Tuesday, December 1, 2020

Moderna applies for EUA for its Covid-19 vaccine

Moderna applies for EUA for its Covid-19 vaccine

 

Pharmaceutical company Moderna on Monday applied to the FDA for authorization of its Covid-19 vaccine.


The company asked the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.

 

"This is striking," said Dr. Paul Offit, a member of the FDA's vaccine advisory committee. "These are amazing data."

 

Moderna's chief medical officer said he became emotional when he saw the data Saturday night.


"It was the first time I allowed myself to cry," Dr. Tal Zaks said. "We have a full expectation to change the course of this pandemic."

 

Moderna is the second company to apply to the FDA for emergency use authorization for a coronavirus vaccine. Pfizer applied on November 20 with data showing similarly high efficacy.

 

Pfizer's and Moderna's vaccines use very similar technology, while AstraZeneca uses a different approach. They are among six vaccines getting some kind of federal government support in the United States, and dozens of others are in development around the world.

 

The FDA will meet with its advisory committee in December to review Pfizer's and Moderna's applications.


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