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: 503322

Reported Deaths: 10057
CountyCasesDeaths
Harrison34400541
DeSoto32318411
Hinds32074631
Jackson24551386
Rankin22103391
Lee15657235
Madison14662281
Jones13894243
Forrest13506253
Lauderdale12037318
Lowndes11091192
Lamar10531138
Pearl River9557238
Lafayette8581140
Hancock7751130
Washington7458161
Oktibbeha7152133
Monroe6796178
Warren6752176
Pontotoc6736104
Neshoba6656206
Panola6572131
Marshall6494135
Bolivar6331150
Union607794
Pike5849154
Alcorn5691102
Lincoln5468135
George502979
Scott474198
Tippah472481
Prentiss471582
Leflore4676144
Itawamba4651105
Tate4632111
Adams4617120
Copiah450092
Simpson4458116
Yazoo445388
Wayne440772
Covington429894
Sunflower4246105
Marion4236108
Coahoma4178108
Leake409888
Newton383179
Grenada3731108
Tishomingo361592
Stone360664
Jasper336565
Attala335290
Winston315391
Clay309077
Chickasaw302367
Clarke295894
Calhoun279947
Holmes268788
Smith266550
Yalobusha237247
Tallahatchie228752
Greene220649
Walthall219364
Lawrence213640
Perry206456
Amite206056
Webster203446
Noxubee186940
Montgomery179757
Jefferson Davis172243
Carroll169639
Tunica160139
Benton149439
Kemper142141
Choctaw134627
Claiborne132838
Humphreys129738
Franklin120728
Quitman106828
Wilkinson105139
Jefferson95934
Sharkey64220
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 821255

Reported Deaths: 15424
CountyCasesDeaths
Jefferson1149051930
Mobile726651340
Madison52400699
Shelby37685350
Baldwin37285552
Tuscaloosa35147613
Montgomery34130740
Lee23556246
Calhoun22255490
Morgan21037378
Etowah19844500
Marshall18390304
Houston17406412
St. Clair16091339
Cullman15493293
Limestone15402199
Elmore15292286
Lauderdale14366295
Talladega13870283
DeKalb12670261
Walker11255370
Blount10227176
Autauga10061148
Jackson9909185
Coffee9215191
Dale8912186
Colbert8907201
Tallapoosa7103198
Escambia6782134
Covington6724183
Chilton6658162
Russell637659
Franklin5992105
Chambers5615142
Marion5016127
Dallas5013202
Pike4799106
Clarke477284
Geneva4577127
Winston4538103
Lawrence4352117
Bibb425686
Barbour358376
Marengo338390
Monroe332064
Randolph330264
Butler328596
Pickens317384
Henry313166
Hale311988
Cherokee303260
Fayette294580
Washington251651
Cleburne247960
Clay245568
Crenshaw245475
Macon235563
Lamar225747
Conecuh186654
Coosa180940
Lowndes175764
Wilcox169139
Bullock151844
Perry139240
Sumter133338
Greene126744
Choctaw88527
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