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: 1506866

Reported Deaths: 20637
CountyCasesDeaths
Marion2056892545
Lake1006641508
Allen935801017
Hamilton72876550
St. Joseph64730759
Elkhart49383628
Vanderburgh48286528
Tippecanoe43764336
Johnson38300526
Hendricks36427460
Porter34494473
Madison29024543
Clark25868326
Vigo25633345
LaPorte23430309
Monroe23133247
Howard22089379
Delaware21603368
Hancock18686220
Bartholomew18152215
Kosciusko17921203
Warrick16933214
Wayne16230302
Floyd15876257
Grant15364298
Morgan14409231
Boone13514138
Noble11815141
Dearborn11676113
Henry11667201
Shelby11649151
Marshall11337168
Dubois11257152
Jackson10586104
Cass10269143
DeKalb10202130
Lawrence10196220
Huntington10156139
Gibson9583126
Montgomery9274143
Knox9043125
Harrison8983117
Whitley874371
Steuben8603105
Jasper8252115
Clinton818995
Miami8128133
Putnam8128100
Jefferson7849127
Wabash7827139
Ripley7180114
Adams6658102
Daviess6558129
Scott645186
White620483
Clay607175
Greene6064112
Decatur5967120
Wells5944120
Jennings591680
Fayette5786122
Posey552648
LaGrange529697
Randolph5073129
Washington503669
Owen4976100
Fountain475880
Spencer451756
Sullivan443065
Starke440586
Fulton434192
Orange429582
Jay414664
Rush410237
Perry386455
Carroll381749
Franklin377550
Vermillion358362
Pike323445
Parke322538
Tipton317375
Blackford274055
Pulaski272275
Newton233661
Brown228956
Benton219021
Crawford217532
Switzerland197814
Martin189422
Warren175922
Union170219
Ohio124016
Unassigned0739

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 2460869

Reported Deaths: 31245
CountyCasesDeaths
Franklin2660682065
Cuyahoga2589843018
Hamilton1711291714
Montgomery1142371604
Summit1077801391
Lucas917461160
Butler81317942
Stark759401400
Lorain63561792
Warren51721475
Mahoning50412915
Lake47212605
Clermont45258429
Delaware40037212
Trumbull39108755
Medina38036419
Licking37943408
Fairfield34857334
Greene33267422
Portage31942360
Clark31218445
Richland29019423
Wood28563297
Allen25249395
Miami23567395
Muskingum22859245
Columbiana22539403
Wayne21740356
Tuscarawas19252427
Erie18390222
Ashtabula18260342
Marion18111232
Scioto17366207
Ross16832252
Pickaway15948178
Hancock15761228
Geauga15374223
Lawrence14350186
Belmont13767247
Union1375384
Huron13682182
Jefferson13250258
Sandusky13047199
Athens12272106
Knox11850198
Seneca11762200
Darke11111198
Ashland11022178
Washington10836168
Auglaize10540142
Crawford10172175
Shelby10101157
Brown9734140
Fulton9531150
Guernsey9423117
Highland9396148
Defiance9321135
Logan9228142
Clinton9087127
Mercer8902111
Madison8836106
Preble8265162
Williams8127135
Putnam7922135
Ottawa7809121
Champaign7782112
Jackson7582117
Perry731298
Coshocton7210136
Morrow712882
Fayette688687
Pike640586
Hardin6397128
Gallia614791
Adams6000124
Van Wert5923121
Henry586493
Hocking5718104
Wyandot491590
Carroll4909100
Holmes4814161
Paulding414664
Meigs387473
Monroe307468
Noble289351
Harrison287961
Morgan283348
Vinton247945
Unassigned08
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