Moderna applies for FDA authorization for its Covid-19 vaccine

Pharmaceutical company Moderna applied on Monday to the US Food and Drug Administration for authorization of its Covid-19 vaccine.The company asked th...

Posted: Nov 30, 2020 5:07 PM
Updated: Nov 30, 2020 8:30 PM

Pharmaceutical company Moderna applied on Monday to the US Food and Drug Administration for authorization of its Covid-19 vaccine.

The company asked the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.

'This is striking,' said Dr. Paul Offit, a member of the FDA's vaccine advisory committee. 'These are amazing data.'

Moderna's chief medical officer said he became emotional when he saw the data Saturday night.

'It was the first time I allowed myself to cry,' Dr. Tal Zaks said. 'We have a full expectation to change the course of this pandemic.'

Moderna is the second company to apply to the FDA for emergency use authorization for a coronavirus vaccine. Pfizer applied on November 20 with data showing similarly high efficacy.

The FDA will meet with its advisory committee in December to review Pfizer's and Moderna's applications.

The first vaccinations in the United States are expected to take place 'towards the latter part of December,' according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Moderna said it also planned to apply for authorization from the European Medicines Agency on Monday.

Moderna's new data

On Monday, Moderna released updated efficacy data for its Phase 3 clinical trial.

Starting in July, Moderna gave either its vaccine or a placebo -- a shot of saline that does nothing -- to some 30,000 people in the United States. With high rates of coronavirus throughout the country over the next following months, many of those study subjects developed Covid-19.

But there was a big difference between the group that got the vaccine and the group that got the placebo.

Among the approximately 15,000 people who received the vaccine, 11 developed Covid-19.

Among the approximately 15,000 people who received the placebo, 185 developed Covid-19.

That amounts to a 94.1% efficacy for Moderna's vaccine.

None of the 11 people who received the vaccine became severely ill, but 30 of the 185 who received the placebo became severely ill, and one of them died.

The vaccine had similar efficacy rates for elderly people and for people in racial minority groups, Zaks said.

In Pfizer's Phase 3 clinical trial, the vaccine proved to be 95% effective, and one study participant who received the vaccine developed a severe case of Covid-19.

While the two vaccines are not identical, both Pfizer and Moderna use messenger RNA to elicit an immune response in the human body. The vaccines are given in two doses a few weeks apart, and can cause side effects, such as a fever or body aches for a few days.

Next steps

The FDA is scheduled to meet with its Vaccines and Related Biological Products Advisory Committee on December 10 to review Pfizer's application and on December 17 to review Moderna's application.

Offit, who is a member of that panel, said it will be important to look and see why some people still got Covid-19 even after being vaccinated.

'Were they more likely to be older? Were they more likely to be African-American or obese or have underlying medical problems like diabetes?' said Offit, a vaccine expert at the University of Pennsylvania.

If the FDA grants the vaccine emergency use authorization -- and it's expected that it will -- within a day or two, an advisory committee to the US Centers for Disease Control and Prevention will make a recommendation about who should get the shots first. That group will likely include health care workers and nursing home residents.

After the CDC issues those recommendations, shots can go into arms.

Zaks said as the pandemic rages on, he looks forward to seeing the vaccines in action.

By the end of 2020, Moderna expects to have approximately 20 million doses of its vaccine available in the United States, and it's on track to manufacture 500 million to 1 billion doses globally next year, according to the company's press release Monday.

'The magnitude of this achievement and the implications of what it means to what's ahead of us in the context of what's going on around us is -- it's just overwhelming emotionally,' Zaks said.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 730969

Reported Deaths: 13434
CountyCasesDeaths
Marion1000031743
Lake53771970
Allen40668678
St. Joseph35733552
Hamilton35629408
Elkhart28577442
Tippecanoe22402219
Vanderburgh22310397
Porter18776308
Johnson17970379
Hendricks17244315
Clark12985191
Madison12673339
Vigo12449247
LaPorte11928211
Monroe11893170
Delaware10696186
Howard9924216
Kosciusko9410117
Hancock8284141
Bartholomew8070156
Warrick7784155
Floyd7669178
Grant7060174
Wayne7051199
Boone6700101
Morgan6576139
Dubois6156117
Marshall6050111
Dearborn581378
Cass5808105
Henry5720103
Noble561384
Jackson501773
Shelby491996
Lawrence4546120
Harrison435872
Gibson435492
DeKalb428485
Clinton427453
Montgomery424189
Whitley396139
Huntington391980
Steuben387857
Miami381866
Knox371990
Jasper366047
Putnam360760
Wabash354179
Adams341354
Ripley339770
Jefferson330981
White314354
Daviess297399
Wells291581
Decatur285492
Fayette280762
Greene278985
Posey271533
LaGrange266770
Scott266354
Clay260247
Randolph240781
Washington240732
Spencer232131
Jennings230149
Starke216654
Fountain212346
Sullivan211942
Owen200256
Fulton195440
Jay195130
Carroll189320
Orange183654
Perry183037
Rush173425
Vermillion169143
Franklin168135
Tipton162845
Parke146316
Blackford134932
Pike134334
Pulaski116845
Newton107834
Brown102141
Crawford99814
Benton98614
Martin89115
Warren82115
Switzerland7918
Union71010
Ohio56811
Unassigned0416

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1085733

Reported Deaths: 19441
CountyCasesDeaths
Franklin1261201400
Cuyahoga1124072120
Hamilton801491206
Montgomery515591014
Summit47292946
Lucas42275788
Butler38396584
Stark32412907
Lorain25046481
Warren24313300
Mahoning21629588
Lake20725369
Clermont19803238
Delaware18537133
Licking16436212
Fairfield16230200
Trumbull16082468
Medina15309264
Greene15099244
Clark14017299
Wood13113189
Portage12890203
Allen11675232
Richland11382199
Miami10686217
Wayne8843211
Columbiana8816229
Muskingum8815133
Pickaway8582121
Marion8539135
Tuscarawas8487244
Erie7917154
Hancock6929127
Ross6858155
Ashtabula6830170
Geauga6697148
Scioto6417101
Belmont5920167
Union571048
Lawrence5560102
Jefferson5544151
Huron5439119
Darke5364123
Sandusky5359121
Seneca5290121
Athens520058
Washington5160109
Auglaize491984
Mercer480885
Shelby470093
Knox4495110
Madison436661
Putnam4287100
Fulton423969
Ashland423189
Defiance421097
Crawford3978107
Brown395057
Logan382376
Preble379898
Clinton372963
Ottawa367479
Highland355662
Williams340275
Champaign333458
Guernsey316253
Jackson312652
Perry295350
Morrow285639
Fayette282250
Hardin271464
Henry269366
Coshocton265357
Holmes2611101
Van Wert243763
Adams238552
Pike237734
Gallia235949
Wyandot231555
Hocking215462
Carroll191647
Paulding173340
Meigs144940
Noble133337
Monroe132342
Harrison108537
Morgan108523
Vinton83515
Unassigned02
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