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.
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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.
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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.
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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.
@MedicalNoteBook
▫️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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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.
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'Likely Link' Between Rare "Heart Inflammation" And Pfizer, Moderna Vaccines: CDC Advisers
▫️Rare Cases of Heart Inflammation In Adolescents And Young Adults Is Likely Linked To Vaccination With The Pfizer-BioNTech And Moderna Covid-19 Shots, A Group of Doctors Advising The U.S. Centers for Disease Control And Prevention (CDC) Said In A Presentation Released on Wednesday.
▫️The Covid-19 Vaccine Safety Technical (VaST) Work Group Said In Their Report That The Risk of Myocarditis or Pericarditis Following Vaccination With The mRNA-Based Shots In Adolescents And Young Adults Is Notably Higher After The Second dose And In Males.
▫️
▫️The CDC Has Received Reports of More Than 300 Cases of Heart Inflammation In Young People After Vaccination With The mRNA-Based Covid-19 Shots.
▫️The Advisory Committee on Immunization Practices (ACIP) Is Meeting on Wednesday To Assess The Possibility Of A Link Between The Heart Condition And The mRNA Vaccines. VaST Is A Sub-Group of ACIP.
▫️The CDC Has Been Investigating Cases of Heart Inflammation Mainly In Young Men for Several Months.
▫️The Israeli Health Ministry Earlier This Month Said It Saw A Possible Link Between Such Cases And Pfizer’s Covid-19 Vaccine.
@MedicalNoteBook
▫️Rare Cases of Heart Inflammation In Adolescents And Young Adults Is Likely Linked To Vaccination With The Pfizer-BioNTech And Moderna Covid-19 Shots, A Group of Doctors Advising The U.S. Centers for Disease Control And Prevention (CDC) Said In A Presentation Released on Wednesday.
▫️The Covid-19 Vaccine Safety Technical (VaST) Work Group Said In Their Report That The Risk of Myocarditis or Pericarditis Following Vaccination With The mRNA-Based Shots In Adolescents And Young Adults Is Notably Higher After The Second dose And In Males.
▫️
Dr. Tom Shimabukuro, Deputy Director of The CDC’s Immunization Safety Office, Said In A Presentation That Data from One of The Agency’s Safety Monitoring Systems - Vaccine Safety Data Link (VSD) - Suggests A Rate of 12.6 Cases Per Million In The Three Weeks After The Second Shot In 12- To 39 Year Olds.▫️The CDC Has Received Reports of More Than 300 Cases of Heart Inflammation In Young People After Vaccination With The mRNA-Based Covid-19 Shots.
▫️The Advisory Committee on Immunization Practices (ACIP) Is Meeting on Wednesday To Assess The Possibility Of A Link Between The Heart Condition And The mRNA Vaccines. VaST Is A Sub-Group of ACIP.
▫️The CDC Has Been Investigating Cases of Heart Inflammation Mainly In Young Men for Several Months.
▫️The Israeli Health Ministry Earlier This Month Said It Saw A Possible Link Between Such Cases And Pfizer’s Covid-19 Vaccine.
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FDA Approves Boehringer’s Oral Blood Thinner Pradaxa For Children
▫️The US Food And Drug Administration (FDA) Has Approved Boehringer Ingelheim Pharmaceuticals’ Pradaxa (Dabigatran Etexilate) Oral Pellets For Pediatric Patients Aged Between Three Months And 12 Years With Venous Thromboembolism.
▫️Venous Thromboembolism Causes The Formation of Blood Clots In The Veins And Could Lead To Complications Such As Swelling And Discomfort Near The Clot, Chest Pain, Lung Damage And Death
▫️Pradaxa Is Indicated For Administration Directly After The Children Have Received A Blood Thinner Given by Injection For At Least Five Days.
▫️The Oral Pellets Also Received FDA Approval To Prevent Recurrent Clots In Children of The Same Age Group Who Have Received Therapy for Their First Venous Thromboembolism.
▫️Furthermore, The Capsule form of The Drug Has Approval for Treating Blood Clots In Children Aged Eight Years And Above With Venous Thromboembolism Who Have Received A Blood Thinner Injection For A Minimum of Five Days.
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▫️The US Food And Drug Administration (FDA) Has Approved Boehringer Ingelheim Pharmaceuticals’ Pradaxa (Dabigatran Etexilate) Oral Pellets For Pediatric Patients Aged Between Three Months And 12 Years With Venous Thromboembolism.
▫️Venous Thromboembolism Causes The Formation of Blood Clots In The Veins And Could Lead To Complications Such As Swelling And Discomfort Near The Clot, Chest Pain, Lung Damage And Death
▫️Pradaxa Is Indicated For Administration Directly After The Children Have Received A Blood Thinner Given by Injection For At Least Five Days.
▫️The Oral Pellets Also Received FDA Approval To Prevent Recurrent Clots In Children of The Same Age Group Who Have Received Therapy for Their First Venous Thromboembolism.
▫️Furthermore, The Capsule form of The Drug Has Approval for Treating Blood Clots In Children Aged Eight Years And Above With Venous Thromboembolism Who Have Received A Blood Thinner Injection For A Minimum of Five Days.
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Oxford, Pfizer Vaccines Effective Against Delta Covid-19 Variants: Study
▫️Covid-19 Vaccines Made by Oxford-AstraZeneca And The Pfizer-BioNTech, Alliance Remain Broadly Effective Against Delta And Kappa Variants of The Covid-19 Causing Virus, Which Were First Identified In India, According To A Scientific Study, Underpinning A Continued Push To Deliver The Shots.
▫️The Study by Oxford University Researchers, Published In The Journal Cell, Investigated The Ability of Antibodies In The Blood from People, Who Were Vaccinated With The Two-Shot Regimens, To Neutralize The Highly Contagious Delta And Kappa Variants, A Statement Said.
▫️"There Is No Evidence of Widespread Escape Suggesting That The Current Generation of Vaccines Will Provide Protection Against The B.1.617 Lineage," The Paper Said, Referring To The Delta And Kappa Variants by A Commonly Used Code.
▫️Last week, An Analysis by The Public Health England (PHE) Showed That Vaccines Made by Pfizer And AstraZeneca Offer High Protection of More Than 90% Against Hospitalization from The Delta Variant.
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▫️Covid-19 Vaccines Made by Oxford-AstraZeneca And The Pfizer-BioNTech, Alliance Remain Broadly Effective Against Delta And Kappa Variants of The Covid-19 Causing Virus, Which Were First Identified In India, According To A Scientific Study, Underpinning A Continued Push To Deliver The Shots.
▫️The Study by Oxford University Researchers, Published In The Journal Cell, Investigated The Ability of Antibodies In The Blood from People, Who Were Vaccinated With The Two-Shot Regimens, To Neutralize The Highly Contagious Delta And Kappa Variants, A Statement Said.
▫️"There Is No Evidence of Widespread Escape Suggesting That The Current Generation of Vaccines Will Provide Protection Against The B.1.617 Lineage," The Paper Said, Referring To The Delta And Kappa Variants by A Commonly Used Code.
▫️Last week, An Analysis by The Public Health England (PHE) Showed That Vaccines Made by Pfizer And AstraZeneca Offer High Protection of More Than 90% Against Hospitalization from The Delta Variant.
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Oxford University Adds Ivermectin To PRINCIPLE Trial For Covid-19
▫️The University of Oxford In The UK Has Added Ivermectin To The Platform Randomised Trial of Treatments In The Community for Epidemic And Pandemic Illnesses (PRINCIPLE) Study for The Treatment of Covid-19.
▫️PRINCIPLE Is A Large Clinical Trial Designed To Assess Potential Covid-19 Therapies for Non-Hospitalised Patients, Including At-Home Recovery, Who Are At Higher Risk of Progressing To Serious illness.
▫️Ivermectin Is Broad Spectrum Antiparasitic Used Commonly To Treat Parasitic Infections Worldwide.
▫️The Drug, Which Is Known To Exhibit Antiviral Properties, Reduced SARS-CoV-2 Replication In Laboratory Studies.
▫️In Small Pilot Studies, Early Use of Ivermectin Was Able To Lower Viral Load And The Duration of Symptoms In Some Mild Covid-19 Patients.
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▫️The University of Oxford In The UK Has Added Ivermectin To The Platform Randomised Trial of Treatments In The Community for Epidemic And Pandemic Illnesses (PRINCIPLE) Study for The Treatment of Covid-19.
▫️PRINCIPLE Is A Large Clinical Trial Designed To Assess Potential Covid-19 Therapies for Non-Hospitalised Patients, Including At-Home Recovery, Who Are At Higher Risk of Progressing To Serious illness.
▫️Ivermectin Is Broad Spectrum Antiparasitic Used Commonly To Treat Parasitic Infections Worldwide.
▫️The Drug, Which Is Known To Exhibit Antiviral Properties, Reduced SARS-CoV-2 Replication In Laboratory Studies.
▫️In Small Pilot Studies, Early Use of Ivermectin Was Able To Lower Viral Load And The Duration of Symptoms In Some Mild Covid-19 Patients.
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Skin Reactions After mRNA Covid-19 Vaccination: Uncommonly Recur After Second dose
▫️Skin Problems Such As Itchiness, Rashes, Hives And Swelling Can Occur In Some Individuals After Receiving A mRNA Covid-19 Vaccine, But It’s Not Clear How Common These Reactions Are Or How Frequently They Recur With A Subsequent Vaccination.
▫️Research by Led by Allergists At Massachusetts General Hospital (MGH) Now Provides Encouraging Indications That The Reactions Are Rare, And That Even When They Do Occur With An Initial Covid-19 Vaccination, They Seldom Recur After Receiving A Second Vaccine dose.
▫️For The Study, Which Is Published In JAMA Dermatology, Prospectively Studied 49,197 Mass General Brigham Employees Who Received mRNA Covid-19 Vaccines. At Least One Symptom Survey Was Completed by 40,640 Employees After The First dose of Vaccine.
▫️Skin Reactions Were Reported by 776 (1.9%) of Survey Respondents After The First dose. Rash And Itching (Other Than At The Injection Site) Were The Most Common Skin Reactions, And The Average Age of Those Reporting Skin Reactions Was 41 Years.
- Skin Reactions Were More Common In Females (85%) Than Males (15%) And Differed by Race (62% White, 7% Black, And 12% Asian).
▫️Among 609 Individuals Who Reported Skin Reactions To The First dose, Received A Second dose, And Completed A Symptom Survey After The Second dose, 508 (83%) Reported No Recurrent Skin Reactions.
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▫️Skin Problems Such As Itchiness, Rashes, Hives And Swelling Can Occur In Some Individuals After Receiving A mRNA Covid-19 Vaccine, But It’s Not Clear How Common These Reactions Are Or How Frequently They Recur With A Subsequent Vaccination.
▫️Research by Led by Allergists At Massachusetts General Hospital (MGH) Now Provides Encouraging Indications That The Reactions Are Rare, And That Even When They Do Occur With An Initial Covid-19 Vaccination, They Seldom Recur After Receiving A Second Vaccine dose.
▫️For The Study, Which Is Published In JAMA Dermatology, Prospectively Studied 49,197 Mass General Brigham Employees Who Received mRNA Covid-19 Vaccines. At Least One Symptom Survey Was Completed by 40,640 Employees After The First dose of Vaccine.
▫️Skin Reactions Were Reported by 776 (1.9%) of Survey Respondents After The First dose. Rash And Itching (Other Than At The Injection Site) Were The Most Common Skin Reactions, And The Average Age of Those Reporting Skin Reactions Was 41 Years.
- Skin Reactions Were More Common In Females (85%) Than Males (15%) And Differed by Race (62% White, 7% Black, And 12% Asian).
▫️Among 609 Individuals Who Reported Skin Reactions To The First dose, Received A Second dose, And Completed A Symptom Survey After The Second dose, 508 (83%) Reported No Recurrent Skin Reactions.
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Novartis’ Zolgensma Improves Motor Function In Phase III SMA Trials
▫️Novartis Has Reported Positive Data from Two Phase III Clinical Trials Which Further Demonstrated The Use of Gene Therapy, Zolgensma (Onasemnogene Abeparvovec), for Treating Spinal Muscular Atrophy (SMA) In Pediatric Patients.
▫️Administered As A Single Intravenous (IV) Infusion, Zolgensma Is Designed To Target The Genetic Root Cause of The SMA by Swapping The Function of The Missing or Non-Working SMN Gene To Stop Disease Progression Via Sustained SMN Protein Expression.
▫️SMA Type 1 Causes Progressive And Permanent Loss of Motor Function And May Lead To Death Or Full-Time Ventilation by The Age of Two Years, If Untreated.
▫️The Open-Label, Single-Arm, Multi-Center Phase III SPR1NT Trial Analyzed The Safety And Efficacy of A One-Time IV dose of Zolgensma In Pre-Symptomatic SMA Patients Aged Six Weeks Or Below With Two Or Three Copies of SMN2.
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▫️Novartis Has Reported Positive Data from Two Phase III Clinical Trials Which Further Demonstrated The Use of Gene Therapy, Zolgensma (Onasemnogene Abeparvovec), for Treating Spinal Muscular Atrophy (SMA) In Pediatric Patients.
▫️Administered As A Single Intravenous (IV) Infusion, Zolgensma Is Designed To Target The Genetic Root Cause of The SMA by Swapping The Function of The Missing or Non-Working SMN Gene To Stop Disease Progression Via Sustained SMN Protein Expression.
▫️SMA Type 1 Causes Progressive And Permanent Loss of Motor Function And May Lead To Death Or Full-Time Ventilation by The Age of Two Years, If Untreated.
▫️The Open-Label, Single-Arm, Multi-Center Phase III SPR1NT Trial Analyzed The Safety And Efficacy of A One-Time IV dose of Zolgensma In Pre-Symptomatic SMA Patients Aged Six Weeks Or Below With Two Or Three Copies of SMN2.
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CDC Panel Says ‘Likely Association’ Between Heart Inflammation And mRNA Vaccines
▫️There Is A “Likely Association of Myocarditis With mRNA Vaccination” In Teenagers And Young Adults, The US Health Agency’s Vaccine Safety Group Has Said, As Scientists Strive To Understand The Cause of The Rare Side Effect In Vaccinated Individuals.
▫️The Centers for Disease Control And Prevention (CDC) Is Monitoring Cases of Myocarditis And Pericarditis, Which Have Been Reported After First And Second doses of The Moderna And BioNTech-Pfizer mRNA Vaccines.
▫️Myocarditis Is Inflammation of The Heart Muscle, While Pericarditis Is Inflammation of The Membrane That Surrounds The Heart.
▫️In People Aged 12-39, There Have Been 4.4 Reports of Either Issue Per Million Vaccine doses Administered And A 12.6 Per Million Report Rate After The Second dose.
- Symptoms Include Chest Pain, Shortness of Breath And Heart Palpitations, With The Majority of Patients Experiencing Symptoms Within A Week of Vaccination.
▫️These Side Effects Have So Far Been Seen far More In Younger Men And After Their Second dose, At A Rate of 32 Per-Million doses Given.
▫️At An Advisory Meeting on Wednesday, The CDC’s Vaccine Safety Technical Work Group Said That Existing Data Suggests A “Likely Association” Between The Heart Condition And The mRNA Vaccines.
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▫️There Is A “Likely Association of Myocarditis With mRNA Vaccination” In Teenagers And Young Adults, The US Health Agency’s Vaccine Safety Group Has Said, As Scientists Strive To Understand The Cause of The Rare Side Effect In Vaccinated Individuals.
▫️The Centers for Disease Control And Prevention (CDC) Is Monitoring Cases of Myocarditis And Pericarditis, Which Have Been Reported After First And Second doses of The Moderna And BioNTech-Pfizer mRNA Vaccines.
▫️Myocarditis Is Inflammation of The Heart Muscle, While Pericarditis Is Inflammation of The Membrane That Surrounds The Heart.
▫️In People Aged 12-39, There Have Been 4.4 Reports of Either Issue Per Million Vaccine doses Administered And A 12.6 Per Million Report Rate After The Second dose.
- Symptoms Include Chest Pain, Shortness of Breath And Heart Palpitations, With The Majority of Patients Experiencing Symptoms Within A Week of Vaccination.
▫️These Side Effects Have So Far Been Seen far More In Younger Men And After Their Second dose, At A Rate of 32 Per-Million doses Given.
▫️At An Advisory Meeting on Wednesday, The CDC’s Vaccine Safety Technical Work Group Said That Existing Data Suggests A “Likely Association” Between The Heart Condition And The mRNA Vaccines.
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Case Report: Remdesivir Induced Dangerously Low Heart Rate In Covid-19 Patient
▫️After Beginning Treatment With Remdesivir for Covid-19, A Patient Experienced Significant Bradycardia, Or Low Heart Rate. Her Physicians Used A Dopamine Infusion To Stabilize Her Through The Five-day Course of Remdesivir Treatment, And Her Cardiac Condition Resolved Itself At The End of The Treatment. The Case Is Discussed In Heart Rhythm Case Reports, An Official Journal of The Heart Rhythm Society, Published by Elsevier.
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▫️After Beginning Treatment With Remdesivir for Covid-19, A Patient Experienced Significant Bradycardia, Or Low Heart Rate. Her Physicians Used A Dopamine Infusion To Stabilize Her Through The Five-day Course of Remdesivir Treatment, And Her Cardiac Condition Resolved Itself At The End of The Treatment. The Case Is Discussed In Heart Rhythm Case Reports, An Official Journal of The Heart Rhythm Society, Published by Elsevier.
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Sciencedirect
Remdesivir-induced symptomatic bradycardia in the treatment of COVID-19 disease
FDA To Add Warning About Rare Heart Inflammation To Pfizer, Moderna Covid-19 Vaccines
▫️The U.S. Food And Drug Administration (FDA) Said on Wednesday It Plans To Move Quickly To Add A Warning About Rare Cases of Heart Inflammation In Adolescents And Young Adults To Fact Sheets for The Pfizer-BioNTech, And Moderna Covid-19 Vaccines.
▫️U.S. Centers for Disease Control And Prevention (CDC) Advisory Groups, Meeting To Discuss Reported Cases of The Heart Condition After Vaccination, Found The Inflammation In Adolescents And Young Adults Is Likely Linked To The Vaccines, But That The Benefits of The Shots Appeared To Clearly Outweigh The Risk.
▫️The Cases of Heart Inflammation Appear To Be Notably Higher In The Week After The Second Vaccine dose And In Males. The CDC Identified 309 Hospitalizations from The Heart Inflammation In Persons Under The Age of 30.
▫️Dr. Tom Shimabukuro, Deputy Director of The CDC’s Immunization Safety Office, Said In A Presentation That Data from One of The Agency’s Safety Monitoring Systems - Vaccine Safety Data Link (VSD) - Suggests A Rate of 12.6 Cases Per Million In The Three Weeks After The Second Shot In 12- To 39 Year-Olds.
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▫️The U.S. Food And Drug Administration (FDA) Said on Wednesday It Plans To Move Quickly To Add A Warning About Rare Cases of Heart Inflammation In Adolescents And Young Adults To Fact Sheets for The Pfizer-BioNTech, And Moderna Covid-19 Vaccines.
▫️U.S. Centers for Disease Control And Prevention (CDC) Advisory Groups, Meeting To Discuss Reported Cases of The Heart Condition After Vaccination, Found The Inflammation In Adolescents And Young Adults Is Likely Linked To The Vaccines, But That The Benefits of The Shots Appeared To Clearly Outweigh The Risk.
▫️The Cases of Heart Inflammation Appear To Be Notably Higher In The Week After The Second Vaccine dose And In Males. The CDC Identified 309 Hospitalizations from The Heart Inflammation In Persons Under The Age of 30.
▫️Dr. Tom Shimabukuro, Deputy Director of The CDC’s Immunization Safety Office, Said In A Presentation That Data from One of The Agency’s Safety Monitoring Systems - Vaccine Safety Data Link (VSD) - Suggests A Rate of 12.6 Cases Per Million In The Three Weeks After The Second Shot In 12- To 39 Year-Olds.
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Roche's Actemra Gets U.S. FDA Approval For Hospitalized COVID-19 Patients
▫️The U.S. Food And Drug Administration (FDA) Issued An Emergency Use Authorization (EUA) For The Drug Actemra (Tocilizumab) For The Treatment of Hospitalized Covid-19 Adults And Pediatric Patients (2 Years of Age And Older) Who Are Receiving Systemic Corticosteroids And Require Supplemental Oxygen, Non-Invasive Or Invasive Mechanical Ventilation, Or Extracorporeal Membrane Oxygenation (ECMO), The Health Agency Said on Thursday.
▫️Actemra Is A Monoclonal Antibody That Reduces Inflammation by Blocking The Interleukin-6 Receptor.
- In The Case of Covid-19 Infection, The Immune System Can Become Hyperactive, Which May Result In Worsening of Disease.
▫️Actemra Does Not Directly Target SARS-COV-2. Actemra Is A Prescription Medication Given By Intravenous Infusion That Is FDA-Approved For Multiple Inflammatory Diseases, Including Rheumatoid Arthritis.
▫️The EUA Is Based on Results From Four Randomized, Controlled Studies That Evaluated Actemra For The Treatment of Covid-19 In More Than 5,500 Hospitalized Patients, Genentech Said In A Separate Statement.
▫️Actemra Is Not Authorized For Use In Outpatients With Covid-19 Or As A Treatment for Covid-19, The Health Agency Said.
▫️In The Clinical Trials, Actemra Was Shown To Reduce The Risk of Death And Time Taken To Recover by Hospitalised Patients, The FDA Added.
▫️Last Year, The FDA Approved Gilead Sciences Inc's Antiviral Drug Remdesivir For Treating Patients Hospitalized With Covid-19.
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▫️The U.S. Food And Drug Administration (FDA) Issued An Emergency Use Authorization (EUA) For The Drug Actemra (Tocilizumab) For The Treatment of Hospitalized Covid-19 Adults And Pediatric Patients (2 Years of Age And Older) Who Are Receiving Systemic Corticosteroids And Require Supplemental Oxygen, Non-Invasive Or Invasive Mechanical Ventilation, Or Extracorporeal Membrane Oxygenation (ECMO), The Health Agency Said on Thursday.
▫️Actemra Is A Monoclonal Antibody That Reduces Inflammation by Blocking The Interleukin-6 Receptor.
- In The Case of Covid-19 Infection, The Immune System Can Become Hyperactive, Which May Result In Worsening of Disease.
▫️Actemra Does Not Directly Target SARS-COV-2. Actemra Is A Prescription Medication Given By Intravenous Infusion That Is FDA-Approved For Multiple Inflammatory Diseases, Including Rheumatoid Arthritis.
▫️The EUA Is Based on Results From Four Randomized, Controlled Studies That Evaluated Actemra For The Treatment of Covid-19 In More Than 5,500 Hospitalized Patients, Genentech Said In A Separate Statement.
▫️Actemra Is Not Authorized For Use In Outpatients With Covid-19 Or As A Treatment for Covid-19, The Health Agency Said.
▫️In The Clinical Trials, Actemra Was Shown To Reduce The Risk of Death And Time Taken To Recover by Hospitalised Patients, The FDA Added.
▫️Last Year, The FDA Approved Gilead Sciences Inc's Antiviral Drug Remdesivir For Treating Patients Hospitalized With Covid-19.
@MedicalNoteBook