Novavax (NVAX) Seeks Nod for Updated COVID-19 Jab in Europe

Core Viewpoint - Novavax has filed a regulatory application with the EMA to update its protein-based COVID-19 vaccine for the 2024/2025 vaccination campaign, aligning with EMA and WHO guidance to target the JN.1 variant [1][2][4]. Company Developments - Novavax's stock has increased by 192.1% year-to-date, contrasting with a 4.1% decline in the industry [3]. - Sanofi will gain global co-marketing rights for Novavax's COVID-19 vaccine starting next year, with Novavax eligible to receive up to $1.2 billion, including $500 million upfront and milestone payments, along with tiered double-digit percentage royalties on sales [6][13]. - The partnership with Sanofi alleviates previous concerns about Novavax's ability to continue as a 'going concern' [7]. Vaccine Efficacy and Market Position - The updated vaccine targets the JN.1 variant but is also effective against currently circulating strains, including KP.2 and KP.3 [8]. - Novavax's COVID-19 vaccine is currently authorized in the EU for individuals aged 12 and older, with a similar filing submitted to the FDA [10]. - Compared to Pfizer and Moderna, Novavax faced challenges during the last vaccination season due to delayed vaccine approval and launch, but early participation in the upcoming season may present new opportunities [12]. Future Plans and Innovations - Novavax is working with global regulatory authorities to secure approvals for the updated vaccine [9]. - The company plans to expand its pipeline using funds from the Sanofi deal, including developing a new approach for H5N1 bird flu vaccination and advancing technology for mucosal vaccination and high-density nanoparticles [14].