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Moderna announced the results Tuesday in a news release, and the results have not yet been peer reviewed or published.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: 515504

Reported Deaths: 10296
CountyCasesDeaths
Harrison34999558
DeSoto33360432
Hinds32743643
Jackson24906392
Rankin22565405
Lee16455245
Madison14954283
Jones14158248
Forrest13834260
Lauderdale12311323
Lowndes11357193
Lamar10693140
Pearl River9748244
Lafayette8868143
Hancock7849132
Washington7559169
Oktibbeha7229138
Monroe7068179
Pontotoc7033110
Warren6885178
Panola6791135
Neshoba6744210
Marshall6707142
Bolivar6468151
Union643598
Pike5942157
Alcorn5921107
Lincoln5540136
George510680
Prentiss508285
Tippah495683
Itawamba4884107
Scott478999
Tate4777117
Adams4776125
Leflore4749144
Copiah458195
Yazoo458092
Simpson4566117
Wayne443472
Covington434895
Sunflower4319106
Marion4295112
Coahoma4244110
Leake414191
Newton396182
Tishomingo386894
Grenada3789109
Stone366166
Jasper341266
Attala340490
Chickasaw318367
Winston318392
Clay312978
Clarke301695
Calhoun286850
Holmes272889
Smith270552
Yalobusha244947
Tallahatchie232353
Greene225149
Walthall222166
Lawrence220242
Perry214556
Amite210357
Webster206548
Noxubee188843
Montgomery182157
Carroll175441
Jefferson Davis174343
Tunica163539
Benton153139
Kemper145441
Choctaw137027
Claiborne134839
Humphreys132239
Franklin126530
Quitman107828
Wilkinson106139
Jefferson97134
Sharkey65321
Issaquena1957
Unassigned00

Alabama Coronavirus Cases

Cases: 848137

Reported Deaths: 16185
CountyCasesDeaths
Jefferson1164052005
Mobile743681384
Madison53497738
Shelby38435371
Baldwin38195589
Tuscaloosa36152644
Montgomery34562782
Lee25655264
Calhoun22630520
Morgan22530411
Etowah20069520
Marshall18846318
Houston17777426
St. Clair16958359
Limestone16195220
Cullman16157306
Elmore15940295
Lauderdale15069307
Talladega14260302
DeKalb13083271
Walker12168380
Blount10779193
Autauga10560157
Jackson10214196
Coffee9435192
Colbert9366210
Dale9044192
Tallapoosa7285202
Russell710065
Chilton7090170
Covington6969197
Escambia6967144
Franklin6364108
Chambers5801142
Marion5437132
Dallas5302210
Pike5129109
Clarke485786
Lawrence4850130
Winston4793110
Geneva4655136
Bibb435795
Barbour370680
Butler3444101
Marengo342993
Monroe338366
Randolph337867
Pickens334890
Fayette331785
Henry321166
Cherokee320364
Hale319189
Crenshaw261678
Washington256852
Cleburne255460
Lamar253555
Clay252969
Macon246367
Conecuh193562
Coosa186048
Wilcox178538
Lowndes178468
Bullock152845
Perry141840
Sumter139841
Greene130545
Choctaw94428
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