Moderna seeks regulatory approval of RSV vaccine for people 60 and older

July 5 (UPI) -- Moderna has submitted its RSV vaccine for people 60 and older regulatory approval in the United States and elsewhere in the world, the company said.

"We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the U.S.," Moderna CEO Stéphane Bancel said in a statement.

"RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions,"

Moderna said the regulatory applications come after positive data from a study of approximately 37,000 adults 60 or older in 22 countries. Its vaccine to protect from respiratory syncytial virus was found in these trials to be 83.7% effective as defined by two or more symptoms.

According to the company, the vaccine was well-tolerated, with a favorable safety profile.

"Most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia and arthralgia," Moderna's statement said.

The U.S. CDC recommended Pfizer and GSK RSV vaccines for adults 60 and older in June. Those vaccines will be available starting this fall.

Moderna said its mRNA-1345 is "an investigational RSV vaccine that consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles as in the Moderna COVID-19 vaccines."

The company has more vaccines in the pipeline, including Phase 3 trials to protect against the flu and a next-generation COVID-19 vaccine candidate.