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1 Medicalxpress,10月11日,Vaccines prevent severe COVID, even from Delta: study 2021-10-15

Vaccination is highly effective at preventing severe cases of COVID-19,even against the Delta variant,a vast study in France has shown. The research published Monday—focusing on prevention of severe COVID and death,not infection—looked at 22 million people over 50 and found those who had received jabs were 90 percent less likely to be hospitalised or die. The results confirm observations from the US,the UK and Israel,but researchers say it is the largest study of its kind so far. Looking at data collected starting in December 2020,when France launched its jab campaign,the researchers compared the outcomes of 11 million vaccinated people with 11 million unvaccinated subjects. They formed pairs matching an unvaccinated individual with avaccinated counterpart from the same region and of the same age and sex,tracking them from the date of the vaccinated person's second jab to July 20. Starting 14 days after asecond dose,a vaccinated subjects'risk of severe COVID was reduced by 90 percent,according to the research conducted by Epi-Phare,an independent medicines safety research group that works closes with the French government. Vaccination appears to be nearly as effective against for the Delta variant,with 84 percent protection for people 75 and older and 92 percent for people 50-75. That estimate,however,is only based on amonth of data,since the variant became dominant in France only in June. "The study should be followed up to include results from August and September,"epidemiologist Mahmoud Zureik,the head of Epi-Phare,told AFP. The study covers vaccination with the Pfizer/BioNtech,Moderna and AstraZeneca jabs,but not Jannsen which was authorised much later and is far less widely used in France. The results also suggest that over the period of study—up to five months—vaccination protection against severe COVID did not diminish. 查看详细>>

来源:Medical Xpress 点击量:0

2 PR Newswire,10月11日,INOVIO Expands INNOVATE Phase 3 for INO-4800, its DNA Vaccine Candidate for COVID-19, to include Colombia following Regulatory Authorization 2021-10-15

PLYMOUTH MEETING,Pa.,Oct.11,2021/PRNewswire/--INOVIO(NASDAQ:INO),a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases,cancer,and HPV-associated diseases,today announced that it has received authorization from Colombia's INVIMA(Instituto Nacional de Vigilancia de Medicamentos yAlimentos,or the National Food and Drug Surveillance Institute),to conduct the Phase 3segment of INOVIO's global Phase 2/3 trial,INNOVATE(INOVIO INO-4800 Vaccine Trial for Efficacy)in Colombia,for INO-4800,its DNA vaccine candidate for COVID-19.INOVIO is working with partner Advaccine Biopharmaceuticals Suzhou Co.,Ltd.(Advaccine)on the INNOVATE Phase 3segment in multiple countries,with afocus on countries in Latin America,Asia,and Africa.INOVIO recently announced that it has received regulatory authorization to proceed in Brazil,Philippines,and Mexico. The global Phase 3segment of INNOVATE will evaluate the efficacy of INO-4800 in atwo-dose regimen(2.0 mg per dose),administered one month apart,in a2-to-1 randomization in men and non-pregnant women 18 years of age and older.The primary endpoint of this case-driven Phase 3trial is virologically confirmed COVID-19. Dr.J.Joseph Kim,President and CEO of INOVIO,said,"INOVIO is pleased to share the news of the regulatory authorization to proceed with our Phase 3trial in Colombia.With COVID-19 rates continuing to rise in many areas,and with continued limitations to vaccine access in many countries globally,we are grateful to the multiple health authorities who are supporting our efforts to advance the efficacy evaluation of our COVID-19 vaccine.INO-4800 is well-positioned to support vaccination efforts in Colombia and beyond,if approved–with the prospects of potentially serving both as aprimary series and as abooster vaccine,with astrong thermostability profile and ability to generate neutralizing antibodies and robust Tcell responses." INNOVATE's Phase 3segment builds upon the Phase 2segment,which was conducted in the U.S.and funded by the U.S.Department of Defense Joint Program Executive Office for Chemical,Biological,Radiological and Nuclear Defense,in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.Phase 2data was disclosed in apre-print in MedRxiv in May 2021 and found INO-4800 to be well-tolerated and immunogenic in adults 18 and older in the trial.In another previously disclosed study using clinical samples,INO-4800 was also found to provide broad cross-reactive immune responses,including neutralizing antibodies and robust Tcell responses,against variants of concern(alpha,beta,gamma and,in subsequent research,delta)–factors which could be critical in containing COVID-19 as it shifts from pandemic to endemic spread. INOVIO also recently announced the authorization to proceed in China with two Advaccine-sponsored clinical trials investigating the safety,tolerability,and immunogenicity of heterologous boost combinations with INO-4800. About INO-4800 INO-4800,INOVIO's DNA vaccine candidate against SARS-CoV-2,is composed of aprecisely designed DNA plasmid that is injected intradermally followed by electroporation using aproprietary smart device,which delivers the DNA plasmid directly into cells in the body and is intended to produce awell-tolerated immune response.As one of the only nucleic-acid based vaccines that is stable at room temperature for more than ayear,at 37°C for more than amonth,has afive-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage,INO-4800 is anticipated to be well-positioned as aprimary series as well as abooster. About INOVIO INOVIO is abiotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases,cancer,and diseases associated with HPV.INOVIO is the first company to have clinically demonstrated that aDNA medicine can be delivered directly into cells in the body via aproprietary smart device to produce arobust and tolerable immune response.Specifically,INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1,the first of two,Phase 3trials for precancerous cervical dysplasia,demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18.INOVIO is also evaluating INO-4800,a DNA vaccine candidate against COVID-19,in aPhase 2/3 clinical trial;the Phase 3efficacy segment of which has received regulatory approvals to begin in Mexico,Brazil and Philippines.INOVIO's partners,Advaccine Biopharmaceuticals,and International Vaccine Institute,are also evaluating INO-4800 in ongoing clinical trials in China and South Korea,respectively. Partners and collaborators include Advaccine,ApolloBio Corporation,AstraZeneca,The Bill&Melinda Gates Foundation,Coalition for Epidemic Preparedness Innovations,Defense Advanced Research Projects Agency/Joint Program Executive Office for Chemical,Biological,Radiological and Nuclear Defense/Department of Defense,HIV Vaccines Trial Network,International Vaccine Institute,Kaneka Eurogentec,Medical CBRN Defense Consortium,National Cancer Institute,National Institutes of Health,National Institute of Allergy and Infectious Diseases,Ology Bioservices,the Parker Institute for Cancer Immunotherapy,Plumbline Life Sciences,Regeneron,Richter-Helm BioLogics,Thermo Fisher Scientific,University of Pennsylvania,Walter Reed Army Institute of Research,and The Wistar Institute.For more information,visit www.inovio.com. 查看详细>>

来源:PR Newswire 点击量:0

3 ACCESSWIRE,10月11日,NanoViricides Announces COVID-19 Clinical Drug Candidate NV-CoV-2 was Effective Against SARS-CoV-2, Further Demonstrating Its Broad-Spectrum Pan-Coronavirus Activity 2021-10-15

SHELTON,CT/ACCESSWIRE/October 11,2021/NanoViricides,Inc.(NYSE American:NNVC)(the"Company"),a leader in the development of highly effective antiviral therapies based on anovel nanomedicines technology,announced today that its Pan-Coronavirus COVID-19 Drug Candidate NV-CoV-2 was found to be effective against SARS-CoV-2 in astandard cell culture pseudovirion assay,demonstrating that the drug indeed has broad-spectrum pan-coronavirus activity.This pan-coronavirus activity implies that the drug NV-CoV-2 should remain active in spite of evolution of variants of SARS-CoV-2 in the field,a highly sought-after characteristic to combat the current global pandemic. In this assay,both the drug candidate NV-CoV-2 and apositive control antibody specific to the Spike antigen S1 of the SARS-CoV-2 virus suppressed the infection by the SARS-CoV-2-pseudovirions in cell culture studies to virtually the same baseline levels. We have now demonstrated that NV-CoV-2 is highly effective in cell cultures against SARS-CoV-2,human coronavirus NL-63,and human coronavirus 229E,all very different human coronaviruses.These results imply that the drug will remain active in spite of novel variants of SARS-CoV-2 evolution in the field,and indeed demonstrate the pan-coronavirus activity of our clinical drug candidate NV-CoV-2. Additionally,the pseudovirion study also showed that NV-CoV-2 neutralizes the virus particles themselves,outside of the cells,validating our design mechanism. "We are now preparing submission documents to enable initiation of human clinical trials,"commented Dr.Anil Diwan,Chairman and President of the Company,adding,"We believe that NV-CoV-2 may help end the pandemic if it is shown to be effective in human clinical trials." A strong SARS-CoV-2 infection inhibition activity of NV-CoV-2 was observed in this pseudovirion study.Pseudovirion assay is astandard method for evaluating virus entry-inhibitors in BSL2 laboratories and is primarily used for viruses that would otherwise require high security BSL3 or BSL4 laboratories.In this study,SARS-CoV-2-pseudovirion virus particles were made that carry agreen fluorescent protein(GFP)producer mRNA inside,and use the SARS-CoV-2 S1 protein on their surface to bind to ACE2 receptor protein on cells.They were incubated with NV-CoV-2(test article),or aknown neutralizing antibody(positive control),or just the vehicle buffer(negative control).Then these solutions were separately used to infect ACE2 positive cells and the cultures were incubated.Only the infected cells produced GFP and were visualized by green fluorescence in microscopy.In this well-known assay,NV-CoV-2 was as effective as the neutralizing antibody in reducing the virus infection.This study demonstrates that NV-CoV-2 attacks the SARS-CoV-2 pseudovirion particles and renders them incapable of binding to the ACE2 positive cells. A"pseudovirion"is avirus particle made of aBSL-2 virus shell,but with its original cell-binding protein replaced by the cell binding protein of aBSL3 or BSL4 virus,in this case,the S1 antigen of SARS-CoV-2.Additionally,the pseudovirion particle contains an mRNA that is packaged like the original virus,except that the mRNA is edited and redesigned so that it cannot produce infectious virus particles.In our study,this mRNA allowed expression and production of the green fluorescent protein(GFP)enabling visual detection of the infected cells(green)in microscopy. 查看详细>>

来源:Accesswire 点击量:0

4 CIDRAP,10月11日,Merck applies for approval of first COVID-19 antiviral pill 2021-10-15

Today,pharmaceutical giant Merck submitted an emergency use authorization(EUA)application to the Food and Drug Administration(FDA)for molnupiravir,its oral antiviral medication,for the treatment of mild to moderate COVID-19 in adults at risk for severe disease. This category includes patients over 60 years and those diagnosed as having obesity,diabetes,or heart disease. The drug,named after Thor's hammer in Norse mythology,would be the first pill authorized by the FDA to treat COVID-19.Other antivirals used to fight COVID-19 have to be injected or administered intravenously.Merck has previously said that,if approved,the company is ready to supply the US government with 1.7 million doses of the antiviral. The submission is based on positive results from aphase 3trial of the drug,which showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%. "The extraordinary impact of this pandemic demands that we move with unprecedented urgency,and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,"said Robert M.Davis,Merck chief executive officer and president,in acompany press release. The suggested use of molnupiravir would be four capsules twice aday for 5days. COVID-19 cases continue to drop According to the New York Times tracker,the country recorded 96,549 COVID-19 cases yesterday and 2,000 deaths.The newspaper said cases are dropping most significantly in Southern states that saw the biggest activity during the nation’s fourth wave this summer,which was fueled by the Delta(B1617.2)variant. Florida,for example,is averaging fewer than 4,000 new cases aday,down from more than 20,000 aday at the end of August. Northern and western states,including Alaska,Montana,North Dakota,Wyoming,and Minnesota,lead the nation in recent cases per capita;Minnesota's daily case counts increased 36%in the last 2weeks. The 7-day average of new daily COVID-19 cases is 95,926,with 1,778 daily deaths,according to the Washington Post tracker.New daily cases fell 10.1%in the past week,deaths fell 6.8%,and hospitalizations fell 8.2%. 查看详细>>

来源:CIDRAP 点击量:0

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