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Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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U.S. Centers for Disease Control and Prevention Endorses Advisory Committee on Immunization Practices’ Recommendation for Novavax COVID-19 Vaccine, AdjuvantedJul 19, 2022• U.S. CDC Advisory Committee unanimously recommended vaccination with Novavax COVID-19 Vaccine, Adjuvanted for individuals aged 18 and older earlier today• Novavax’ vaccine is the first protein-based vaccine to receive Emergency Use Authorization and CDC endorsement in the U.S.Today the U.S. Centers for Disease Control and Prevention (CDC) endorsed the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) for active immunization against SARS-CoV-2, following the Advisory Committee on Immunization Practices’ (ACIP) unanimous vote to recommend the vaccine as a two-dose primary series in individuals aged 18 and older. The CDC establishes its vaccine recommendations and schedules based on advice from ACIP.The recommendation follows the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA). The FDA has determined that the first vaccine lot has met all release specifications and is acceptable for use under EUA. Novavax expects to ship doses to the U.S. Government-designated distribution center in the coming days.Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a two-dose primary series to individuals 18 years of age and older to prevent Coronavirus Disease 2019 (COVID-19).The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.Authorized UseThe Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.https://ir.novavax.com/U-S-Centers-for-Disease-Control-and-Prevention-Endorses-Advisory-Committee-on-Immunization-Practices-Recommendation-for-Novavax-COVID-19-Vaccine,-Adjuvanted
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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U.S. CDC Advisory Committee Unanimously Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Primary Series for Individuals Aged 18 and Olderhttps://ir.novavax.com/2022-07-19-U-S-CDC-Advisory-Committee-Unanimously-Recommends-Novavax-COVID-19-Vaccine,-Adjuvanted-as-a-Primary-Series-for-Individuals-Aged-18-and-OlderJul 19, 2022Recommendation follows U.S. FDA Emergency Use Authorization for the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary seriesFDA has determined that first vaccine lot has met all release specifications and is acceptable for use under Emergency Use AuthorizationNovavax expects to ship doses to the U.S. Government-designated distribution center in the coming daysNovavax' vaccine is the first FDA-authorized and ACIP-recommended protein-based COVID-19 vaccine in the U.S.GAITHERSBURG, Md., July 19, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the use of the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary series in individuals aged 18 and older.The recommendation follows the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA). ACIP will submit its recommendation to the Director of the CDC for review and endorsement."We think vaccine choice is important, particularly as we expect to see ongoing surges of COVID-19 and work to increase vaccination rates," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With demonstrated efficacy and a reassuring safety profile, our vaccine is the country's first protein-based option."The Committee based its recommendation on use in individuals aged 18 and older on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled 29,960 participants aged 18 years and older in the U.S. and Mexico. In the trial, the Novavax COVID-19 Vaccine, Adjuvanted demonstrated 90.4% efficacy (95% confidence interval [CI], 83.8% to 94.3%; P<0.001) with a reassuring safety profile. Among participants 18 through 64 years of age, solicited adverse reactions (ARs) following administration of any dose of the vaccine, were injection site pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%), headache (52.9%), joint pain (25.4%), nausea/vomiting (15.6%), injection site redness (7.0%), injection site swelling (6.3%), and fever (6.0%). In participants ≥65 years of age, solicited ARs following administration of any dose of the vaccine were injection site pain/tenderness (63.4%), fatigue/malaise (39.2%), muscle pain (30.2%), headache (29.2%), joint pain (15.4%), nausea/vomiting (7.3%), injection site swelling (5.3%), injection site redness (4.8%), and fever (2.0%). In addition to the FDA EUA, the Novavax COVID-19 vaccine has received conditional authorization for use in individuals aged 18 and older from multiple regulatory agencies worldwide, including the European Commission (EC), and Emergency Use Listing from the World Health Organization.This project has been supported in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number MCDC2011-001.
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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Y aquí la press release de Novavax sobre ese asunto, la acaban de sacarhttps://ir.novavax.com/2022-07-19-Novavax-Announces-Expanded-Agreement-with-SK-bioscience-to-Manufacture-COVID-19-Vaccine-Containing-Omicron-Variant-and-Manufacture-the-Novavax-COVID-19-Vaccine-in-Prefilled-Syringes
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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SK bioscience Announces Agreement with Novavax to Manufacture COVID-19 Vaccine Containing Omicron VariantSK bioscience and Novavax agreement also includes production of the Novavax COVID-19 vaccine in prefilled syringehttps://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=135SK bioscience (“Company”) announced on July 19th that the Company has extended its partnership with Novavax, Inc. (Nasdaq: NVAX), a U.S. biotechnology company specializing in next-generation vaccines, for the manufacturing and supply ofd Novavax COVID-19 vaccine targeting Omicron variants and in prefilled syringes. SK bioscience and Novavax signed an agreement for the technology transfer of Novavax proprietary COVID-19 variant antigen materials and manufacturing drug substance targeting COVID-19 variants including Omicron BA.5 subvariant in response to the recent spread of SARS-CoV-2 variants. In addition, SK Bioscience and Novavax have signed an agreement to manufacture and supply the Novavax COVID-19 vaccine in prefilled syringe, already loaded with the vaccine for injection. The Company will prepare the manufacturing process this year for commercial supply of the Novavax COVID-19 vaccine in prefilled syringe in 2023. Stanley C. Erck, President and Chief Executive Officer, Novavax, said, “Clinical data generated to-date demonstrate that the Novavax COVID-19 vaccine offers broad immune responses including against circulating variants, such as the Omicron BA.5. We are accelerating our clinical program on Omicron BA.5 and look forward to working with SK bioscience to bring this vaccine to market.” Preclinical data on Omicron BA.5 will be available in the late summer or fall, with an Omicron-containing vaccine available by Q4 of this year. Jaeyong Ahn, CEO of SK bioscience, said, "We will play a role as a global vaccine hub through the contracts in a situation where new vaccines against variants are required," adding, "We will take the lead in protecting public health as an innovative vaccine/bio partner based on the cooperation with various global companies, as well as developing diverse vaccines independently." The Novavax COVID-19 vaccine is the fifth vaccine officially approved in S. Korea, and recently became the fourth vaccine to receive emergency use authorization from the U.S. Food and Drug Administration .
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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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.
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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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..
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Se sabe si el acuerdo con GAVI está dentro de la previsión de ingresos de Novavax para este año?
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Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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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.
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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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