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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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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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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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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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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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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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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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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Oxford Scientists Say They Developed Blood Test Predictor of Vaccine Efficacy

▫️Oxford University Scientists Said on Thursday They Have Developed A Method To Predict The Efficacy of New Covid-19 Vaccines Based on A Blood Test, Potentially Offering A Short-Cut Around Massive Clinical Trials That Are Increasingly Difficult To Conduct.
▫️The Researchers Looked At The Concentration of A Range of Virus-Fighting Antibodies In The Blood of Trial Participants After They Had Received The Vaccine Developed by AstraZeneca And Oxford University, Now Known As Vaxzevria.
▫️By Looking At Which of Those Trial Volunteers Later Contracted Symptomatic Covid-19 And Which Did Not, The Researchers Came Up With A Model They Hope Will Predict How Powerful Other Vaccines Will Be, Based on Those Blood Readings.
▫️"The Data Can Be Used To Extrapolate Efficacy Estimates For New Vaccines Where Large Efficacy Trials Cannot Be Conducted," They Said In Their Paper, Which Was Posted Online on Thursday And Submitted for Peer-Review for Future Publication In A Scientific Journal.
▫️The Oxford Researchers Cautioned More Work Was Needed To Validate Their Model for Many of The Highly Contagious New Virus Variants of Concern.

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Eli Lilly To Seek Accelerated FDA Approval for Alzheimer's Drug This Year

▫️Eli Lilly And Co Said on Thursday It Will Apply For U.S. Health Regulator’s Accelerated Approval This Year for Its Experimental Alzheimer’s Drug, Weeks After Biogen Inc’s Controversial Drug For The Disease Was Approved.
▫️Like Aduhelm (Aducanumab), Lilly’s Dug Candidate, Donanemab, Too Is Designed To Remove Clumps of A Protein Called Beta Amyloid From The Brain. The Protein Is Believed To Be A Contributing Cause of Alzheimer’s.
▫️Lilly In January Said Early Results from A Mid-Stage Trial of 272 Patients Showed Donanemab Met Its Main Goal of Slowing The Rate of Decline In Cognition And Function In Patients At An Early Stage of The Mind-Wasting Disease.
▫️Results For The Trial’s Secondary Goals Measuring Cognition And Function Were Positive, But Not All of Them Reached Statistical Significance.
▫️Lilly Is Continuing To Study The Drug In A Late-Stage Study.
▫️The Company Said It Would File A Marketing Application for Donanemab Based on Data from The Mid-Stage Trial.
▫️The FDA on Thursday Granted Donanemab A Breakthrough Therapy Designation, Meant To Expedite The Development And Review of Medicines for Serious Or Life-Threatening Conditions.

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Gilead Reports Interim Late-Stage Data From Viral Hepatitis Drug Trial

▫️Gilead Sciences Has Reported Interim Data from Its Phase IIb And Phase III Clinical Trials, Which Showed Hepcludex (Bulevirtide) Provided A Substantial Response In Patients With Chronic Hepatitis Delta Virus (HDV).
▫️Hepcludex Is An Investigational Entry Inhibitor Agent In The Developmental Stage.
▫️According To Data from The Phase III MYR301 Trial, 36.7% of The HDV Patients Receiving Bulevirtide 2mg Had Combined Virological And Biochemical Response After 24 Weeks, Along With 28% of Those Who Were Given Bulevirtide 10mg.
▫️Bulevirtide 2mg Was Observed To Offer An Increased Response Rate As Against The 10mg dose In 24-Week Treatment.
▫️Gilead Noted That The Phase III Trial Results Support The Safety And Efficacy Profile of The Once-Daily dose of Bulevirtide 2mg.
▫️The Company Intends To Submit The Phase III Data of Bulevirtide To The US Food And Drug Administration (FDA) Later This Year.

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Novel mRNA Vaccine Provides Full Protection Against Malaria In Mice

▫️Scientists from The Walter Reed Army Institute of Research (WRAIR) And Naval Medical Research Center, Both US, Have Partnered With Researchers At The University of Pennsylvania and Acuitas Therapeutics To Develop A Novel Malaria Vaccine Based on mRNA Technology. The Researchers Found That The Vaccine Protects Against The Disease In Animal Models.
▫️According To The Team, The Most Advanced Malaria Vaccine Is RTS,S, Based on The Circumsporozoite Protein of Plasmodium Falciparum, The Most Dangerous And Widespread Species of Malaria Parasite.
▫️The Results of The Study Are Published In NPJ Vaccines.
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U.S. Pauses Distribution of Lilly's Covid-19 Antibody Combination Therapy

▫️U.S. Health Officials on Friday Paused The Distribution of Eli Lilly's Covid-19 Antibody Cocktail Therapy As It Failed To Show Effectiveness Against The Coronavirus Variants That Were First Identified In Brazil And South Africa.
▫️The Decision by The U.S. Department of Health And Human Services (HHS) Is Based on Laboratory Analyses That Showed Lilly's Dual-Antibody Therapy - Bamlanivimab And Etesevimab - Was Not Active Against Either Variant.
▫️The Centers for Disease Control and Prevention (CDC) Said The Gamma Variant, First Seen In Brazil, And The Beta Variant, First Found In South Africa, Together Made Up For More 11% of Infections In The United States And That The Number Is Growing.
▫️The U.S. Health Regulator in April Revoked The Emergency Use Authorization for Lilly's Bamlanivimab And Required It To Be Used Along With Etesevimab To Achieve Greater Effectiveness Against Emerging Variants.
▫️The HHS Also Said Regeneron's Antibody Therapy, REGEN-COV, And GlaxoSmithKline And Partner Vir Biotechnology's Sotrovimab Are Likely To Be Effective Against The Variants.

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Argentina Says Oxford-AstraZeneca, Sputnik V Single dose Cuts Mortality Up To 80%

▫️A Single dose of Russia's Sputnik V Or The Oxford University-AstraZeneca Vaccine Reduces Mortality from Covid-19 By Between 70% And 80% In People Aged 60-Plus, Real-World Data from Argentina's National Inoculation Program Show.
▫️The Preliminary Study Data, Released on Friday by The Country's Health Ministry, Involved Some 450,000 People Aged 60 Years of Age And Above Who Received One Or Two doses of Either Vaccine, Which Are The Most Widely Used In Argentina.
▫️"The First dose Generates Almost 80% Immunity, The Second, In General, Increases That Response And Makes It More Durable Over Time," Health Minister Carla Vizzotti Said In A Statement, Adding With A Second dose Mortality Decreased Around 90%.
▫️Argentina's Inoculation Campaign Has Been Built Around The Sputnik V And AstraZeneca Vaccines, As Well As Using Sinopharm And CoviShield Shots.

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Mix-And-Match Approach Boosts Immune Response of Oxford-AstraZeneca Shot, Study Finds

▫️A Mixed Schedule of Vaccines Where A Shot of Pfizer’s Covid-19 Vaccine Is Given Four Weeks After An Oxford-AstraZeneca Shot Will Produce Better Immune Responses Than Giving Another dose of AstraZeneca, An Oxford Study Said on Monday.
▫️The Study, Called Com-COV, Compared Mixed Two-dose Schedules of Pfizer And Oxford-AstraZeneca Vaccines, And Found That In Any Combination, They Produced High Concentrations of Antibodies Against The Coronavirus Spike Protein.
▫️The Data Provides Support for The Decision of Some European Countries That Have Started Offering Alternatives To AstraZeneca As A Second Shot.
▫️An AstraZeneca Shot Followed by Pfizer Produced The Best T-Cell Responses, And Also A Higher Antibody Response Than Pfizer Followed by AstraZeneca.
▫️The Results Were for Combinations of Vaccines Given At Four Week Intervals To 830 Participants.
▫️Com-COV Is Also Looking At Mixed Schedules Over A 12-Week Interval, And Noted That AstraZeneca’s Shot Was Known To Produce A Better Immune Response With A Longer Interval Between doses.

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Clinical Observations Show Acute Myocarditis Developed After mRNA Covid-19 Vaccination

▫️A New Clinical Report From The Duke Cardiovascular Magnetic Resonance Center In Durham, North Carolina, Shows Novel Cases of Acute Myocarditis Following mRNA Covid-19 Vaccination.
▫️The Report Follows Patients Suffering From Acute Myocarditis And Specifically Examined Patients That Had Been Vaccinated Prior To Hospitalization In North Carolina.
▫️4 of The 7 Patients That Showed Symptoms Post-Vaccination Were Aged Between 23 And 70 Years Old And Presented Severe Chest Pain As Well As Biomarker Evidence of Myocardial Injury.
▫️The Patients Were Hospitalized And Had Cardiac Magnetic Resonance Imaging Findings Typical of Myocarditis. The Diagnosis of Acute Myocarditis 5 Days After The Vaccination Suggests That Patients Experienced Symptoms As Potential Side Effects From Having The Vaccine Administered.
▫️The Study Appears Online In JAMA Cardiology.

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Molnupiravir: An Oral Antiviral Pill For Covid-19 Shows Promise

▫️Recently, Researchers At The University of North Carolina At Chapel Hill Reported Molnupiravir As The First Oral And Direct-Acting Antiviral That Is Highly Effective At Reducing Nasopharyngeal SARS-CoV-2 Infectious Virus And Viral Ribonucleic Acid (RNA) Levels.
▫️The Study, Which Appeared In The Pre-Print Server medRxiv, Demonstrates That Molnupiravir Has Favorable Safety And Tolerability Profiles, Thus Making It A Promising Antiviral Against SARS-CoV-2.
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Roche's Neuromyelitis Optica Drug "Enspryng" Wins EU Approval

▫️Roche’s Enspryng Has Been Approved by The European Commission, The Swiss Drugmaker Said on Monday, The Latest Regulatory Blessing for The Injectible Drug That Can Be Given At Home To Treat Neuromyelitis Optica Spectrum Disorder.
▫️The EU Approval Follows The U.S. Food And Drug Administration’s (FDA) Green Light Last August To Treat The Rare Condition, Also Called Devic’s Disease, Where The Immune System Damages The Spinal Cord And The Nerves of The Eyes.
▫️Three Drugs Have U.S. Approval For Treating The Disease, Including Enspryng, Alexion’s Soliris And Horizon Therapeutics’ Uplizna, In What Is One of The Healthcare World’s Most-Costly Treatment Areas Where Therapies’ Price Tags Can Run To Hundreds of Thousands of Dollars Annually.
▫️Neuromyelitis Optica (NMO) Is A Central Nervous System Disorder That Primarily Affects The Eye Nerves (Optic Neuritis) And The Spinal Cord (Myelitis). NMO Is Also Known As Neuromyelitis Optica Spectrum Disorder Or Devic's Disease.

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Oxford Covid-19 Vaccine Produces Strong Immune Response from Booster Shot - Study

▫️A Third Shot of The Oxford-AstraZeneca Covid-19 Vaccine Produces A Strong Immune Response, Researchers Said on Monday, Adding There Was Not Yet Evidence That Such Shots Were Needed, Especially Given Shortages In Some Countries.
▫️The Oxford University Study Found That A Third dose of The Vaccine Increases Antibody And T-Cell Immune Responses, While The Second dose Can Be Delayed Up To 45 Weeks And Also Lead To An Enhanced Immune Response.
▫️Studies Had Previously Shown That The Shot, Invented At Oxford University And Licensed To AstraZeneca Has Higher Efficacy When The Second dose Is Delayed To 12 Weeks Instead of Four Weeks.
▫️Monday’s Research Was Released In A Preprint, And Looked At 30 Participants Who Received A Late Second dose And 90 Who Received A Third dose, All of Whom Were Under 55.

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Study Suggests Vitamin B12 As A SARS-CoV-2 Antiviral

▫️Researchers In The UK And Spain Have Used A Novel Drug Screening Approach To Identify Compounds That Could Serve As Effective Antivirals Against SARS-CoV-2.
▫️In Vitro Analyses Revealed That Different Types of Vitamin B12 Were Effective At Inhibiting The Replication of SARS-CoV-2 Variants.
▫️A Pre-Print Version of The Research Paper Is Available on The bioRxiv Server While The Article Undergoes Peer Review.
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New Discovery Shows Human Cells Can Write RNA Sequences Into DNA

▫️Cells Contain Machinery That Duplicates DNA Into A New Set That Goes Into A Newly Formed Cell. That Same Class of Machines, Called Polymerases, Also Build RNA Messages, Which Are Like Notes Copied from The Central DNA Repository of Recipes, So They Can Be Read More Efficiently Into Proteins.
▫️Now, Thomas Jefferson University Researchers Provide The First Evidence That RNA segments Can Be Written Back Into DNA, Which Potentially Challenges The Central dogma In Biology And Could Have Wide Implications Affecting Many Fields of Biology.
▫️In A Series of Elegant Experiments, The Researchers Tested Polymerase Theta Against The Reverse Transcriptase from HIV, Which Is One of The Best Studied of Its Kind.
▫️They Showed That Polymerase Theta Was Capable of Converting RNA Messages Into DNA, Which It Did As Well As HIV Reverse Transcriptase, And That It Actually Did A Better Job Than When Duplicating DNA To DNA.
▫️The Work Was Published June 11th In The Journal Science Advances.
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