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Moderna's flu shot faces setback, shares fall

Moderna shares are down Tuesday on news that the biotech's potential flu vaccine will need further review to determine its efficacy against influenza.

Shares of Moderna fell almost 5% as U.S. trading opened Tuesday after the drugmaker disclosed that its potential flu vaccine didn't meet criteria to be declared successful in a late-stage clinical trial. 

Moderna said there weren't enough flu cases to determine efficiency during the interim data collection period.

As a result, an independent Data and Safety Monitoring Board (DSMB) determined that its first influenza candidate, mRNA-1010, "did not meet the statistical threshold necessary to declare early success" in the clinical trial being conducted in the Northern Hemisphere, Moderna continued. 

The company's first influenza candidate, which is being developed in adults, is currently being evaluated in two Phase 3 trials.

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The independent group of scientific experts recommended that the trial continue in order to gather more data to determine the efficacy of the vaccine. 

Moderna currently has five vaccine candidates in clinical development to combat influenza, which kills between 290,000 and 650,000 people worldwide every year, the company said.

The biotech is also working to develop a respiratory syncytial virus (RSV) and a next-generation COVID-19 vaccine candidate as it aims to gain more market share.

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"Respiratory infections are a top cause of death globally and are particularly harmful to the young, immunocompromised, and older adults who experience more severe illness, greater incidence of hospitalization, and greater mortality than younger adults," Moderna said. 

More than 270 million doses of Moderna’s original COVID-19 vaccine and booster shots have already been administered in the U.S., according to the U.S. Centers for Disease Control and Prevention, making it the second most popular coronavirus vaccine, trailing the shot made by Pfizer. 

However, demand for such vaccines have slipped and the company fourth-quarter profit tumbled 70%.

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The Associated Press contributed to this report. 

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