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FDA panel endorses lower-dose Moderna COVID shot for booster

The advisers to the Food and Drug Administration voted Thursday to recommend a lower-dose booster shot for seniors and other high-risk groups.

Posted: Oct 14, 2021 2:39 PM

U.S. health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine should get a half-dose booster to bolster protection against the virus.

The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, adults with other health problems, jobs or living situations that put them at increased risk for COVID-19.

The recommendation is non-binding but it’s a key step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already getting a booster after the FDA authorized their use last month.

As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster.

The agency convened its experts Thursday and Friday to weigh-in on who should get boosters and when for people that received the Moderna and Johnson & Johnson shots earlier this year.

The FDA will use its advisers’ recommendations in making final decisions for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one.

THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

U.S. health advisers are debating if millions of Americans who received Moderna vaccinations should get a booster shot -- this time, using half the original dose.

Already millions who got their initial Pfizer shots at least six months ago are getting a booster of that brand. Thursday, advisers to the Food and Drug Administration evaluated the evidence that Moderna boosters should be offered, too -- and on Friday, they’ll tackle the same question for those who got Johnson & Johnson’s vaccine.

U.S. officials stress that the priority is to get shots to the 66 million unvaccinated Americans who are eligible for immunization -- those most at risk as the extra-contagious delta variant of the coronavirus has burned across the country.

“It’s important to remember that the vaccines still provide strong protection against serious outcomes” such as hospitalization and death from COVID-19, said FDA vaccine chief Dr. Peter Marks.

But Marks said it’s also become clear there is some waning of protection against milder infections with all three of the coronavirus vaccines used in the U.S. And he encouraged the advisory panel to consider if the evidence backs similar booster recommendations for all of them as well, since that would “create the least confusion” for the public.

Moderna is seeking FDA clearance for a booster used just like Pfizer’s: For people 65 and older, or adults with other health problems, jobs or living situations that put them at increased risk of serious coronavirus -- once they are at least six months past their last dose.

The FDA will use its advisers’ recommendations in deciding whether to authorize Moderna boosters. If it does, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one.

What's the evidence that the Moderna vaccine's protection is waning? As the delta variant surged in July and August, people who were more recently vaccinated had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago, Moderna's Dr. Jacqueline Miller told FDA's advisers.

As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster. The company said that would trigger fewer uncomfortable shot reactions such as fever and achiness while also leaving more vaccine available for the global supply.

A study of 344 people found the booster shot six months after initial vaccinations restored virus-fighting antibodies to levels seen after recipients' last dose — and that included large jumps in antibodies able to target the delta variant, Miller said.

One very rare side effect of both the Moderna and Pfizer vaccines is heart inflammation, particularly among young men soon after the second dose — and one lingering question is whether another dose could spark more cases. Moderna's booster study wasn't large enough to spot such a rare risk.

But Israel began offering Pfizer boosters sooner than the U.S. and to more of its population. Thursday, Dr. Sharon Alroy-Preis of Israel's health ministry told the FDA panel that after 3.7 million booster doses administered, there's no sign the extra shot is any riskier — despite an intense investigation into heart inflammation.

In the U.S., scientists are divided about exactly who needs boosters and their purpose — whether they're needed mostly for people at risk of severe disease or whether they should be used to try to reduce milder infections, too. While Pfizer's boosters are only for certain high-risk groups of Americans, Israeli officials credit wider booster use in their country to stemming the delta surge.

“There is no question in my mind that the break of the curve was due to the booster dose,” Alroy-Preis said in response to FDA advisers who noted that other countries have seen a lowering of delta cases without widespread booster use.

As Thursday’s deliberations began, FDA’s advisers highlighted one confusing issue: People with severely weakened immune systems already can get a third full dose of the Moderna vaccine soon after the initial vaccinations — so a question is whether they should be eligible for a booster, too, which would be their fourth dose.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 915942

Reported Deaths: 9606
CountyCasesDeaths
Hennepin1786832038
Ramsey739711046
Dakota67683587
Anoka64112577
Washington40545359
Stearns33631279
St. Louis29591409
Scott25994186
Wright25957217
Olmsted22339130
Sherburne19000127
Carver1670669
Clay12104105
Blue Earth1147970
Rice11451138
Crow Wing11213123
Chisago995379
Kandiyohi9815108
Otter Tail9813127
Benton9033125
Beltrami816997
Goodhue811798
Douglas7875101
Itasca772299
Mower733449
McLeod713084
Winona710258
Isanti700783
Steele685731
Morrison672879
Becker628574
Polk603187
Freeborn561246
Carlton546974
Mille Lacs532479
Lyon528461
Nobles525054
Nicollet522460
Pine515043
Cass501253
Todd492843
Brown470759
Le Sueur459734
Meeker433458
Martin386544
Wabasha375510
Waseca374333
Dodge361112
Hubbard355249
Roseau316231
Fillmore305315
Wadena302940
Redwood281445
Houston272017
Renville268451
Faribault258233
Sibley252317
Pennington252130
Kanabec250136
Cottonwood230132
Aitkin222450
Chippewa220542
Pope207410
Watonwan198020
Yellow Medicine188023
Rock177729
Koochiching176725
Swift173123
Stevens167511
Jackson161016
Clearwater158020
Marshall153522
Murray151811
Pipestone149729
Lake132924
Lac qui Parle123025
Wilkin121116
Mahnomen106014
Norman10509
Grant101510
Big Stone9485
Lincoln8805
Kittson73223
Red Lake71410
Traverse6056
Unassigned545124
Lake of the Woods5265
Cook3071

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 525758

Reported Deaths: 7379
CountyCasesDeaths
Polk81677809
Linn32838430
Scott27126295
Black Hawk22334382
Woodbury20736263
Johnson20150108
Dubuque18996243
Pottawattamie16215214
Dallas15573115
Story1398059
Warren8637107
Cerro Gordo8141125
Clinton7928115
Webster7419124
Des Moines7153106
Marshall675494
Muscatine6717117
Wapello6546145
Jasper630591
Sioux622477
Lee5977106
Marion567697
Buena Vista503449
Plymouth493388
Henry427155
Benton414760
Jones413564
Bremer403873
Boone397042
Washington395464
Carroll373355
Mahaska372366
Crawford355647
Jackson324047
Dickinson317555
Buchanan312743
Delaware303255
Clay297636
Kossuth293477
Fayette290356
Hardin289253
Tama282878
Page276133
Wright270050
Cedar269527
Winneshiek267744
Hamilton262757
Floyd261049
Clayton252360
Poweshiek242043
Harrison240979
Madison237425
Butler237346
Cass235667
Iowa234336
Jefferson228544
Mills225330
Hancock222840
Winnebago222339
Cherokee217347
Appanoose210157
Lyon209842
Allamakee209456
Calhoun199519
Shelby199542
Union197141
Humboldt188231
Franklin188031
Grundy186137
Chickasaw184522
Mitchell184343
Emmet180146
Louisa178653
Sac175626
Guthrie169338
Clarke163629
Montgomery163146
Keokuk152639
Palo Alto152332
Howard150624
Monroe144340
Ida134141
Greene128818
Davis126825
Lucas126127
Monona124940
Worth12309
Pocahontas122125
Adair118239
Osceola105718
Decatur104813
Taylor100914
Fremont98913
Van Buren95922
Wayne86125
Ringgold78429
Audubon77617
Adams5869
Unassigned500
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