People Aged Over 60 In Addition To Younger Age Groups, Amid Fears Over Very Rare Blood Clotting And As Alternative Vaccines Become Available.
- The AstraZeneca Shot “Maintains A Favourable Benefit Risk Profile In All Ages But Particularly In The Elderly Above 60,” He Said.
▫️The EMA’s Position Is That The AstraZeneca Shot Is Safe And Can Be Used For All Age Groups Over 18.
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Novavax Covid-19 Vaccine More Than 90% Effective In U.S. Trial
▫️Novavax Inc on Monday Said Its Covid-19 Vaccine Was More Than 90% Effective, Including Against A Variety of Concerning Variants of The Coronavirus In A Large, Late-Stage US-Based Clinical Trial.
▫️The Study of Nearly 30,000 Volunteers In The United States And Mexico Puts Novavax on Track To File For Emergency Authorization In The United States And Elsewhere In The Third Quarter of 2021, The Company Said.
▫️The Protein-Based Vaccine Was More Than 93% Effective Against The More Easily Transmissible Predominant Coronavirus Variants That Have Caused Concern Among Scientists And Public Health Officials, Novavax Said.
▫️Protein-Based Vaccines Are A Conventional Approach That Use Purified Pieces of The Virus To Spur An Immune Response, Such As Those Used Against Whooping Cough And Shingles.
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▫️Novavax Inc on Monday Said Its Covid-19 Vaccine Was More Than 90% Effective, Including Against A Variety of Concerning Variants of The Coronavirus In A Large, Late-Stage US-Based Clinical Trial.
▫️The Study of Nearly 30,000 Volunteers In The United States And Mexico Puts Novavax on Track To File For Emergency Authorization In The United States And Elsewhere In The Third Quarter of 2021, The Company Said.
▫️The Protein-Based Vaccine Was More Than 93% Effective Against The More Easily Transmissible Predominant Coronavirus Variants That Have Caused Concern Among Scientists And Public Health Officials, Novavax Said.
▫️Protein-Based Vaccines Are A Conventional Approach That Use Purified Pieces of The Virus To Spur An Immune Response, Such As Those Used Against Whooping Cough And Shingles.
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Delta Variant Doubles Risk of Covid-19 Hospitalization
▫️The Delta Variant of The Coronavirus First Identified In India May Double The Risk of Hospitalization Among Covid-19 Patients, Compared With The Alpha Variant First Discovered In The UK, A Study from Scotland Suggests.
▫️Researchers Looked At 19,543 Covid-19 Cases And 377 Hospitalizations Among 5.4 Million People, Including 7,723 Cases And 134 Hospitalizations In Patients With The Delta Variant, Who Tended To Be Younger And More Affluent.
▫️The Risk of Covid-19 Hospital Admission Was About Double With The delta Variant Compared To The Alpha Variant, With The Risk Particularly Increased In Those With Five Or More Medical Conditions Known To Contribute To More Severe Disease, The Researchers Reported on Monday In The Lancet.
▫️They Found That Two doses of The Vaccines from Pfizer-BioNTech And from Oxford-AstraZeneca Still Provide Strong Protection, Although Not As Strong As The Protection Provided Against The Alpha Variant (B.1.1.7).
▫️Two Weeks After The Second dose, The Pfizer-BioNTech Vaccine Was found To Provide 79% Protection Against Infection from The Delta Variant, Compared To 92% Against The Alpha Variant.
▫️With Oxford-AstraZeneca's Vaccine, There Was 60% Protection Against Delta Variant Compared With 73% for Alpha. Because This Was An Observational Study, More Research Is Needed To Confirm The Findings, The Research Team Said.
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▫️The Delta Variant of The Coronavirus First Identified In India May Double The Risk of Hospitalization Among Covid-19 Patients, Compared With The Alpha Variant First Discovered In The UK, A Study from Scotland Suggests.
▫️Researchers Looked At 19,543 Covid-19 Cases And 377 Hospitalizations Among 5.4 Million People, Including 7,723 Cases And 134 Hospitalizations In Patients With The Delta Variant, Who Tended To Be Younger And More Affluent.
▫️The Risk of Covid-19 Hospital Admission Was About Double With The delta Variant Compared To The Alpha Variant, With The Risk Particularly Increased In Those With Five Or More Medical Conditions Known To Contribute To More Severe Disease, The Researchers Reported on Monday In The Lancet.
▫️They Found That Two doses of The Vaccines from Pfizer-BioNTech And from Oxford-AstraZeneca Still Provide Strong Protection, Although Not As Strong As The Protection Provided Against The Alpha Variant (B.1.1.7).
▫️Two Weeks After The Second dose, The Pfizer-BioNTech Vaccine Was found To Provide 79% Protection Against Infection from The Delta Variant, Compared To 92% Against The Alpha Variant.
▫️With Oxford-AstraZeneca's Vaccine, There Was 60% Protection Against Delta Variant Compared With 73% for Alpha. Because This Was An Observational Study, More Research Is Needed To Confirm The Findings, The Research Team Said.
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Novavax Covid-19 Vaccine Co-Administered With Flu Vaccine Appears Safe And Effective
▫️Novavax Inc Said on Monday Vaccine Efficacy Appeared To Be Preserved In Those Receiving An Approved Influenza Vaccine Along With Its Covid-19 Vaccine Candidate Compared To Those Receiving Its Covid-19 Vaccine Alone.
▫️The Company Released The Results from A Sub-Study It Conducted As Part of Its Late-Stage Clinical Trial of NVX-CoV2373, Its Protein-Based Covid-19 Vaccine Candidate, In The United Kingdom.
▫️The 431 Participants Enrolled In The Sub-Study Received An Approved Seasonal Influenza Vaccine With About Half The Participants Administered NVX-CoV2373, While The Rest Received Placebo.
▫️The Company Said Vaccine Efficacy Was 87.5% Compared To 89.8% In The Main Study.
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▫️Novavax Inc Said on Monday Vaccine Efficacy Appeared To Be Preserved In Those Receiving An Approved Influenza Vaccine Along With Its Covid-19 Vaccine Candidate Compared To Those Receiving Its Covid-19 Vaccine Alone.
▫️The Company Released The Results from A Sub-Study It Conducted As Part of Its Late-Stage Clinical Trial of NVX-CoV2373, Its Protein-Based Covid-19 Vaccine Candidate, In The United Kingdom.
▫️The 431 Participants Enrolled In The Sub-Study Received An Approved Seasonal Influenza Vaccine With About Half The Participants Administered NVX-CoV2373, While The Rest Received Placebo.
▫️The Company Said Vaccine Efficacy Was 87.5% Compared To 89.8% In The Main Study.
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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…
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.
@MedicalNoteBook