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 3, 2021 4:31 PM

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.

Pfizer and Moderna both are testing their vaccines in children as young as 6 months and expect to ask the FDA for EUAs covering infants and children later this year.

Extending EUA to younger children will be a different matter, the 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 official said. "For the younger children, we almost certainly will consider more strongly going to an advisory committee meeting."

Maryland-based Novavax, meanwhile, announced Monday it has expanded its Phase 3 trial for its Covid-19 vaccine to include up to 3,000 children ages 12 to 17 across the United States. They will receive the vaccine candidate or placebo in two doses 21 days apart.

Novavax's Covid-19 vaccine is not yet authorized for emergency use in the United States.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 314841

Reported Deaths: 3624
CountyCasesDeaths
Multnomah51325643
Washington35086277
Marion32748396
Clackamas26680275
Lane24145248
Jackson21050257
Deschutes16703103
Umatilla12736125
Douglas10795188
Linn1051487
Josephine8685169
Yamhill752099
Klamath651892
Polk629171
Malheur485567
Benton463728
Coos420669
Columbia325439
Jefferson315347
Lincoln277930
Union274838
Wasco242339
Crook213639
Clatsop213225
Tillamook182023
Baker176123
Morrow168621
Curry167817
Hood River163435
Harney82319
Grant7848
Lake6988
Wallowa50811
Gilliam1374
Sherman1283
Wheeler651
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 4651497

Reported Deaths: 68087
CountyCasesDeaths
Los Angeles144634825870
Riverside3583834802
San Diego3502674021
San Bernardino3475745507
Orange3150815355
Sacramento1507202105
Santa Clara1407321841
Kern1362881521
Fresno1361631889
Alameda1164051330
Ventura978991120
San Joaquin975341615
Contra Costa95858924
Stanislaus808921235
Tulare73111896
San Mateo52311607
San Francisco52008605
Monterey49485565
Solano44247312
Santa Barbara43189500
Sonoma39476378
Merced39446536
Placer36612364
Imperial34285755
Kings30179285
San Luis Obispo28351313
Madera21749263
Butte21379231
Shasta20763279
Santa Cruz20176211
Yolo19192239
Marin17127242
El Dorado16037127
Sutter13122153
Napa1228795
Yuba928061
Nevada850185
Humboldt831988
Tehama827784
San Benito709567
Mendocino691176
Lassen637927
Tuolumne616993
Lake605887
Amador493059
Glenn399030
Siskiyou391541
Calaveras342766
Del Norte339034
Colusa291018
Inyo166739
Mono14935
Plumas12406
Mariposa100712
Trinity72610
Modoc6278
Unassigned2120
Sierra1980
Alpine1000
Out of CA00
Medford
Clear
64° wxIcon
Hi: 80° Lo: 52°
Feels Like: 64°
Brookings
Clear
66° wxIcon
Hi: 81° Lo: 53°
Feels Like: 66°
Crater Lake
Clear
64° wxIcon
Hi: 58° Lo: 42°
Feels Like: 64°
Grants Pass
Partly Cloudy
64° wxIcon
Hi: 82° Lo: 50°
Feels Like: 64°
Klamath Falls
Clear
63° wxIcon
Hi: 73° Lo: 49°
Feels Like: 63°
Cooler afternoon temperatures and thin haze return on the first day of fall
KDRV Radar
KDRV Fire Danger
KDRV Weather Cam

Community Events