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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 10:48 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: 482902

Reported Deaths: 9425
CountyCasesDeaths
Harrison33063488
Hinds31021589
DeSoto30610358
Jackson23687348
Rankin21340370
Lee14909220
Madison14166271
Jones13404227
Forrest13160240
Lauderdale11601305
Lowndes10443176
Lamar10214130
Pearl River9098221
Lafayette8241137
Hancock7514112
Washington7102150
Oktibbeha6964124
Monroe6514164
Neshoba6475201
Warren6464164
Pontotoc630393
Panola6250126
Marshall6126123
Bolivar6115144
Union574186
Pike5613136
Alcorn537290
Lincoln5303131
George471472
Scott459196
Leflore4476140
Prentiss446779
Tippah446480
Itawamba4444100
Adams4416116
Tate4394101
Simpson4335112
Wayne433066
Copiah431787
Yazoo423386
Covington415792
Sunflower4148104
Marion4099104
Leake397586
Coahoma3957100
Newton370875
Grenada3556104
Stone350860
Tishomingo336289
Attala325387
Jasper314162
Winston304691
Clay296473
Chickasaw287065
Clarke282190
Calhoun266141
Holmes262187
Smith250649
Yalobusha221047
Tallahatchie220450
Walthall211058
Greene209045
Lawrence206833
Perry199953
Amite198452
Webster196542
Noxubee178939
Montgomery172454
Jefferson Davis168342
Carroll162137
Tunica153334
Benton142535
Kemper138640
Choctaw127026
Claiborne126834
Humphreys126637
Franklin116728
Quitman103926
Wilkinson101936
Jefferson91333
Sharkey63020
Issaquena1926
Unassigned00

Alabama Coronavirus Cases

Cases: 789054

Reported Deaths: 14022
CountyCasesDeaths
Jefferson1115991765
Mobile708511234
Madison49865633
Shelby36274315
Baldwin36242495
Tuscaloosa33931548
Montgomery33190678
Lee22680220
Calhoun21211410
Morgan19816335
Etowah19300462
Marshall17680274
Houston16823386
St. Clair15442305
Cullman14602258
Limestone14581188
Elmore14480264
Lauderdale13520281
Talladega12958236
DeKalb12199237
Walker10588330
Blount9720157
Autauga9667137
Jackson9385158
Coffee8882175
Dale8609173
Colbert8534184
Tallapoosa6673181
Escambia6591121
Covington6452167
Chilton6385144
Russell607255
Franklin5795101
Chambers5416134
Marion4800120
Dallas4705189
Clarke463279
Pike462397
Geneva4413117
Winston425895
Lawrence4117108
Bibb409381
Barbour347270
Marengo326285
Monroe320053
Butler318290
Randolph305956
Pickens305274
Henry301858
Hale292685
Cherokee289855
Fayette279673
Washington245448
Crenshaw238470
Cleburne235851
Clay228565
Macon220158
Lamar197743
Conecuh182046
Lowndes170758
Coosa170235
Wilcox159736
Bullock149243
Perry136537
Sumter124536
Greene121443
Choctaw73427
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While some cool mornings are again in store for the weekend, afternoons start to warm up a bit, so plan on dressing in layers if you're heading to the MSU or Bama games, because you'll need to utilize them in different ways.
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