U.S. FDA authorizes Moderna's COVID-19 vaccine for emergency use

[rooster59]

U.S. FDA authorizes Moderna's COVID-19 vaccine for emergency use

By Michael Erman

 

FILE PHOTO: Moderna's logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration

 

(Reuters) - Moderna Inc's coronavirus vaccine on Friday became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration, welcome news to a nation with a staggering COVID-19 death toll of over 307,000 lives lost.

 

The FDA announced the authorization the day after the agency's panel of outside experts endorsed its use.

 

The decision marks the first regulatory authorization in the world for Moderna's vaccine and validation of its messenger RNA technology. It came less than a year after the first COVID-19 case was identified in the United States.

 

The biotech company has worked with the U.S. government to prepare for the distribution of 5.9 million shots as early as this weekend.

 

The FDA decision is based on results from a late-stage study of 30,000 volunteers that found the vaccine was nearly 95% effective at preventing illness from COVID-19 with no serious safety concerns.

 

The authorization follows an EUA granted for a similar vaccine from Pfizer Inc and German partner BioNTech SE that has been put into the arms of thousands of U.S. healthcare workers this week in a massive nationwide rollout.

 

"With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn, M.D, said in a statement.

 

Moderna's shot is expected to be used in harder-to-reach locations, such as rural hospitals. The vaccine needs to be stored and shipped frozen, but does not require the ultra-cold temperatures of the Pfizer/BioNTech shot.

 

Once thawed, the Moderna vaccine can be kept at typical refrigerator temperatures. It is administered in two shots 28 days apart.

 

Moderna has deals with the U.S. government to provide 20 million doses this year and a total of 200 million doses by the end of June 2021.

 

(Reporting by Reporting by Kanishka Singh and Manojna Maddipatla in Bengaluru, Michael Erman and Rebecca Spalding in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer, Bill Berkrot and David Gregorio)

 

-- © Copyright Reuters 2020-12-19

 

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[Stargeezr]

Good Luck USA, Meanwhile,  try to wear your masks, and arrest the anti maskers

and especially the anti vaxxers.   This Covid virus is a Killer/.....  need I say more.

  The vaccine is not going to be all you need to do to get the virus under control.

Geezer

[Tug]

I wish we could arrest the anti maskers unfortunately we can’t,the wife and I did the monthly stocking up today Costco and 2 big Asian markets I’m pleased to say I saw 100% compliance with the masks and 90%+ with the separation protocols better but it should have been this way 8 months ago 

[Tropicalevo]

I keep misreading the name of the company as Madonna. It takes me a while to 're-set'. (I speed read - not always accurate.)

Yes - good luck USA. You deserve some by now.