Moderna Doses First Participants In Ebola Vaccine Trial Ahead Of Key FDA Decision On Flu Shot

Moderna began a Phase 1 clinical trial of its experimental vaccine mRNA-1469 targeting the Bundibugyo strain of Ebola virus.

• The trial is expected to include about 80 adults and will be conducted across three sites in Canada.
• The program is supported by the Coalition for Epidemic Preparedness Innovations, which has committed up to $50 million to fund early development and manufacturing.
• The U.S. Food and Drug Administration is expected to announce its decision on mRNA-1010, Moderna’s investigational seasonal influenza vaccine for adults aged 50 and older.

Moderna (MRNA) on Tuesday announced that it has kicked off a Phase 1 clinical trial of its experimental vaccine targeting the Bundibugyo strain of Ebola virus, ahead of a closely watched regulatory decision on its influenza vaccine expected this week.

MRNA shares were up 4.4% at the time of writing.

Trial To Evaluate Impact Of Vaccine On 80 Adults

Following approval from Health Canada, the first participants have been enrolled and dosed with mRNA-1469. Overall, the trial is expected to include about 80 adults and will be conducted across three sites in Canada. The trial will evaluate the vaccine’s safety, tolerability and ability to generate an immune response.

The vaccine is being developed using Moderna’s mRNA technology, the same platform behind its COVID-19 vaccines.

The program is supported by the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to $50 million to fund early development and manufacturing. The funding is intended to speed the transition into larger Phase 2 and Phase 3 studies if the initial results are positive.

Why It Matters

The Bundibugyo virus is one of several strains that cause Ebola, but unlike the more common Zaire strain, there is currently no approved vaccine. The virus is behind the ongoing Ebola outbreak in the Democratic Republic of the Congo, where more than 1,700 people have died, according to a report by Al Jazeera on Monday.

“This fast-growing epidemic is already the second-largest Ebola outbreak in history, and cases are rising more quickly than they did in the 2014 - 2016 West Africa epidemic, which remains the largest on record,” said Richard Hatchett, CEPI’s CEO.

FDA Decision On Flu Vaccine Expected This Week

While the Ebola program expands Moderna’s infectious disease pipeline, investor attention remains on the U.S. Food and Drug Administration’s (FDA) decision on mRNA-1010, the company’s investigational seasonal influenza vaccine for adults aged 50 and older.

Moderna is seeking full approval for its flu vaccine in adults aged 50 to 64 and accelerated approval for those aged 65 and older.

A Prescription Drug User Fee Act (PDUFA) target action date has been set for August 5. It is the FDA’s target date for making a decision on a drug application, which allows the drug to be marketed in the U.S.

In June, an independent advisory committee voted unanimously that the vaccine’s benefits outweigh its risks.

Retail’s Take On MRNA Stock

Retail sentiment surrounding MRNA on Stocktwits remained in the ‘neutral’ territory over the past 24 hours.

One user turned cautious over the stock’s movement.

View this Stocktwits post

MRNA shares have seen significant buying interest so far this year, surging nearly 86%.

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