FDA Pauses Trial For Moderna mRNA Vaccine

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The Food and Drug Administration (FDA) paused Moderna’s trial for its norovirus vaccine due to a reported case of Guillain-Barré syndrome.

In its fourth-quarter earnings release, the biotechnology company said the “trial is currently on FDA clinical hold following a single adverse event report of a case of Guillain-Barré syndrome, which is currently under investigation.”

“The Company does not expect an impact on the study’s efficacy readout timeline as enrollment in the Northern Hemisphere has already been completed. The timing of the Phase 3 readout will be dependent on case accruals,” Moderna added.

Per Reuters:

The trial of the vaccine, dubbed mRNA-1403, was put on clinical hold following a single adverse event report of a case of Guillain-Barre syndrome, which is currently under investigation, Moderna said.

A Moderna executive said during a conference call that the case of Guillain-Barre was reported relatively soon after the vaccine’s administration, although it was difficult to determine a causal relationship between the two.

“The FDA needs time to review the materials we submitted and they may come back with questions,” an executive said.

The company said enrollment for the norovirus vaccine trial had been completed in the Northern Hemisphere and that it does not expect delays in Southern Hemisphere enrollment.

Moderna has been banking on revenue from newer mRNA shots to make up for waning post-pandemic demand for COVID-19 vaccines and less-than-expected uptake of its respiratory syncytial virus vaccine, which sent shares down nearly 60% last year.

Fierce Biotech reports:

Moderna’s president, Stephen Hoge, M.D., expanded on the news, pointing out in a call with investors this morning that “GBS does happen.”

“It’s usually seen in older adults—about one to two per 100,000 people per year—and given we’ve enrolled a little over 250,000 patients in studies over the last couple of years, it wouldn’t be surprising to see cases in our clinical trials,” Hoge explained.

“As relates to this case, when we identified it, we proactively decided to pause our activities and update our study documents,” Hoge said, adding that “we really don’t expect there to be any impact on the conduct of the study or the timeline for readout on efficacy.”

“From our side, this is just about being prudent and transparent and making sure that we’re prioritizing patient safety,” he stressed.

Designed to protect against multiple norovirus genotypes, Moderna’s mRNA-1403 is a trivalent formulation that contains mRNA encoded for virus-like particles.



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