FDA to authorize Pfizer's Covid-19 vaccine for 12-to-15-year-olds by early next week, official says

The US Food and Drug Administration is poised to authorize Pfizer/BioNTech's coronavirus vaccine in children and teens ages 12 to 15 by early next week, a fe...

Posted: May 4, 2021 9:16 AM
Updated: May 4, 2021 10:00 AM

The US Food and Drug Administration is poised to authorize Pfizer/BioNTech's coronavirus vaccine in children and teens ages 12 to 15 by early next week, a federal government official tells CNN.

Pfizer has applied for emergency use authorization for its coronavirus vaccine for teens and children ages 12 to 15. The FDA will have to amend the emergency use authorization for the vaccine, but the process should be straightforward, said the official, who was not authorized to speak about the process publicly and requested anonymity.

The FDA is currently reviewing data submitted by Pfizer to support the extended use. Pfizer said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed its efficacy is 100% and it is well tolerated. The vaccine is currently authorized in the US for emergency use in people 16 and older.

Before issuing the EUAs for the three authorized coronavirus vaccines, the FDA held meetings of its independent Vaccines and Related Biological Products Advisory Committee to review the data and vote on whether to recommend EUA.

That will not happen in extending EUA to 12-to-15-year-olds, the FDA has told CNN.

'While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,' the FDA said in an email to CNN last week.

'Based on an initial evaluation of the information submitted, at this time, the agency does not plan to hold a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on this request to amend the EUA for the Pfizer-BioNTech COVID-19 Vaccine, which was discussed and recommended for authorization at a VRBPAC meeting in December 2020. As with all FDA-authorized COVID-19 vaccines, we are committed to transparency with this EUA review process.'

A US Centers for Disease Control and Prevention advisory committee known as the Advisory Committee on Immunization Practices will schedule a meeting for after any FDA decision to extend the EUA to new age groups. ACIP will advise CDC on whether to recommend use of the vaccine in 12-to-15-year-olds, and then CDC Director Dr. Rochelle Walensky will decide whether the agency will recommend its use in the new age group.

Covid-19 vaccines for younger children

Pfizer said Tuesday morning it expects to submit for FDA emergency use authorization for its Covid-19 for children ages 2 to 11 years old in September. The vaccine safety and efficacy study in children age 6 months to 11 years old is ongoing.

'We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September,' Pfizer CEO Alert Bourla said Tuesday during a call with investors.

Bourla said the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.

Moderna is also testing its vaccine in children as young as 6 months and expect to ask the FDA for EUA covering infants and children later this year.

Extending EUA to younger children will be a different from what's happening with older children and young teens, the federal government official said.

'In the older group of children if there is nothing exceptional, if everything looks very similar to adults, the feeling is that it is not necessary to take this to an advisory committee meeting,' the government official said. 'For the younger children, we almost certainly will consider more strongly going to an advisory committee meeting.'

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 512632

Reported Deaths: 10262
CountyCasesDeaths
Harrison34853555
DeSoto33162432
Hinds32556641
Jackson24830389
Rankin22442402
Lee16238242
Madison14874283
Jones14086247
Forrest13741259
Lauderdale12249324
Lowndes11286193
Lamar10644140
Pearl River9707244
Lafayette8827143
Hancock7835132
Washington7550169
Oktibbeha7204138
Monroe6989179
Pontotoc6970109
Warren6849178
Panola6746134
Neshoba6726210
Marshall6653141
Bolivar6440151
Union633897
Pike5924156
Alcorn5862107
Lincoln5525136
George510180
Prentiss500884
Tippah490282
Itawamba4829107
Scott477499
Adams4766125
Tate4748116
Leflore4723144
Copiah455895
Yazoo455591
Simpson4543117
Wayne442772
Covington432895
Sunflower4299106
Marion4265112
Coahoma4227109
Leake413790
Newton395581
Tishomingo381793
Grenada3775109
Stone365666
Jasper340166
Attala337790
Winston317792
Chickasaw313367
Clay311878
Clarke301195
Calhoun284449
Holmes271289
Smith268952
Yalobusha243747
Tallahatchie231453
Greene224749
Walthall221366
Lawrence217840
Perry213356
Amite209557
Webster205148
Noxubee188642
Montgomery181557
Carroll174441
Jefferson Davis173643
Tunica163239
Benton152639
Kemper144941
Choctaw136527
Claiborne134238
Humphreys131139
Franklin124929
Quitman107528
Wilkinson105939
Jefferson96834
Sharkey65121
Issaquena1957
Unassigned00

Alabama Coronavirus Cases

Cases: 844951

Reported Deaths: 16115
CountyCasesDeaths
Jefferson1161002006
Mobile741871379
Madison53279732
Shelby38325368
Baldwin38068589
Tuscaloosa36009641
Montgomery34482781
Lee25550263
Calhoun22585518
Morgan22451406
Etowah20013517
Marshall18777316
Houston17727425
St. Clair16875358
Limestone16135218
Cullman16044303
Elmore15904294
Lauderdale14968306
Talladega14189299
DeKalb12967269
Walker12020380
Blount10714192
Autauga10517157
Jackson10157194
Coffee9414192
Colbert9334208
Dale9018191
Tallapoosa7254201
Russell707765
Chilton7018170
Escambia6955143
Covington6932195
Franklin6340108
Chambers5783142
Marion5401130
Dallas5285209
Pike5118109
Clarke484986
Lawrence4826129
Winston4780110
Geneva4642136
Bibb434094
Barbour369480
Butler3434100
Marengo342393
Monroe337066
Randolph334367
Pickens333188
Fayette330085
Henry320666
Hale318189
Cherokee317563
Crenshaw260477
Washington256952
Cleburne254460
Lamar251253
Clay250869
Macon244764
Conecuh192762
Coosa184947
Lowndes178168
Wilcox177438
Bullock152645
Perry141840
Sumter139241
Greene130245
Choctaw93228
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