FDA panel endorses booster shot for J&J COVID-19 vaccine

A panel of U.S. health advisers has endorsed booster doses of Johnson & Johnson’s single-shot COVID-19 vaccine. The Food and Drug Administration panel said Friday that the booster should be offered at least two months after immunization but didn't suggest a firm time.

Posted: Oct 15, 2021 1:57 PM

WASHINGTON (AP) — U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing growing worry that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.

Advisers to the Food and Drug Administration weighed J&J’s proposal for a flexible booster schedule. The company said the extra dose adds important protection as early as two months after initial vaccination -- but that it might work better if people wait until six months later.

The FDA’s advisory panel voted unanimously that a booster should be offered without setting a firm time. The advisers cited growing evidence that J&J recipients are more vulnerable to infection than people who got vaccines from competitors Pfizer or Moderna— and that most got their single dose many months ago.

Although Friday’s meeting is part of an ongoing evaluation of vaccine boosters, many of the experts said it makes more sense to think of J&J's vaccine as a two-dose vaccine.

“I think this frankly was always a two-dose vaccine,” said FDA adviser Dr. Paul Offit of Children’s Hospital of Philadelphia. “It would be hard to recommend this as a single-dose vaccine at this point.”

The government says all three U.S. vaccines continue to offer strong protection against hospitalization and death from COVID-19, and that the priority is getting first shots to the 66 million eligible but unvaccinated Americans who are most at risk. But J&J's vaccine has consistently shown lower effectiveness across a series of studies, while “breakthrough” infections become a bigger concern due to the extra-contagious delta variant of the coronavirus.

"This is really -- with the second dose -- bringing it I think on par with those other vaccines in terms of effectiveness,” said Dr. Archana Chatterjee of Rosalind Franklin University.

The FDA isn’t bound by the vote but its ultimate decision could help expand the nation’s booster campaign.

Booster doses of Pfizer’s vaccine began last month for people at high risk of COVID-19 at least six months after their last shot, and the FDA advisory panel has recommended the same approach for Moderna recipients. In contrast, the panel Friday backed boosters for anyone who received the J&J vaccine, which is authorized for people 18 and older.

The FDA will use its advisers’ recommendations to decide whether to authorize boosters for both J&J and Moderna, after which another government agency will rule on who should roll up their sleeves.

Adding another twist, the experts also discussed preliminary data from a government “mix-and-match” study that suggested J&J recipients may have a far stronger immune response if they get either a Moderna or Pfizer booster rather than a second J&J dose.

J&J’s single-shot vaccine is made with a different technology than the two-shot Pfizer and Moderna vaccines.

The vast majority of the 188 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while J&J recipients account for only about 15 million.

On Friday, J&J executives pitched a booster as a way to strengthen a robust vaccine that they said has retained its protective power over eight months. But FDA scientists pointedly challenged that assertion.

“There are data that suggest the effectiveness of this vaccine is actually less robust than the company’s presentation here," said Dr. Peter Marks, FDA's top vaccines official. “And that is a finding of concern particularly because that’s been seen in minority communities potentially and others.”

J&J presented results from a large study that found giving a second dose just two months after the first bumped protection against symptomatic COVID-19 to 94% from 70% in U.S. recipients. Giving that booster six months later instead prompted an even bigger jump in virus-fighting antibodies.

But in their own review, FDA scientists flagged a number of shortcomings with J&J's booster studies, including only a tiny portion of cases involving the delta variant, by far the dominant strain in the U.S. Reviewers also warned that J&J had only followed booster recipients for a little more than a month after a second dose, making it hard to draw conclusions about the durability of protection. Finally, FDA staff emphasized that they had not had time to independently confirm J&J's findings, which were submitted shortly before the meeting.

FDA's reviewers found no new safety concerns after a second J&J dose, but again, they cautioned about the small number of patients studied and short follow-up period.

The J&J vaccine was highly anticipated for its one-and-done formulation. But its rollout earlier this year 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.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 895229

Reported Deaths: 9462
CountyCasesDeaths
Hennepin1749772017
Ramsey722701040
Dakota66032572
Anoka62513568
Washington39357355
Stearns32821275
St. Louis28761399
Wright25354211
Scott25329181
Olmsted21750127
Sherburne18478126
Carver1629166
Clay11923103
Blue Earth1126366
Rice11234138
Crow Wing11003122
Chisago974676
Kandiyohi9660106
Otter Tail9611126
Benton8815124
Beltrami801794
Goodhue786596
Douglas7689100
Itasca752796
Mower721349
Winona702756
McLeod694483
Isanti681383
Steele669431
Morrison663479
Becker620873
Polk591684
Freeborn550846
Carlton529474
Nobles521654
Lyon518761
Mille Lacs516573
Nicollet510960
Pine500641
Cass491252
Todd483642
Brown465057
Le Sueur445933
Meeker422357
Martin378143
Wabasha366010
Waseca365132
Dodge351511
Hubbard349848
Roseau307931
Fillmore299115
Wadena298239
Redwood277845
Houston266817
Renville264151
Faribault253032
Pennington247529
Sibley246917
Kanabec241536
Cottonwood225032
Chippewa216342
Aitkin215850
Pope203210
Watonwan194920
Yellow Medicine185423
Rock174728
Swift169322
Koochiching168123
Stevens164511
Jackson159216
Clearwater155720
Marshall151122
Murray150911
Pipestone148329
Lake129824
Lac qui Parle120025
Wilkin119416
Mahnomen104714
Norman10389
Grant9719
Big Stone9365
Lincoln8705
Kittson71523
Red Lake70710
Traverse5996
Unassigned572124
Lake of the Woods5235
Cook3020

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 516453

Reported Deaths: 7289
CountyCasesDeaths
Polk80319799
Linn32142424
Scott26637292
Black Hawk21974378
Woodbury20490258
Johnson19778105
Dubuque18515241
Pottawattamie15890213
Dallas15320113
Story1380258
Warren8450104
Cerro Gordo7964123
Clinton7725114
Webster7326122
Des Moines7098105
Marshall669093
Muscatine6645117
Wapello6441144
Jasper619591
Sioux610177
Lee5908105
Marion557897
Buena Vista502149
Plymouth488388
Henry418655
Benton404859
Jones404862
Bremer395372
Washington391463
Boone389739
Carroll367755
Mahaska365365
Crawford353747
Dickinson314655
Jackson307747
Buchanan305741
Clay295536
Delaware294654
Kossuth289077
Fayette286353
Hardin284353
Tama279777
Page272533
Wright266149
Cedar265527
Hamilton259857
Winneshiek258143
Floyd255449
Clayton244459
Poweshiek237243
Madison234525
Harrison234379
Cass233466
Butler232744
Iowa229634
Jefferson223043
Mills220930
Winnebago215938
Hancock214639
Cherokee211347
Lyon206142
Appanoose205357
Allamakee203955
Calhoun196919
Shelby196442
Union191141
Humboldt185130
Grundy183637
Franklin183029
Mitchell182043
Chickasaw178922
Emmet178246
Louisa176953
Sac171026
Guthrie168137
Montgomery161745
Clarke160829
Keokuk150839
Palo Alto150532
Howard146824
Monroe142739
Ida130141
Greene127517
Davis124625
Lucas124426
Monona122939
Worth12139
Pocahontas120724
Adair114337
Osceola104818
Decatur101913
Taylor98514
Fremont95913
Van Buren93222
Wayne84525
Ringgold76729
Audubon74917
Adams5748
Unassigned480
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