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Moderna says its Covid-19 vaccine is safe and appears effective in adolescents

Moderna's Covid-19 vaccine is safe and appears to be effective in adolescents, the company said Tuesday.In a Phase 2/3 trial of 3,732 children ages 12...

Posted: May 25, 2021 1:10 PM
Updated: May 25, 2021 1:11 PM

Moderna's Covid-19 vaccine is safe and appears to be effective in adolescents, the company said Tuesday.

In a Phase 2/3 trial of 3,732 children ages 12 to 17 in the United States, blood tests showed that the vaccine produced an immune response that was equivalent to earlier findings in adults.

The trial wasn't designed to look specifically at efficacy. However, initial observations found that none of the children who received the vaccine got sick with Covid-19 starting 14 days after their second dose. Four of the children who received the placebo tested positive for Covid-19, which Moderna says is "consistent with a vaccine efficacy of 100%." The company notes that figure could change as more data is collected.

In the trial, a case was defined as someone who had at least two coronavirus symptoms or one symptom and a positive Covid-19 test.

The company also reviewed how well the vaccine worked after just one dose. The results suggest the vaccine was 93% effective after one dose at preventing mild cases of Covid-19, involving only one symptom of coronavirus disease instead of two or more symptoms.

Moderna announced the results Tuesday in a news release, and the results have not yet been peer reviewed or published.

The company said the vaccine was "generally well tolerated" and that no significant safety concerns were identified. Side effects included headache, fatigue, muscle pain and chills after administration of the second dose. Pain at the injection site was also sometimes observed.

Moderna says it plans to submit the results to the US Food and Drug Administration in early June along with a request for authorization to use the vaccine in adolescents. It also plans to submit the data to a peer-reviewed publication.

The Moderna vaccine is already authorized for use in people ages 18 and older. After Moderna asks the FDA for emergency use authorization of its vaccine for adolescents, the agency will review data submitted by the company, potentially consulting its advisers. If the data is solid, the FDA will give the vaccine the green light for this vaccine to be used in younger people.

The FDA has already expanded the emergency use authorization for Pfizer/BioNTech's Covid-19 vaccine to include people ages 12 to 15 earlier this month. The vaccine had previously been authorized for people ages 16 and older.

Because these vaccines have been used safely in adults, vaccine experts said that was a relatively easy process. The Pfizer decision was made without a meeting of the FDA's independent Vaccines and Related Biological Products Advisory Committee. The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices met a few days later to recommend use Pfizer's vaccines in adolescents.

Both Pfizer and Moderna are currently testing their vaccines in younger children, ages 6 months to 11 years. Because those age groups may require varying doses, the process will likely take a little longer.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently said elementary age children likely won't be vaccinated until the end of the year.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 343505

Reported Deaths: 7543
CountyCasesDeaths
Hinds23932444
DeSoto23229283
Harrison20527329
Rankin15411291
Jackson15232252
Madison10959227
Lee10719179
Jones9047169
Forrest8723159
Lauderdale7884244
Lowndes7054151
Lamar702989
Lafayette6548124
Washington5595139
Pearl River5196152
Bolivar4954134
Oktibbeha494398
Panola4771112
Warren4728128
Marshall4701106
Pontotoc447773
Union433279
Monroe4330137
Neshoba4281181
Hancock428088
Lincoln4176116
Pike3667113
Leflore3627125
Tate353388
Alcorn350974
Sunflower347694
Scott341176
Adams340988
Yazoo339376
Copiah324968
Simpson322891
Itawamba314680
Coahoma314085
Tippah306568
Prentiss298863
Covington293484
Leake285475
Marion284181
Wayne277543
George272251
Grenada269488
Newton262364
Tishomingo239770
Winston236784
Jasper230648
Stone229637
Attala226373
Chickasaw219060
Holmes200174
Clay197654
Clarke186880
Tallahatchie183742
Calhoun181332
Smith179235
Yalobusha171540
Walthall145748
Lawrence142826
Greene140134
Amite137543
Noxubee135235
Perry133538
Montgomery133044
Carroll126431
Webster121232
Jefferson Davis116734
Tunica114227
Benton106725
Claiborne105331
Kemper102429
Humphreys100133
Franklin87923
Quitman84719
Choctaw82619
Wilkinson78032
Jefferson71328
Sharkey51618
Issaquena1736
Unassigned00

Alabama Coronavirus Cases

Cases: 585607

Reported Deaths: 11536
CountyCasesDeaths
Jefferson851431591
Mobile48584864
Madison37411533
Shelby27192257
Tuscaloosa27145465
Montgomery26119627
Baldwin25207329
Lee17184181
Calhoun15382334
Morgan15147291
Etowah14928370
Marshall13079235
Houston12021293
Elmore10890219
St. Clair10737252
Limestone10699158
Cullman10503205
Lauderdale10240254
DeKalb9498192
Talladega8935188
Walker7775288
Autauga7537114
Jackson7384117
Blount7352139
Colbert6691142
Coffee6342132
Dale5605117
Russell478943
Chilton4763117
Covington4738125
Franklin456681
Tallapoosa4511156
Escambia439283
Chambers3936125
Dallas3742163
Clarke370563
Marion3455107
Pike332079
Lawrence3257100
Winston298373
Bibb289765
Geneva282883
Marengo262267
Barbour250661
Pickens245262
Butler240172
Hale235178
Fayette226765
Henry212845
Monroe201541
Randolph200344
Cherokee198848
Washington184339
Macon169752
Crenshaw167758
Clay165659
Cleburne161145
Lamar150938
Lowndes145355
Wilcox132331
Bullock126542
Conecuh120632
Coosa118129
Perry110328
Sumter110333
Greene99137
Choctaw64425
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