THE U.S. Food and Drug Administration (FDA) has lifted a clinical hold on a late-stage trial of a combined COVID-19 and influenza vaccine candidate, allowing the study to resume following an investigation into a reported adverse event. This decision supports manufacturer’s ambitions to offer a combined seasonal vaccine, which could simplify immunizations and improve vaccination rates for respiratory illnesses.
Novavax (Gaithersburg, Maryland) had paused the trial in October after a participant in a mid-stage study reported symptoms of motor neuropathy, initially suggesting a possible adverse reaction to the COVID-flu vaccine. However, after further assessment, the participant’s condition was reclassified as amyotrophic lateral sclerosis. Novavax provided additional details to the FDA, supporting its finding that the event was not vaccine-related. Following this submission, the FDA agreed that the trial could safely proceed.
“We remain committed to advancing this critical program and expect to resume late-stage trial activities as quickly as possible,” said Robert Walker, Novavax’s Chief Medical Officer. Novavax views the COVID-influenza combination vaccine as a key asset for its growth strategy, especially as its traditional protein-based COVID-19 vaccine, though offering an alternative to mRNA options from Pfizer-BioNTech and Moderna, has yet to gain substantial traction in the U.S. market.
Novavax has also expanded its COVID vaccine’s reach through a recent $1.2 billion licensing deal with Sanofi, providing liquidity crucial for continued innovation. With the resumed trial, Novavax hopes to progress toward regulatory approvals, potentially positioning itself as a leader in combination vaccines for respiratory illnesses.
Reference: Reuters. US FDA lifts clinical hold on Novavax’s combo COVID-flu shot. November 11, 2024. Available at: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-lifts-clinical-hold-novavaxs-combo-covid-flu-shot-2024-11-11/. Last accessed: November 12, 2024.
