Japan Approves Oxford-AstraZeneca, Moderna Covid-19 Vaccines

▫️After Health Regulators' Green Light A Day Earlier, The Government Said It Approved Vaccines Developed by Moderna And Oxford-AstraZeneca, Which Will Join That Developed by Pfizer & BioNTech In A Vaccination Drive That Began In Mid-February.
▫️Japanese Regulators Recommended The Approval of Covid-19 Vaccines Developed by Moderna And Oxford On Thursday, Paving The Way For The Country To Speed Up Its Slow-Moving Vaccination Campaign.
▫️The Government Has Arranged To Buy 120 million doses of AstraZeneca's Vaccine, Enough For 60 Million People. Most of The doses Will be Made in Japan by Daiichi Sankyo Co And JCR Pharmaceuticals Co And Other Local Partners.
▫️Takeda Pharmaceutical Co, Japan's Biggest Drugmaker, Is Handling Imports of About 50 Million doses of The Moderna Shot, Or Enough for 25 Million People.

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CytoDyn To Seek Regulatory Approval for Covid-19 Drug Vyrologix

▫️CytoDyn Is Set To Submit The Results from The Phase III CD12 Clinical Trial of Vyrologix (Leronlimab-PRO 140), Seeking Potential Regulatory Approval for The Drug To Treat Severe To Critically ill Patients With Covid-19.
▫️An Investigational Humanised IgG4 Monoclonal Antibody, Leronlimab Hinders C-C Chemokine Receptor Type 5, A Cellular Receptor Vital in HIV Infection, Tumor Metastases And Various Other Diseases.
- So far, Leronlimab Has Been Analysed in 11 Clinical Trials in More Than 1,200 Individuals. CytoDyn Is Assessing The Therapeutic In Multiple Covid-19 Studies.
▫️In The Phase III CD12 Trial, Subjects Were Given Two doses of Leronlimab At Day Zero And Day Seven And Were Examined For 28 Days.
▫️The Mortality Rate in Subjects Who Received The Treatment Lowered To 50% And 31% by Day 21 And Day 28, Respectively.

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Two doses of The Oxford Covid-19 Vaccine Shots 89% Effective: UK Real-World Analysis

▫️Two doses of The Oxford & AstraZeneca Covid-19 Vaccine Are Around 85% To 90% Effective Against Symptomatic Disease, Public Health England (PHE) Said on Thursday, Citing An Analysis of Real-World Data from The Rollout of The Shot.
▫️In A Weekly Surveillance Report, Public Health England Said The Estimated Effectiveness of The AstraZeneca Vaccine, Invented At The University of Oxford, Was 89% Compared To Unvaccinated People.
▫️That Compares To 90% Estimated Effectiveness Against Symptomatic disease for The Pfizer-BioNTech Vaccine.
▫️PHE Said The Analysis Was The First of Its Kind on The Effectiveness of Two doses of AstraZeneca In A Real-World Setting But Was Not Yet Published in A Journal, Adding More Data Would Boost Its Confidence In The Finding.

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South Korea Approves Moderna's Covid-19 Vaccine

▫️South Korea on Friday Approved Moderna Covid-19 Vaccine, As The Country Attempts To Speed Up Its Inoculation Efforts.
▫️The Green Light Comes After Two of Three Expert Panels Recommended Approval Be Granted for The Two-dose Vaccine Based on Safety And Efficacy in Late-Stage Trials in The United States.
▫️Moderna is The fourth Covid-19 Vaccine To Be Approved in South Korea, following doses Developed by Oxford-AstraZeneca, Pfizer, And Johnson & Johnson.
▫️Moderna Has A Deal With South Korea To Supply 40 Million doses of Its Vaccine, Although The Shipment Timeline Is Yet To be Announced.
▫️Seoul Has Ordered Up To 192 Million doses of Coronavirus Vaccines, Including Those Made by AstraZeneca, Pfizer, Novavax And Johnson & Johnson.

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The European Medicines Agency Permits Use of GSK-Vir Antibody To Treat Covid-19

▫️The European Medicines Agency (EMA) Said on Friday a Covid-19 Antibody Treatment Developed by GlaxoSmithKline (GSK) And Vir Biotechnology Can Be Used To Treat Patients Who Are At Risk of Severe Disease And Do Not Need Supplemental Oxygen.
▫️The Opinion Relates To The Use of The Treatment, Sotrovimab, In Adults And Adolescents Aged 12 Years Or Older And Weighing At Least 40 Kilograms.
▫️“Based on Our Most Recent In Vitro Data, Sotrovimab Continues To Combat Covid-19 As It Evolves And Has Retained Activity Against All Circulating Variants of Concern,” Vir Chief Executive George Scangos Said In A Joint Statement With GSK.
▫️Interim Data from A Study of The Experimental Therapy Showed 85% Reduction in Hospitalization And Deaths Among Covid-19 Patients, GSK And Vir Had Said.
▫️The Rolling Review of The Drug Is Ongoing, The European Medicines Agency (EMA) Said.

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The European Medicines Agency Backs Extending Approval for Remdesivir For Another Year

▫️The European Medicines Agency (EMA) on Friday Recommended Extending Conditional Marketing Approval By A Year for Gilead Sciences’ Covid-19 Treatment, Remdesivir, The Only Drug So far That Has Been Authorized for Use In The Region.
▫️The Regulator Said Its Human Medicines Committee (CHMP) found That Benefits of The Drug Outweighed Risks, Although The Company Was Required To Submit More Data by The End of The Year for The Next Scheduled Renewal.
▫️Remdesivir, Sold Under The Brand Name Veklury, Was Conditionally Authorized In July Last Year for Treating Covid-19 In Adults And Adolescents Over 12 Years With Pneumonia Requiring Oxygen Support.

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People With Newly Diagnosed AD Are Less Likely To Have Cataract Surgery Than People Without AD

▫️People With Alzheimer's Disease (AD) Are Less Likely To Have Cataract Surgery Than People Without Alzheime's Disease. The Procedure Rate Starts To Decrease Already One Year After The Diagnosis, According To A New Study from The University of Eastern Finland.
▫️The Lower Likelihood of Cataract Surgery Among People With Cognitive Disorders Has Been Reported Previously.

Scientists Identify Receptor in Cells That Could Be Key To Preventing Cancer Drug-Induced Hearing Loss

▫️University of Alberta Scientists Have Identified A Receptor in Cells That Could Be Key To Preventing Permanent Hearing Loss In Childhood Cancer Survivors Who Are Being Treated with The Drug Cisplatin.
▫️The Researchers Believe by Inhibiting The Receptor, They May be Able To Eliminate Toxic Side-Effects from The Drug That Cause The Hearing Loss.
http://dx.doi.org/10.15252/embr.202051280
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Biogen’s Eye Disease Gene Therapy Fails Ahead of FDA Alzheimer’s Ruling

▫️Biogen Has Downbeat News About Its Gene Therapy for The Rare Inherited Eye Disease, X-Linked Retinitis Pigmentosa, Announcing The Shot Failed To Meet Its Target In A Phase 2/3 Study.
▫️A Final FDA Decision on Biogen’s Controversial Alzheimer’s Drug Aducanumab Is Due Before The Beginning of Next Month And The Company Needs Some Positive Pipeline News Ahead of The Make-Or-Break Ruling.
▫️In Ophthalmology, Unfortunately The Phase 2/3 Study of Cotoretigene Toliparvovec (BIIB112), A Gene Therapy Being Investigated As A One-Time Therapy for Patients With X-Linked Retinitis Pigmentosa (XLRP), Did Not Meet Its Primary Endpoint of Demonstrating A Statistically Significant Improvement In The Proportion of Treated Study Eyes Improving from Baseline Using A Macular Integrity Assessment.
▫️This Assessment Was Performed at 12 Months And Compared To The Study Eye of Patients Randomized To The Untreated Control Group.
▫️Biogen Said That Positive Trends Were Observed Across Several Clinically Relevant Pre-Specified Secondary Endpoints.
▫️A Phase 3 Trial Is Ongoing And Although There Was No Update On Efficacy Or Safety, The Company Said It Plans To Provide Early Access for A Group of Patients With Severe, Rapidly Developing Disease.

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Asthma Vaccine Shows Success In Pre-Clinical Studies

▫️A New Conjugate Vaccine Has Shown Promise At Protecting Mice Against The Effects of Cytokines Associated With Asthma.
▫️Researchers Have Developed A Vaccine That Could Induce Long-Term Protection Against Allergic Asthma, Reducing The Severity of Its Symptoms And Thus Significantly Improving Patient Quality of Life. The Vaccine Was Created At Inserm, Institut Pasteur And NEOVACS, All France.
▫️According To The Team, Allergic Asthma Is Characterized By Inflammation of The Bronchial Tubes And Respiratory Discomfort Caused by The Inhalation of Allergens, Most Often Dust Mites.
- This Exposure To Allergens Leads To The Production of Antibodies Called Immunoglobulin E (IgE) And Type 2 Cytokines (Such As Interleukin-4 (IL-4) And IL-13) In The Airways.
- This Leads To A Cascade of Reactions Resulting In Hyperresponsiveness of The Respiratory Tract, Overproduction of Mucus And Eosinophilia.
▫️The Study Was Published In Nature Communications.
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FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination

▫️The U.S. Food And Drug Administration (FDA) Issued A Safety Communication Informing The Public That Results from SARS-CoV-2 Antibody Tests Should Not Be Used To Evaluate Immunity Or Protection from Covid-19 At Any Time, And Especially After The Person Received A Covid-19 Vaccination.
▫️The FDA Is Reminding The Public of The Limitations of Covid-19 Antibody, Or Serology, Testing And Providing Additional Recommendations About The Use of Antibody Tests In People Who Received A Covid-19 Vaccination.
▫️Antibody Tests Can Play An Important Role In Identifying Individuals Who May Have Been Exposed To The SARS-CoV-2 Virus And May Have Developed An Adaptive Immune Response.
- However, Antibody Tests Should Not Be Used At This Time To Determine Immunity Or Protection Against Covid-19 At Any Time.

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Pfizer And Oxford Covid-19 Shots 'Highly Effective' Against India Variant, Study Shows

▫️The Covid-19 Vaccines Developed By Pfizer-BioNTech And Oxford-AstraZeneca Are "Highly Effective" Against The Indian Variant, A New Study Has Found.
▫️Two Jabs of Either Vaccine Give A Similar Level of Protection Against Symptomatic Disease from The Indian Variant As They do for The B.1.1.7 “Kent" Strain.
- However, Both Vaccines Were Only 33% Effective Against The Indian Variant Three Weeks After The First dose.
▫️The Study Involved 1,054 People Confirmed Through Genomic Sequencing To Have Contracted The B.1.617.2 Variant Between Early April And Mid-May.
▫️A Study by Public Health England found The Pfizer Vaccine Was 88% Effective Against Symptomatic Disease from The B.1.617.2 Variant Two Weeks After The Second dose.
- That Compared With 93% Effectiveness Against The B.1.1.7 “Kent” Strain Which Is Britain’s Dominant Covid-19 Variant.
▫️Two doses of The Oxford Vaccine Were 60% Effective Against Symptomatic Disease from The Indian Variant Compared With 66% Effectiveness Against The Kent Variant, PHE Said.

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U.S. CDC Looking Into Heart Inflammation In Some Young Adults Who Received mRNA Covid-19 Vaccines

▫️Some Teenagers And Young Adults Who Received mRNA Covid-19 Vaccines Experienced Heart Inflammation, A U.S. Centers for Disease Control And Prevention (CDC) Advisory Group Said, Recommending Further Study of The Rare condition.
▫️The CDC Said The Cases Typically Occurred Within Four Days After Receiving The mRNA Vaccines. The United States Has Given Emergency Authorization To Two mRNA Vaccines, from Moderna And Pfizer-BioNTech.
▫️The CDC's Advisory Committee on Immunization Practices In A Statement Dated May 17 Said It Had Looked Into Reports That A Few Young Vaccine Recipients, Predominantly Adolescents And Young Adults, And Predominantly Male, Developed Myocarditis, An Inflammation of The Heart Muscle.
▫️Israel's Health Ministry In April Said It Was Examining A Small Number of Cases of Heart Inflammation In People Who Had Received Pfizer's Vaccine.

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Study Indicates That Certain Anti-Cancer Therapies May Hasten Cellular Aging

▫️New Research Indicates That Certain Anti-Cancer Therapies May Hasten Cellular Aging, Where Changes In The DNA of Patients May Contribute To Greater Inflammation And Fatigue.
▫️The Findings Are Published by Wiley Early Online In Cancer, A Peer-Reviewed Journal of The American Cancer Society.
▫️Some Individuals May Experience Epigenetic Age Acceleration (EAA) That Puts Them At A Higher Risk of Age-Related Conditions Than Other Individuals of The Same Chronological Age.
▫️In The Study of 133 Patients With Head And Neck Cancer (HNC), Half of The Patients Experienced Severe Fatigue At Some Point.
▫️EAA Was Most Prominent Immediately After Radiation Therapy, When The Average Epigenetic Age Was Accelerated by 4.9 Years.
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Little Evidence for mRNA Covid-19 Vaccine-Associated Thrombocytopenia, Suggests New FDA Study

▫️A New Study In The Journal Vaccine Reports The Results of An Evaluation of Reported Cases of This Condition, Using Data from The Vaccine Adverse Event Reporting System (VAERS).
▫️The FDA-Designed VAERS System Envisages The Monitoring of Adverse Events of Special Interest Like Thrombocytopenia That Are Passively Reported. Soon After The Emergency Use Authorization (EUA), Several Reports of Immune Thrombocytopenia (ITP) Came In.
▫️Of The Approximately 19 Million And 16 Million doses of Pfizer And Moderna Vaccine Administered In The USA, Respectively, These Careful Selection Criteria Identified 15 And 13 Cases of Thrombocytopenia, Corresponding To Less Than One Reported Case Per Million doses of Either Vaccine.
- No Sex Difference Was Observed, And The Median Age Was 49 Years, Though The Condition Was Reported From 22 To 82 years.
▫️The Median Duration from Vaccination To Onset of Thrombocytopenia Was 5.5 Days, With A Range of 1-23 Days. Earlier Reports on ITP In Covid-19 Cases Indicated A Median Time of Onset At 13 Days.
- Typically, However, The Presentation Occurred at 2-3 Weeks from Symptom Onset, With Only One In five Patients Presenting Within A Week Or Less.
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Repurposed Gout Medication "Probenecid' Shows Potent Inhibition of SARS-CoV-2 Replication

▫️New Research by A Team of Scientists In The USA Describes The Potential Utility of A Drug Called Probenecid, Commonly Used To Treat Gout, To Treat This Devastating Viral illness Caused by The SARS-CoV-2 - The Causative Virus of Covid-19.
▫️A Preprint Version of The Study Is Available on The bioRxiv Server, While The Article Undergoes Peer-Review.
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Study Confirms Longer-Term Lung Damage After Covid-19

▫️In A Paper Published In Radiology, The World's Leading Radiology Journal, The Researchers from The University of Oxford And University of Sheffield Said That Hyperpolarised Xenon MRI (XeMRI) Scans Had found Abnormalities In The Lungs of Some Covid-19 Patients More Than Three Months - And In Some Cases, Nine Months - After Leaving Hospital, When Other Clinical Measurements Were Normal.
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Methotrexate Users Have A Reduced Immune Response To mRNA Covid-19 Vaccine

▫️Up To A Third of Patients Taking Methotrexate - A Common Treatment for Immune Mediated Inflammatory Conditions Such As Rheumatoid Arthritis And Psoriasis/Psoriatic Arthritis - Failed To Achieve An Adequate Immune Response To mRNA Covid-19 Vaccines In A Small Study Accepted for Publication In The Journal Annals of Rheumatic Diseases.
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The Viruses In Our Genes: When Activated, They Damage Brain Development

▫️New Research Shows That Activation of Distinct Human Endogenous Retroviruses, Which Are Part of Our Genome, Impair Brain Development Dramatically. The Finding Could Help To Advance Research Into Therapies for Neurodegenerative Diseases.
▫️In Fact, Humans Possess Five Times More "Human Endogenous Retroviruses, Or HERVs" In Non-Coding Parts Than Coding Genes. So far, Strong focus Has Been Devoted To The Correlation of HERVs And The Onset Or Progression of Diseases.
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Immune System May Never Forget Mild Covid-19

▫️Months After Recovery from Mild Covid-19, When Antibody Levels In The Blood Have Declined, Immune Cells In Bone Marrow Remain Ready To Pump Out New Antibodies Against The Coronavirus, Researchers Reported on Monday In Nature.
▫️Months After Recovering from Mild Cases of Covid-19, People Still Have Immune Cells In Their Body Pumping Out Antibodies Against The Virus That Causes Covid-19, According To A Study from Researchers At Washington University School of Medicine in St. Louis.
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Covid-19 Virus Variants Seen More Often In Young U.S. Children

▫️Young Children Appear To Be Significant Carriers of More Contagious Variants of The New Coronavirus, Such As The Ones Identified In The UK And In California, According To A New U.S. Study.
▫️From March 2020 To April 2021, Researchers At Nine Children's Hospitals Tested A Total of 2,119 Covid-19 Patients Age 18 Or Younger for So-Called Variants of Concern, Along With Key Mutations That Help The Variants Become More Contagious Or Hide From The Patient's Immune System.
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