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 morning, we announced that we have initiated the rolling submission process for a Biologics License Application (BLA) with the U.S. FDA for our #mRNA COVID-19 vaccine. Read more: https://t.co/IQJaE8ONTp pic.twitter.com/B9gQnV7sfo
— Moderna (@moderna_tx) June 1, 2021
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
Utah’s Coronavirus Information
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
