Novavax Inc Stock Price, News & Analysis

Novavax (Nasdaq: NVAX) has announced positive results from its Phase 1/2 trial of a COVID-19-Influenza Combination (CIC) vaccine. This innovative trial is the first to evaluate a combined vaccine for COVID-19 and influenza. Data showed robust immune responses, including antibodies and polyfunctional T-cells against SARS-CoV-2 and various influenza strains. The CIC demonstrated a safety profile consistent with standalone vaccines, with rare serious adverse events. Results will inform a Phase 2 confirmation trial scheduled for late 2022.

Novavax presented significant data at the World Vaccine Congress Europe 2022, demonstrating its prototype COVID-19 vaccine, NVX-CoV2373, effectively induced robust antibody responses against Omicron variants BA.1, BA.2, and BA.5. Study 307 confirmed the consistency of immune responses across three vaccine lots. The PREVENT-19 trial showed a significant rise in antibody levels after booster doses in adults and adolescents, suggesting promising protective efficacy against COVID-19 variants. The findings indicate a solid safety profile, enhancing confidence in the vaccine's potential effectiveness as a booster.

On October 10, 2022, Novavax (Nasdaq: NVAX) announced it will present new data on its COVID-19-Influenza Combination vaccine and COVID-19 booster at the World Vaccine Congress Europe from October 11-14, 2022. The data will showcase the vaccine's safety and immunogenicity, reinforcing its use in adults and adolescents. Additionally, Novavax will present updated Phase 3 data from the PREVENT-19 trial, demonstrating the effectiveness of its COVID-19 vaccine as a heterologous booster. Gregory Glenn, M.D., will also participate in a keynote panel discussing the future of COVID vaccination.

Novavax, Inc. (NASDAQ: NVAX) announced the availability of one million doses of its COVID-19 vaccine, Nuvaxovid™ (NVX-CoV2373), in the United Kingdom. This protein-based vaccine is the first of its kind authorized by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). Nuvaxovid is essential for addressing COVID-19 and flu co-infections, which significantly increase mortality risk. The vaccine's complete clinical trials have shown efficacy rates of 90.4% in adults and 80% in adolescents. Future plans include seeking further authorization for its use as a booster in adults.

Novavax, Inc. (Nasdaq: NVAX) announced that the Taiwan Food and Drug Administration (TFDA) has granted expanded emergency use authorization (EUA) for its COVID-19 vaccine, Nuvaxovid™, for adolescents aged 12 to 17. This decision follows positive data from the Phase 3 PREVENT-19 clinical trial, which demonstrated 78.29% efficacy against COVID-19 during the Delta variant's predominance. Adverse reactions were generally mild to moderate and comparable to those observed in adults. Nuvaxovid has already been authorized in over 10 markets for this age group, enhancing vaccine access as COVID-19 cases are anticipated to rise in colder months.

The Israeli Advisory Committee on Epidemics has recommended the approval of Nuvaxovid™, Novavax's COVID-19 vaccine, for individuals aged 12 and older as a primary series and a heterologous booster. The Israel Ministry of Health has granted an import and use permit, allowing access to the vaccine. Nuvaxovid is already authorized for adults in over 40 markets globally, including the U.S. and WHO. The vaccine utilizes a protein-based approach and is part of ongoing Phase 3 trials, showing efficacy rates of up to 90.4% in adult populations and 80% in adolescents.

Novavax, Inc. (Nasdaq: NVAX) announced that its protein-based COVID-19 vaccine, NVX-CoV2373, has received full product registration with conditions from the South African Health Products Regulatory Authority. This two-dose vaccine is authorized for use in adults aged 18 and older and is marketed as Covovax™. The registration is based on Phase 3 clinical trials, which demonstrated overall efficacy rates of 90.4% and 89.7% in separate studies. The vaccine has also received approvals from over 43 countries, including the U.S. and WHO.

Novavax, Inc. (Nasdaq: NVAX) announced the European Commission's approval of its Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a booster for adults aged 18 and older. This expanded conditional marketing authorization allows the vaccine to be administered regardless of prior vaccination. The approval follows favorable results from multiple Phase 2 trials demonstrating increased immune responses and overall safety. Nuvaxovid is already approved in several other regions, including Japan and Australia, and targets variants, showing efficacy against Omicron strains.

On September 7, 2022, Novavax (Nasdaq: NVAX) announced its participation in two investor conferences. The discussions will focus on its COVID-19 vaccine, NVX-CoV2373. The first conference, H.C. Wainwright 24th Annual Global Investment Conference, is scheduled for September 12, 2022, from 4:00 to 4:30 p.m. EDT at Lotte New York Palace Hotel. The second, Baird 2022 Global Healthcare Conference, will take place on September 13, 2022, from 8:30 to 9:00 a.m. EDT at Intercontinental New York Barclay Hotel. Recordings of the sessions will be available on Novavax's website for 90 days.