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

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

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 3:26 PM

WASHINGTON (AP) — The Food and Drug Administration is wrestling with whether and when to offer a booster of the single-shot Johnson & Johnson COVID-19 vaccine — at six months or as early as two months. And a new study raises the prospect that using a different vaccine might give a better boost.

In an online review posted Wednesday, FDA scientists didn't reach a firm conclusion about whether there's enough evidence for J&J boosters, citing shortcomings with the company's data and 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.

Adding to the complexity is whether it's OK to use a booster that's a different brand than someone's initial shots. Preliminary results of a U.S. government study suggest that mixing and matching boosters will work at least as well — and maybe far better for J&J recipients. Those people had a stronger immune response if they got either a Moderna or Pfizer shot as their booster than if they received another dose of the J&J vaccine, according to results posted online Wednesday. Mix-and-match is also up for discussion by the FDA panel this week.

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.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 497790

Reported Deaths: 9917
CountyCasesDeaths
Harrison34102530
DeSoto31839398
Hinds31837622
Jackson24314377
Rankin21881388
Lee15427234
Madison14525279
Jones13772241
Forrest13412250
Lauderdale11937314
Lowndes10934185
Lamar10470135
Pearl River9431237
Lafayette8454138
Hancock7697126
Washington7365156
Oktibbeha7111129
Monroe6727174
Warren6642176
Pontotoc6609101
Neshoba6606205
Panola6460131
Marshall6386132
Bolivar6266145
Union596094
Pike5784152
Alcorn5633101
Lincoln5417134
George491879
Scott470998
Tippah465381
Prentiss464181
Leflore4627143
Itawamba4596104
Adams4570119
Tate4546109
Copiah445191
Simpson4421116
Wayne438572
Yazoo438586
Covington427394
Marion4216107
Sunflower4215104
Coahoma4115104
Leake407787
Newton380879
Grenada3692108
Stone358464
Tishomingo356391
Attala330289
Jasper328265
Winston313191
Clay306375
Chickasaw296767
Clarke290694
Calhoun277945
Holmes266987
Smith262550
Yalobusha232647
Tallahatchie225251
Walthall217763
Greene215548
Lawrence211140
Perry204755
Amite203954
Webster201645
Noxubee185340
Montgomery179056
Jefferson Davis170642
Carroll167438
Tunica158639
Benton147438
Kemper141241
Choctaw133026
Claiborne131237
Humphreys129038
Franklin119128
Quitman106227
Wilkinson104539
Jefferson94234
Sharkey64020
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 814025

Reported Deaths: 15179
CountyCasesDeaths
Jefferson1140561910
Mobile722691323
Madison52017686
Shelby37304341
Baldwin37087540
Tuscaloosa34966599
Montgomery33971725
Lee23149240
Calhoun22159470
Morgan20659372
Etowah19764496
Marshall18254300
Houston17310405
St. Clair15921337
Cullman15325290
Limestone15222198
Elmore15086284
Lauderdale14157294
Talladega13723272
DeKalb12574259
Walker11089366
Blount10102174
Autauga9901146
Jackson9793180
Coffee9182189
Dale8864181
Colbert8791200
Tallapoosa7044195
Escambia6743127
Covington6685179
Chilton6592160
Russell626158
Franklin5935105
Chambers5560142
Marion4958126
Dallas4889199
Clarke473482
Pike4720105
Geneva4564126
Winston4476101
Lawrence4266117
Bibb421786
Barbour355675
Marengo334089
Monroe330462
Randolph327663
Butler324894
Pickens313982
Henry311265
Hale309487
Cherokee300057
Fayette290979
Washington251151
Cleburne247058
Crenshaw243775
Clay240767
Macon230762
Lamar217846
Conecuh185652
Coosa178838
Lowndes174161
Wilcox167738
Bullock151744
Perry138040
Sumter131138
Greene125844
Choctaw87027
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