By Patrick Wingrove and Mariam Sunny
(Reuters) -Moderna said on Friday that the American FDA paused a late phase study of his experimental Norovirus vaccine after a case of a rare neurological side effect was reported.
The test with the vaccine, dubbed mrna-1403, was put on a clinical hold after a single side effects of a case of the Guillain-Barre syndrome, which is currently being investigated, Moderna said.
A moderna director said during a conference call that the Guillain-Barre case was reported relatively shortly after the vaccine administration, although it was difficult to determine a causal relationship between the two.
“The FDA needs time to assess the material we have submitted and they can come back with questions,” said a director.
The company said that the registration for the Norovirus vaccine process was completed in the northern hemisphere and that it does not expect delays in the registration of the southern hemisphere.
Moderna is based on income from newer MRNA recordings to purchase from the decreasing mail-beltemic demand for COVID-19 vaccines and less than expected to include his respiratory syncytial virus vaccine, which fell nearly 60% last year.
Shares of Moderna, together with other vaccine makers, fell further this year as the legislators promote the choice of US President Donald Trump for health and human services Secretary Robert F. Kennedy through the congress. Kennedy, a pronounced vaccincerus, was confirmed in the role on Thursday.
The total turnover of Moderna for the fourth quarter fell nearly 66% to $ 966 million, but defeated the expectations of analysts of $ 942.84 million. Most of those sales were generated by Covid’s shot, which yielded $ 923 million, compared to $ 15 million for his RSV vaccine.
Despite the clinical handle, the shares of Moderna were more than 4% at $ 33.31 in the afternoon trade, far below 52 weeks high of around $ 170 and Pandemie of all time of more than $ 484.
The vaccine maker said in January that it would lower cash costs by $ 1 billion, as well as with an extra $ 500 million in 2026.
“We saw appropriate reductions and … evidence that Modernna began to save the costs in order to better manage a lower income line,” said Bernstein analyst Courtney Breen.
The company reported a larger than expected loss of $ 2.91 per share, compared to the expectations of analysts of a loss of $ 2.68 per share, according to LSEG data. It booked a profit of 55 cents per share last year.
Financial Chief James Mock In an interview, the loss attributed to a non-continuous costs of $ 238 million with regard to the termination of the agreement with a contract manufacturer.
