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

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.

Posted: May 25, 2021 9:49 AM
Updated: May 25, 2021 11:35 AM

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Moderna announced the results Tuesday in a news release, and the results have not yet been peer reviewed or published.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

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 775686

Reported Deaths: 14025
CountyCasesDeaths
Marion1066871814
Lake572681031
Allen43500701
Hamilton37653427
St. Joseph37508568
Elkhart29882471
Tippecanoe23732232
Vanderburgh23634405
Porter19690327
Johnson19020394
Hendricks18271323
Clark13730199
Madison13719348
Vigo12949256
Monroe12691180
LaPorte12645225
Delaware11218198
Howard10832237
Kosciusko9851124
Hancock8855150
Bartholomew8343157
Warrick8216157
Floyd8128183
Grant7457181
Boone7289105
Wayne7273201
Morgan6988143
Marshall6376117
Dubois6327118
Cass6130112
Noble607391
Dearborn605878
Henry6001111
Jackson520977
Shelby514898
Lawrence5020128
Gibson471697
Montgomery464792
Clinton462755
DeKalb461485
Harrison459277
Huntington429082
Whitley421045
Steuben414561
Miami411573
Jasper403957
Knox397291
Putnam388762
Wabash373884
Adams358956
Ripley354571
Jefferson351487
White341854
Daviess3110100
Wells305981
Greene298485
Decatur294393
Posey288235
Fayette287764
Scott285458
LaGrange278873
Clay277649
Washington257638
Randolph248583
Jennings243349
Spencer240531
Fountain239050
Starke231559
Owen226759
Sullivan224143
Fulton210446
Jay204132
Carroll200623
Orange194456
Perry193139
Vermillion183444
Rush179127
Tipton174348
Franklin173935
Parke157816
Pike144034
Blackford138732
Pulaski124748
Newton124137
Benton111615
Brown106743
Crawford106716
Martin92715
Warren88715
Switzerland8568
Union73910
Ohio58711
Unassigned0429

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1132798

Reported Deaths: 20530
CountyCasesDeaths
Franklin1312911496
Cuyahoga1180592268
Hamilton830231263
Montgomery541901064
Summit491891018
Lucas43982835
Butler40324615
Stark34056941
Lorain26232511
Warren25125312
Mahoning22881614
Lake21602397
Clermont20592261
Delaware19295138
Licking16977227
Fairfield16959207
Trumbull16940493
Medina16019278
Greene15721254
Clark14439309
Portage13548219
Wood13411201
Allen12124245
Richland11870214
Miami11140229
Wayne9344228
Columbiana9282236
Muskingum9207137
Pickaway8796123
Marion8774140
Tuscarawas8756257
Erie8220166
Ashtabula7318180
Hancock7080135
Ross7070165
Geauga7032153
Scioto6887108
Belmont6261179
Lawrence6033106
Union595149
Jefferson5787162
Huron5678122
Sandusky5536130
Darke5476131
Seneca5391128
Washington5391111
Athens528660
Auglaize510587
Mercer492885
Shelby487798
Knox4678112
Ashland450198
Madison450066
Defiance444599
Fulton443275
Putnam4366104
Crawford4152112
Brown414163
Preble3988107
Logan396379
Clinton395667
Ottawa378281
Highland370768
Williams361878
Champaign351760
Guernsey334054
Jackson324954
Perry300550
Morrow298544
Fayette291350
Hardin280465
Henry279067
Coshocton275161
Holmes2735102
Van Wert254465
Gallia254150
Adams253658
Pike247137
Wyandot236557
Hocking224163
Carroll203349
Paulding181542
Meigs153940
Monroe139446
Noble138739
Harrison115738
Morgan112024
Vinton88217
Unassigned04
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