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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 10:47 AM
Updated: 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: 473413

Reported Deaths: 9214
CountyCasesDeaths
Harrison32339474
Hinds30703575
DeSoto29814346
Jackson23263336
Rankin21111358
Lee14600217
Madison14043265
Jones13165218
Forrest12953233
Lauderdale11418297
Lowndes10249175
Lamar10048128
Pearl River8737209
Lafayette8078136
Hancock7324111
Washington6837147
Oktibbeha6820118
Neshoba6404201
Monroe6372158
Warren6326161
Pontotoc610393
Panola6071124
Bolivar6016143
Marshall5972118
Union564086
Pike5491133
Lincoln5232130
Alcorn520888
George457868
Scott451993
Leflore4401140
Prentiss437276
Itawamba436198
Tippah436180
Simpson4268111
Copiah425586
Wayne424863
Tate4234100
Adams4219114
Yazoo415886
Sunflower4088104
Covington407391
Marion4032100
Leake393185
Coahoma388198
Newton364474
Grenada3517101
Stone345657
Tishomingo324888
Attala321185
Jasper310262
Winston300391
Clay288273
Chickasaw282164
Clarke277487
Calhoun259739
Holmes259485
Smith243947
Yalobusha216747
Tallahatchie215649
Walthall205557
Greene204045
Lawrence203831
Perry196453
Amite193751
Webster191941
Noxubee174538
Montgomery169853
Jefferson Davis165541
Carroll159937
Tunica148434
Benton139433
Kemper137439
Claiborne125634
Choctaw124925
Humphreys123337
Franklin115227
Quitman101825
Wilkinson99835
Jefferson86632
Sharkey62120
Issaquena1916
Unassigned00

Alabama Coronavirus Cases

Cases: 764839

Reported Deaths: 13048
CountyCasesDeaths
Jefferson1089971721
Mobile698041173
Madison48181574
Baldwin35619445
Shelby35053289
Tuscaloosa32903508
Montgomery32475655
Lee21787203
Calhoun19941374
Morgan19234315
Etowah18509422
Marshall17217258
Houston16028347
St. Clair14866275
Limestone14059179
Elmore13943241
Cullman13942234
Lauderdale13030266
Talladega12307211
DeKalb11829226
Walker10171306
Autauga9439124
Blount9357149
Jackson9055136
Coffee8625157
Colbert8287164
Dale8241151
Escambia6436103
Tallapoosa6353166
Covington6291154
Chilton6215129
Russell590154
Franklin561294
Chambers5211130
Dallas4610176
Marion4579114
Clarke449471
Pike448289
Geneva4223102
Winston404685
Lawrence4040101
Bibb394776
Barbour337067
Marengo319979
Monroe310346
Butler308483
Pickens298369
Randolph291655
Henry291455
Hale285281
Cherokee278249
Fayette270671
Washington242645
Crenshaw231664
Clay220761
Macon213254
Cleburne208746
Lamar186339
Conecuh176538
Lowndes168756
Coosa162531
Wilcox153934
Bullock146842
Perry134035
Sumter122935
Greene118541
Choctaw72225
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