Novavax Inc - NVAX STOCK NEWS

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.

Novavax announced that the FDA's Vaccines Advisory Committee voted 21-0, with one abstention, to recommend Emergency Use Authorization for its COVID-19 vaccine (NVX-CoV2373) for individuals 18 and older. This would make it the first protein-based COVID-19 vaccine in the U.S. The Phase 3 PREVENT-19 trial demonstrated a 90.4% efficacy rate with a good safety profile. The vaccine has already received authorization in over 40 countries. As the FDA considers this recommendation, Novavax continues to prepare for final approvals and collaborations with regulatory bodies.

Novavax achieved $704 million in revenue and $203 million in net income for Q1 2022, marking its first profitable quarter as a commercial-stage company. The company reiterated its full-year revenue guidance of $4 to $5 billion. Key developments included ongoing label expansions for Nuvaxovid™, EUA submissions to the FDA, and positive Phase 1/2 results for its COVID-19-Influenza Combination vaccine. Novavax continues to expand its global footprint, with new authorizations across several countries.

Novavax, a biotechnology company based in Gaithersburg, Maryland, will participate in the BofA Securities 2022 Healthcare Conference on May 11, 2022. The company's COVID-19 vaccine candidate, NVX-CoV2373, will be discussed during the fireside chat scheduled from 5:20 - 5:50 p.m. PDT. Executives Gregory M. Glenn and John J. Trizzino will represent Novavax. A replay of the session will be available on the company’s website for 90 days following the event. Novavax continues to develop innovative vaccines for serious infectious diseases and has received conditional authorization for NVX-CoV2373 globally.

Novavax, Inc. (Nasdaq: NVAX) will report its first quarter 2022 financial results and operational highlights on May 9, 2022, at 4:30 p.m. EDT. A conference call will allow participants to discuss the results and ask questions. The earnings call can be accessed via dial-in or webcast. Additionally, a replay will be available shortly after the call until May 16, 2022. Novavax is recognized for its COVID-19 vaccine, which has received multiple global authorizations and is under review by various regulatory agencies. The company is also evaluating a COVID-influenza combination vaccine.