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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: 497790

Reported Deaths: 9917
CountyCasesDeaths
Harrison34102530
DeSoto31839398
Hinds31837622
Jackson24314377
Rankin21881388
Lee15427234
Madison14525279
Jones13772241
Forrest13412250
Lauderdale11937314
Lowndes10934185
Lamar10470135
Pearl River9431237
Lafayette8454138
Hancock7697126
Washington7365156
Oktibbeha7111129
Monroe6727174
Warren6642176
Pontotoc6609101
Neshoba6606205
Panola6460131
Marshall6386132
Bolivar6266145
Union596094
Pike5784152
Alcorn5633101
Lincoln5417134
George491879
Scott470998
Tippah465381
Prentiss464181
Leflore4627143
Itawamba4596104
Adams4570119
Tate4546109
Copiah445191
Simpson4421116
Wayne438572
Yazoo438586
Covington427394
Marion4216107
Sunflower4215104
Coahoma4115104
Leake407787
Newton380879
Grenada3692108
Stone358464
Tishomingo356391
Attala330289
Jasper328265
Winston313191
Clay306375
Chickasaw296767
Clarke290694
Calhoun277945
Holmes266987
Smith262550
Yalobusha232647
Tallahatchie225251
Walthall217763
Greene215548
Lawrence211140
Perry204755
Amite203954
Webster201645
Noxubee185340
Montgomery179056
Jefferson Davis170642
Carroll167438
Tunica158639
Benton147438
Kemper141241
Choctaw133026
Claiborne131237
Humphreys129038
Franklin119128
Quitman106227
Wilkinson104539
Jefferson94234
Sharkey64020
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 813481

Reported Deaths: 15179
CountyCasesDeaths
Jefferson1139971910
Mobile722271323
Madison51970686
Shelby37279341
Baldwin37069540
Tuscaloosa34934599
Montgomery33953725
Lee23142240
Calhoun22142470
Morgan20639372
Etowah19758496
Marshall18245300
Houston17302405
St. Clair15912337
Cullman15306290
Limestone15202198
Elmore15075284
Lauderdale14143294
Talladega13715272
DeKalb12569259
Walker11085366
Blount10094174
Autauga9893146
Jackson9789180
Coffee9182189
Dale8859181
Colbert8789200
Tallapoosa7044195
Escambia6732127
Covington6682179
Chilton6587160
Russell625958
Franklin5930105
Chambers5559142
Marion4955126
Dallas4882199
Clarke472782
Pike4719105
Geneva4564126
Winston4473101
Lawrence4264117
Bibb421686
Barbour355475
Marengo334089
Monroe330262
Randolph327063
Butler324794
Pickens313882
Henry310965
Hale309187
Cherokee299957
Fayette290679
Washington250951
Cleburne246958
Crenshaw243575
Clay240367
Macon230562
Lamar215846
Conecuh185652
Coosa178538
Lowndes173761
Wilcox167438
Bullock151744
Perry138040
Sumter131038
Greene125544
Choctaw86927
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Columbus
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A cold front passing through our area overnight will bring into our area some of the coolest temperatures of the season so far. We will see most of the highs this weekend only in the upper 60s to lower 70s. While overnight lows will drop off down into the 40s Saturday night.
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