Novavax Inc Stock Price, News & Analysis

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.

Novavax's NVX-CoV2373 COVID-19 Vaccine is set for review by the FDA's VRBPAC on June 7, 2022. This landmark review marks NVX-CoV2373 as the first protein-based COVID-19 vaccine to undergo evaluation in the U.S. The vaccine demonstrated 90.4% efficacy in a Phase 3 trial involving 29,960 participants. Notably, it has not yet received U.S. authorization, although it has conditional approvals in other regions. Novavax continues to collaborate with international partners for manufacturing and distribution, emphasizing the urgent need for diverse vaccine options amid ongoing pandemic challenges.

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.