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 9:30 AM

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.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 500286

Reported Deaths: 9968
CountyCasesDeaths
Harrison34281537
DeSoto32039402
Hinds31911626
Jackson24466379
Rankin21971390
Lee15501235
Madison14566279
Jones13825242
Forrest13438250
Lauderdale11984316
Lowndes11003188
Lamar10510135
Pearl River9494237
Lafayette8542139
Hancock7727126
Washington7418157
Oktibbeha7139131
Monroe6765176
Warren6679176
Pontotoc6655102
Neshoba6625206
Panola6511131
Marshall6460134
Bolivar6302148
Union601294
Pike5815152
Alcorn5662101
Lincoln5431134
George496579
Scott472198
Tippah468381
Prentiss466581
Leflore4654144
Itawamba4628105
Adams4584119
Tate4579109
Copiah447792
Simpson4440116
Yazoo443687
Wayne439172
Covington428694
Sunflower4235105
Marion4225107
Coahoma4154104
Leake408088
Newton381679
Grenada3703108
Stone359764
Tishomingo359492
Attala331089
Jasper329565
Winston314091
Clay307676
Chickasaw299467
Clarke292194
Calhoun278945
Holmes267887
Smith263350
Yalobusha233347
Tallahatchie226851
Walthall218763
Greene218248
Lawrence212440
Perry205256
Amite204755
Webster202646
Noxubee186440
Montgomery179456
Jefferson Davis171442
Carroll168738
Tunica159439
Benton148438
Kemper141941
Choctaw133326
Claiborne132237
Humphreys129238
Franklin119428
Quitman106428
Wilkinson104839
Jefferson94434
Sharkey64020
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 815989

Reported Deaths: 15311
CountyCasesDeaths
Jefferson1144621915
Mobile723961330
Madison52114694
Shelby37488348
Baldwin37167547
Tuscaloosa35013606
Montgomery34031734
Lee23177245
Calhoun22190476
Morgan20719376
Etowah19774497
Marshall18277302
Houston17333411
St. Clair15967339
Cullman15365292
Limestone15270198
Elmore15126284
Lauderdale14205294
Talladega13783276
DeKalb12598260
Walker11142369
Blount10132175
Autauga9910146
Jackson9819182
Coffee9190191
Dale8874185
Colbert8803201
Tallapoosa7063198
Escambia6755130
Covington6695184
Chilton6608161
Russell626659
Franklin5947105
Chambers5563142
Marion4966126
Dallas4902200
Clarke474083
Pike4722105
Geneva4567126
Winston4493103
Lawrence4286117
Bibb423686
Barbour356576
Marengo337489
Monroe330863
Randolph328263
Butler325396
Pickens314182
Henry311865
Hale310688
Cherokee301660
Fayette291379
Washington251151
Cleburne247160
Crenshaw244075
Clay241268
Macon231763
Lamar219547
Conecuh185753
Coosa179439
Lowndes174464
Wilcox167839
Bullock151644
Perry138440
Sumter132038
Greene126244
Choctaw87827
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