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US FDA authorizes Pfizer's Covid-19 vaccine for use in people ages 12 to 15

Is the staff vaccinated? Are masks required? Dr. Leana Wen tells you what you need to know before sending your kids to summer camp.

Posted: May 11, 2021 10:11 AM
Updated: May 11, 2021 10:57 AM


The US Food and Drug Administration expanded the emergency use authorization for Pfizer's Covid-19 vaccine on Monday to include people ages 12 to 15.

This is the first Covid-19 vaccine in the United States authorized for use in younger teens and adolescents; the vaccine had previously been authorized for people age 16 and older. Covid-19 vaccines from Moderna and Johnson & Johnson are authorized for use in people age 18 and older.

To support the extended use, the FDA reviewed data submitted by Pfizer. The company said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed the vaccine's efficacy is 100% and it is well tolerated.

"It was a relatively straightforward decision," Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research, the arm of the FDA that regulates vaccines, told reporters Monday evening.

The FDA looked at the Pfizer safety and efficacy data. The agency also looked at the immune responses of some of the children who were vaccinated, and compared them to the immune responses of older teens and adults who got the shot.

"The response to the vaccine was excellent and in fact it was even better, really, in the younger age group than it was in the 16-25 age group," Marks said.

"The safety profile was very similar in 12-15-year-olds as in 16-25-year-olds."

"FDA has done everything we can to ensure that the Covid-19 vaccines we have authorized have met the agency's high standards for quality, safety and effectiveness. We know that every time an American, including members of our own families, receives a Covid-19 vaccine dose, you are putting your trust in us," FDA Acting Commissioner Dr. Janet Woodcock told the briefing.

The FDA's independent Vaccines and Related Biological Products Advisory Committee did not meet to vote on whether to recommend the expansion of the EUA to 12-to-15-year-olds.

But the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to meet Wednesday to advise CDC on whether to recommend use of the vaccine in this age group. CDC Director Dr. Rochelle Walensky will then decide whether the agency will recommend the vaccine's use in the new group.

Vaccinations for 12-to-15-year-olds are not expected to begin until after that recommendation. The Biden administration has said it will quickly mobilize to ready vaccinations for 12-to-15-year-olds through the federal pharmacy program, pediatricians and family doctors.

States make the decision on who gives the vaccines, and when.

"It may be that the local pharmacy will not be able to administer because they may not be able to give a vaccine to someone younger than 16 or 17 years of age," Marks said.

"And with good reason. A 12-year-old is not the same, emotionally, as an 18-year-old. There is a difference there. So there may be differences from state to state and from location to location."

The FDA does not decide that question, Marks added. "Our authorization is for across all the United States, its territories, so it applies everywhere. It's just who will administer the vaccine may vary from jurisdiction to jurisdiction. We don't regulate the practice of medicine at FDA. We regulate these products. How they are administered may be regulated different in some states in terms of who can give a vaccine to a 12-year-old," added Marks.

State licensing boards make these decisions, said Woodcock.

"These are the state licensing boards, OK. They have the board of pharmacy, the board of medicine," Woodcock said. "And then there are different criteria under that. And local rules and regulations are what we are talking about. And then they permit the conditions of practice. So the states regulate those conditions of practice."

Expanding authorization to people 12 to 15 opens Covid-19 vaccination to another 5% of the US population, nearly 17 million more people. The expanded authorization means 85% of the US population is eligible to receive a Covid-19 vaccine.

"The light at the end of the tunnel is growing, and today it got a little brighter," President Joe Biden said in a statement.

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

The FDA also scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for June 10 to discuss the potential extension of EUA to children under 12.

"During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age," the FDA said in a statement Monday.

"The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products," it added. A BLA would mean full FDA approval.

Vaccines made by Moderna and by Johnson & Johnson are currently authorized for use in people 18 and older.

"We recognize that the next critical step is having vaccines available for use throughout the pediatric population," Marks said in a statement.

"As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range."

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 752108

Reported Deaths: 13816
CountyCasesDeaths
Marion1033831790
Lake558431013
Allen41736693
St. Joseph37007565
Hamilton36617417
Elkhart29425461
Tippecanoe22938228
Vanderburgh22565400
Porter19369327
Johnson18486389
Hendricks17696317
Clark13233195
Madison13176344
Vigo12631253
LaPorte12429221
Monroe12226176
Delaware10970198
Howard10349224
Kosciusko9643121
Hancock8578147
Bartholomew8174157
Warrick7864156
Floyd7815180
Grant7248179
Wayne7164201
Boone6979103
Morgan6768141
Dubois6224118
Marshall6214116
Cass6024110
Henry5903110
Dearborn589878
Noble581688
Jackson509476
Shelby502396
Lawrence4753122
Gibson445595
Clinton443555
Harrison441775
DeKalb440385
Montgomery439890
Whitley406744
Huntington403381
Steuben400859
Miami395769
Jasper389155
Knox377691
Putnam373461
Wabash362383
Ripley347370
Adams345555
Jefferson336186
White332753
Daviess3035100
Wells295481
Decatur289892
Greene286885
Fayette284864
Posey274335
LaGrange273272
Scott270356
Clay267148
Washington246336
Randolph245183
Jennings235349
Spencer234531
Starke228159
Fountain222048
Sullivan214843
Owen212358
Fulton204043
Jay201032
Carroll193820
Orange188255
Perry187237
Rush175926
Vermillion175344
Franklin170435
Tipton166646
Parke149616
Pike138334
Blackford136232
Pulaski120847
Newton114936
Brown104443
Benton102614
Crawford102516
Martin91815
Warren84115
Switzerland8158
Union72810
Ohio57911
Unassigned0424

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1109697

Reported Deaths: 20213
CountyCasesDeaths
Franklin1289521469
Cuyahoga1158802216
Hamilton814201251
Montgomery525861049
Summit484551006
Lucas43384824
Butler39098606
Stark33355930
Lorain25689506
Warren24612305
Mahoning22388602
Lake21219389
Clermont20138253
Delaware18892136
Licking16671225
Fairfield16589204
Trumbull16560483
Medina15618273
Greene15292248
Clark14244306
Wood13296200
Portage13254216
Allen11919239
Richland11611211
Miami10857225
Wayne9153225
Columbiana9039230
Muskingum8909135
Pickaway8664122
Tuscarawas8654251
Marion8649139
Erie8058165
Ashtabula7171179
Hancock6999133
Ross6948163
Geauga6850151
Scioto6540106
Belmont6159174
Union585049
Lawrence5741102
Jefferson5683159
Huron5554122
Sandusky5444126
Darke5420129
Seneca5350128
Washington5321109
Athens524460
Auglaize502487
Mercer487785
Shelby477095
Knox4573112
Madison444566
Ashland435997
Putnam4336104
Defiance432399
Fulton432274
Crawford4046110
Brown402761
Logan387678
Preble3859105
Clinton379266
Ottawa373581
Highland360266
Williams348578
Champaign344959
Guernsey325254
Jackson318454
Perry297350
Morrow291940
Fayette285750
Hardin275765
Henry273867
Holmes2703101
Coshocton269360
Van Wert247264
Adams243156
Pike242835
Gallia240850
Wyandot234756
Hocking220663
Carroll197548
Paulding176642
Meigs148540
Monroe136345
Noble136239
Harrison114138
Morgan110124
Vinton85717
Unassigned03
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Angola
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