Novavax announced on November 11, 2024, that the FDA has removed the clinical hold on its Investigational New Drug (IND) application for COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The company can now proceed with enrolling participants in the planned Phase 3 trial after satisfactorily addressing all clinical hold issues.The clinical hold, initially imposed on October 16, 2024, was triggered by a serious adverse event in a Phase 2 trial participant who received the investigational CIC vaccine in 2023. After review, the event was reclassified as amyotrophic lateral sclerosis, a condition not known to be vaccine-related, and was assessed as unrelated to vaccination.The company plans to expedite the resumption of trial activities in collaboration with clinical investigators and partners. This development marks a significant step forward for Novavax's vaccine pipeline, which includes both the combination COVID-19-influenza vaccine and standalone influenza vaccine candidates.

Novavax announced on November 11, 2024, that the FDA has removed the clinical hold on its Investigational New Drug (IND) application for COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The company can now proceed with enrolling participants in the planned Phase 3 trial after satisfactorily addressing all clinical hold issues.The clinical hold, initially imposed on October 16, 2024, was triggered by a serious adverse event in a Phase 2 trial participant who received the investigational CIC vaccine in 2023. After review, the event was reclassified as amyotrophic lateral sclerosis, a condition not known to be vaccine-related, and was assessed as unrelated to vaccination.The company plans to expedite the resumption of trial activities in collaboration with clinical investigators and partners. This development marks a significant step forward for Novavax's vaccine pipeline, which includes both the combination COVID-19-influenza vaccine and standalone influenza vaccine candidates.