Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine
Summary
Europe has approved Moderna’s combination vaccine that protects against both flu and COVID-19, making it the first such vaccine authorized worldwide. The vaccine is not yet available in the United States, where its approval process faces delays linked to changes in government health policy.Key Facts
- The European Commission approved Moderna’s mRNA-1083 (mCOMBRIAX) vaccine to protect against flu and COVID-19.
- This is the first combined vaccine authorized for these two respiratory viruses anywhere in the world.
- The authorization was based on positive results from a large clinical trial showing stronger immune responses and no significant safety issues.
- mCOMBRIAX combines Moderna’s COVID-19 vaccine with an experimental flu vaccine called mRNA-1010, which is still under review.
- The vaccine will be available in the 27 EU countries plus Iceland, Liechtenstein, and Norway, potentially for the upcoming flu season.
- In the U.S., the vaccine’s approval has been delayed since President Trump’s second term began in 2025, influenced by Health Secretary Robert F. Kennedy Jr.’s anti-vaccine stance.
- Moderna withdrew its FDA application in May 2025 to gather more data and has not resubmitted it yet.
- The FDA briefly refused to review Moderna’s flu vaccine application earlier this year but reversed the decision; a final decision is expected by August 5.
Read the Full Article
This is a fact-based summary from The Actual News. Click below to read the complete story directly from the original source.