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21/07/22 12:45
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Thonn
21/07/22 10:11
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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CDC Novavax COVID-19 Vaccination Operational Planning Guidehttps://www.cdc.gov/vaccines/covid-19/downloads/Novavax-COVID-19-Vaccination-Operational-Planning-Guide.pdf A limited number of doses of Novavax COVID-19 vaccine will be distributed and not all providers are expected to carry Novavax COVID-19 vaccine. There will be a limited supply of Novavax COVID-19 vaccine of approximately 3 million doses, which should be directed to providers with expected demand among unvaccinated patients. While jurisdictions and providers are encouraged to adopt strategies to minimize unnecessary wastage, they should not miss any opportunities to vaccinate every eligible person who requests a vaccination, even if it means puncturing a multidose vial to administer vaccine without having enough people available to receive each dose in the vial. A limited quantity of doses will be held and distributed based on need.Parece que, a diferencia de lo que hemos visto en el resto de países, donde se enviaban las vacunas independientemente de la cantidad que tenían sin inocular, en el caso de USA van a ser prudentes y harán los pedidos en función de la aceptación y la necesidad de vacunas.Siguiendo la encuesta que se mencionó en la conferencia del otro día, que decía que de los 26-34 millones de estadounidenses no vacunados, el 16% "probablemente" o "definitivamente" se vacunarian con una vacuna de proteínas como la de Novavax, eso supone entre 8.32 y 10.88 millones de dosis (2 dosis por persona, suponiendo que no se desperdicia ninguna). Entiendo que ese es el pedido mínimo que deberíamos esperar en el corto plazo, hasta tener más noticias de la aprobación como Booster.
Thonn
20/07/22 20:50
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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https://www.reuters.com/business/healthcare-pharmaceuticals/eu-seals-deal-with-valneva-cut-volume-covid-vaccine-supplies-2022-07-20/EU drops nearly all of its order for Valneva COVID vaccine
Thonn
20/07/22 17:44
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
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Novavax says U.S. FDA clears COVID vaccine doses for release https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-says-us-fda-clears-covid-vaccine-doses-release-2022-07-19/
Thonn
20/07/22 10:33
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
Thonn
19/07/22 22:39
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.
Thonn
19/07/22 14:47
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
Thonn
19/07/22 09:06
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 .
Thonn
18/07/22 16:23
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.
Thonn
18/07/22 15:25
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..