Moderna’s RSV vaccine mRNA-1345 was more than 80% effective in a Phase 3 study 

mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434).

The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a briefing note.

MRNA shares were up 5.70% in after-hours trading, hitting $201.55.

“Importantly, we think this is a milestone for MRNA’s pipeline beyond COVID in demonstrating the competitive efficacy of mRNA vaccines,” noted UBS Eliana Merle. “We think RSV could be a meaningful opportunity with no vaccine yet approved.

UBS sees an opportunity worth more than $5 billion in RSV.

The Moderna study, enrolling roughly 37,000 adults aged 60 or older in 22 countries, tested mRNA-1345 in older adults divided into two groups. One group had two or more symptoms of RSV…

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Moderna wins FDA fast track designation for RSV vaccine

COVID-19 vaccine pioneer Moderna (NSDQ:MRNA) is aiming to develop one of the first mRNA-based vaccines against respiratory syncytial virus (RSV).

Now, the FDA has granted fast track designation for mRNA-1345, an experimental single-dose mRNA RSV vaccine in adults 60 and older.

Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), GlaxoSmithKline (LON:GSK), Novavax (NSDQ:NVAX) and Bavarian Nordic (CPH:BAVA) are also developing RSV vaccines. None of those, however, use a mRNA platform.

RSV generally causes mild cold-like symptoms, according to the CDC, but can lead to serious illness in infants and the elderly. In infants, RSV frequently leads to pneumonia and another type of respiratory tract infection known as bronchiolitis.

Cambrdige, Mass.–Moderna hopes to ultimately win regulatory approval to use the mRNA-1345 vaccine to “protect the most vulnerable populations – young children and older adults,” said Stéphane Bancel, CEO of Moderna, in a statem…

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