Novavax Inc Stock Price, News & Analysis

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the use of the Novavax COVID-19 Vaccine, Adjuvanted, as a two-dose primary series for individuals aged 18 and older. This follows the Emergency Use Authorization (EUA) granted by the U.S. FDA. Novavax expects to begin shipping doses to designated distribution centers soon. The vaccine is the first FDA-authorized protein-based COVID-19 vaccine in the U.S., with a reported efficacy of 90.4% based on the Phase 3 PREVENT-19 trial involving nearly 30,000 participants.

Novavax, Inc. (Nasdaq: NVAX) has expanded its collaboration with SK bioscience to manufacture a version of its COVID-19 vaccine (NVX-CoV2373) targeting the Omicron variant. This includes a technology transfer for creating COVID-19 variant antigens and the manufacture of the vaccine in prefilled syringes, expected to begin in 2023. Non-clinical data shows the vaccine elicits broad immune responses against variants, including Omicron BA.5. Additionally, Novavax is evaluating the efficacy of their vaccine in Phase 3 trials, with previous trials showing over 90% efficacy. Funding includes up to $1.75 billion from the U.S. government.

On July 13, 2022, Novavax announced that its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), received Emergency Use Authorization (EUA) from the U.S. FDA, marking it as the first protein-based COVID-19 vaccine authorized in the U.S. The two-dose series will be available for individuals aged 18 and over upon CDC recommendation. The vaccine demonstrated 90.4% efficacy in clinical trials involving 30,000 participants. Novavax will supply an initial 3.2 million doses, which will be provided for free through federal health agencies.

Novavax (Nasdaq: NVAX) announced a partnership with the U.S. government to secure 3.2 million doses of its protein-based COVID-19 vaccine, NVX-CoV2373, pending FDA Emergency Use Authorization (EUA) and CDC recommendation. This vaccine, developed using recombinant nanoparticle technology, targets serious infectious diseases and will be provided free to various health entities. The FDA's advisory committee previously recommended EUA for adults aged 18 and older. Novavax's vaccine demonstrated 90.4% efficacy in Phase 3 trials and is under review for further authorizations globally.

Novavax, Inc. (Nasdaq: NVAX) announced that the European Commission has granted expanded conditional marketing authorization for its COVID-19 vaccine, Nuvaxovid™, for adolescents aged 12 to 17. This approval follows a positive recommendation from the European Medicines Agency on June 23, 2022. The pediatric expansion trial involved 2,247 adolescents and demonstrated an 80% efficacy against the Delta variant. Nuvaxovid is already approved for individuals aged 18 and over in the EU and has received emergency use authorization in India for the same age group.

Novavax's prototype vaccine, NVX-CoV2373, shows significant immune responses against Omicron and other variants, as presented at the FDA Advisory Committee meeting. The vaccine is set to be ready for supply this fall, adhering to FDA recommendations. Pre-clinical data indicates that both the prototype and Omicron vaccines induce strong immune responses, particularly with boosters. Additionally, NVX-CoV2373 achieved 90.4% efficacy in Phase 3 trials. The company is preparing for Emergency Use Authorization in the U.S. while continuing global regulatory reviews.

Novavax announced that its COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), received emergency use authorization (EUA) from the Taiwan Food and Drug Administration for individuals aged 18 and over. This EUA allows Novavax to fulfill its commitment to the COVAX Facility, marking the company's first shipment to a participating country. The authorization is based on comprehensive clinical trial data, demonstrating 90.4% efficacy in its Phase 3 trial.

The vaccine has received authorization in over 40 countries globally, although it has yet to secure authorization in the U.S.

Novavax announced that its COVID-19 vaccine, Nuvaxovid™, has been recommended for expanded conditional marketing authorization in the EU for adolescents aged 12-17. The recommendation is based on the Phase 3 PREVENT-19 trial, which demonstrated an efficacy of 80% against COVID-19 and a favorable safety profile among the adolescent population, with lower reactogenicity compared to adults. Nuvaxovid is the first protein-based COVID-19 vaccine option for this age group. The vaccine is yet to receive U.S. authorization.

Novavax announced that the Australian Therapeutic Goods Administration has granted provisional registration for Nuvaxovid™ (NVX-CoV2373) as a COVID-19 booster for individuals aged 18 and over. This marks it as Australia's first protein-based COVID-19 vaccine for booster use, regardless of prior vaccination history. The decision was based on positive Phase 2 trial data showing increased immune responses. The vaccine's side effects were generally mild and short-lived. However, it has yet to receive authorization in the U.S.