Novavax Inc - NVAX STOCK NEWS

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.

Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 vaccine, Nuvaxovid™, has been recommended for expanded conditional marketing authorization (CMA) in the EU as a homologous and heterologous booster for adults 18 and older. This recommendation by the CHMP is based on data from Phase 2 trials conducted in Australia, South Africa, and the UK. Nuvaxovid has already been approved in Japan, Australia, and New Zealand. As the pandemic evolves, Novavax aims to enhance global access to diversified vaccine options.

Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 vaccine, Nuvaxovid™, received expanded conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency for use in adolescents aged 12 to 17. This marks the first protein-based COVID-19 vaccine available for this age group in the UK. The authorization is based on data from the pediatric expansion of the Phase 3 PREVENT-19 trial, where Nuvaxovid demonstrated 80% clinical efficacy during the Delta variant surge. The next step involves a policy recommendation from the UK Joint Committee on Vaccination and Immunisation.

Novavax, Inc. (Nasdaq: NVAX) announced the FDA has granted expanded emergency use authorization for its COVID-19 Vaccine, Adjuvanted for adolescents aged 12-17. This marks it as the first protein-based COVID-19 vaccine authorized in the U.S. A clinical trial involving 2,247 participants demonstrated an overall efficacy of 78.29% against the Delta variant. Vaccination immunizations for adolescents can start following CDC recommendations. Safety data indicates a well-tolerated profile with mild side effects. The vaccine remains authorized under EUA and is designed to enhance vaccination rates as COVID-19 cases surge.