Novavax flu vaccine. The dose-confirming trial will evaluate the safety .

Novavax flu vaccine 30, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced publication of complete results from a pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M Dec 11, 2006 · The first combination vaccine candidate (NCT06695117) consists of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. These influenza vaccines have significantly reduced flu-related hospitalisations in real-world evidence studies. Oct 30, 2025 · Listing of latest press releases and statements by Novavax. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent Jan 15, 2020 · To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza. Apr 10, 2025 · Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season. Jul 21, 2025 · The respiratory vaccine codes and crosswalk tables for RSV, COVID-19, and Influenza are provided in Jan 13, 2025 · Novavax is embarking on an ambitious new corporate growth strategy to maximize the impact of our cutting-edge technology. The technology allows for seasonal influenza strain vaccine to be produced in ten to 12 weeks, rather than the 20–24 weeks needed to use traditional egg-based vaccine production methods. -licensed quadrivalent influenza vaccine - NanoFlu™ vaccine candidate induced significantly Sep 12, 2023 · This Emergency Use Authorization and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID vaccine option in the U. , April 1, 2024 /PRNewswire/ -- Novavax, Inc. (NASDAQ: NVAX) are also climbing. May 10, 2021 · GAITHERSBURG, Md. During the 2022-2023 flu season among Dec 10, 2024 · The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax's updated 2024-2025 COVID-19 vaccine, trivalent nanoparticle stand-alone seasonal influenza vaccine candidate and patented saponin-based Matrix-M adjuvant relative to separate administrations of Oct 16, 2024 · GAITHERSBURG, Md. Apr 2, 2007 · Novavax said in a statement the virus-like particle vaccine got a robust immune response and provided protection against the H9N2 strain of avian influenza, or bird flu. NVAX claimed that this vaccine uses a new approach to immunize against the virus. Dec 11, 2024 · The FDA bestows a Fast Track designation to Sanofi's two combination vaccine candidates to prevent influenza and COVID-19 infections. Novavax has a bird flu vaccine in clinical trials in addition to a COVID-19-influenza combination vaccine in late-stage clinical trials. Dec 10, 2024 · --Novavax, Inc. Novavax flu and COVID vaccine Novavax is planning to launch a phase 3 trial for its combination COVID and flu vaccine during the second half Apr 1, 2024 · GAITHERSBURG, Md. Here’s what you need to know. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data Sep 23, 2021 · Novavax previously announced that NanoFlu achievedthe trial's primary endpoints, demonstrating non-inferior immunogenicity to Fluzone®Quadrivalent against all four influenza virus strains included in the vaccine, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous strains (22-66% increased) and six heterologous A/H3N2 strains (34-46% Aug 27, 2025 · Novavax COVID-19 Vaccine, Adjuvanted On August 27, 2025, the Food and Drug Administration revoked the Emergency Use Authorization (EUA) for Novavax COVID-19 Vaccine, Adjuvanted. Dec 10, 2024 · The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax's updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older. Based on these results, Pfizer is looking at adjusting the combination vaccine for better protection against influenza B. Jun 27, 2024 · Updated 2024-2025 Flu Vaccine Recommendation CDC recommends everyone 6 months of age and older, with rare exceptions, receive an updated 2024-2025 flu vaccine to reduce the risk of influenza and its potentially serious complications this fall and winter. Jun 11, 2025 · Novavax, Inc. The first vaccine combines Fluzone High-Dose, an inactivated trivalent vaccine indicated for the prevention of influenza types A and B in persons 65 years and older, with the Novavax COVID-19 vaccine, an Jul 24, 2025 · Peer-reviewed data shows Novavax's H5N1 vaccine candidate demonstrated immunogenicity against currently circulating variants following either single or two-dose administration Potential for single Oct 16, 2024 · FDA puts Novavax flu vaccine trials on hold The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza. Apr 1, 2024 · GAITHERSBURG, Md. About Novavax Novavax, Inc. The designation was granted to expedite the Jun 14, 2024 · Novavax's updated JN. Nov 12, 2024 · The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials. Dec 30, 2022 · GAITHERSBURG, Md. May 11, 2024 · Announces co-exclusive licensing agreement with Sanofi to co-commercialize COVID-19 vaccine, develop novel COVID-19-Influenza combination vaccines and develop multiple new vaccines utilizing Novavax's Oct 16, 2024 · ir. , May 10, 2021 /PRNewswire/ -- Novavax, Inc. Nov 12, 2024 · Novavax yesterday announced that the US Food and Drug Administration (FDA) has released a clinical hold on its new drug application for its COVID-flu combination and standalone flu vaccines. Apr 20, 2022 · At the WVC, Novavax also reviewed key findings from the Phase 3 trial of its stand-alone influenza candidate, previously referred to as NanoFlu, which met its primary immunogenicity endpoint Apr 20, 2022 · At the WVC, Novavax also reviewed key findings from the Phase 3 trial of its stand-alone influenza candidate, previously referred to as NanoFlu, which met its primary immunogenicity endpoint Latest press releases, statements and materials. . Oct 13, 2022 · Trial is the first of its kind to evaluate a combined COVID-19 and influenza vaccine Dose insights from Phase 1/2 trial will inform Phase 2 confirmation trial to begin in late 2022 GAITHERSBURG TipRanks Dec 21, 2009 · Novavax’s trivalent seasonal influenza virus-like particle (VLP) vaccine was developed to address the need to produce vaccines in a short time. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U. Mar 24, 2020 · Novavax’s influenza vaccine NanoFlu has outperformed Sanofi’s Fluzone Quadrivalent on measures of immunogenicity in a phase 3 trial. , June 11, 2025 /PRNewswire/ -- Novavax, Inc. novavax. Less than a month after putting Novavax’s investigational combo COVID-19/influenza and standalone influenza vaccine candidates on a clinical hold, the FDA has lifted it, greenlighting enrollment in the company’s planned Phase III trial. Jan 7, 2025 · In July last year, Moderna was awarded $176mn by the US government to develop a bird flu vaccine using its messenger-RNA technology. COVID (Novavax) ® - Now available, please check appointments as eligibility varies by state COVID-19 is a common respiratory illness that can be very contagious and spreads quickly. govThis is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax trivalent hemagglutinin (HA) nanoparticle influenza vaccine (NIV) with Matrix-M (tNIV) in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains Join Update on Novavax INVESTIGATIONAL NanoFlu vaccine and COVID-19-INFLUENZA Combination Vaccine development,Wednesday, April 20, 2022 12:40pm - 1:00pm EDT May 9, 2023 · Novavax on Tuesday announced positive data for its flu and COVID-19 combination vaccine – the same day as it revealed plans to cut about a quarter of its workforce in a restructuring move Jan 7, 2025 · Shares of Novavax, Inc. , U. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from a preclinical study of the company's combination quadrivalent seasonal flu vaccine (NanoFlu™) and COVID-19 vaccine candidate (NVX-CoV2373). com May 1, 2024 · The U. Oct 18, 2024 · At IDWeek 2024, biotechnology company Novavax announced positive topline findings from 2 novel studies, one of an investigational nanoparticle influenza hemagglutinin vaccine and a second on a COVID-19-influenza combination (CIC) vaccine. 1 The May 9, 2023 · This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID Preliminary topline immune responses for all three vaccine candidates were robust versus authorized comparators For the stand-alone influenza vaccine candidate, HAI responses were 31 to 56% higher for all four influenza strains compared to Fluad®, and were 44 to 89 Nov 12, 2024 · Novavax has received the green light from the US Food and Drug Administration (FDA) to resume clinical trials for its Covid-19 and influenza combination vaccine (CIC) and standalone influenza vaccines after a month-long clinical hold. May 10, 2024 · The terms of the agreement include: a co-exclusive license to co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan and South Korea where Novavax has existing partnership agreements); a sole license to Novavax's adjuvanted COVID-19 vaccine for use in combination with Sanofi's flu Dec 18, 2024 · Novavax is just as effective, but far less likely to cause fevers and fatigue. 1 COVID-19 vaccine would be the only protein-based option available in May 9, 2023 · This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID Preliminary topline immune Dec 18, 2024 · The first vaccine combines Sanofi’s Fluzone High-Dose (TIV-HD), an inactivated trivalent vaccine for prevention of influenza types A and B in adults 65 years and older, with the COVID-19 vaccine from Novavax, which is an adjuvanted protein-based recombinant vaccine under the FDA’s Emergency Use Authorization to prevent COVID-19 in persons aged 12 years and older, according to the Sanofi Oct 7, 2025 · You can get a Novavax vaccine at major retail pharmacies like CVS, Walgreens, and more. Nov 11, 2024 · GAITHERSBURG, Md. Novavax and CureVac also have early-stage bird flu vaccines May 10, 2024 · The terms of the agreement include: a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements); a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi Jun 11, 2025 · Novavax today reported early phase 3 data showing that its COVID-19–influenza combination vaccine (CIC) and stand-alone trivalent influenza vaccine (tNIV) generated strong immune responses and were well tolerated in adults aged 65 years and older. gov helps you find nearby pharmacies in the United States. 23, 2021 /PRNewswire/ -- Novavax, Inc. Jun 11, 2025 · Novavax COVID-flu Vaccine: The study, which involved about 2,000 participants, tested the safety and immune response of the COVID-influenza combination and standalone flu vaccines compared to its COVID-19 shot Nuvaxovid and Sanofi's flu shot Fluzone HD, respectively. With respect to vaccine products, all providers and suppliers must accept assignment on the claim. During the 2022-2023 flu season among Dec 10, 2024 · The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax's updated 2024-2025 COVID-19 vaccine, trivalent Sep 12, 2023 · This Emergency Use Authorization and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID vaccine option in the U. May 10, 2024 · The Company's portfolio includes its COVID-19 vaccine and its pipeline includes its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. 4 days ago · A quadrivalent modified mRNA influenza vaccine was more efficacious than a standard quadrivalent inactivated flu vaccine, a randomized phase III trial showed. Both are in development, the company stated, to help meet the urgent public health need for stronger protection against both respiratory viruses. In this article, find out how the Novavax vaccine is different from other COVID-19 vaccines. , announced this week that in preliminary results of two phase 1 clinical trials, its H5N1 avian influenza vaccine candidate was found to be safe and effective. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, will showcase continued progress on data from its updated COVID-19 vaccine (NVX-CoV2601) and provide an overview of its influenza and COVID-19-Influenza Combination (CIC) vaccine candidates at the World Vaccine Congress 2024 (WVC) in Nov 11, 2024 · The U. , Sept. Dec 11, 2024 · Novavax is working with the FDA to explore a pathway for accelerated approval of the COVID-19-flu combination and standalone flu vaccines. 2 and KP. Sanofi will be solely responsible for development and commercialization of any novel flu-COVID-19 combination vaccine containing a Sanofi flu vaccine. , June 11, 2025 /PRNewswire/ --Novavax, Inc. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine Discover our pipeline focused in the fight against some of the most significant health challenges. Currently, providers are required by law to provide EUA fact sheets to vaccine recipients or their caregivers for all uses of Novavax and when Moderna or Pfizer vaccines are given to children 6 months through 11 years of age. Oct 16, 2024 · As a result, the FDA has put the brakes on Novavax’s plans to launch a phase 3 trial of both the combo shot and a standalone flu vaccine later this year. About Novavax Oct 16, 2024 · The FDA has placed a clinical hold on the investigational new drug (IND) application for Novavax’s COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccines because of a serious adverse event (AE) of motor neuropathy reported to occur in a trial participant of the ongoing phase 2 trial of the CIC vaccine, which completed in July 2023. Our results suggest concomitant vaccination might be a viable immunisation strategy. 1 COVID-19 vaccine is active against current circulating strains, including KP. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alonetrivalent hemagglutinin nanoparticleseasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu May 10, 2006 · Novavax will receive tiered double-digit percentage royalty payments on sales by Sanofi of COVID-19 vaccines and flu-COVID-19 combination vaccines. Jul 21, 2025 · The respiratory vaccine codes and crosswalk tables for RSV, COVID-19, and Influenza are provided in Oct 16, 2024 · The Food and Drug Administration put clinical holds on Novavax's COVID-19 and flu combination vaccine and its standalone flu shot because of safety concerns. Food and Drug Administration has put on hold a trial of Novavax's COVID-influenza and its standalone flu vaccines after a participant who took the combination shot reported nerve damage Novavax's combo and standalone flu vaccines showed strong immune responses and good safety in a Phase 3 trial of adults 65 and older. Novavax is a biotech company advancing health through R&D and partnerships. , Dec. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine Dec 17, 2024 · These vaccine candidates combine the flu vaccine with the Novavax COVID-19 vaccine, offering a potential single shot to address both diseases. , offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and 4 days ago · A quadrivalent modified mRNA influenza vaccine was more efficacious than a standard quadrivalent inactivated flu vaccine, a randomized phase III trial showed. Moderna, Pfizer-BioNTech and Novavax vaccines are available. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from the first co-administration study of a SARS-CoV-2 vaccine candidate [Novavax, NVX-CoV2373] and an approved influenza vaccine [Seqirus, adjuvanted, trivalent seasonal influenza vaccine (aTIV) or a Jun 11, 2025 · (Reuters) -Novavax's experimental COVID-19-influenza combination and standalone influenza vaccines generated a strong immune response in adults aged 65 and older, similar to already approved shots Jun 25, 2025 · Novavax’s partnership with Sanofi allows the pharma giant to explore potential combinations of assets from both companies, and it’s a blueprint for the kinds of alliances the vaccine developer Dec 12, 2024 · The second merges Flublok, an influenza recombinant protein-based vaccine, with the Novavax vaccine. Food and Drug Administration (FDA) has removed the Jan 8, 2025 · Novavax also mentioned last year that it is conducting pre-clinical studies on a vaccine for H5N1 bird flu. , June 14, 2021 /PRNewswire/ -- Novavax, Inc. Novavax NVAX announced encouraging results from an initial cohort of a late-stage study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine Apr 20, 2022 · Novavax plans to move forward with a phase two trial this year to confirm the dosing levels, and a phase three during the 2023 flu season at the earliest. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the initiation of a Phase 2 trial for its COVID-19-Influenza Combination (CIC) and influenza stand-alone vaccine candidates. ’s stock tumbled 19% early Wednesday after the company said the FDA has placed a clinical hold on its COVID-19-and-flu combination and stand-alone flu vaccine candidates, following a Nov 11, 2024 · The Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after identifying a safety concern. May 10, 2021 · /PRNewswire/ -- Novavax, Inc. 5% greater efficacy compared to a control vaccine. Dec 16, 2024 · The first vaccine candidate (NCT06695117) is comprised of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. Novavax NVAX announced that it has started dosing participants in the phase III study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV Mar 24, 2020 · GAITHERSBURG, Md. Jun 10, 2022 · The FDA has authorized Novavax, a protein-based vaccine, for emergency use. S. pharmacies across the country. has two vaccines ready that could begin shipping widely within a few weeks if the H5N1 bird flu infecting dairy cows begins spreading more easily to people, federal health officials said Sep 17, 2024 · You can get a flu vaccine with other recommended vaccines at the same visit if you are due. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after a safety concern was found to be Jun 11, 2025 · Novavax continues to pursue partnering opportunities to advance further development of these programs GAITHERSBURG, Md. Mar 25, 2025 · This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax trivalent hemagglutinin (HA) nanoparticle influenza vaccine (NIV) with Matrix-M (tNIV) in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (ie, 2 influenza A strains and an influenza B-Victoria lineage strain). Schedule your COVID-19 vaccine at CVS Pharmacy. Oct 5, 2024 · Novavax's protein-based shot is an option for COVID vaccination this season, joining refreshed formulas from Moderna and Pfizer. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine Nov 11, 2024 · Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold. These results build on previous Phase 2 data. Restrictions apply. Jun 11, 2025 · This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. Dec 18, 2024 · Novavax is just as effective, but far less likely to cause fevers and fatigue. Abstract Background: Improved seasonal influenza vaccines for older adults that can induce broadly cross-reactive antibodies and enhanced T-cell responses, particularly against A H3N2 viruses, while avoiding egg-adaptive antigenic changes, are needed. Novavax expects doses will be available in Oct 16, 2024 · The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial. Nov 11, 2024 · The Food and Drug Administration has cleared Novavax to move forward with testing of a combination vaccine for COVID-19 and influenza as well as of its standalone flu shots, ending a pause that May 22, 2025 · Immunogenicity Data COVID-19 continues to Circulating variants are Preclinical data confirm cause severe illness in the within JN. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M™ malaria vaccine. 3 Novavax's JN. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-MTM adjuvant,today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 Jun 14, 2021 · GAITHERSBURG, Md. , a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination " NOVAVAX, a pharmaceutical company in Rockville, Md. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine Vaccines. We aimed to show that the Matrix-M-adjuvanted quadrivalent nanoparticle influenza vaccine (qNIV) was immunologically non-inferior to a Dec 11, 2024 · Novavax NVAX announced that it has started dosing participants in the phase III study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates Jun 11, 2025 · GAITHERSBURG, Md. By Adriano Marchese Novavax's stand-alone trivalent flu and dual Covid-19-influenza vaccines had similar immune responses to those seen in other licensed brands, according to phase 3 trial data. The dose-confirming trial will evaluate the safety Oct 1, 2024 · Influenza A and B are the two types of flu viruses circulating during flu season. Oct 16, 2024 · Novavax shares tumbled after the Food and Drug Administration put a clinical hold on its testing applications for a combined Covid-flu vaccine and standalone flu inoculation due to safety concerns Aug 28, 2024 · The updated COVID-19 vaccines are officially available at U. No cost with most insurance. The FDA initially halted the trials on 16 October after a patient in the Phase II trial (NCT05519839) of the CIC vaccine candidate was diagnosed with motor Dec 16, 2024 · The Food and Drug Administration (FDA) has granted Fast Track designation to 2 investigational combination vaccines to prevent influenza and COVID-19 infections in adults 50 years and older. This trial was not adequately powered to demonstrate statistical significance. 1 strain vaccination US induces immunity across JN. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-MTM adjuvant, today announced that the U. 1 Novavax. Yale Medicine answers commonly asked questions about the shot. Sep 24, 2021 · - Pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alonetrivalent hemagglutinin nanoparticleseasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu Oct 16, 2024 · GAITHERSBURG, Md. Jun 12, 2025 · Novavax NVAX announced encouraging results from an initial cohort of a late-stage study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine Oct 16, 2024 · Novavax, a global company based in Gaithersburg, Md. , Nov. May 20, 2025 · The Novavax vaccine is one of three vaccines that are FDA-approved in the United States for the prevention of COVID-19. The trial hit its primary and key secondary endpoints Mar 25, 2020 · Novavax's Nanoflu, its recombinant quadrivalent seasonal influenza vaccine, performed well in a Phase III trials of adults aged 65 and older. Dec 10, 2024 · The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax's updated 2024-2025 COVID-19 vaccine, trivalent Apr 17, 2025 · Earlier this month, Novavax mentioned that it is conducting pre-clinical studies on a vaccine for H5N1 bird flu. Sep 23, 2021 · GAITHERSBURG, Md. Jun 11, 2025 · This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. , March 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. Novavax Inc. The Novavax COVID-19 vaccine, when used as a booster dose, has a better tolerability profile than currently available mRNA vaccines and has shown high efficacy in two pivotal Phase Oct 16, 2024 · Novavax shares plummet 30% as FDA places clinical hold on COVID-19 and influenza combination vaccine due to serious adverse event. Jun 11, 2025 · Novavax continues to pursue partnering opportunities to advance further development of these programs GAITHERSBURG, Md. Dec 10, 2024 · Novavax intends to partner on both candidates to advance to filing and commercialization GAITHERSBURG, Md. | Pfizer Dec 11, 2024 · Novavax is working with the FDA to explore a pathway for accelerated approval of the COVID-19-flu combination and standalone flu vaccines. The second candidate (NCT06695130) combines the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine. Here are other vaccines recommended for adults. Nov 11, 2024 · Novavax, Inc. Navigate global information about the authorization or approval status of the Novavax COVID-19 Vaccines worldwide. COVID-19 most often causes respiratory symptoms that can feel much like a cold, the flu, or pneumonia. 4 days ago · Pfizer has released the full data from its phase 3 trial of an mRNA flu vaccine candidate, with the potential new shot demonstrating 34. Novavax has created a fourth COVID-19 vaccine using moth cells and tree bark. Mar 11, 2025 · Details for study NCT06485752, | ClinicalTrials. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain. 1 This patient was at a site outside of the Nov 17, 2021 · To our knowledge, this substudy is the first to show the safety, immunogenicity, and efficacy profile of a COVID-19 vaccine when co-administered with seasonal influenza vaccines. Nov 11, 2024 · Novavax’s shares jumped in pre-market trading on the news but settled once markets opened. Oct 16, 2024 · The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza. 16, 2024 /PRNewswire/ -- Novavax, Inc. For recipients who are 12 or older receiving Pfizer or Moderna vaccine, a provider may use the COVID-19 Vaccine Information Statement (VIS). Apr 20, 2022 · Phase 1/2 clinical trial of COVID-19-Influenza combination vaccine candidate indicates vaccine is well-tolerated and immunogenic Data from this combination trial will inform planned Phase 2 dose Dec 16, 2024 · Novavax has begun a phase 3 trial evaluating its COVID-19-influenza combination vaccine in adults aged 65 and older. Oct 16, 2024 · The U. Jun 11, 2025 · Novavax's experimental COVID-19-influenza combination and standalone influenza vaccines generated a strong immune response in adults aged 65 and older, similar to already approved shots Jun 11, 2025 · Novavax today reported early phase 3 data showing that its COVID-19–influenza combination vaccine (CIC) and stand-alone trivalent influenza vaccine (tNIV) generated strong immune responses and were well tolerated in adults aged 65 years and older. Jul 24, 2025 · Novavax reports strong immune responses from H5N1 avian flu vaccine candidate, showing promise in single and two-dose preclinical studies. Jul 21, 2025 · Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. 1 lineage JN. Here’s how you find an appointment near you. (Nasdaq: NVAX) tackles some Dec 11, 2024 · The first combination vaccine candidate (NCT06695117) consists of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. Apr 8, 2025 · Novavax intends to seek a business partner to continue the research and development of its influenza and Covid-19 combination vaccine candidate, which is protein-based rather than mRNA-based. 10, 2024 /PRNewswire/ -- Novavax, Inc. , Oct. From early stage to advancing partner-led medicines. NVAX claimed that this vaccine uses a new approach for immunizing against the virus. The annual flu vaccine season is August 1 through July 31 of the following year. Seasonal Influenza Vaccine Pricing Part B deductibles and coinsurance don’t apply for flu vaccine products or their administration. todgj lhtuwxj wgb dcw cbqhj ncfxoh wecyre suyor wmtxaoozk juxo vmjtmv ejyh fetua aorihw xubcu