Novavax has received FDA clearance to resume clinical trials for its COVID-19 and influenza combination (CIC) vaccine and standalone influenza vaccines after a clinical hold initiated in October. The Phase III trial, set to begin enrollment by the end of 2024, will evaluate the efficacy and safety of the CIC vaccine in adults aged 65 and older.
The FDA initially halted the trials following a diagnosis of amyotrophic lateral sclerosis (ALS) in a Phase II trial participant. However, after a thorough evaluation, the FDA concluded that the ALS diagnosis was unrelated to Novavax’s vaccine. Robert Walker, Novavax’s chief medical officer, stated that the FDA “satisfactorily addressed all clinical hold issues,” paving the way for the resumption of trial activities.
Phase III Trial Details
The upcoming Phase III trial (NCT06291857) will assess the immune response of the CIC vaccine, named NVX-CoV2373, against standard flu and COVID-19 vaccines. It will also investigate the effectiveness of Novavax’s investigational flu vaccine, tNIV, compared to the standard-of-care Fluzone High-Dose. The trial will involve approximately 8,000 participants and will be divided into two parts: the first focusing on immune response and side effects, and the second further monitoring safety outcomes. Preliminary results are expected by mid-2025.
Market Context and Competition
The CIC vaccine represents a significant opportunity for Novavax, which has faced challenges competing with established COVID-19 vaccine leaders such as Pfizer and Moderna. The company's COVID-19 vaccine experienced limited adoption after its US launch in July 2022, leading to cost-cutting measures, including a 30% workforce reduction and concerns about its operational future.
In response to these challenges, Novavax has undertaken financial restructuring, aiming to reduce combined R&D and SG&A spending below $500 million in 2025 and under $350 million by 2026. The company has also formed strategic partnerships, including a $1.2 billion licensing agreement with Sanofi to co-commercialize its standalone adjuvanted COVID-19 vaccine.
Competitive Landscape
Other companies, including Pfizer-BioNTech and Moderna, are also developing COVID-19 and influenza combination vaccines. Moderna's candidate, mRNA-1083, demonstrated statistically significantly higher immune responses than existing vaccines in a Phase III trial (NCT06097273). However, Pfizer and BioNTech's combo vaccine failed to meet one of its two primary endpoints in a Phase III trial (NCT06178991), showing insufficient efficacy against influenza B despite high responses for neutralizing influenza A titres.
