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FDA grapples with timing of booster for J&J COVID-19 vaccine

The Food and Drug Administration is wrestling with how to decide on booster doses of the single-shot Johnson & Johnson COVID-19 vaccine.

Posted: Oct 13, 2021 12:22 PM

WASHINGTON (AP) — The Food and Drug Administration said Wednesday it is wrestling with whether and when recipients of the single-shot Johnson & Johnson COVID-19 vaccine need another dose — at six months or as early as two months.

In an online review, FDA scientists didn't reach a firm conclusion, citing shortcomings with J&J's data, including little information on protection against the extra-contagious delta variant of the coronavirus.

The review comes ahead of meetings Thursday and Friday when an FDA advisory panel will recommend whether to back booster doses of both the J&J and Moderna vaccines. That's one step in the government's vaccine review process: Next week, the FDA will make a final decision on authorizing those boosters and then the Centers for Disease Control and Prevention will debate who actually should get them.

Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19. But amid signs that protection against milder infections may be waning, the government already has cleared booster doses of the Pfizer vaccine for certain people starting at six months after their last shot.

Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.

FDA reviewers wrote that a study of the two-month booster plan suggests “there may be a benefit," while pointing to only small numbers of people who got another shot at six months instead.

Overall, the J&J vaccine "still affords protection against severe COVID-19 disease and death," the FDA's reviewers concluded. But data about its effectiveness “are consistently less” than the protection seen with Pfizer and Moderna shots.

For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80% effective against hospitalizations in the U.S.

J&J’s single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot's benefits outweighed those risks.

Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies’ two-dose shots while less than 15 million Americans got the J&J shot.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 755401

Reported Deaths: 8531
CountyCasesDeaths
Hennepin1513291905
Ramsey62614972
Dakota56158520
Anoka53010513
Washington33145327
Stearns27922252
St. Louis23178352
Scott21316159
Wright20879170
Olmsted17821118
Sherburne15232111
Carver1336954
Clay1006598
Rice9855131
Blue Earth949559
Crow Wing9254105
Kandiyohi819195
Chisago816662
Otter Tail7807104
Benton7363108
Beltrami633276
Mower631740
Douglas616189
Goodhue603683
Winona603653
Itasca596978
McLeod580868
Steele572425
Isanti558172
Morrison541565
Becker518762
Polk502577
Freeborn480842
Nobles477052
Lyon444456
Carlton438666
Nicollet423051
Pine419930
Cass413142
Mille Lacs403565
Brown398846
Todd389336
Le Sueur378331
Meeker350452
Waseca322629
Martin316534
Wabasha28495
Hubbard283644
Dodge26819
Roseau258924
Fillmore236312
Redwood234143
Wadena230229
Houston229017
Renville224249
Faribault214630
Pennington213227
Sibley204512
Cottonwood193027
Kanabec187130
Chippewa185839
Aitkin178442
Watonwan168711
Pope15328
Rock153219
Yellow Medicine151120
Jackson144114
Koochiching137219
Clearwater133318
Swift132619
Pipestone131627
Marshall131419
Murray131310
Stevens122311
Lake106221
Wilkin100214
Lac qui Parle95024
Mahnomen86312
Norman8459
Big Stone7874
Grant7669
Lincoln7525
Kittson59522
Red Lake5769
Unassigned528124
Traverse5005
Lake of the Woods4524
Cook2420

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 467281

Reported Deaths: 6685
CountyCasesDeaths
Polk73698716
Linn28680379
Scott24441271
Black Hawk20130355
Woodbury18854242
Johnson17800100
Dubuque15577228
Pottawattamie14073197
Dallas13894107
Story1275148
Warren763496
Webster6876111
Cerro Gordo6816107
Clinton6814100
Des Moines657893
Marshall635484
Muscatine6294113
Wapello5807136
Jasper571478
Lee560787
Sioux560276
Marion499791
Buena Vista489745
Plymouth459187
Henry378647
Jones365160
Washington362255
Bremer353867
Benton352056
Boone344837
Carroll341753
Crawford337345
Mahaska313656
Dickinson297651
Clay274631
Buchanan274239
Jackson270445
Kossuth269373
Hardin266448
Tama261476
Fayette253848
Delaware253444
Cedar246326
Page244827
Wright240945
Winneshiek230837
Hamilton228553
Floyd216744
Harrison215277
Madison214325
Clayton210058
Poweshiek206840
Iowa204229
Butler203237
Jefferson197340
Mills197227
Allamakee192952
Cherokee191943
Lyon190641
Cass190557
Winnebago185432
Hancock184739
Calhoun184115
Appanoose175950
Shelby174239
Louisa169651
Grundy167937
Emmet163842
Franklin163328
Humboldt161826
Mitchell161843
Union159437
Chickasaw156418
Sac156323
Guthrie154034
Palo Alto140831
Clarke140028
Montgomery138941
Keokuk137534
Monroe131534
Howard125422
Ida116641
Davis113825
Greene113712
Lucas112224
Pocahontas109323
Monona107436
Worth10678
Adair103634
Osceola91117
Fremont83711
Van Buren82721
Decatur81212
Taylor78612
Wayne72024
Ringgold66827
Audubon64514
Adams4984
Unassigned150
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