June 16, 2024

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The FDA just approved Moderna’s second-ever product.
Image: Dado Ruvic (Reuters)

The Food and Drug Administration on Friday approved Moderna’s mRNA-based respiratory syncytial virus (RSV) vaccine for people 60 and older. The approval paves the way for the pharma giant, known for its COVID-19 vaccine, to launch its second-ever product.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” \Moderna CEO Stéphane Bancel said in a statement.

It’s also the FDA’s first approval for an mRNA vaccine protecting against a disease other than COVID-19.

A phase 3 trial of mRESVIA involving about 37,000 adults aged 60 years or older found that it was almost 84% effective at protecting against RSV lower respiratory tract disease. About 60,000 to 160,000 older adults are hospitalized annually and about about 6,000 to 10,000 die in the U.S. from RSV, according to the Centers for Disease Control and Prevention.

Moderna has been steadily building its pipeline of new medications as its previously only product on the market has dropped in demand.

The company reported this month that its revenue in the first quarter of 2024 plummeted 91% year-over-year to $167 million, down from $1.9 billion in the same quarter last year.

Only 14% U.S. adults have received an updated COVID-19 vaccine, according to the CDC.

Moderna is forecasting that its respiratory franchise, which includes its COVID-19 vaccine and its RSV vaccine, will generate $4 billion in revenue this year.

The company is also developing a combined COVID and flu vaccine. Moderna has more than 40 products in development including a vaccine for the digestive system bug, norovirus.

Modern stock was down about 5% in Friday afternoon trading. But the stock is up 28% so far this year.

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