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Moderna to seek full FDA approval for COVID vaccine

Jun 1, 2021, 7:24 AM | Updated: 7:58 am

Drug maker Moderna announced on Tuesday that it is seeking full FDA approval of its COVID-19 vaccine, following just a few weeks after Pfizer began the same process.

Moderna’s mRNA vaccine received an emergency use authorization from the FDA in December, which gave a conditional approval of the drug based on two months of safety data. 

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

 

This story will be updated

Moderna says its Covid-19 vaccine is safe and appears effective in kids as young as 12

CDC study finds Pfizer, Moderna vaccines are 90% effective after two doses in real-world conditions


How To Prevent the Spread of COVID-19 Coronavirus

COVID-19 coronaviruses transmitted from person to person. It is a virus that is similar to the common cold and the flu. So, to prevent it from spreading:

  • Wash hands frequently and thoroughly, with soap and water, for at least 20 seconds.
  • Wear a mask.
  • Don’t touch your face.
  • Keep children and those with compromised immune systems away from someone who is coughing or sneezing (in this instance, at least six feet)
  • If there is an outbreak near you, practice social distancing (stay at home, instead of going to the movies, sports events, or other activities.)
  • Obtain a flu shot.
  • Receive a COVID vaccine.

Local resources

KSL Coronavirus Q&A

Utah’s Coronavirus Information

Utah State Board of Education

Utah Hospital Association

The Church of Jesus Christ of Latter-day Saints

Utah Coronavirus Information Line – 1-800-456-7707

National Resources

Centers for Disease Control and Prevention

Commonly asked questions, World Health Organization

Cases in the United States

 

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