FDA Issues Emergency Use Authorization For Moderna COVID-19 Vaccine
WASHINGTON (AP/KDKA) — The U.S. added a second COVID-19 vaccine to its arsenal Friday, boosting efforts to beat back an outbreak so dire that the nation is regularly recording more than 3,000 deaths a day.
Much-needed doses are set to arrive Monday after the Food and Drug Administration authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.
The move marks the world's first authorization for Moderna's shots. The vaccine is very similar to one from Pfizer Inc. and Germany's BioNTech that's now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up.
The two work "better than we almost dared to hope," NIH Director Dr. Francis Collins told The Associated Press. "Science is working here, science has done something amazing."
Early results of large, still unfinished studies show both vaccines appear safe and strongly protective although Moderna's is easier to handle since it doesn't need to be stored at ultra-frozen temperatures.
Allegheny County Executive Rich Fitzgerald participated in the Moderna trial.
"Having known that it looks like the most successful one of the highest percentage of positive ethical efficacy -- sure, I'm happy that that's the one I'm in," he said.
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While the county executive says there was no reaction from the first shot, that was not the case for dose two.
"I had about a 12-hour slight fever. I probably would not have known about the fever had I not been taking my temperature to log in to their study. I had a little bit of ache, and a little bit of fatigue. It lasted about 12 hours, and that was it," he said.
A second vaccine represents a ray of hope amid despair as the virus continues to spread unabated even before holiday gatherings that are certain to further fuel the outbreak.
"We're on a roll here. Another remarkable vaccine with awesome efficacy," says Kelly Stefano, Director of Microbiology at the Allegheny Health Network, adding "to end a pandemic like this, we are really going to need the best of anything we can get right now."
The scourge has claimed more than 312,000 U.S. lives and killed 1.7 million people worldwide. New cases in the U.S. are running at over 216,000 per day on average. Deaths per day have hit all-time highs, eclipsing 3,600 on Wednesday.
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