The company's trivalent vaccine (mRNA-1403) was being studied in a phase 3 trial.
Image credit: FDA
In Moderna’s quarterly financial reporting released last Friday, the company disclosed their investigational norovirus trivalent vaccine (mRNA-1403) was placed on hold by the FDA after a case of Guillain-Barré syndrome was discovered. It is currently under investigation, and no further information was provided about the person’s condition.1
The 2-season phase 3 study Nova 301 trial was fully enrolled in the Northern Hemisphere. Moderna said it is preparing second season enrollment in the Southern Hemisphere.1
The company says it does not expect an impact on the study's efficacy readout timeline as enrollment in the Northern Hemisphere had already been completed. The timing of the phase 3 readout will be dependent on case accruals.1
Last fall, the company reported they began dosing of patients for the trial. The phase 3 trial is an ongoing randomized, observer-blind, placebo-controlled trial evaluating the efficacy, safety and immunogenicity of mRNA-1403. The trial was looking to include 25,000 participants 18 years of age and older globally, including in countries in the Northern Hemisphere (US, Canada, UK, Japan), the equatorial region, and the Southern Hemisphere (Australia and countries in South America).2
In order to try and prevent from contracting the virus, the Centers for Disease Control and Prevention (CDC) says people should do the following:
Additionally, the company was looking to enroll approximately 20,000 participants 60 years of age and older and 5,000 participants between 18 and 59 years of age to be enrolled to assess the investigational vaccine's ability to protect against moderate to severe norovirus acute gastroenteritis (AGE) in adults, with a focus on the older age group that is at greatest risk of severe outcomes including hospitalization.2
"By advancing our investigational norovirus vaccine into a pivotal phase 3 trial, we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus, which places a significant burden on health systems globally," Stéphane Bancel, CEO of Moderna said at that time. 2
Norovirus is highly contagious virus that causes vomiting and diarrhea. It can be referred to as the stomach flu or stomach bug. It causes acute gastroenteritis, an inflammation of the stomach or intestines. There is no treatment for the virus, and it typically lasts 1-2 days.3
