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What does emergency use for a COVID-19 vaccine mean?

Full approval of a vaccine will likely take several more months, and the vaccine makers are not expected to complete that step until spring or summer. Full approval would allow for vaccination of the general population.

Posted: Nov 20, 2020 9:27 AM

What does emergency use of a COVID-19 vaccine mean?

It's when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing.

Before any vaccine is permitted in the U.S., it must be reviewed by the Food and Drug Administration, which requires study in thousands of people. Normally, the process to approve a new vaccine can take about a decade. But the federal government is using various methods to dramatically speed up the process for COVID-19 vaccines.

During a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines and other medical products. The first vaccines to get the provisional green light in the U.S. are almost certain to be made available under this process, known as emergency use authorization.

Instead of the usual requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market as long as their benefits are likely to outweigh their risks. It has already used its emergency powers to authorize hundreds of coronavirus tests and a handful of treatments during the pandemic.

But the agency has almost no experience granting emergency use for vaccines and has laid out extra standards it will use to make decisions on upcoming COVID-19 shots.

In October, FDA officials told vaccine makers they should have two months of safety follow-up from half of the people enrolled in their studies before requesting emergency authorization. That data is expected to be enough for FDA to allow vaccinations of certain high-risk groups, such as front-line health workers and nursing home residents.

Full approval of a vaccine will likely require six months of safety follow-up as well as extensive inspections of company manufacturing sites. The leading vaccine makers are not expected to complete that process until next spring or summer. Only then is the FDA expected to grant full approval, which would allow vaccinations of the general population.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 333626

Reported Deaths: 3843
CountyCasesDeaths
Hennepin700691145
Ramsey29459521
Dakota23564198
Anoka23541236
Washington14864125
Stearns14564125
St. Louis9549121
Scott896460
Wright847548
Olmsted714637
Sherburne618746
Clay529960
Carver509715
Kandiyohi440828
Rice432338
Blue Earth431217
Crow Wing383339
Otter Tail338925
Chisago334516
Benton322753
Nobles316032
Winona297832
Douglas283040
Mower274823
Polk271527
Morrison246731
McLeod233721
Lyon232812
Beltrami230718
Goodhue222932
Becker221521
Steele21038
Itasca206324
Isanti203917
Carlton201417
Todd190314
Nicollet172126
Mille Lacs164632
Freeborn16227
Le Sueur157012
Brown156115
Cass153511
Pine14498
Meeker144812
Waseca143411
Roseau13035
Martin124721
Hubbard119729
Wabasha11301
Redwood104620
Chippewa9808
Renville95530
Cottonwood9454
Dodge9311
Watonwan8944
Wadena8637
Sibley8404
Rock8249
Houston8004
Aitkin79930
Fillmore7690
Pipestone76518
Pennington7058
Yellow Medicine69612
Kanabec68614
Swift63610
Murray6124
Faribault6093
Pope5721
Clearwater55410
Marshall5459
Stevens5403
Jackson5321
Lake4518
Koochiching4216
Wilkin4175
Lac qui Parle4124
Lincoln3811
Unassigned38159
Norman3718
Big Stone3392
Mahnomen3225
Grant2986
Kittson2518
Red Lake2303
Traverse1531
Lake of the Woods1071
Cook800

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 237371

Reported Deaths: 2571
CountyCasesDeaths
Polk34873347
Linn14787169
Scott1184692
Black Hawk11288147
Woodbury10763137
Johnson985939
Dubuque947999
Story701924
Pottawattamie682474
Dallas661260
Sioux383829
Webster378339
Cerro Gordo373252
Marshall360950
Clinton345645
Buena Vista316614
Muscatine305172
Des Moines300623
Warren294115
Plymouth287044
Wapello265072
Jones237118
Jasper231546
Lee228719
Marion211922
Carroll204325
Bremer202713
Henry19367
Crawford183116
Benton175423
Tama157442
Jackson151117
Washington150216
Delaware147621
Dickinson145812
Boone144912
Mahaska133928
Wright13107
Clay12505
Buchanan123410
Hardin122812
Hamilton119514
Page11925
Kossuth11768
Clayton115510
Cedar114614
Harrison113432
Floyd111921
Mills11129
Calhoun10987
Fayette109812
Lyon10769
Butler10748
Winneshiek105513
Poweshiek103714
Iowa101414
Cherokee9674
Winnebago96325
Chickasaw9195
Hancock9138
Sac9068
Louisa90122
Grundy89514
Allamakee88413
Cass84725
Union8437
Mitchell8429
Appanoose81613
Humboldt8125
Shelby80511
Emmet79026
Guthrie78315
Franklin76421
Jefferson7635
Madison7265
Unassigned7090
Palo Alto6744
Keokuk6567
Pocahontas6024
Howard5859
Ida54915
Osceola5461
Greene5422
Montgomery51411
Clarke5064
Davis4839
Taylor4833
Monona4567
Adair4539
Monroe45113
Worth3881
Fremont3823
Van Buren3815
Decatur3410
Lucas3416
Audubon3112
Wayne3087
Ringgold2432
Adams1812
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