02:35 PM EDT, 05/31/2024 (MT Newswires) -- Moderna ( MRNA ) said Friday the US Food and Drug Administration approved its respiratory syncytial virus vaccine, or RSV, for people aged 60 years and above.

The drug, called mRESVIA, will help protect people from lower respiratory tract disease caused by RSV infection. The drugmaker said May 10 that the FDA pushed back its pending review of mRESVIA to the end of the month due to "administrative constraints." The agency has granted the approval under a breakthrough therapy designation, Moderna ( MRNA ) said Friday.

This is the first time a messenger ribonucleic acid vaccine has been approved for a disease other than COVID-19, Chief Executive Stephane Bancel said. MRESVIA is the only RSV vaccine available in a pre-filled syringe, Bancel added.

The company said the approval is based on positive data from a phase 3 clinical trial covering about 37,000 adults. Results showed a roughly 84% efficacy against RSV lower respiratory tract disease. An additional longer-term analysis demonstrated continued protection against the disease over 8.6 months median follow-up, according to a statement.

Moderna ( MRNA ) said no serious safety concerns were identified in the study, while injection site pain and fatigue were among the most commonly reported solicited adverse reactions.

The company said it expects the drug to be available for eligible populations in the US by the 2024/2025 respiratory virus season.

Moderna ( MRNA ) shares were down 6.8% in Friday late-afternoon trade. The FDA didn't respond to MT Newswires' request for comment.

Earlier this month, the company reported that its first-quarter revenue plunged to $167 million from $1.86 billion a year earlier. Product sales tanked 91% primarily driven by lower sales volume of its Spikevax COVID-19 vaccine outside the US, Chief Financial Officer James Mock said at the time during a conference call, according to a Capital IQ transcript.

Price: 142.03, Change: -9.46, Percent Change: -6.24