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Pfizer/BioNTech seek full FDA approval for their Covid-19 vaccine

Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and old...

Posted: May 7, 2021 1:02 PM
Updated: May 7, 2021 1:17 PM

Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the first Covid-19 vaccine in the United States to be assessed for full approval from the FDA.

Pfizer's mRNA two-shot vaccine is currently being used in the US under emergency use authorization (EUA) from the FDA. The companies say 170 million doses of the vaccine have been distributed across the US to date.

"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government," Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement. "We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months."

To apply for full FDA approval Pfizer/BioNTech submitted a Biologics License Application, known as a BLA. The FDA requires vaccine manufacturers submit data on manufacturing processes, facilities and additional information that demonstrates that the vaccine can be produced reliably and consistently. They are also required to submit all pre-clinical and clinical trial data.

Pfizer/BioNTech will submit that information to the FDA over the next few weeks on a rolling basis. Once all the required information is submitted, a goal date will be set for a decision by the FDA. Pfizer/BioNTech has requested priority review, which asks the FDA to take action within 6 months, compared to the 10 months designated under standard review.

The application to the FDA is only intended for adults 16 and older. Pfizer/BioNTech is simultaneously applying to expand its EUA to include children ages 12 to 15. The companies then plan to submit an additional BLA to cover this younger age group once the essential data has been collected six months after administering second doses.

EUA vs. approval

The vaccine, named BNT162b2, was the first Covid-19 vaccine to be awarded FDA emergency use authorization in December.

Emergency use authorization is what its name suggests -- a medical product, such as a vaccine, that gets special FDA authorization to be used during an emergency. For an EUA to be issued for a vaccine, the FDA says there must be adequate manufacturing information to ensure quality and consistency, and the known and potential benefits of the vaccine must outweigh its known and potential risks.

Due to the seriousness of the pandemic, vaccine makers originally applied for EUAs because the authorization process takes less time than what would be required for full approval. As a condition of the EUA, the companies were expected to work toward full approval from the FDA.

Progressing from authorization to approval could have an impact on vaccine mandates, as some organizations and schools have said they intend to require vaccination against Covid-19, but only once a vaccine is approved by the FDA. It could also have an impact on vaccine hesitancy; a Kaiser Family Foundation survey released this week says about 15% of American adults say they'll "wait and see" to get a Covid-19 vaccine, and some cite the lack of full approval as a reason to delay.

Clinical trials and recently published real-word data show the vaccine is up to 95% effective at preventing infection, severe illness and hospitalization. Pfizer/BioNTech reported last month that trial results show the vaccine remains more than 91% effective against disease with any symptoms for six months.

Recent research suggests the vaccine is effective against some worrying virus variants, and Pfizer/BioNtech is currently testing booster and variant-specific vaccines.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 752108

Reported Deaths: 13816
CountyCasesDeaths
Marion1033831790
Lake558431013
Allen41736693
St. Joseph37007565
Hamilton36617417
Elkhart29425461
Tippecanoe22938228
Vanderburgh22565400
Porter19369327
Johnson18486389
Hendricks17696317
Clark13233195
Madison13176344
Vigo12631253
LaPorte12429221
Monroe12226176
Delaware10970198
Howard10349224
Kosciusko9643121
Hancock8578147
Bartholomew8174157
Warrick7864156
Floyd7815180
Grant7248179
Wayne7164201
Boone6979103
Morgan6768141
Dubois6224118
Marshall6214116
Cass6024110
Henry5903110
Dearborn589878
Noble581688
Jackson509476
Shelby502396
Lawrence4753122
Gibson445595
Clinton443555
Harrison441775
DeKalb440385
Montgomery439890
Whitley406744
Huntington403381
Steuben400859
Miami395769
Jasper389155
Knox377691
Putnam373461
Wabash362383
Ripley347370
Adams345555
Jefferson336186
White332753
Daviess3035100
Wells295481
Decatur289892
Greene286885
Fayette284864
Posey274335
LaGrange273272
Scott270356
Clay267148
Washington246336
Randolph245183
Jennings235349
Spencer234531
Starke228159
Fountain222048
Sullivan214843
Owen212358
Fulton204043
Jay201032
Carroll193820
Orange188255
Perry187237
Rush175926
Vermillion175344
Franklin170435
Tipton166646
Parke149616
Pike138334
Blackford136232
Pulaski120847
Newton114936
Brown104443
Benton102614
Crawford102516
Martin91815
Warren84115
Switzerland8158
Union72810
Ohio57911
Unassigned0424

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1109697

Reported Deaths: 20213
CountyCasesDeaths
Franklin1289521469
Cuyahoga1158802216
Hamilton814201251
Montgomery525861049
Summit484551006
Lucas43384824
Butler39098606
Stark33355930
Lorain25689506
Warren24612305
Mahoning22388602
Lake21219389
Clermont20138253
Delaware18892136
Licking16671225
Fairfield16589204
Trumbull16560483
Medina15618273
Greene15292248
Clark14244306
Wood13296200
Portage13254216
Allen11919239
Richland11611211
Miami10857225
Wayne9153225
Columbiana9039230
Muskingum8909135
Pickaway8664122
Tuscarawas8654251
Marion8649139
Erie8058165
Ashtabula7171179
Hancock6999133
Ross6948163
Geauga6850151
Scioto6540106
Belmont6159174
Union585049
Lawrence5741102
Jefferson5683159
Huron5554122
Sandusky5444126
Darke5420129
Seneca5350128
Washington5321109
Athens524460
Auglaize502487
Mercer487785
Shelby477095
Knox4573112
Madison444566
Ashland435997
Putnam4336104
Defiance432399
Fulton432274
Crawford4046110
Brown402761
Logan387678
Preble3859105
Clinton379266
Ottawa373581
Highland360266
Williams348578
Champaign344959
Guernsey325254
Jackson318454
Perry297350
Morrow291940
Fayette285750
Hardin275765
Henry273867
Holmes2703101
Coshocton269360
Van Wert247264
Adams243156
Pike242835
Gallia240850
Wyandot234756
Hocking220663
Carroll197548
Paulding176642
Meigs148540
Monroe136345
Noble136239
Harrison114138
Morgan110124
Vinton85717
Unassigned03
Fort Wayne
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Angola
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Daily rounds of showers and thunderstorms will increase the flood threat across northeast Indiana and northwest Ohio.
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