Pharmaceutical giant Moderna announced Friday it has won Food and Drug Administration approval for its vaccine to protect against respiratory syncytial virus, or RSV.

The second mRNA vaccine to be approved for a disease other than COVID-19, mRESVIA is intended for adults aged 60 or older who are at risk of disease in their lower respiratory tract if they are infected with RSV.

What You Need To Know

  • Moderna has received FDA approval for its vaccine to protect against respiratory synctial virus, or RSV

  • It is the second mRNA vaccine to be approved for a disease other than COVID-19

  • mRESVIA is intended for adults aged 60 or older who are a risk of disease in their lower respiratory tract if they are infected with RSV

  • A highly contagious seasonal virus, RSV kills about 14,000 adults aged 65 and older each year in the U.S. 

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stephane Bancel said in a statement. “It is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors.”

RSV is a seasonal virus that is highly contagious. Infecting the lungs and breathing passages, it can cause serious illness or death in vulnerable individuals, including infants, children with chronic lung disease and people over the age of 65, according to the National Institute of Allergy and Infectious Diseases.

RSV infection causes about 14,000 deaths annually in the U.S. in adults 65 and older, according to the NIAID. Globally, it affects 64 million people and causes 160,000 deaths each year.

FDA approval for mRESVIA was granted after a clinical trial of 37,000 adults aged 60 and older in 22 countries. Moderna said the vaccine was 83.7% effective after 3.7 months. The FDA found similar results in its own review of the drug, the company said.

"Older adults, especially those with underlying health issues like heart or lung disease or compromised immune systems, are highly susceptible to severe illness from RSV," an FDA spokesperson told Spectrum News. "Today’s approval of mRESVIA for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older provides another available vaccine for the prevention of this potentially life-threatening disease and underscores the FDA’s ongoing commitment toward helping advance the development of safe and effective vaccines for use in the U.S."

The most common side effects of mRESVIA are injection site pain, fatigue, headache, muscle aches and joint pain, according to a company statement.

Moderna expects the vaccine to be available this fall.