FDA advisers to consider third possible Covid-19 vaccine Friday

US Food and Drug Administration vaccine advisers are scheduled to meet Friday to discuss the potential emergency authorization of a third coronavirus vaccine for the US, this one made by Johnson & Johnson's vaccine arm Janssen Biotech.

Posted: Feb 26, 2021 11:12 AM
Updated: Feb 26, 2021 12:07 PM

US Food and Drug Administration vaccine advisers are scheduled to meet Friday to discuss the potential emergency authorization of a third coronavirus vaccine for the US, this one made by Johnson & Johnson's vaccine arm Janssen Biotech.

It's the next step in a process that could end with the new vaccine's rollout early next week. As with the two currently authorized vaccines, advisers and federal agencies are meeting over a weekend to try to get the vaccines to the US public as soon as possible.

The FDA has already considered the advanced, Phase 3 clinical trial testing data presented by Janssen and says it shows the vaccine is safe and effective.

The Vaccines and Related Biological Products Advisory Committee or VRBPAC is made up of vaccine experts and other medical professionals, industry and consumer representatives who will consider presentations from FDA about its findings, as well as from Janssen.

They'll also hear the latest from the Centers for Disease Control and Prevention about the spread of the virus, including worrying new variants, and on the CDC's surveillance for any safety worries from the currently authorized vaccines made by Pfizer/BioNTech and Moderna.

The VRPBAC will vote Friday on whether to recommend FDA emergency use authorization (EUA), and the FDA will then take that vote into consideration in deciding whether to authorize the vaccine.

That decision could come very quickly after the VPBPAC vote.

On Sunday, a second advisory group weighs in. The CDC's Advisory Committee on Immunization Practices will look at all the same data and will discuss whether people should get the vaccine and if so who, and when. A vote is expected by 3 p.m. ET from ACIP.

The CDC then takes the ACIP vote into consideration and the CDC director -- who is currently Dr. Rochelle Walensky -- will decide whether the vaccine has her agency's OK.

Typically, this is a slow and deliberative process, but the schedule was sped up because of the urgency of the pandemic. The authorization and subsequent CDC nod for the Pfizer/BioNTech and Moderna vaccines in December each took place over a period of days.

After that, distribution can begin. The White House has promised to begin immediately, with 2 million doses going to states and the rest directly to pharmacies and community health centers. The federal government has said it expects to have up to 4 million doses of Johnson & Johnson vaccine on the first day. The company has promised to ramp up production to deliver 20 million doses by the end of March and 100 million doses by the end of June.

While Pfizer and Moderna's vaccines require two doses for full efficacy, the Johnson & Johnson vaccine requires only one dose, although the company is testing at two-dose regimen to see if it works any better.

Johnson & Johnson's data indicates its vaccine was 66% effective across all global trials in preventing moderate to severe Covid-19 disease 28 days after immunization. It was 85% effective in preventing severe disease. No one who got the vaccine died from Covid-19.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 1007681

Reported Deaths: 16470
CountyCasesDeaths
Marion1355212121
Lake664101166
Allen57993801
Hamilton46350465
St. Joseph44397615
Elkhart35949510
Vanderburgh32251480
Tippecanoe27933260
Johnson25107445
Hendricks23897359
Porter22929365
Madison18748409
Clark18557252
Vigo17479303
Monroe15263200
LaPorte15173250
Delaware15073263
Howard14748290
Kosciusko12348148
Hancock11728176
Bartholomew11639180
Warrick11292189
Floyd11108215
Wayne10986253
Grant10082220
Morgan9472176
Boone8926115
Dubois8271131
Henry8229152
Dearborn822393
Noble8031106
Marshall7939135
Cass7546121
Lawrence7457171
Shelby7189119
Jackson698289
Gibson6597115
Harrison649192
Knox6421106
Huntington6395100
DeKalb632399
Montgomery6264111
Miami593398
Putnam581278
Clinton576171
Whitley565755
Steuben562576
Wabash5332104
Jasper532079
Jefferson511297
Ripley500586
Adams482576
Daviess4677114
Scott438974
Greene425196
Wells424888
Clay423360
White418764
Decatur4169102
Fayette406587
Jennings387361
Posey376644
Washington359151
LaGrange359078
Randolph3452100
Spencer340243
Fountain335760
Sullivan329452
Starke317171
Owen314771
Fulton312667
Orange293664
Jay284645
Franklin265643
Perry265452
Rush262432
Carroll261934
Vermillion258654
Parke231426
Pike229243
Tipton228159
Blackford193142
Pulaski183757
Crawford159823
Newton158348
Benton150617
Brown146747
Martin138719
Switzerland135011
Warren121116
Union107016
Ohio84613
Unassigned0540

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1519304

Reported Deaths: 23955
CountyCasesDeaths
Franklin1642651696
Cuyahoga1464072459
Hamilton1053661431
Montgomery740661279
Summit617841111
Lucas56338917
Butler51580718
Stark466811064
Lorain35628585
Warren32836377
Mahoning30787693
Clermont28193330
Lake27063448
Delaware24208164
Licking23939294
Trumbull22885561
Fairfield22395247
Greene22350326
Medina22047313
Clark19863354
Richland18586292
Portage17978252
Wood17454224
Allen16001279
Miami15582306
Muskingum14831185
Columbiana14080274
Wayne13791271
Tuscarawas12724311
Marion11976180
Scioto11469162
Pickaway11373142
Erie10904184
Ross10586203
Lawrence9759153
Ashtabula9741204
Hancock9707155
Belmont9309209
Geauga8965157
Jefferson8567199
Huron8404143
Union819859
Washington8093144
Sandusky7827151
Athens777779
Knox7739144
Darke7689158
Seneca7372145
Ashland6967130
Auglaize679799
Shelby6530115
Brown636491
Crawford6274130
Defiance6218105
Mercer616493
Fulton602896
Highland600499
Madison594578
Guernsey593071
Logan591096
Clinton583793
Preble5720125
Putnam5335110
Williams529288
Perry518363
Champaign513173
Jackson510273
Ottawa488586
Coshocton484683
Morrow458858
Pike434367
Fayette429263
Hardin419480
Gallia418467
Adams417195
Van Wert372382
Henry365372
Holmes3642125
Hocking356782
Wyandot324662
Carroll302365
Paulding280347
Meigs265851
Monroe216254
Noble200347
Morgan194033
Harrison182146
Vinton166625
Unassigned05
Fort Wayne
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Showers on tap for Sunday with the chance of a few thunderstorms.
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