FDA advisers recommend authorization of Pfizer/BioNTech coronavirus vaccine

Vaccine advisers to the US Food and Drug Administration voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech's cor...

Posted: Dec 10, 2020 6:45 PM
Updated: Dec 11, 2020 12:15 AM

Vaccine advisers to the US Food and Drug Administration voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech's coronavirus vaccine.

Seventeen members of the Vaccines and Related Biological Products Advisory Committee voted yes, four voted no and one abstained.

'The question is never when you know everything. It's when you know enough and I think we know enough now to say that this appears to be our way out of this awful, awful mess,' Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the committee, told CNN's Wolf Blitzer after the vote.

'That's why I voted yes.'

Dr. James Hildreth, president and chief executive officer of Meharry Medical College, said he would have hoped more minorities had been enrolled in the clinical trials of the vaccine.

'I just feel that we need this vaccine and the benefits outweigh the risks,' Hildreth, a temporary voting member of the committee, told CNN.

Several committee members expressed concern about reports of allergic reactions in two people who were vaccinated in Britain, which authorized Pfizer's vaccine ahead of the US.

FDA staff said that, as with any vaccines, paperwork would accompany the Pfizer vaccine to warn against administering it to anyone with a history of severe allergic reactions to vaccines or allergies to any of the ingredients of the vaccine.

An EUA is short of a full approval. Pfizer would have to file a separate application for full FDA approval for its vaccine. Plus, Thursday's vote doesn't mean the vaccine will be authorized immediately.

The FDA will now decide whether to accept the recommendation, but has signaled that it will issue the EUA for the vaccine.

'Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA's career officials,' the agency said in a statement after the vote.

'In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. However, they know that they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect,' FDA Commissioner Dr. Stephen Hahn said in the statement.

'The whole of the FDA—myself included—remains committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, Americans can have trust and confidence in receiving the vaccine for their families and themselves.'

Then, the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices must meet to decide whether it recommends that the vaccine be deployed for use.

ACIP has a meeting scheduled for Friday, and expects to vote during a meeting scheduled for Sunday.

Operation Warp Speed officials say they will start shipping the vaccine within 24 hours of FDA authorization.

President-elect Joe Biden weighed in. 'We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point,' Biden said in a statement.

The process starts all over again next week. VRPBAC is scheduled to meet again December 17 to discuss Moderna's EUA application.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 918230

Reported Deaths: 15011
CountyCasesDeaths
Marion1252491952
Lake623371084
Allen52301746
Hamilton43009443
St. Joseph41155584
Elkhart32831485
Vanderburgh29698436
Tippecanoe26442247
Johnson23106414
Hendricks21708338
Porter21255340
Clark16988222
Madison16899378
Vigo15562272
Monroe14186190
LaPorte13961235
Delaware13613215
Howard13531258
Kosciusko11150134
Hancock10534159
Warrick10431174
Bartholomew10233166
Floyd10099202
Wayne9557216
Grant8858194
Morgan8654158
Boone8231109
Dubois7521123
Henry7391126
Dearborn734186
Noble7208100
Marshall7168127
Cass7060117
Lawrence6803150
Jackson638980
Shelby6386106
Gibson5999105
Harrison587984
Huntington586490
Montgomery5663101
DeKalb555691
Knox532999
Miami523183
Clinton522464
Putnam519067
Whitley509851
Steuben480267
Wabash470192
Jasper465760
Jefferson456091
Ripley439074
Adams435565
Daviess4008106
Scott389563
White383457
Decatur376895
Clay376455
Greene375589
Wells375183
Fayette363074
Posey351841
Jennings341756
Washington324046
LaGrange312074
Spencer310734
Fountain306553
Randolph302087
Sullivan294947
Owen275961
Orange269659
Starke268961
Fulton264451
Jay248134
Perry244950
Carroll239926
Franklin229337
Vermillion225850
Rush225530
Parke212020
Tipton205354
Pike200938
Blackford163834
Pulaski155250
Crawford140818
Benton138316
Newton138141
Brown130646
Martin124416
Switzerland122310
Warren112616
Union92211
Ohio75811
Unassigned0461

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1319265

Reported Deaths: 21265
CountyCasesDeaths
Franklin1480641537
Cuyahoga1311202313
Hamilton948871307
Montgomery647451122
Summit548531041
Lucas49502853
Butler45993649
Stark39954963
Lorain30438525
Warren29170326
Mahoning25988629
Clermont24726278
Lake24088411
Delaware21722140
Licking19822239
Fairfield19780218
Greene19671266
Medina19208285
Trumbull19195506
Clark17188321
Portage15585224
Richland15540228
Wood15187208
Allen13654254
Miami13283244
Muskingum11821148
Wayne11448234
Columbiana11100239
Tuscarawas10388264
Marion10273144
Pickaway10162128
Scioto9766124
Erie9479170
Ross8979172
Lawrence8225116
Hancock8105140
Ashtabula8083184
Geauga7976155
Belmont7791183
Jefferson7093168
Huron7087125
Union703549
Washington6823116
Athens666163
Sandusky6608132
Darke6394135
Knox6308120
Seneca6113135
Auglaize569888
Ashland5631110
Shelby555799
Mercer545188
Brown533067
Defiance5278100
Madison527368
Crawford5148113
Highland514876
Fulton508781
Clinton505379
Logan494582
Preble4788110
Putnam4733106
Guernsey439057
Williams437281
Champaign426463
Ottawa425783
Perry414051
Jackson402259
Pike367140
Morrow359149
Fayette353951
Coshocton345064
Hardin341868
Adams338864
Gallia329254
Holmes3148107
Henry312668
Van Wert299269
Hocking280467
Wyandot271858
Carroll250451
Paulding231742
Meigs197842
Monroe178649
Noble160340
Morgan153528
Harrison145740
Vinton130217
Unassigned05
Fort Wayne
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Angola
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Huntington
Partly Cloudy
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Decatur
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Van Wert
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Friday is the beginning for a more summer-like forecast, with more heat and humidity returning to the region.
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