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: 764448

Reported Deaths: 13965
CountyCasesDeaths
Marion1049701803
Lake567981029
Allen42685698
St. Joseph37253568
Hamilton37131426
Elkhart29699470
Tippecanoe23347230
Vanderburgh23106404
Porter19538327
Johnson18755391
Hendricks18012321
Madison13463345
Clark13450198
Vigo12789255
LaPorte12533224
Monroe12494178
Delaware11100198
Howard10612237
Kosciusko9736123
Hancock8707149
Bartholomew8235157
Warrick8031157
Floyd7975181
Grant7337181
Wayne7222201
Boone7145105
Morgan6886142
Marshall6323116
Dubois6267118
Cass6083111
Dearborn598578
Noble595790
Henry5939111
Jackson514677
Shelby509097
Lawrence4901127
Gibson460696
Montgomery454492
Clinton453555
DeKalb451585
Harrison450576
Whitley414745
Huntington411781
Steuben409560
Miami404073
Jasper399455
Knox387091
Putnam383762
Wabash367383
Adams351656
Ripley350471
Jefferson340486
White338954
Daviess3084100
Wells302281
Greene292285
Decatur291493
Fayette285864
Posey280435
Scott278058
LaGrange276972
Clay273048
Washington252437
Randolph247083
Jennings238149
Spencer237531
Fountain233750
Starke229859
Owen221059
Sullivan219043
Fulton207645
Jay202832
Carroll196522
Orange190556
Perry189139
Vermillion179644
Rush177027
Franklin171635
Tipton171547
Parke153616
Pike141234
Blackford137832
Pulaski122948
Newton122436
Benton109215
Brown105743
Crawford105116
Martin92515
Warren87615
Switzerland8308
Union73510
Ohio58211
Unassigned0428

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1122104

Reported Deaths: 20467
CountyCasesDeaths
Franklin1302141493
Cuyahoga1171052259
Hamilton823021259
Montgomery534221059
Summit488431014
Lucas43716832
Butler39925614
Stark33777937
Lorain25975509
Warren24887312
Mahoning22677612
Lake21448396
Clermont20360260
Delaware19105138
Licking16838227
Trumbull16770491
Fairfield16750207
Medina15818276
Greene15497254
Clark14336308
Portage13410218
Wood13332201
Allen12037245
Richland11722213
Miami10993228
Wayne9249227
Columbiana9195236
Muskingum9118137
Pickaway8735123
Tuscarawas8710254
Marion8697140
Erie8116166
Ashtabula7270179
Hancock7043134
Ross7011165
Geauga6946153
Scioto6665108
Belmont6207179
Lawrence5912104
Union590449
Jefferson5722162
Huron5624122
Sandusky5473130
Darke5436130
Seneca5376128
Washington5360111
Athens526360
Auglaize506987
Mercer490585
Shelby480997
Knox4609112
Madison447266
Ashland442698
Defiance438499
Fulton435675
Putnam4351104
Crawford4108111
Brown409462
Preble3944107
Logan391679
Clinton388666
Ottawa375381
Highland364968
Williams356178
Champaign348060
Guernsey329754
Jackson321154
Perry298350
Morrow294543
Fayette288150
Hardin279065
Henry276967
Coshocton272561
Holmes2725102
Van Wert251765
Adams249158
Gallia248950
Pike244537
Wyandot235257
Hocking222263
Carroll200649
Paulding179342
Meigs151040
Noble137739
Monroe137445
Harrison115138
Morgan111624
Vinton87217
Unassigned03
Fort Wayne
Clear
72° wxIcon
Hi: 89° Lo: 64°
Feels Like: 72°
Angola
Clear
70° wxIcon
Hi: 87° Lo: 62°
Feels Like: 70°
Huntington
Clear
69° wxIcon
Hi: 87° Lo: 62°
Feels Like: 69°
Decatur
Clear
72° wxIcon
Hi: 88° Lo: 64°
Feels Like: 72°
Van Wert
Clear
75° wxIcon
Hi: 87° Lo: 65°
Feels Like: 75°
The summer heat sticks around as we start the work week. Make sure to stay hydrated. Stay inside in the air conditioning or in the shade as much as possible to stay cool.
WFFT Radar
WFFT Temperatures
WFFT National

Community Events