Novavax Inc - NVAX STOCK NEWS

Novavax has initiated the administration of booster doses of NVX-CoV2373, its COVID-19 vaccine, in the pediatric expansion of the PREVENT-19 Phase 3 trial for participants aged 12 to 17. This trial aims to evaluate the safety and immunogenicity of a third dose, with initial results expected in the second half of 2022. The booster dose mirrors the previous two-dose regimen and will be given at least five months after the second dose. While Novavax emphasizes the ongoing need for alternative vaccine options, NVX-CoV2373 has yet to receive U.S. FDA authorization.

Novavax has announced initial data from its Phase 1/2 trial for a COVID-19-Influenza combination vaccine, demonstrating that the candidate is well-tolerated and immunogenic. The study involved 642 healthy adults aged 50-70 and showed that immune responses were comparable to stand-alone vaccines. This combination vaccine could potentially reduce antigen amounts by 50%, optimizing production. While data support further advancement to a Phase 2 trial, neither the COVID-19 vaccine NVX-CoV2373 nor the influenza candidate have received FDA authorization in the U.S.

Novavax announced that its COVID-19 vaccine, Nuvaxovid, received approval from Japan's Ministry of Health for use in adults aged 18 and older, marking it as the first protein-based COVID-19 vaccine authorized in the country. The approval includes both primary and booster vaccinations. This milestone was achieved through positive results from Takeda's Phase 1/2 study in Japan and Novavax's pivotal Phase 3 trials in the U.K., U.S., and Mexico. Takeda will handle the manufacturing and distribution of the vaccine in Japan.

On April 18, 2022, Novavax (Nasdaq: NVAX) announced its participation in the World Vaccine Congress and the 32nd European Congress of Clinical Microbiology & Infectious Diseases. The company will showcase new data on its COVID-19 influenza combination vaccine and NVX-CoV2373. Presentations will cover updates on vaccine safety, efficacy, and clinical trials, indicating their commitment to addressing COVID-19 and flu. Key sessions include ‘How long will our immunity against COVID-19 last?’ and ‘Clinical Update on Novavax's Recombinant Nanoparticle Protein Subunit COVID-19 Vaccine as a Booster.’

Novavax has received conditional marketing authorization from Swissmedic for its COVID-19 vaccine, Nuvaxovid™, making it the first protein-based COVID-19 vaccine authorized in Switzerland. This authorization is based on substantial clinical trial data, including two pivotal Phase 3 studies with nearly 45,000 participants, demonstrating strong efficacy and a reassuring safety profile. Novavax will supply up to six million doses to Switzerland. The vaccine is designed to prevent COVID-19 in individuals aged 18 and older and utilizes Novavax's proprietary technology, which aims to enhance immune response.

Novavax (Nasdaq: NVAX) announced that the Thailand Food and Drug Administration granted Emergency Use Authorization (EUA) for its COVID-19 vaccine, NVX-CoV2373, in individuals aged 18 and older. The vaccine, manufactured by Serum Institute of India under the brand name Covovax™, demonstrated efficacy of 90.4% in the U.S. and Mexico trials and 89.7% in the U.K. trial. These trials indicated a favorable safety profile. Covovax™ is also authorized in several countries and the company aims to provide additional vaccination options to combat COVID-19.

Novavax (Nasdaq: NVAX) announced its request for expanding the conditional marketing authorization of Nuvaxovid™ COVID-19 Vaccine for adolescents aged 12-17 in the EU. This potential approval would make Nuvaxovid the first protein-based COVID-19 vaccine option for this age group in Europe. The submission includes clinical trial data showing 80% efficacy during the Delta variant surge. The vaccine was well-tolerated, with minimal serious adverse events. Novavax aims to increase vaccination rates amid rising COVID-19 cases in Europe and plans to file for regulatory approval in additional markets.

Novavax, Inc. (Nasdaq: NVAX) announced its participation in two ongoing clinical trials evaluating NVX-CoV2373, its COVID-19 vaccine, as a booster. One trial, sponsored by NIAID, will assess boosting regimens after initial vaccination with FDA-approved or authorized vaccines, enrolling 1,130 participants. The second trial in the UAE focuses on individuals previously vaccinated with Sinopharm’s vaccine, targeting around 1,000 participants. Topline results from these studies are anticipated later in 2022, contributing to the understanding of NVX-CoV2373's safety and efficacy in booster scenarios.

Novavax has received emergency use authorization (EUA) for its COVID-19 vaccine, Covovax™, aimed at adolescents aged 12 to 18, in India. This marks the first authorization of a protein-based COVID-19 vaccine for this age group in the country. Data from a Phase 2/3 study indicates Covovax has a reassuring safety profile and is immunogenic. The vaccine is manufactured by Serum Institute of India and represents a significant milestone in immunization efforts. Notably, NVX-CoV2373 has yet to be authorized for use in the U.S.