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: 996341

Reported Deaths: 16245
CountyCasesDeaths
Marion1343262101
Lake658231151
Allen57160791
Hamilton45963460
St. Joseph43954607
Elkhart35546503
Vanderburgh31975473
Tippecanoe27694256
Johnson24821440
Hendricks23647353
Porter22735362
Madison18538404
Clark18383248
Vigo17274300
Monroe15117197
LaPorte14987249
Delaware14931256
Howard14574286
Kosciusko12166147
Hancock11597175
Bartholomew11447179
Warrick11225188
Floyd10983214
Wayne10840248
Grant9898217
Morgan9361176
Boone8819115
Dubois8210129
Dearborn815492
Henry8107150
Noble7944106
Marshall7786134
Cass7462119
Lawrence7379168
Shelby7115114
Jackson691788
Gibson6480113
Harrison641591
Huntington630299
Knox6269105
DeKalb623796
Montgomery6184109
Miami586595
Putnam573477
Clinton567171
Whitley558055
Steuben550473
Wabash5250101
Jasper520475
Jefferson504695
Ripley492485
Adams472773
Daviess4596112
Scott433968
Greene421196
Wells419787
Clay418460
White414261
Decatur4118101
Fayette402186
Jennings383260
Posey374243
LaGrange352078
Washington352049
Randolph339999
Spencer336442
Fountain331858
Sullivan326652
Starke310868
Owen310169
Fulton304566
Orange290562
Jay278445
Perry264452
Franklin262742
Carroll258232
Rush257232
Vermillion254254
Parke229726
Pike227343
Tipton225659
Blackford187840
Pulaski181155
Crawford158122
Newton155648
Benton150117
Brown144047
Martin137319
Switzerland133911
Warren120116
Union106615
Ohio84012
Unassigned0532

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1494160

Reported Deaths: 23327
CountyCasesDeaths
Franklin1623021662
Cuyahoga1442512412
Hamilton1042291409
Montgomery729771240
Summit607921094
Lucas55462904
Butler50923707
Stark457361053
Lorain34972568
Warren32373369
Mahoning30168672
Clermont27861321
Lake26543434
Delaware23920162
Licking23442283
Trumbull22420552
Fairfield22117241
Greene22014311
Medina21673305
Clark19567349
Richland18260280
Portage17616247
Wood17174220
Allen15672269
Miami15305296
Muskingum14481174
Columbiana13656263
Wayne13538263
Tuscarawas12415298
Marion11760175
Scioto11336154
Pickaway11264141
Erie10613180
Ross10425196
Lawrence9638137
Hancock9504149
Ashtabula9410197
Belmont9086197
Geauga8795157
Jefferson8455191
Huron8193139
Union809156
Washington8009137
Sandusky7677145
Athens767072
Knox7571138
Darke7530151
Seneca7184144
Ashland6776125
Auglaize664896
Shelby6392111
Brown627382
Crawford6159130
Mercer606793
Defiance6059102
Fulton590596
Highland587199
Madison585776
Clinton575190
Logan569092
Guernsey568467
Preble5640121
Putnam5238108
Williams516784
Perry511761
Champaign502971
Jackson495470
Ottawa477886
Coshocton468382
Morrow449056
Pike429962
Fayette420760
Adams409987
Gallia409865
Hardin409276
Van Wert362378
Henry357171
Holmes3549122
Hocking350378
Wyandot316561
Carroll295459
Paulding275145
Meigs257849
Monroe212153
Noble195646
Morgan190132
Harrison177842
Vinton161724
Unassigned05
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