Moderna norovirus vaccine trial on maintain by US FDA over neurological facet impact
By Patrick Wingrove and Mariam Sunny
(Reuters) -Moderna mentioned on Friday that the U.S. FDA paused a late-stage trial of its experimental norovirus vaccine after a case of a uncommon neurological facet impact was reported.
The trial of the vaccine, dubbed mRNA-1403, was placed on medical maintain following a single hostile occasion report of a case of Guillain-Barre syndrome, which is at the moment underneath investigation, Moderna mentioned.
A Moderna government mentioned throughout a convention name that the case of Guillain-Barre was reported comparatively quickly after the vaccine’s administration, though it was tough to find out a causal relationship between the 2.
“The FDA wants time to assessment the supplies we submitted and so they might come again with questions,” an government mentioned.
The corporate mentioned enrollment for the norovirus vaccine trial had been accomplished within the Northern Hemisphere and that it doesn’t count on delays in Southern Hemisphere enrollment.
Moderna has been banking on income from newer mRNA photographs to make up for waning post-pandemic demand for COVID-19 vaccines and less-than-expected uptake of its respiratory syncytial virus vaccine, which despatched shares down practically 60% final yr.
Shares of Moderna, together with different vaccine makers, dropped additional this yr as lawmakers superior U.S. President Donald Trump’s decide for Well being and Human Companies Secretary Robert F. Kennedy by way of Congress. Kennedy, an outspoken vaccine critic, was confirmed to the position on Thursday.
Moderna’s complete income for the fourth quarter fell practically 66% to $966 million, however beat analysts’ expectations of $942.84 million. Most of these gross sales have been generated by the COVID shot, which introduced $923 million, in comparison with $15 million for its RSV vaccine.
Regardless of the medical maintain, Moderna shares have been up greater than 4% at $33.31 in afternoon buying and selling, far under its 52-week excessive of round $170 and pandemic all-time excessive of over $484.
The vaccine maker mentioned in January it could slash money prices by $1 billion, in addition to by a further $500 million in 2026.
“We noticed applicable reductions and… proof of Moderna starting to chop prices to have the ability to handle a decrease income line extra appropriately,” Bernstein analyst Courtney Breen mentioned.
The corporate reported a larger-than-expected quarterly lack of $2.91 per share, in comparison with analysts’ expectations of a $2.68 per share loss, in response to LSEG information. It posted a revenue of 55 cents per share final yr.
Finance chief James Mock in an interview attributed the loss to a $238 million non-cash cost associated to the termination of its settlement with a contract producer.
