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...

Posted: Feb 26, 2021 10:12 AM
Updated: Feb 26, 2021 10:15 AM

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.

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Alabama Coronavirus Cases

Cases: 522131

Reported Deaths: 10790
CountyCasesDeaths
Jefferson754831494
Mobile39111799
Madison34084500
Tuscaloosa25396444
Montgomery24037573
Shelby23210242
Baldwin20714302
Lee15614166
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Morgan14164273
Etowah13696348
Marshall12007220
Houston10408279
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DeKalb8760183
Talladega8122173
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Autauga6760106
Jackson6760110
Blount6529133
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Dale4779111
Russell430939
Franklin420982
Chilton4114110
Covington4068115
Tallapoosa3915148
Escambia390374
Dallas3525150
Chambers3516122
Clarke347260
Marion3072100
Pike306576
Lawrence296295
Winston273272
Bibb256361
Marengo248461
Geneva246275
Pickens233259
Barbour227155
Hale218675
Butler213168
Fayette209460
Henry188144
Cherokee182744
Randolph177241
Monroe172740
Washington165338
Macon156148
Clay150155
Crenshaw149557
Cleburne146741
Lamar139734
Lowndes137353
Wilcox124727
Bullock121940
Conecuh109528
Perry107626
Sumter103232
Coosa99428
Greene91434
Choctaw58824
Out of AL00
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Tennessee Coronavirus Cases

Cases: 830484

Reported Deaths: 12049
CountyCasesDeaths
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Davidson87309923
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Williamson27237214
Sumner23155339
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McMinn634295
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Dyer5357104
Franklin508388
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Obion449996
Cocke442998
Cheatham442254
Rhea430375
Lincoln429563
Marshall410358
Campbell408462
Weakley401962
Giles393998
Henderson372475
Macon357376
Carroll357182
White353968
Hardin349166
Hardeman345863
Lauderdale314244
Henry311875
Marion308346
Claiborne305573
Scott305145
Overton296360
Wayne294234
Hickman279645
McNairy276754
DeKalb274953
Smith273938
Haywood268161
Grainger258449
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Morgan245539
Fentress238046
Johnson230238
Bledsoe209411
Chester209351
Crockett200948
Polk199024
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Lewis155726
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Perry105728
Moore99717
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