Pfizer asks FDA to allow Covid-19 vaccine for children 12 to 15 years old

Pfizer on Friday asked the FDA for an amendment to its emergency use authorization of its Covid-19 vaccine to expand its use in people ages 12-15 in the United States.

Posted: Apr 9, 2021 2:34 PM

(CNN) -- Pfizer on Friday asked the FDA for an amendment to its emergency use authorization of its Covid-19 vaccine to expand its use in people ages 12-15 in the United States.

The pharmaceutical company said in a statement it will seek similar rulings by other authorities around the world in coming days.

"These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine," Pfizer said in a statement.

The FDA currently allows the vaccine's use in people 16 and up.

The other two Covid-19 vaccines -- made by Moderna and Johnson & Johnson -- are authorized for emergency use in people age 18 and older.

Meanwhile, as the country races against Covid-19 variants, more than 1 in 4 adults are now fully vaccinated.

While more than 66 million people have received two doses, more than a third of Americans -- or 112 million -- have received at least one dose, according to data published Thursday by the US Centers for Disease Control and Prevention.

Officials and experts hope to get Americans vaccinated quickly as lockdown fatigue takes its toll and many people are letting down their guard just as more transmissible, and perhaps more deadly, variants of the virus become dominant. In that effort, all 50 states have committed to opening vaccinations to all Americans 16 and up by April 19.

"It's almost a race between getting people vaccinated and this surge that seems to want to increase," Dr. Anthony Fauci said earlier this week, noting Europe is experiencing a spike much like the one experts worry about for the US.

The US added 79,878 new cases Thursday, the highest since March 24. And the country is still averaging above 60,000 new cases a day -- a level Fauci, the director of the National Institute for Allergy and Infectious Disease, said puts the US at risk for another surge. Experts are especially concerned about the spread of the B.1.1.7 variant, first identified in the UK and now the dominant strain in the US.

"I wish we had another three or four months before this B.1.1.7 variant surge started to occur," Dr. Michael Osterholm, director for the Center for Infectious Disease Research and Policy at the University of Minnesota, said this week.

As states including California and Vermont plan to fully reopen this summer, experts are warning that to truly declare victory against the variants, Americans need to get vaccinated and continue measures like social distancing and mask wearing.

Experts address vaccine reaction concerns
Though some in the public have expressed concern over their possible adverse reactions to vaccines, health experts are advising that the benefits outweigh the risks.

On Thursday, the Colorado Department of Public Health and Environment (CDPHE) said it determined that the adverse reaction suffered by 11 people who received the Johnson & Johnson vaccine at the Dick's Sporting Goods Park vaccination site was "no cause for concern."

"After reviewing each patient's symptoms, analyzing other vaccinations from the same lot of the vaccine and speaking with the CDC to confirm our findings, we are confident in saying that there is no reason for concern," Dr. Eric France, chief medical officer with CDPHE said.

Meanwhile, the National Institutes of Health has begun a clinical trial to determine whether people who are highly allergic or have mast cell disorder are more likely to experience an immediate allergic reaction to the Moderna or Pfizer-BioNTech Covid-19 vaccines, according the agency's news release.

Mast cell disorder is caused by an abnormal accumulation of a type of white blood cell that leads to allergic reactions.

"The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines," Fauci said. "The information gathered during this trial will help doctors advise people who are highly allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of COVID-19 vaccination far outweigh the risks."

Universities aim to protect against outbreaks
Recent cases of Covid-19 are skewing younger, in part because of activities like school sports and because of more older people being vaccinated, Fauci said Wednesday. Now, some universities are implementing policies to avoid further outbreaks among their students.

The University of Chicago issued a stay-at-home order for students living in residence halls for the next seven days, a letter from the dean and vice president said Thursday.

The order comes after more than 50 cases of Covid-19 were detected among students. It is the largest cluster of cases the school has experienced since the beginning of the academic year, according to the letter.

"Many of these cases may have been connected to one or more parties held by off-campus fraternities over the last week," the letter said.

Meanwhile, the University of Notre Dame in Indiana as well as Syracuse University and Ithaca College in New York are joining the growing list of colleges and universities requiring the Covid-19 vaccine for students prior to returning to campuses in the fall.

Several other schools made similar announcements this week. CNN counts 14 college and universities nationwide that have announced they will require students to be fully vaccinated.

"After a long year, this should give all of us hope for a return to a normal campus experience," said Syracuse Chancellor Kent Syverud. "At every turn, you have demonstrated what it means to be Orange by navigating these extraordinary times with grit, grace and determination. Now, I ask that each of you take the next step by being vaccinated."

Correction: An earlier version of this story misstated how many Americans have received at least one dose of Covid-19 vaccine. It is a third of all Americans.

The-CNN-Wire
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Cases: 1363409

Reported Deaths: 24725
CountyCasesDeaths
Cook54578510114
DuPage906281281
Will75577990
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Kane58414774
Winnebago33247475
Madison30525520
McHenry28604288
St. Clair27862514
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Kendall1306094
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Macon10762199
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Adams8466123
Williamson7433130
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Ogle611481
Grundy589375
Clinton576090
Coles568795
Knox5565145
Jackson502764
Henry498167
Livingston482585
Stephenson475983
Woodford475176
Effingham472972
Macoupin470282
Marion4472115
Franklin445075
Monroe435793
Jefferson4296120
Lee416952
Randolph413184
Fulton392756
Morgan390382
Logan388058
Bureau372082
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Christian366773
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Fayette317455
Iroquois302266
McDonough285647
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Saline256454
Lawrence240525
Shelby229837
Union226040
Crawford212026
Bond205024
Cass199225
Jo Daviess181524
Clark179833
Warren179846
Pike179152
Ford178647
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Hancock176032
Carroll175436
Richland175040
Edgar170440
White169726
Washington164525
Moultrie161028
De Witt151324
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Piatt149814
Clay148143
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Johnson144415
Greene143733
Wabash134512
Massac134340
Cumberland129019
Menard123612
Jasper115018
Marshall107318
Hamilton83315
Schuyler7587
Brown7066
Pulaski6877
Stark63823
Edwards57112
Henderson52514
Calhoun5182
Putnam4823
Scott4791
Alexander46811
Gallatin4584
Hardin38612
Pope3224
Out of IL40
Unassigned02356

Indiana Coronavirus Cases

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Cases: 733591

Reported Deaths: 13466
CountyCasesDeaths
Marion1003871748
Lake54020975
Allen40829679
St. Joseph35898552
Hamilton35735408
Elkhart28745442
Tippecanoe22432219
Vanderburgh22342397
Porter18871310
Johnson18028381
Hendricks17283315
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Monroe11928170
Delaware10726187
Howard9959218
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Hancock8325142
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Warrick7792155
Floyd7677178
Grant7080174
Wayne7064199
Boone6722101
Morgan6596139
Dubois6162117
Marshall6083112
Cass5839105
Dearborn582178
Henry5767104
Noble563684
Jackson502773
Shelby493696
Lawrence4571120
Harrison436372
Gibson436292
DeKalb429685
Clinton428153
Montgomery425389
Whitley397439
Huntington393380
Steuben390057
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Ripley340270
Jefferson331581
White315654
Daviess298299
Wells291981
Decatur285692
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Greene280085
Posey271933
LaGrange268370
Scott267254
Clay260647
Washington241832
Randolph241481
Spencer232631
Jennings230649
Starke217854
Fountain213246
Sullivan212142
Owen202156
Jay196730
Fulton195640
Carroll189620
Orange184154
Perry184037
Rush173725
Vermillion169743
Franklin168435
Tipton163045
Parke146616
Blackford135132
Pike135134
Pulaski117145
Newton108334
Brown102641
Crawford101315
Benton99014
Martin89515
Warren82415
Switzerland7938
Union71110
Ohio57111
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