FDA panel takes up tough questions on J&J COVID-19 boosters

Credit: Johnson & Johnson Services, Inc. | Image Source

U.S. health advisers are meeting to tackle who needs boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when.

Posted: Oct 15, 2021 9:28 AM

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson’s single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection.

The push for boosters kicked off last month after the Food and Drug Administration authorized third doses of the Pfizer vaccine for seniors and younger adults with health problems, jobs or living conditions that place them at higher risk from the coronavirus. On Thursday, an FDA advisory panel unanimously recommended a half-dose booster of the similar Moderna vaccine for the same groups.

Friday, the same panel discussed a booster of J&J's vaccine — but the decision is more complex. Moderna and Pfizer asked the FDA to OK boosters at least six months after immunization, but J&J proposed a sliding schedule with an extra dose as early as two months later.

Adding another twist, the experts also will discuss 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.

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

All three vaccines in the U.S. still offer strong protection against severe illness and death from COVID-19 — and the nation's priority remains getting first doses to 66 million eligible but unvaccinated Americans who are most at risk as the extra-contagious delta variant continues to circulate.

But experts continue to debate whether there’s value in using boosters to head off milder infections in most vaccinated adults, an approach proposed by the Biden administration.

FDA scientists recently flagged shortcomings in the data J&J submitted in applying for a booster dose, including little data on the strength of protection in people who got a six-month booster. A review released earlier this week said a study of the two-month boost suggests “there may be a benefit.”

J&J’s single-shot vaccine has consistently shown lower effectiveness than the two-shot mRNA vaccines developed by Pfizer and Moderna, a point FDA reviewers noted in their review. That gap in protection is likely to play a key role as panelists weigh the need and scope of boosters.

The J&J vaccine was highly anticipated for its one-and-done formulation, and it is made with a different technology than its Pfizer and Moderna competitors. 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.

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.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 512632

Reported Deaths: 10262
CountyCasesDeaths
Harrison34853555
DeSoto33162432
Hinds32556641
Jackson24830389
Rankin22442402
Lee16238242
Madison14874283
Jones14086247
Forrest13741259
Lauderdale12249324
Lowndes11286193
Lamar10644140
Pearl River9707244
Lafayette8827143
Hancock7835132
Washington7550169
Oktibbeha7204138
Monroe6989179
Pontotoc6970109
Warren6849178
Panola6746134
Neshoba6726210
Marshall6653141
Bolivar6440151
Union633897
Pike5924156
Alcorn5862107
Lincoln5525136
George510180
Prentiss500884
Tippah490282
Itawamba4829107
Scott477499
Adams4766125
Tate4748116
Leflore4723144
Copiah455895
Yazoo455591
Simpson4543117
Wayne442772
Covington432895
Sunflower4299106
Marion4265112
Coahoma4227109
Leake413790
Newton395581
Tishomingo381793
Grenada3775109
Stone365666
Jasper340166
Attala337790
Winston317792
Chickasaw313367
Clay311878
Clarke301195
Calhoun284449
Holmes271289
Smith268952
Yalobusha243747
Tallahatchie231453
Greene224749
Walthall221366
Lawrence217840
Perry213356
Amite209557
Webster205148
Noxubee188642
Montgomery181557
Carroll174441
Jefferson Davis173643
Tunica163239
Benton152639
Kemper144941
Choctaw136527
Claiborne134238
Humphreys131139
Franklin124929
Quitman107528
Wilkinson105939
Jefferson96834
Sharkey65121
Issaquena1957
Unassigned00

Alabama Coronavirus Cases

Cases: 844594

Reported Deaths: 16115
CountyCasesDeaths
Jefferson1160612006
Mobile741651379
Madison53255732
Shelby38313368
Baldwin38061589
Tuscaloosa35996641
Montgomery34473781
Lee25541263
Calhoun22582518
Morgan22441406
Etowah20009517
Marshall18771316
Houston17723425
St. Clair16863358
Limestone16123218
Cullman16032303
Elmore15902294
Lauderdale14945306
Talladega14186299
DeKalb12957269
Walker12011380
Blount10700192
Autauga10512157
Jackson10151194
Coffee9412192
Colbert9325208
Dale9013191
Tallapoosa7248201
Russell707465
Chilton7015170
Escambia6951143
Covington6926195
Franklin6337108
Chambers5778142
Marion5400130
Dallas5283209
Pike5114109
Clarke484986
Lawrence4826129
Winston4777110
Geneva4640136
Bibb434094
Barbour369180
Butler3433100
Marengo342393
Monroe336666
Randolph334067
Pickens333188
Fayette329885
Henry320566
Hale317989
Cherokee316963
Crenshaw260477
Washington256952
Cleburne254360
Lamar251253
Clay250869
Macon244764
Conecuh192762
Coosa184647
Lowndes178168
Wilcox177438
Bullock152545
Perry141840
Sumter139041
Greene130245
Choctaw93228
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