NanoFlu (recombinant hemagglutinin protein nanoparticle) / Novavax - LARVOL DELTA

A Modified Novel Validated High-Throughput Hemagglutinin Inhibition Assay Using Recombinant Virus-like Particles and Human Red Blood Cells for the Objective Evaluation of Recombinant Hemagglutinin Nanoparticle Seasonal Influenza Vaccine. (PubMed, Microorganisms) - "An improved and objective novel HAI assay was developed with recombinant virus-like particles (VLPs) and an egg-derived virus as agglutinins, the oseltamivir treatment of VLPs, human red blood cells, and using an automated image reader-based analysis of hemagglutination...Validated HAI results were equivalent for the single and duplicate sample testing and correlated well with a qualified live wild-type influenza microneutralization assay. These findings demonstrate the suitability of this high-throughput novel modified validated HAI assay for evaluating vaccine immunogenicity and efficacy."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults (clinicaltrials.gov) - P3 | N=2654 | Completed | Sponsor: Novavax | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases • SPR

"For comparison the pace of $NVAX the "LEADER IN COVID, NANOFLU AND COMBINATION VACCINE DEVELOPMENT"" (@TOWiU2)

Clinical • Novel Coronavirus Disease

Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults (clinicaltrials.gov) - P2 | N=1375 | Terminated | Sponsor: Novavax | Completed ➔ Terminated; This study was terminated 182 days after initial dosing.

Trial termination • Infectious Disease • Influenza • Respiratory Diseases • SPR

Moderna wouldn’t share its vaccine technology, so South Africa and the WHO made a COVID jab based on it anyway - "Like the new Novavax jab, Corbevax uses relatively traditional protein subunit technology—Hotez earlier this month called mRNA COVID vaccines 'shiny new toys' that couldn't reach the manufacturing scale urgently needed for the developing world. Uniquely, however, it is being offered patent-free."

Novel Coronavirus Disease

"Novavax combo Covid-NanoFlu is the answer." (@ri4po)

Novel Coronavirus Disease

"Novavax Inc #novavax #nanoflu #coronavirus #COVID19" (@lukas_choleva)

Infectious Disease • Novel Coronavirus Disease

"Novavax Inc #novavax #nanoflu #coronavirus #COVID19 @BillGates" (@Luk06443835)

Infectious Disease • Novel Coronavirus Disease

"@Merck FTW. #novavax Considering Matrix-M and Nanoflu, + RSV and the strong likelihood of upcoming combination vaccine. Plus I heard Merck was doing Christmas shopping in Maryland this week...." (@Ira_The_Iron)

Novavax to Present COVID-19, Influenza and RSV Candidate Vaccine Data at World Vaccine Congress Washington 2020 (GlobeNewswire) - "Novavax, Inc....today announced that it will present on its lead vaccine candidates, NVX-CoV2373, NanoFlu™ and ResVax™, the Company’s COVID-19, influenza and respiratory syncytial virus (RSV) vaccines. The presentations are part of the 2020 World Vaccine Congress Washington, taking place virtually September 28-October1, 2020."

Clinical • Live event • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"How about you guys hurry up and approve Nanoflu before flu season" (@curtisw502)

"#Biotech Key Data Expected in March $AXSM Ph3 TRD & Migraine $BHVN Ph3 Prevention $AKRO Ph2 NASH $ASND Ph2 TransCon PTH $ITRM Ph3 cUTI $MIST Ph3 PSVT $MYOV Ph3 Endometriosis $NVAX Ph3 NanoFlu $NWRN Ph3 Rett $PRQR Ph1/2 Usher $SELB Ph2 Gout $SNGX Ph3 CTCL $SVRA Ph2a NTM" (@AndyBiotech)

P2a data

"Pivotal $NVAX NanoFlu ph3 trial results by end of March." (@Karl_E_B)

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults (clinicaltrials.gov) - P3; N=2650; Active, not recruiting; Sponsor: Novavax; Trial primary completion date: Dec 2019 ➔ Mar 2020

Clinical • Trial primary completion date

"Approve the Nanoflu vaccine! People are dying! And I can but me a beach house;) (NVAX stock)" (@RichardHeadII)

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults (clinicaltrials.gov) - P3; N=2650; Active, not recruiting; Sponsor: Novavax; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults (clinicaltrials.gov) - P3; N=2650; Recruiting; Sponsor: Novavax; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults (clinicaltrials.gov) - P3; N=2650; Not yet recruiting; Sponsor: Novavax

Clinical • New P3 trial

Induction of Broadly Cross-reactive Immune Responses Against A(H3N2) Airuses: Results of a Phase 2 Trial of a Novel Recombinant Hemagglutinin Saponin-adjuvanted Nanoparticle Seasonal Influenza Vaccine (IDWeek 2019) - "Background : We developed a recombinant saponin-adjuvanted (Matrix-M1) quadrivalent hemagglutinin nanoparticle influenza vaccine (qNIV; NanoFlu) for older adults to address two impediments to efficacy of current, predominantly egg-derived, seasonal influenza vaccines: 1) limited protection against antigenic drift variants, particularly H3N2 viruses; and 2) antigenic mismatch between vaccine and circulating strains due to egg-adaptive mutations arising during manufacturing...We undertook a Phase 2 trial to optimize the formulation of qNIV, and to compare qNIV immune responses to those of IIV3-HD and quadrivalent recombinant influenza vaccine (RIV4; FluBlok).Methods : In this phase 2 dose and formulation finding RCT, we randomized 1375 subjects aged ≥65 years to be immunized with 1 of 7 test vaccines: 5 different formulations of qNIV, IIV3-HD, or RIV4; and assessed wild-type hemagglutinin-inhibition (wt-HAI) and microneutralization (wt-MN) antibody responses (Day..."

Clinical • P2 data

QUILT-3.040: Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu) (clinicaltrials.gov) - P1/2; N=330; Completed; Sponsor: Novavax; Active, not recruiting ➔ Completed

Clinical • Trial completion

"@US_FDA @FDA_Drug_Info @Surgeon_General @WHO @CDCgov @BillGates @melindagates Can you tell me what non egg based flu vaccine outperforms Nanoflu for prevention across strains? None! Do you know what compound outperforms ResVax for RSV related conditions? None! So badly needed!" (@AL_P26)