Johnson & Johnson asks FDA to authorize its Covid-19 vaccine

Johnson & Johnson...

Posted: Feb 5, 2021 12:06 PM
Updated: Feb 6, 2021 12:45 AM

Johnson & Johnson officially asked the US Food and Drug Administration for an emergency use authorization of its Covid-19 vaccine Thursday, taking forward the possibility of a third coronavirus vaccine for the US market.

'Today's submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,' Dr. Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, said in a statement.


FOX 55: Tracking the COVID-19 Vaccine

The FDA has scheduled a public meeting of its Vaccines and Related Biological Products Advisory Committee for Feb. 26. The independent group of experts will look at the data and make a recommendation that the agency takes into consideration when it makes a decision.

This means an EUA will not come before the end of the month, if the FDA decides to grant one. But adding a third vaccine to the mix would add both supply and flexibility to the struggling US efforts to vaccinate the population.

If the FDA decides to authorize the vaccine, the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet to discuss whether the vaccine should be given to Americans and if so, who should get it first.

This same regulatory process for Pfizer took a little over three weeks. For Moderna it was a little more than two.

The Johnson & Johnson vaccine is a little different than the two authorized Covid-19 vaccines. The vaccine, made through a collaboration of J&J's vaccine division, Janssen Pharmaceutical, and Beth Israel Deaconess Medical Center in Boston, is delivered in a single shot. Pfizer and Moderna's require two.

Janssen's is considered versatile since it is considered stable for up to three months kept in regular refrigerated temperatures and doesn't need the deep freeze like Pfizer's.

Johnson & Johnson's Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, according to the company. The vaccine is 85% effective overall at preventing hospitalization and 100% at preventing death in all regions where it was tested.

Its efficacy against moderate and severe disease ranged from one country to another: 72% in the US, 66% in Latin America and 57% in South Africa. This was measured starting one month after the shot.

In the South African arm of the clinical trial, the majority of the cases were due to a variant known as B.1.351, which is more transmissible and which carries mutations that make it less susceptible to the antibody immune response -- including antibodies that would be prompted by vaccination. People who did get a moderate case of Covid-19 in the trial tended to develop a milder course of the disease with fewer symptoms, according to the company.

The J&J vaccine works a little differently than the Moderna and Pfizer vaccines. Those two use messenger RNA, genetic instructions delivered in a fat droplet that prompt the body to make what looks like a piece of the virus. With the J&J vaccine the genetic material is delivered in a a common cold virus called an adenovirus, which has been disabled so it doesn't replicate itself or make people sick.

The US government has ordered 100 million doses and J&J says it can meet this commitment by June. 'Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,' Stoffels 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
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