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

Johnson & Johnson...

Posted: Feb 5, 2021 11:27 AM
Updated: Feb 5, 2021 11:45 PM

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.

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.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 313166

Reported Deaths: 7228
CountyCasesDeaths
DeSoto21496257
Hinds20294414
Harrison17814309
Rankin13573278
Jackson13411246
Madison10066217
Lee9962173
Jones8364163
Forrest7649152
Lauderdale7181240
Lowndes6370145
Lamar621686
Lafayette6171118
Washington5323133
Bolivar4797132
Oktibbeha461498
Panola4561105
Pearl River4499145
Marshall4397103
Warren4380121
Pontotoc419572
Monroe4100133
Union409076
Neshoba4026176
Lincoln3950110
Hancock377786
Leflore3487125
Sunflower335790
Tate332484
Pike3301105
Scott315373
Alcorn311968
Yazoo310769
Itawamba299477
Copiah296465
Simpson294788
Coahoma294379
Tippah287768
Prentiss279560
Adams269582
Marion268880
Leake266273
Wayne262341
Grenada260386
Covington256381
George246848
Newton246061
Winston226881
Tishomingo225967
Jasper220848
Attala214173
Chickasaw207157
Holmes188673
Clay184754
Stone182033
Tallahatchie178140
Clarke177879
Calhoun170132
Yalobusha163337
Smith162234
Walthall133845
Greene130333
Lawrence128323
Montgomery126742
Noxubee126734
Perry125938
Amite122842
Carroll121728
Webster114532
Jefferson Davis106932
Tunica104826
Claiborne102230
Benton99125
Humphreys96133
Kemper95428
Franklin83623
Quitman80216
Choctaw76118
Wilkinson66930
Jefferson65428
Sharkey50317
Issaquena1686
Unassigned00

Alabama Coronavirus Cases

Cases: 530988

Reported Deaths: 10978
CountyCasesDeaths
Jefferson765291522
Mobile40971804
Madison34751503
Tuscaloosa25775452
Montgomery24329589
Shelby23431249
Baldwin21131308
Lee15884171
Calhoun14501314
Morgan14293279
Etowah13831353
Marshall12222223
Houston10567281
Elmore10061205
Limestone9960151
Cullman9664193
St. Clair9655243
Lauderdale9424241
DeKalb8830186
Talladega8223176
Walker7235277
Autauga6920108
Jackson6810112
Blount6660137
Colbert6298134
Coffee5511119
Dale4831111
Russell441138
Chilton4290112
Franklin425782
Covington4121118
Tallapoosa4027152
Escambia393376
Chambers3563123
Dallas3551151
Clarke351061
Marion3118101
Pike310877
Lawrence300298
Winston274472
Bibb260764
Geneva249977
Marengo249764
Pickens234461
Barbour230857
Hale222977
Butler215969
Fayette212362
Henry188744
Cherokee184845
Randolph180241
Monroe177440
Washington167339
Macon159150
Clay156256
Crenshaw152257
Cleburne148941
Lamar142535
Lowndes138853
Wilcox127130
Bullock123041
Conecuh110529
Perry107726
Coosa107228
Sumter104532
Greene92334
Choctaw60624
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