Novavax Inc - NVAX STOCK NEWS

Novavax, Inc. (Nasdaq: NVAX) will report its third quarter 2022 financial results on November 8, 2022, after the U.S. market closes. A conference call will be held at 4:30 p.m. EDT, with dial-in options available for both domestic and international participants. A replay of the call will be accessible from 7:30 p.m. EDT on the same day until November 15, 2022. Novavax continues to develop innovative vaccines, including its COVID-19 vaccine and other candidates currently undergoing clinical trials.

Novavax presented new data from its Phase 3 PREVENT-19 trial at IDWeek 2022, highlighting the effectiveness of its COVID-19 vaccine (NVX-CoV2373) as a booster for adults. The study demonstrated significant increases in anti-spike antibody responses, regardless of age or booster intervals (8 or 11 months). Additionally, data from a Phase 1/2 trial on a COVID-19-Influenza Combination vaccine showed positive antibody and T-cell responses against multiple strains. The company's growing vaccine portfolio aims to address global health needs amidst ongoing evaluation by regulatory authorities.

Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) received Emergency Use Authorization (EUA) from the FDA for a first booster dose for adults 18+ who cannot receive or opt not to receive an FDA-authorized mRNA booster. The EUA is based on Phase 3 trial data showing significant increases in antibody levels post-booster. The vaccine has been authorized in various countries and can help boost vaccination rates, particularly among adults who have not yet received their first booster.

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.