Moderna Scores FDA Approval For Its Second Product - Respiratory Syncytial Virus Vaccine

On Friday, the FDA approved Moderna Inc’s MRNA mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection.

The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna, the first being the famed COVID-19 vaccine.

Earlier this month, the FDA, citing administrative constraints, delayed the review of the vaccine’s application.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, Chief Executive Officer of Moderna. He added that mRESVIA is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration.

Each year in the U.S., approximately 60,000-160,000 older adults are hospitalized, and 6,000-10,000 die due to RSV infection.

The FDA’s approval of mRESVIA is based on data from the Phase 3 clinical trial ConquerRSV. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7%.

During the FDA review, a follow-up analysis of the primary endpoint was performed, including cases that started before the primary analysis cut-off date but were not confirmed until afterward.

The results were consistent with the primary analysis [vaccine efficacy of 78.7%] and were included in the U.S. package insert.

An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up.

Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

The news comes as Moderna seeks to add more revenue avenues amid falling sales from its COVID-19 vaccine.

Moderna reaffirmed its 2024 sales expectations of around $4 billion versus the consensus of $4.21 billion from its respiratory franchise.

Price Action: MRNA shares are down 6.32% at $141.91 at last check Friday.

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