Moderna Gets European Approval for RSV Vaccine
By Don Nico Forbes
Moderna said its mResvia vaccine received marketing authorization from the European Commission, following U.S. approval earlier this year.
The pharmaceutical and biotechnology company said on Friday that approval in the European Union for the vaccine--which is designed to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection--follows a positive opinion from the European Medicines Agency.
RSV, or respiratory syncytial virus, is a highly-contagious seasonal virus and a leading cause of lower respiratory tract infections and pneumonia.
The authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway, the company said.
The U.S. Food and Drug Administration approved mResvia in May. On Thursday, the U.S. FDA green lit the rollout of new Covid-19 vaccines from Moderna and Pfizer.
"This approval marks the first time an mRNA vaccine has been approved for a disease beyond Covid-19 in Europe," said Chief Executive Stephane Bancel.
Write to Don Nico Forbes at don.forbes@wsj.com
(END) Dow Jones Newswires
August 23, 2024 07:41 ET (11:41 GMT)
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