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 11:12 AM
Updated: Feb 26, 2021 1:53 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.

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Illinois Coronavirus Cases

(Widget updates once daily at 7 p.m. CT)

Cases: 1309459

Reported Deaths: 24018
CountyCasesDeaths
Cook5245929847
DuPage869211254
Will72209968
Lake64862965
Kane55955753
Winnebago31341460
Madison29912515
St. Clair27220504
McHenry27207278
Peoria21504284
Champaign19902139
Sangamon17870230
McLean17096171
Tazewell16095259
Rock Island14319305
Kankakee13576199
Kendall1241790
LaSalle11835232
Macon10284190
DeKalb9390118
Vermilion9101127
Adams8231117
Williamson7229126
Whiteside6913164
Boone642971
Ogle579978
Clinton570890
Grundy562971
Coles554894
Knox5344137
Jackson486763
Henry474863
Effingham468471
Livingston461883
Macoupin460681
Stephenson454280
Woodford443063
Marion4415115
Franklin433770
Monroe431790
Jefferson4167119
Randolph409684
Lee400151
Morgan377679
Logan365456
Fulton364850
Montgomery364773
Bureau355181
Christian352772
Fayette314054
Perry313059
Iroquois291064
Jersey263549
McDonough261144
Douglas255335
Saline251453
Lawrence239525
Shelby225037
Union223040
Crawford209325
Bond198924
Cass194824
Pike177451
Jo Daviess176824
Clark176732
Warren173946
Wayne173452
Hancock173030
Richland172140
Carroll171736
Ford170746
Edgar166939
White166526
Washington162825
Moultrie157526
Clay147343
Mason142842
Greene142433
Piatt141914
Johnson139814
De Witt139723
Mercer136933
Wabash134112
Massac131439
Cumberland128319
Menard118812
Jasper114317
Marshall99817
Hamilton82415
Schuyler7095
Brown6916
Pulaski6807
Stark61223
Edwards55812
Henderson52114
Calhoun5122
Scott4691
Alexander46211
Gallatin4534
Putnam4483
Hardin37012
Pope3073
Out of IL70
Unassigned02296

Indiana Coronavirus Cases

(Widget updates once daily at 8 p.m. ET)

Cases: 710607

Reported Deaths: 13248
CountyCasesDeaths
Marion968581722
Lake51908949
Allen39337672
Hamilton34643406
St. Joseph34306543
Elkhart27477432
Vanderburgh22099394
Tippecanoe21927213
Porter17987301
Johnson17571374
Hendricks16854310
Clark12715190
Madison12367337
Vigo12240244
Monroe11510166
LaPorte11204204
Delaware10382184
Howard9698211
Kosciusko9165114
Hancock8014139
Bartholomew7913155
Warrick7702155
Floyd7568176
Wayne6917198
Grant6855171
Boone6568100
Morgan6414138
Dubois6091117
Marshall5801109
Dearborn571276
Cass5698104
Henry5588101
Noble543683
Jackson494172
Shelby481395
Lawrence4349118
Gibson429589
Harrison429171
Clinton420953
Montgomery418986
DeKalb413284
Whitley382239
Huntington379780
Miami373365
Knox367189
Steuben367157
Putnam353460
Jasper352546
Wabash348178
Adams338253
Ripley335469
Jefferson318080
White308854
Daviess289999
Wells286881
Decatur279592
Fayette277362
Greene271085
Posey269533
Scott261553
Clay255445
LaGrange255470
Randolph236080
Washington231631
Spencer228131
Jennings225448
Fountain209345
Sullivan208042
Starke206252
Owen192756
Fulton192140
Jay186429
Carroll186120
Perry181436
Orange178353
Rush170824
Vermillion166343
Franklin166035
Tipton161543
Parke144616
Blackford133931
Pike130734
Pulaski114345
Newton104234
Brown100740
Crawford97914
Benton97413
Martin83115
Warren80215
Switzerland7698
Union70110
Ohio56011
Unassigned0408