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

Johnson & Johnson...

Posted: Feb 5, 2021 11:06 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: 294994

Reported Deaths: 6681
CountyCasesDeaths
DeSoto19660230
Hinds18785386
Harrison16679278
Rankin12675264
Jackson12575226
Lee9683160
Madison9448199
Jones7945146
Forrest7204136
Lauderdale6833226
Lowndes6021137
Lamar587680
Lafayette5730113
Washington5218130
Bolivar4608123
Oktibbeha440993
Panola430394
Pearl River4159130
Warren4126114
Pontotoc408769
Marshall403192
Monroe3988126
Union395174
Neshoba3800168
Lincoln3539102
Hancock346974
Leflore3374118
Sunflower318386
Tate302474
Pike300095
Scott293670
Alcorn291761
Itawamba289675
Yazoo288762
Tippah278565
Copiah277757
Coahoma277568
Simpson274778
Prentiss269758
Wayne253741
Marion252578
Leake252471
Covington248879
Grenada247377
Adams234277
George231745
Newton229452
Winston221675
Jasper213245
Tishomingo212165
Attala206569
Chickasaw201151
Holmes181870
Clay179150
Stone172429
Tallahatchie170539
Clarke169371
Calhoun157828
Smith152731
Yalobusha144836
Greene127633
Walthall124140
Noxubee122829
Montgomery122238
Perry121634
Lawrence120221
Carroll118125
Amite111333
Webster110630
Jefferson Davis101731
Tunica99023
Claiborne98429
Benton93324
Humphreys92827
Kemper90123
Quitman77114
Franklin76019
Choctaw69516
Wilkinson62426
Jefferson62327
Sharkey48817
Issaquena1676
Unassigned00

Alabama Coronavirus Cases

Cases: 493252

Reported Deaths: 9929
CountyCasesDeaths
Jefferson709861374
Mobile36108725
Madison32405455
Tuscaloosa24110410
Montgomery22565500
Shelby21929215
Baldwin19732283
Lee14961153
Morgan13659251
Calhoun13275286
Etowah13176319
Marshall11261209
Houston10086261
Elmore9376185
Limestone9359134
Cullman8891181
St. Clair8822223
Lauderdale8603211
DeKalb8446175
Talladega7517163
Walker6518255
Jackson6492102
Autauga626491
Blount6097127
Colbert6001118
Coffee5245102
Dale4640107
Russell404730
Franklin399177
Covington3957106
Chilton3870100
Escambia377472
Tallapoosa3585142
Clarke343650
Chambers3410110
Dallas3403141
Pike293372
Lawrence282984
Marion281895
Winston246767
Bibb245060
Geneva239670
Marengo235855
Pickens224654
Barbour211551
Hale209768
Fayette200256
Butler196166
Henry182441
Cherokee177038
Monroe166139
Randolph163640
Washington156535
Clay144354
Crenshaw144354
Macon142043
Cleburne137739
Lamar132833
Lowndes131051
Wilcox121825
Bullock116936
Conecuh106724
Perry105527
Sumter98331
Coosa88823
Greene87632
Choctaw55023
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