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Thonn 18/07/22 16:23
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
6. Documented receipt of either 2 or 3 doses of the investigational Novavax vaccine with Matrix-M adjuvant (NVX- CoV2373); OR documented receipt of a full course of an FDA-authorized/approved COVID-19 vaccine; OR documented receipt of a full course of heterologous COVID-19 vaccines mentioned above. The most recent dose must have been administered at least 6 months prior to study vaccination.No lo había visto. Entonces quizá sea un requisito de la FDA de cara a la aprobación como Booster.
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Thonn 18/07/22 15:25
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adultshttps://clinicaltrials.gov/ct2/show/NCT05463068Publicado hoy.Estimated Study Completion Date: August 19, 2022Quieren hacer un estudio comparativo de 3 lotes de la misma vacuna... ¿Quizá cada lote sea de una fábrica distinta?Los centros asociados al estudio son todos de USA. ¿Cabe la posibilidad de que haya sido la CDC/FDA quien haya requerido este estudio antes de dar el visto bueno definitivo? Si ese fuera el caso, retrasamos de nuevo la entrada de Novavax en el mercado estadounidense más de un mes..
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Thonn 16/07/22 12:28
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Ten en cuenta que en Japón es Takeda quien se ocupa de fabricación y venta; Novavax solo cobra un % de las ventas, que no supera el 20% si mal no recuerdo (creo que el número exacto no es público). Y también cabe destacar que no sabemos a cuánto venderá Takeda cada dosis.
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Thonn 12/07/22 00:07
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
SEC Filing 8-khttps://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=116819569&type=HTML&symbol=NVAX&companyName=Novavax+Inc.&formType=8-K&dateFiled=2022-07-11&CK=1000694Item 1.01. Entry into a Material Definitive Agreement. On July 6, 2022, Modification No. 14 (the “Modification”) to Project Agreement No. 01 (“Project Agreement”), dated July 6, 2020, between Novavax, Inc. (the “Company”) and Advanced Technology International, the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed (“OWS”), was entered between the parties. The Modification amended the Project Agreement to provide for (i) an initial delivery to the United States Government (“USG”) of approximately 3 million doses of NVX-CoV2373, the Company’s vaccine candidate for the SARS-CoV-2 virus (the “Vaccine Product”), to be manufactured by Serum Institute of India Private Limited (Pune, India), or another location approved by the United States Food and Drug Administration (the “FDA”), contingent on the timing of Emergency Use Authorization (“EUA”) approval by the FDA, as well as the timing of label language and artwork approvals by the FDA and the recommendation of the Advisory Committee on Immunization Practices within the United States Centers for Disease Control and Prevention, and (ii) any additional manufacture and delivery of the Vaccine Product by the Company to the USG up to an aggregate of 100 million doses (inclusive of the initial lot of approximately 3 million doses) dependent on USG demand, FDA guidance on strain selection and agreement between the parties on price. OWS is a partnership among components of the U.S. Department of Health and Human Services and the U.S. Department of Defense working to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The foregoing description of the material terms of the Modification does not purport to be complete and is qualified in its entirety by reference to the Modification, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022
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Thonn 11/07/22 15:07
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
The government’s announcement on Monday said that Novavax is expected to finish its quality testing “in the next few weeks,” a step needed for the product to be released.
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Thonn 11/07/22 14:15
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
U.S. Government Secures 3.2 Million Doses of Novavax COVID-19 Vaccinehttps://ir.novavax.com/2022-07-11-U-S-Government-Secures-3-2-Million-Doses-of-Novavax-COVID-19-VaccineJul 11, 2022Agreement will provide the first protein-based vaccine option in the U.S., pending FDA Emergency Use Authorization and CDC recommendation.GAITHERSBURG, Md., July 11, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced an agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to secure an initial 3.2 million doses of Novavax' COVID-19 vaccine (NVX-CoV2373) should it receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention (CDC). Novavax' protein-based vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers."We are pleased to come one step closer to potentially offering our vaccine to physicians, healthcare organizations, and consumers who have been awaiting a protein-based vaccine option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We are grateful for the U.S. government's ongoing support and partnership to bring Novavax' COVID-19 vaccine to the U.S., and we look forward to the FDA's decision on an emergency use authorization."The Novavax COVID-19 vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.On June 7, 2022, the FDA's Vaccines and Related Biological Products Advisory Committee voted to recommend that the FDA grant an EUA for the Novavax COVID-19 vaccine for individuals aged 18 and over. The FDA is currently reviewing Novavax' application for EUA. If EUA is granted, a potential policy recommendation from the CDC would be the final step before immunizations with the Novavax COVID-19 vaccine could begin.Authorization in the U.S.NVX-CoV2373 has not yet been authorized for use in the U.S.------------No entiendo muy bien este anuncio, Novavax ya tenía firmados acuerdos de compra de millones de vacunas, no? 100 millones con posibilidad de ampliación si mal no recuerdo 
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Thonn 07/07/22 14:43
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Lo que ya sabíamosEuropean Medicines Agency Approves SK bioscience as a Supplier of Novavax Nuvaxovid™ COVID-19 Vaccinehttps://ir.novavax.com/European-Medicines-Agency-Approves-SK-bioscience-as-a-Supplier-of-Novavax-Nuvaxovid-TM-COVID-19-Vaccine
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Thonn 06/07/22 19:57
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Tan solo me gustaría hacer un apunte sobre el título, y es que igual que tú pienso que debe tener uno... pero tal y como está redactado podría hacer pensar al lector que lo que está a punto de leer es propaganda antivacunas y por tanto descartarlo sin pasar del primer párrafo. Ten en cuenta que el conocimiento acerca de la existencia de otras vacunas que no sean de ARNm (la de Novavax) es limitado, y no todas las personas que vayan a leer el texto tienen porqué saber de la existencia de alternativas, de modo que desprestigiar las que algunos piensas que son las únicas vacunas que tenemos desde un inicio sin indicar que esas alternativas si existen podría dar lugar a malos entendidos y por tanto a la no-lectura completa del documentoQuizá para el resto no tiene ningún sentido lo que estoy diciendo, pero prefería comentarlo por si acasoEn otro orden de cosas, entiendo que el texto es un borrador y que los typos y demás se corregirán más adelante, creo que es importante para transmitir seriedadPor otra parte, dada mi actividad laboral tengo fácil acceso al editor de texto LaTeX, que se usa en el ámbito científico-matemático y otorga un formato más sólido que el word (es software libre pero quizá nadie antes ha oído hablar de ello ni lo ha utilizado, y yo lo uso casi a diario). Me ofrezco a redactar la versión final (básicamente copiarla), realizar la correspondiente corrección de typos/faltas ortográficas y haceros llegar el documento en pdfSaludos y gracias por el magnífico trabajo!
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