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Johnson & Johnson asks FDA to authorize Covid-19 vaccine booster shots

Johnson & Johnson Single-Dose Vaccine

Johnson & Johnson said Tuesday it has asked the US Food and Drug Administration to authorize booster shots for its coronavirus vaccine, but has left it up to the FDA and the US Centers for Disease Control and Prevention to decide just who should get their boosters and when.

Posted: Oct 5, 2021 12:24 PM

Johnson & Johnson said Tuesday it has asked the US Food and Drug Administration to authorize booster shots for its coronavirus vaccine, but has left it up to the FDA and the US Centers for Disease Control and Prevention to decide just who should get their boosters and when.

"We're describing the data to them," Dr. Mathai Mammen, head of global research and development for J&J's vaccine arm, Janssen, told CNN.

"The process is not that we asked for a very specific interval -- we're providing them data and we're going to be presenting to the committee. They'll take all that into consideration when they ultimately decide on an appropriate interval."

The FDA's Vaccine and Related Biological Products Advisory Committee is scheduled to meet October 14 and 15 to consider requests from Moderna and Johnson & Johnson to add booster doses for their Covid-19 vaccines.

Last month, Janssen released some data from three different studies that showed boosting its single-shot vaccine at two months or at six months increased immune protection.

"We announced that the six month data are a very strong, very strong boost, like an amazingly strong boost," Mammen said. "And that two months is a good boost, and the two month good boost was associated with 94% vaccine efficacy, right across the board, all ages."

Boosting Janssen's vaccine two months after the first shot increased antibody response fourfold, the company said, and was associated in real life with 94% effectiveness. Waiting until six months to boost increase antibody protection 12-fold, the company said last month. "So either of those intervals can make sense. We think six months, immunologically, is even better," Mammen said.

Pfizer received the FDA's OK last month for booster doses for certain people who got the original two doses six months ago or longer.

Janssen maintains that protection from its vaccine remains stable over time. In asking for FDA authorization for a booster, Pfizer presented data showing vaccine efficacy was waning over time. Mammen said that doesn't happen with Janssen's shot.

"Our core rationale for boosting is very different," Mammen said.

"We have multiple data sets, but for example a real-world efficacy study, the largest of its kind that was done, shows about an 80% vaccine efficacy, protection against infection, that goes, month after month after month after month, so it's a very stable," he added.

"So our argument is not that our vaccine efficacy is fading or waning, but rather that from a personal standpoint, one can get to an even higher level of protection with a boost. So therefore there's some more latitude on the exact time because you're not up again, you're not fighting a clock."

Janssen says its vaccine is designed to elicit a strong cellular response. Vaccines stimulate the production of both antibodies -- the first line of defense against invaders -- and immune cells known as B cells and T cells. "It is the reason we have a long-lived response," Mammen said.

According to the CDC, about 15 million people in the US have received a J&J Covid-19 vaccine.

Mammen said there's plenty of supply in the United States for everyone who got the Janssen vaccine and wants a booster to get one.

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Indiana Coronavirus Cases

Data is updated nightly.

Cases: 1560117

Reported Deaths: 20796
CountyCasesDeaths
Marion2118112563
Lake1021301523
Allen964791027
Hamilton75541551
St. Joseph66476761
Elkhart51045634
Vanderburgh50511531
Tippecanoe45721338
Johnson39600527
Hendricks37933463
Porter35132476
Madison30330547
Clark27296331
Vigo26401347
Monroe24100249
LaPorte23921313
Howard23237381
Delaware22453370
Hancock19314220
Bartholomew18980216
Kosciusko18400204
Warrick17733216
Wayne16982303
Floyd16686257
Grant15966300
Morgan15091232
Boone13924138
Dearborn12235113
Shelby12225152
Noble12170142
Henry12027202
Dubois11696152
Marshall11625171
Jackson11111104
Cass10578143
Lawrence10529221
Huntington10523140
DeKalb10482132
Gibson10114127
Montgomery9671144
Harrison9471117
Knox9415125
Whitley902571
Steuben8934105
Putnam8542100
Miami8533135
Clinton849397
Jasper8462116
Jefferson8319127
Wabash8027140
Ripley7504117
Scott685787
Adams6829103
Daviess6825130
White638184
Greene6317112
Clay628975
Decatur6261121
Jennings619781
Wells6090121
Fayette6054122
Posey580148
LaGrange549097
Randolph5364129
Washington528071
Owen5211100
Fountain493681
Spencer467456
Sullivan462066
Fulton450993
Orange449784
Starke448887
Rush433941
Jay432564
Perry409155
Carroll394749
Franklin394650
Vermillion370762
Pike334246
Parke331239
Tipton330475
Blackford282255
Pulaski281775
Brown239856
Newton239761
Benton228921
Crawford224932
Switzerland207914
Martin196722
Warren183922
Union178119
Ohio129216
Unassigned0763

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 2515949

Reported Deaths: 31987
CountyCasesDeaths
Franklin2719422100
Cuyahoga2606673087
Hamilton1758091756
Montgomery1177451651
Summit1089011418
Lucas935321193
Butler83907963
Stark771001431
Lorain64214809
Warren53428489
Mahoning51224930
Lake47591611
Clermont46928452
Delaware41107220
Trumbull39746790
Licking38790416
Medina38646427
Fairfield35828349
Greene34313435
Portage32429366
Clark32361453
Richland29653444
Wood29379301
Allen25875403
Miami24243408
Muskingum23564255
Columbiana23046409
Wayne22093365
Tuscarawas19637428
Marion18616235
Erie18608224
Ashtabula18569362
Scioto18159214
Ross17594260
Pickaway16419181
Hancock16115232
Geauga15511229
Lawrence15094186
Belmont14236248
Union1419584
Huron13908184
Jefferson13656261
Sandusky13268200
Athens12877107
Knox12160201
Seneca12055204
Darke11440202
Ashland11248184
Washington11152172
Auglaize10873147
Crawford10432178
Shelby10402160
Brown10094145
Highland9746151
Fulton9726154
Guernsey9683122
Defiance9567137
Logan9470147
Clinton9428132
Mercer9099112
Madison9032111
Preble8524170
Williams8305138
Putnam8069136
Champaign8040113
Ottawa7971123
Jackson7848121
Perry7514102
Coshocton7411136
Morrow729184
Fayette715992
Pike666689
Hardin6564133
Gallia638891
Adams6227127
Van Wert6065121
Henry602596
Hocking5918105
Wyandot503594
Carroll5009101
Holmes4880167
Paulding426465
Meigs400974
Monroe316468
Harrison299162
Noble296952
Morgan292748
Vinton258646
Unassigned08
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Angola
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Huntington
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Decatur
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Van Wert
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