The FDA grants an emergency use authorization for Moderna’s COVID vaccine

WASHINGTON – The U.S. added a second COVID-19 vaccine to its arsenal on Friday, boosting efforts to combat such a serious outbreak that the nation regularly records more than 3,000 deaths a day.

The much-needed doses are expected to arrive Monday after the Food and Drug Administration authorized the emergency deployment 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 that of Pfizer Inc. and the German BioNTech, which is now being distributed to millions of health workers and residents of nursing homes as it begins to increase the momentum for the largest vaccination in U.S. history.

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The two work “better than we almost dared expect,” said NIH director Dr. Francis Collins, in The Associated Press. “Science works here. Science has done something amazing.”

The first results of large, unfinished studies show that both vaccines appear safe and strongly protective, although Moderna’s is easier to handle, as it does not need to be stored at freezing temperatures.

A second vaccine represents a ray of hope amid despair, as the virus continues to spread non-stop even before the holiday meetings that are sure to fuel the outbreak.

The scourge has killed more than 312,000 people in the United States and killed 1.7 million people worldwide. New cases in the United States exceed 216,000 daily on average. Daily deaths have reached all-time highs, eclipsing 3,600 on Wednesday.

California has become one of the deadliest hotspots as hospitals run out of intensive care beds and ambulances are placed outside the emergency room in scenes reminiscent of the New York City disaster last spring. . California reported more than 41,000 new cases and 300 more deaths on Friday.

When New York hospitals were in crisis, health workers from across the country came to help them. This time, “there’s no cavalry,” because there are a lot of hospitals flooded, said Dr. Marc Futernick, an emergency physician in Los Angeles.

The nation is struggling to expand vaccines as quickly as Moderna and Pfizer can produce doses. Moderna is for people over 18, Pfizer starts at 16 years old.

It’s just the beginning of “what we hope will be a big boost to get this terrible virus, even though it will take many more months to reach all Americans,” Collins said.

Even if there are additional candidates in the pipeline, there will not be enough for the general population until spring and in the meantime the shots will be rationed. And while health workers enthusiastically accept vaccination, authorities are concerned that citizens may need more reassurance to ensure more people line up when it comes to.

SEE: What are the side effects of COVID-19 vaccines?

“Frankly, if we don’t get 80% of Americans immunized against COVID-19 by the middle of this year 2021, we run the risk that this epidemic may continue and continue,” Collins said.

He is particularly concerned that accurate information on the value of dams is reaching communities of color, which have been hard hit by COVID-19, but are also wary after years of health disparities and abuse in research.

To try to build trust, Vice President Mike Pence was fired from Pfizer-BioNTech on live television on Friday, along with surgeon general Jerome Adams.

The FDA decision could help pave the way for other countries that are considering the Modern Vaccine, the first regulatory clearance from the small business in Cambridge, Massachusetts. European regulators could authorize its use as soon as 6 January. Britain, Canada and a few other countries have already eliminated the Pfizer-BioNTech feature, with a European Union decision due to be delivered on Monday.

“What we always want to remember is that one size fits not all. We want to have options,” said Dr. Paul Duprex of the University of Pittsburgh.

According to Operation Warp Speed, the government’s vaccine development program, Moderna has about 5.9 million doses ready for shipment. Injections of health workers and nursing home residents continue next week before other essential workers and vulnerable groups are allowed to line up.

SEE: Dismantling rumors and myths about the COVID-19 vaccine

Both the features of Moderna and Pfizer-BioNTech are the so-called mRNA vaccines, made with a new innovative technology. They do not contain any coronavirus, that is, they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real one arrives.

Its development less than a year after the advent of the coronavirus set a speed record, but Collins stressed that this should not worry people. The speed was due to billions of investments from companies and governments paired with years of previous scientific research, and not to any corner.

“The rigor of the analysis of these vaccines is unprecedented,” Collins said. “We’re not done with that, but hope is on the way, and hope comes from that scientific confidence in the brain that has made it all out.”

Experts expect the two vaccines to “break the back of the pandemic” when combined with masks and other precautions, said Dr. Arnold Monto of the University of Michigan, who chaired an advisory committee that publicly debated the evidence. of traits before the FDA. decisions.

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright © 2020 by The Associated Press. All rights reserved.

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