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Moderna wins FDA fast track designation for RSV vaccine

Several other companies are also developing vaccines for respiratory syncytial virus.

By Brian Buntz | August 3, 2021

ModernaCOVID-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.

Cambridge, 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 statement.

The company currently has a Phase 1 study underway, involving mRNA-1345 assessing its performance in younger adults, older adults and children.

The company currently has 11 vaccines for infectious diseases in human clinical trials.

The pandemic has increased Moderna’s capacity to develop drugs independently and sharpened its focus on infectious diseases.

Before it developed its mRNA-1273 COVID-19 vaccine, the company had relied on partners, including Merck, Alexion and AstraZeneca, to assist with drug development.

Moderna has won fast track designation for other investigational therapies including its COVID-19 vaccine, Zika vaccine candidate (mRNA-1893), methylmalonic acidemia (MMA) (mRNA-3704) and propionic acidemia (mRNA-3927) programs.


Filed Under: Infectious Disease
Tagged With: covid-19, FDA, Moderna, mRNA-1345, respiratory syncytial virus, RSV
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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