Threat LensBiologicalStop testing for adverse effects of the COVID-19-influenza vaccine Novavax

Stop testing for adverse effects of the COVID-19-influenza vaccine Novavax

Type of event:
Public Health

Victims

Wounded

1

Date

October 18, 2024

What happened

In a statement released by the pharmaceutical company Novavax, the US Food and Drug Administration (FDA) announced its decision to impose a clinical suspension on the company’s applications for its combined COVID-19-influenza and single influenza vaccine candidate. The regulatory body’s decision was prompted by the emergence of a spontaneous report of a severe adverse event, namely motor neuropathy, in an individual participant involved in the phase 2 trial of the combined vaccine. The pharmaceutical company is engaging in close collaboration with the FDA to facilitate the provision of requisite information, to resolve the current clinical suspension promptly, and to initiate the phase 3 trial, as stated by Robert Walker, the company’s Chief Medical Officer.

Where it happened

Main sources