Pfizer/BioNTech says its Covid-19 vaccine is 100% effective and well tolerated in adolescents

Clinical trial results of Pfizer/BioNTech's Covid-19 vaccine showed its efficacy is 100% and it is well tolerated in youths ages 12 to 15, the companies said...

Posted: Mar 31, 2021 10:48 AM

Clinical trial results of Pfizer/BioNTech's Covid-19 vaccine showed its efficacy is 100% and it is well tolerated in youths ages 12 to 15, the companies said Wednesday.

Pfizer/BioNTech plan to submit the data to the US Food and Drug Administration as soon as possible for expanded emergency use authorization of the two-dose vaccine.

In a Phase 3 trial of 2,260 participants ages 12 to 15 in the US, the vaccine elicited strong antibody responses one month after the second dose -- exceeding those demonstrated in people ages 16 to 25 in previous trials, Pfizer reported. The vaccine is currently authorized in the US for emergency use in people 16 and older.

Researchers observed 18 Covid-19 cases among the 1,129 participants who were given a placebo, and none among the 1,131 volunteers who got the vaccine. The data has yet to be peer reviewed.

Pfizer/BioNTech added that the side effects seen in the young teens were similar to those seen among 16 to 25-year-olds. Common side effects include pain at the injection site, fatigue and fever. The participants will be monitored for protection and safety for two years after their second dose.

Those comparisons to the older population are important, because researchers are building off of the knowledge they gained in the adult trials.

Researchers can define a number of antibodies that are a correlate of the protection seen in adults, and then look for that level of antibodies in pediatric participants to know that the vaccine is providing protection. That's why the Covid-19 vaccine trials in children and adolescents have generally required fewer volunteers than the adult trials.

"We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," said Pfizer CEO Albert Bourla. "We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year."

Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital, said on CNN's New Day Wednesday, said schools can open without vaccinating students, but vaccines will help.

"I think it's likely a green light to move forward, to move down in terms of vaccinating adolescents 12 to 15," Hotez said, noting that the vaccine will still need to be evaluated for authorization in that age group.

"The bottom line is that by the fall I think there's a good possibility we'll be vaccinating teenagers, 12 and up, and for middle schools, junior high schools, high schools, it's really good news in the United States for both teachers and staff. We'll have teachers and staff vaccinated, we'll have the students vaccinated in those middle schools and high schools."

A return to the classroom isn't the only factor at play. Health experts have emphasized the importance of protecting as many people as possible through vaccination, as more infectious Covid-19 variants continue to spread throughout the nation.

"We all long for a normal life. This is especially true for our children," said BioNTech CEO Ugur Sahin. "The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant."

Pfizer recently told CNN that the safety demonstrated in this adolescent trial helped the company make the decision to begin testing its vaccine in younger children.

A separate Phase 1/2/3 study of the Pfizer/BioNTech vaccine in children ages 6 months to 11 years launched last week, when the first children ages 5 to 11 received a shot. Pfizer/BioNTech plans to begin dosing 2 to 5-year-olds next week and work its way down to participants ages 6 months to 2 years. The company aims to enroll 4,644 children in the trial and expects results by the end of 2021.

Moderna is also testing its vaccine in adolescents and children, in two clinical trials of children ages 12 to 17 and those ages 6 months to 11 years.

Experts anticipate Covid-19 vaccines won't be available for children 11 and younger in time for the upcoming school year. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said those younger children may have to wait until the first quarter of 2022.

Dr. Buddy Creech, director of Vanderbilt University's Vaccine Research Program and an investigator in Moderna's pediatric trials, estimates a Covid-19 vaccine could be available for high-risk kids 12 and older by July or August, but likely won't be available for children 11 and younger until November or December, at the earliest.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 313166

Reported Deaths: 7228
CountyCasesDeaths
DeSoto21496257
Hinds20294414
Harrison17814309
Rankin13573278
Jackson13411246
Madison10066217
Lee9962173
Jones8364163
Forrest7649152
Lauderdale7181240
Lowndes6370145
Lamar621686
Lafayette6171118
Washington5323133
Bolivar4797132
Oktibbeha461498
Panola4561105
Pearl River4499145
Marshall4397103
Warren4380121
Pontotoc419572
Monroe4100133
Union409076
Neshoba4026176
Lincoln3950110
Hancock377786
Leflore3487125
Sunflower335790
Tate332484
Pike3301105
Scott315373
Alcorn311968
Yazoo310769
Itawamba299477
Copiah296465
Simpson294788
Coahoma294379
Tippah287768
Prentiss279560
Adams269582
Marion268880
Leake266273
Wayne262341
Grenada260386
Covington256381
George246848
Newton246061
Winston226881
Tishomingo225967
Jasper220848
Attala214173
Chickasaw207157
Holmes188673
Clay184754
Stone182033
Tallahatchie178140
Clarke177879
Calhoun170132
Yalobusha163337
Smith162234
Walthall133845
Greene130333
Lawrence128323
Montgomery126742
Noxubee126734
Perry125938
Amite122842
Carroll121728
Webster114532
Jefferson Davis106932
Tunica104826
Claiborne102230
Benton99125
Humphreys96133
Kemper95428
Franklin83623
Quitman80216
Choctaw76118
Wilkinson66930
Jefferson65428
Sharkey50317
Issaquena1686
Unassigned00

Alabama Coronavirus Cases

Cases: 530988

Reported Deaths: 10978
CountyCasesDeaths
Jefferson765291522
Mobile40971804
Madison34751503
Tuscaloosa25775452
Montgomery24329589
Shelby23431249
Baldwin21131308
Lee15884171
Calhoun14501314
Morgan14293279
Etowah13831353
Marshall12222223
Houston10567281
Elmore10061205
Limestone9960151
Cullman9664193
St. Clair9655243
Lauderdale9424241
DeKalb8830186
Talladega8223176
Walker7235277
Autauga6920108
Jackson6810112
Blount6660137
Colbert6298134
Coffee5511119
Dale4831111
Russell441138
Chilton4290112
Franklin425782
Covington4121118
Tallapoosa4027152
Escambia393376
Chambers3563123
Dallas3551151
Clarke351061
Marion3118101
Pike310877
Lawrence300298
Winston274472
Bibb260764
Geneva249977
Marengo249764
Pickens234461
Barbour230857
Hale222977
Butler215969
Fayette212362
Henry188744
Cherokee184845
Randolph180241
Monroe177440
Washington167339
Macon159150
Clay156256
Crenshaw152257
Cleburne148941
Lamar142535
Lowndes138853
Wilcox127130
Bullock123041
Conecuh110529
Perry107726
Coosa107228
Sumter104532
Greene92334
Choctaw60624
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