New York State In-depth

According to Moderna, the RSV vaccine is effective in older adults

(The Hill) – Moderna’s respiratory syncytial virus (RSV) vaccine was 83 percent effective in preventing lower respiratory tract disease in adults age 60 and older in a large clinical study, the company announced Tuesday.

Based on the results, Moderna said it intends to submit the vaccine for Food and Drug Administration (FDA) approval in the first half of 2023. The announcement puts Moderna in a crowded market for RSV vaccines for older adults, including giants GlaxoSmithKline and Pfizer.

Both companies have applied for FDA approval of their respective RSV vaccines and expect decisions in May.

According to Moderna, the vaccine was 83.7 percent effective in preventing two key symptoms, such as a fever, cough or difficulty breathing. The vaccine was 82.4 percent effective in preventing severe RSV cases with three or more symptoms present, the company said.

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There is no vaccination against RSV for either adults or children. In healthy adults and older children, RSV typically causes mild, cold-like symptoms that resolve with moderate rest and self-care. But it can lead to serious illnesses in infants and older adults.

RSV infections kill between 6,000 and 10,000 adults over the age of 65 each year and result in 60,000 to 120,000 hospitalizations, according to the Centers for Disease Control and Prevention. RSV kills between 100 and 300 children in the US each year.

Like the flu, the RSV season usually takes place in colder weather, although this year it hit unusually hard and early, contributing to a spate of respiratory infections that resulted in overwhelmed hospitals nationwide.

Moderna’s RSV vaccine uses the same messenger RNA technology as the company’s COVID-19 vaccines. The company said its vaccine will also be tested in pediatric populations in an ongoing early-stage study.

“Today’s results represent an important step forward in the prevention of RSV-related lower respiratory tract disease in adults 60 years and older. These data are encouraging and follow the second demonstration of positive Phase 3 study results of our infectious disease mRNA vaccine platform Spikevax, our COVID-19 vaccine,” Moderna CEO Stéphane Bancel said in a statement.

The company said it would publish the full dataset in a peer-reviewed journal and present it at an upcoming infectious disease conference.

Moderna said its phase 3 trial involved about 37,000 people ages 60 and older in 22 countries, including the United States. About half received a single dose of the RSV vaccine and the other half received a placebo.

The vaccine was well tolerated with no safety concerns. Most side effects were mild or moderate and the most commonly reported were injection site pain, fatigue, headache, muscle pain and joint stiffness.

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