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Update 2.55 PM EST: Adds latest stock reaction and concerns over efficacy
COVID-19 vaccine maker Moderna (NASDAQ:MRNA) announced Friday that the U.S. Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345), its messenger-based vaccine to protect older adults from respiratory syncytial virus (RSV).
Even as the Cambridge, Massachusetts-based biotech won regulatory nod to market its second FDA-approved product, its shares traded lower amid concerns over a potentially lower-than-expected efficacy indicated in mRESVIA’s label.
In July 2023, Moderna (MRNA) started an FDA process for real-time review of mRNA-1345 backed by late-stage data, which indicated a vaccine efficacy of 83.7% as defined by two or more RSV symptoms related to the lower respiratory tract.
However, its FDA approval on Friday indicated a vaccine efficacy of 78.7% based on the same criteria.
Moderna (MRNA) said mRESVIA will be indicated in the U.S. to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The company expects to launch mRESVIA in time for the 2024–2025 respiratory virus season.
With the approval, the company becomes the latest to join the U.S. RSV vaccine market, dominated by its rivals Pfizer (PFE) and GSK (GSK), which won regulatory nods for their vaccines, Abrysvo and Arexvy last year.
Meanwhile, Jefferies analyst Michael Yee noted investor concerns over the FDA’s labeling information for mRESVIA, which, in the final analysis, indicated a lower level of effectiveness compared to Arexvy, the current market leader in the RSV vaccine market.
However, Yee, who has a Buy rating and a $155 target on MRNA, pointed out that Moderna (MRNA) conducted its vaccine trial when RSV was highly prevalent.