Coronavirus

	COVID-19 Traitements autorisés dans l'Union européenne . Evusheld (tixagevimab / cilgavimab) . Kineret (anakinra) . Paxlovid (PF-07321332 / ritonavir) . Regkirona (regdanvimab) . RoActemra (tocilizumab) . Ronapreve (casirivimab / imdevimab) . Veklury (remdesivir) . Xevudy (sotrovimab) Marketing : demande d'authorisation effectuée . Lagevrio (molnupiravir) https://www.ema.europa.eu/en/human-regulatory/overview/public-health -threats/ coronavirus-disease-covid-19/treatments-vaccines/covid-19-treatments
	Covid-19 en Afrique Suivre au jour le jour l’avancée de l’épidémie https://infogram.com/nombre-de-cas-de-coronavirus-en-afrique-par-pays-1h7g6kv3v9j04oy
	mRNA made in Africa 16 March 2022 BioNTech, the drug company that produced an mRNA vaccine for COVID-19 with Pfizer, has developed a new type of vaccine factory for Africa. The biotech has miniaturized all the processes needed to manufacture mRNA vaccines into a modular unit. The factory, made up of two groups of six 40-foot containers, can be loaded on trucks, planes, boats or trains. Once on site, the so-called ‘bioNTainer’, containing the 50,000 steps needed to manufacture a mRNA vaccine, can be assembled for plug-and-play manufacturing. The first containers will arrive in Rwanda and Senegal in the second half of 2022 and potentially also in South Africa. https://www.nature.com/articles/s41587-022-01268-4.pdf https://twitter.com/WHOAFRO/status/1526515658493771778?s=20&t=1MfjxGYjFDvDPue10EytRQ
	CORBEVAX, a new patent-free COVID-19 vaccine, could be a pandemic game changer globally Publié le19 janvier 2022, Mis à jour le: 3 février 2022 Dubbed “The World’s COVID-19 Vaccine”, it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children’s Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELDTM vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELDT™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. https://www.texaschildrens.org/texas-children%E2%80%99s-hospital-and-baylor -college-medicine- covid-19-vaccine-technology-secures-emergency
	Lilly's bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19 February 11, 2022 FDA has authorized bebtelovimab for emergency use for certain non-hospitalized patients with mild-to-moderate COVID-19 at high risk of progression to severe disease for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate Bebtelovimab neutralizes Omicron as demonstrated by pseudovirus and authentic virus data. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and Company (NYSE: LLY) announced today. Bebtelovimab can now be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
	Valneva annonce des résultats de Phase 3 positifs pour son candidat vaccin inactivé et adjuvanté contre la COVID-19, VLA2001 18 octobre 2021 . VLA2001 remplit avec succès les deux principaux critères d’évaluation de l’essai . Niveaux de titres d’anticorps supérieurs comparés au vaccin d’AstraZeneca AZD1222 (ChAdOx1-S) .Taux de séroconversion des anticorps neutralisants supérieur à 95% . VLA2001 a entraîné une large réponse des lymphocytes T produisant de l'interféron gamma spécifique contre les protéines S, N et M. . VLA2001 a été bien toléré, démontrant un profil de tolérance meilleur, de façon statistiquement significative, que celui du vaccin comparateur. Saint Herblain (France), le 18 octobre 2021 - Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), société spécialisée dans les vaccins, a annoncé aujourd’hui des résultats initiaux positifs pour l’essai pivot de Phase 3 Cov-Compare de son candidat vaccin inactivé et adjuvanté contre la COVID-19, VLA2001.
	Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study. October 1, 2021 At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died. Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide. If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19
REGN10933 (blue) and REGN10987 (orange) bound to SARS-CoV-2 spike protein (pink). From PDB: 6VSB, 6XDG.	Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19 Basel, 30 September 2021 Trial met primary endpoint, showing Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19 who did not require high-flow oxygen or mechanical ventilation at baseline Clinical data complement previous findings in hospitalised setting, including from United Kingdom (UK) University of Oxford-led RECOVERY trial Basel, 30 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own (seronegative) and who required low-flow or no supplemental oxygen (p=0.0172). Full results of the study will be presented at ID Week 2021 today. About Ronapreve™ (casirivimab and imdevimab) Ronapreve™ (casirivimab and imdevimab) is being jointly developed by Roche and Regeneron. It is a combination of two monoclonal antibodies, casirivimab and imdevimab (also known as REGN10933 and REGN10987), and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two potent, virus-neutralising antibodies are believed to bind non-competitively to the critical receptor binding domain of the virus's spike protein, which is hypothesised to diminish the ability of mutant viruses to escape treatment and to protect against spike variants that may arise in the human population, as detailed in Science publications. In addition, data from preclinical studies showed that Ronapreve retained neutralisation activity against key emerging variants, as referenced in publications in Cell and Nature. https://www.roche.com/media/releases/med-cor-2021-09-30.htm
	Variant Delta : les scientifiques se préparent à l’impact L’expansion rapide de cette souche virale hautement transmissible au Royaume-Uni met ses voisins européens et d’autres pays en alerte. Lorsque les premiers cas de Covid-19 dus au variant Delta du SARS-CoV-2 – repéré pour la première fois en Inde – ont été détectés au Royaume-Uni à la mi-avril, le pays se préparait à se déconfiner. Le nombre de cas de Covid-19, d’hospitalisations et de décès était en chute libre, grâce à des mois de confinement et à l’un des programmes de vaccination les plus rapides du monde. Deux mois plus tard, ce variant provoque une troisième vague au Royaume-Uni et contraint le gouvernement à retarder la réouverture complète de la société, initialement prévue pour le 21 juin. Après avoir observé la progression étonnamment rapide du variant Delta au Royaume-Uni, d’autres pays se préparent à être frappés par ce variant, si ce n’est pas déjà le cas. Les pays qui ont accès aux vaccins en quantité, notamment en Europe et en Amérique du Nord, espèrent que la vaccination pourra freiner la montée inévitable du variant Delta. Mais dans les pays mal approvisionnés en vaccins, notamment en Afrique, certains scientifiques craignent que ce variant ne soit dévastateur.
	PFIZER AND BIONTECH CONFIRM HIGH EFFICACY AND NO SERIOUS SAFETY CONCERNS THROUGH UP TO SIX MONTHS FOLLOWING SECOND DOSE IN UPDATED TOPLINE ANALYSIS OF LANDMARK COVID-19 VACCINE STUDY Thursday, April 01, 2021 - Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose - Vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration - Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent - Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose - The companies plan to share these results with worldwide regulatory agencies soon https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-confirm-high-efficacy-and-no-serious
	Vaccins contre le COVID-19 : liste des essais cliniques Outre les vaccins actuellement disponibles, la liste des candidats vaccins en cours d'études cliniques est disponible sur la plateforme Infovac. https://www.infovac.ch/fr/infovac/actualites/955-vaccins-contre-le-covid-19-liste-des-essais-cliniques
	Décontamination des surfaces Face à la reprise de l’épidémie actuelle du fait de variants plus contagieux du Sras-Cov-2, il convient de rappeler l’importance de la décontamination des postes de travail et appareils partagés dans nos bureaux et laboratoires. Les organisations compétentes recommandent le recours, après nettoyage, à des solutions aqueuses d’hypochlorite de sodium - eau de javel (environ 0,1 % m/m) ou de peroxyde d’hydrogène - eau oxygénée (environ 0,5 %) ou d’éthanol (environ 70%). Voir : https://apps.who.int/iris/bitstream/handle/10665/332167/WHO-2019-nCoV-Disinfection-2020.1-fre.pdf. Ces produits éliminent le virus en quelques minutes sur les surfaces. Cependant les deux premières ne peuvent être appliquées à des surfaces craignant l’oxydation, comme les claviers d’ordinateurs ou d’appareils de mesure ou d’analyse. Pour ces surfaces nous recommandons d’utiliser une solution aqueuse d'isopropanol ou d'éthanol à environ 70%. Pour les autres surfaces nous recommandons des sprays à base d’ammoniums quaternaires dont l’efficacité a été montrée pour l’élimination des coronavirus, mais requérant un temps de contact généralement supérieur à 10 min (ex : chlorure de benzalkonium à 1,5-2,0 % associé à des tensioactifs, alcools (éthanol, isopropanol) et éventuellement des biocides complémentaires). Il conviendra d’opter pour des produits conformes à la norme EN 14476 et de suivre le mode d’emploi du fournisseur. Rappelons aussi que l’exposition à des lampes UV-C (ex. : 254 nm) est efficace, mais qu'il convient de veiller à éviter l’exposition des personnes et de s’assurer que les surfaces visées sont entièrement traitées. Soulignons enfin que les chimistes innovent pour proposer des solutions plus durables. Ex: https://www.solvay.com/en/brands/actizone-disinfection-that-lasts
	Rogue antibodies could be driving severe COVID- 19 Nature, 19 February 2021 Evidence is growing that self-attacking ‘autoantibodies’ could be the key to understanding some of the worst cases of SARS-CoV-2 infection. Scientists studying COVID are increasingly highlighting the role of autoantibodies: rogue antibodies that attack either elements of the body’s immune defences or specific proteins in organs such as the heart. Rogue antibodies could be driving severe COVID- 19
	Monographie BioNTech-Pfizer sur leur vaccin à ARNm contre la Covid-19 Cette monographie décrit synthétiquement : les indications et contre-indications, les mises en gardes et les précautions importantes, la posologie et l'administration, le surdosage, les formes pharmaceutiques, les mises en gardes et les précautions importantes, les effets indésirables, les indications médicamenteuses, la pharmacologie clinique, (mode d'action) la conservation, la stabilité et la mise au rebut, les particularités de manipulation du produit, les renseignements pharmaceutiques, les études cliniques, la microbiologie, la toxicologie non clinique, les renseignements destinés aux patients. Monographie BioNTech-Pfizer