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: 1011197

Reported Deaths: 16524
CountyCasesDeaths
Marion1359292129
Lake666181167
Allen58254802
Hamilton46498467
St. Joseph44559617
Elkhart36044510
Vanderburgh32333481
Tippecanoe28037260
Johnson25196446
Hendricks23960360
Porter22985367
Madison18820410
Clark18609253
Vigo17530303
Monroe15319200
LaPorte15230252
Delaware15127264
Howard14801290
Kosciusko12410149
Hancock11773176
Bartholomew11695180
Warrick11305189
Floyd11138215
Wayne11023253
Grant10131220
Morgan9506177
Boone8965116
Dubois8281131
Henry8252153
Dearborn823493
Noble8064106
Marshall7981135
Cass7556123
Lawrence7479172
Shelby7216119
Jackson700990
Gibson6614115
Harrison651892
Huntington6447100
Knox6427106
DeKalb6363100
Montgomery6293112
Miami595298
Putnam584179
Clinton579271
Whitley568455
Steuben566876
Wabash5363104
Jasper536180
Jefferson513297
Ripley501987
Adams483777
Daviess4684115
Scott439875
Greene427296
Clay426960
Wells426088
White420964
Decatur4177104
Fayette407387
Jennings390262
Posey377544
LaGrange361778
Washington360451
Randolph3476100
Spencer340743
Fountain336160
Sullivan330852
Starke319171
Owen315571
Fulton313468
Orange295064
Jay285546
Franklin266443
Perry265752
Rush263832
Carroll262434
Vermillion259854
Parke232029
Pike229643
Tipton229059
Blackford195042
Pulaski184657
Crawford160125
Newton159848
Benton151217
Brown147047
Martin139319
Switzerland135311
Warren121416
Union107216
Ohio84613
Unassigned0544

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1524169

Reported Deaths: 23955
CountyCasesDeaths
Franklin1646591696
Cuyahoga1468932459
Hamilton1056051431
Montgomery742551279
Summit620221111
Lucas56539917
Butler51696718
Stark468601064
Lorain35783585
Warren32903377
Mahoning30927693
Clermont28271330
Lake27179448
Delaware24263164
Licking24027294
Trumbull22993561
Fairfield22438247
Greene22414326
Medina22149313
Clark19920354
Richland18643292
Portage18073252
Wood17505224
Allen16054279
Miami15627306
Muskingum14890185
Columbiana14153274
Wayne13852271
Tuscarawas12777311
Marion12016180
Scioto11497162
Pickaway11386142
Erie10951184
Ross10614203
Ashtabula9809204
Lawrence9783153
Hancock9741155
Belmont9333209
Geauga9008157
Jefferson8600199
Huron8427143
Union822259
Washington8114144
Sandusky7875151
Athens779579
Knox7766144
Darke7695158
Seneca7405145
Ashland6993130
Auglaize681799
Shelby6540115
Brown640091
Crawford6292130
Defiance6241105
Mercer617893
Fulton605196
Highland602899
Guernsey596371
Madison595678
Logan594596
Clinton585193
Preble5730125
Putnam5354110
Williams530888
Perry519863
Champaign514273
Jackson512473
Ottawa490586
Coshocton488383
Morrow460558
Pike435067
Fayette430363
Hardin420780
Gallia419367
Adams417995
Van Wert374082
Henry366972
Holmes3653125
Hocking357582
Wyandot325262
Carroll304365
Paulding280747
Meigs267251
Monroe216254
Noble201247
Morgan194333
Harrison182646
Vinton167225
Unassigned05
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