Novavax's COVID-19 Vaccine Nears FDA Full Approval, Stock Jumps

Core Viewpoint - Novavax, Inc. is optimistic about the approvability of its Biologics License Application (BLA) based on discussions with the FDA, despite delays and additional data requests from the agency [1][2][3]. Group 1: FDA Communication and Approval Process - Novavax believes its BLA is approvable following conversations with the FDA, with the Prescription Drug User Fee Act date set for April 1 [1]. - The company received a formal information request from the FDA for a post-marketing commitment to generate additional clinical data [1]. - The FDA has delayed its decision on full approval and requested more data, making immediate approval unlikely [3]. Group 2: Clinical Study Results - Preliminary results from the SHIELD-Utah study indicated that Novavax's COVID-19 vaccine resulted in fewer and less severe reactogenicity symptoms compared to Pfizer-BioNTech's mRNA vaccine [4]. - The SHIELD-Utah study was conducted at the University of Utah Health and focused on the effects of COVID-19 vaccine doses [3]. Group 3: Regulatory Approvals and Recommendations - The FDA granted Emergency Use Authorization for Novavax's COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) in September 2024 for individuals aged 12 and older [4]. - Novavax's vaccine was included in the CDC recommendations issued on June 27, 2024 [5]. Group 4: Stock Performance and Predictions - Novavax stock (NVAX) increased by 19.5% to $7.47 on Wednesday [9]. - The 200-day moving average for Novavax is $9.94, which is above the current stock price of $7.33, indicating potential bullish signals if the stock remains above this average [8].