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: 730969

Reported Deaths: 13434
CountyCasesDeaths
Marion1000031743
Lake53771970
Allen40668678
St. Joseph35733552
Hamilton35629408
Elkhart28577442
Tippecanoe22402219
Vanderburgh22310397
Porter18776308
Johnson17970379
Hendricks17244315
Clark12985191
Madison12673339
Vigo12449247
LaPorte11928211
Monroe11893170
Delaware10696186
Howard9924216
Kosciusko9410117
Hancock8284141
Bartholomew8070156
Warrick7784155
Floyd7669178
Grant7060174
Wayne7051199
Boone6700101
Morgan6576139
Dubois6156117
Marshall6050111
Dearborn581378
Cass5808105
Henry5720103
Noble561384
Jackson501773
Shelby491996
Lawrence4546120
Harrison435872
Gibson435492
DeKalb428485
Clinton427453
Montgomery424189
Whitley396139
Huntington391980
Steuben387857
Miami381866
Knox371990
Jasper366047
Putnam360760
Wabash354179
Adams341354
Ripley339770
Jefferson330981
White314354
Daviess297399
Wells291581
Decatur285492
Fayette280762
Greene278985
Posey271533
LaGrange266770
Scott266354
Clay260247
Randolph240781
Washington240732
Spencer232131
Jennings230149
Starke216654
Fountain212346
Sullivan211942
Owen200256
Fulton195440
Jay195130
Carroll189320
Orange183654
Perry183037
Rush173425
Vermillion169143
Franklin168135
Tipton162845
Parke146316
Blackford134932
Pike134334
Pulaski116845
Newton107834
Brown102141
Crawford99814
Benton98614
Martin89115
Warren82115
Switzerland7918
Union71010
Ohio56811
Unassigned0416

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1085733

Reported Deaths: 19441
CountyCasesDeaths
Franklin1261201400
Cuyahoga1124072120
Hamilton801491206
Montgomery515591014
Summit47292946
Lucas42275788
Butler38396584
Stark32412907
Lorain25046481
Warren24313300
Mahoning21629588
Lake20725369
Clermont19803238
Delaware18537133
Licking16436212
Fairfield16230200
Trumbull16082468
Medina15309264
Greene15099244
Clark14017299
Wood13113189
Portage12890203
Allen11675232
Richland11382199
Miami10686217
Wayne8843211
Columbiana8816229
Muskingum8815133
Pickaway8582121
Marion8539135
Tuscarawas8487244
Erie7917154
Hancock6929127
Ross6858155
Ashtabula6830170
Geauga6697148
Scioto6417101
Belmont5920167
Union571048
Lawrence5560102
Jefferson5544151
Huron5439119
Darke5364123
Sandusky5359121
Seneca5290121
Athens520058
Washington5160109
Auglaize491984
Mercer480885
Shelby470093
Knox4495110
Madison436661
Putnam4287100
Fulton423969
Ashland423189
Defiance421097
Crawford3978107
Brown395057
Logan382376
Preble379898
Clinton372963
Ottawa367479
Highland355662
Williams340275
Champaign333458
Guernsey316253
Jackson312652
Perry295350
Morrow285639
Fayette282250
Hardin271464
Henry269366
Coshocton265357
Holmes2611101
Van Wert243763
Adams238552
Pike237734
Gallia235949
Wyandot231555
Hocking215462
Carroll191647
Paulding173340
Meigs144940
Noble133337
Monroe132342
Harrison108537
Morgan108523
Vinton83515
Unassigned02
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