BusinessFebruary 11, 2026

Why the FDA Paused Review of Moderna's mRNA Flu Shot

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② Start Lesson

Key Vocabulary

vaccine/ˈvæk.siːn/

A medicine that protects people from a disease.

"The flu vaccine helps protect many people."

refusal-to-file/rɪˈfjuː.zəl tə faɪl/

An official letter saying a government agency will not start a review.

"The company received a refusal-to-file letter from the agency."

approval/əˈpruː.vəl/

Official permission to sell or use a new product.

"Moderna has filed for approval in other countries."

Listening

Why the FDA Paused Review of Moderna's mRNA Flu Shot

The U.S. Food and Drug Administration refused to start a review of Moderna's new flu vaccine, called mRNA-1010. The agency sent a 'refusal-to-file' letter because the company used a standard-dose flu shot as the comparison in a main study. The FDA did not list safety or efficacy problems.

Moderna asked for a meeting with the agency. The company said it has also filed for approval in Europe, Canada and Australia. The U.S. health department has cut about $500 million from mRNA vaccine programs under Health Secretary Robert F. Kennedy Jr., and this move has changed the environment for new vaccines.

100 words

Quiz

1. What did the FDA send to Moderna?

2. What is the vaccine called?

3. Where has Moderna also filed for approval?

Reading Practice

Read the article from the Listening section aloud. Your AI teacher will give you pronunciation feedback.

Discussion

Do you get a flu vaccine each year? Why or why not?

Have you ever changed a health decision after new news? What happened?

What do you think when a company asks for a meeting with a regulator?