Johnson & Johnson pauses Covid-19 vaccine trial after 'unexplained illness'

Drugmaker Johnson & Johnson said Monday it has paused the advanced clinical trial of its experimental...

Posted: Oct 13, 2020 3:41 PM

Drugmaker Johnson & Johnson said Monday it has paused the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.

"Following our guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians," the company said in a statement. ENSEMBLE is the name of the study.

"Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, especially large studies." The pause was first reported by Stat News.

Johnson & Johnson's Janssen vaccine arm is developing the shot. The company did not say what the unexplained illness was, but one point of clinical trials is to find out if vaccines cause dangerous side effects. Trials are stopped when they pop up while doctors check to see if the illness can be linked to the vaccine or is a coincidence.

"Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study," the company said.

"We must respect this participant's privacy. We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information," the company added.

"Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants."

On Tuesday, the company said it was still not known if the illness was in someone who got the vaccine or who got the placebo.

"We are now awaiting further medical information and evaluation, which we will then forward to the DSMB for further independent recommendations," Mathai Mammen, Global Head of Research and Development at Janssen, said Tuesday on the company's third quarter earnings call.

Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo."

Such a pause is not immediately concerning, agreed Dr. Ashish Jha, the dean of the Brown University School of Public Health."This is completely expected, and it's just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3," Jha told CNN's Chris Cuomo.

"The Johnson & Johnson trial is the biggest trial of the vaccine that I know of -- 60,000 people," Jha said. "Within that trial you'd expect a few pauses."

The drugmaker said there is a "significant distinction" between a study pause and a regulatory hold on a clinical trial.

"A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol," Johnson & Johnson said.

"A regulatory hold of a clinical trial is a requirement by a regulatory health authority, such as the U.S. Food and Drug Administration. As outlined in our transparency commitments, we proactively disclose any regulatory hold of a pivotal clinical trial."

This is the second Phase 3 coronavirus vaccine trial to be paused in the US. AstraZeneca's vaccine trial was paused last month because of a neurological complication in a volunteer in Britain. While the trial resumed there and in other countries, it remains paused in the United States while the US Food and Drug Administration investigates.

"We want the vaccine to be safe and we've got to let the process play out and it's going to take a while," Jha said. "To me it's reassuring that companies are acting responsibly and pausing when they need to."

Johnson's Phase 3 trial started in September. It's one of six coronavirus vaccines being tested in the US, and one of four in the most advanced, Phase 3 stage. It requires just one dose of vaccine, so federal officials have said they hope testing may be completed a bit faster than other vaccines, including those being made by Moderna and Pfizer, which require two doses.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 501097

Reported Deaths: 9990
CountyCasesDeaths
Harrison34338538
DeSoto32117403
Hinds31939628
Jackson24494382
Rankin21995390
Lee15543235
Madison14581280
Jones13851242
Forrest13453251
Lauderdale11991317
Lowndes11050188
Lamar10521135
Pearl River9533237
Lafayette8550140
Hancock7732127
Washington7438158
Oktibbeha7146131
Monroe6777177
Warren6694176
Pontotoc6664102
Neshoba6637206
Panola6531131
Marshall6467134
Bolivar6317148
Union602894
Pike5820152
Alcorn5669101
Lincoln5436135
George496879
Scott472898
Tippah469281
Prentiss467281
Leflore4658144
Itawamba4636105
Tate4588111
Adams4587119
Copiah448592
Simpson4446116
Yazoo444187
Wayne439772
Covington428894
Sunflower4239105
Marion4226108
Coahoma4160105
Leake408288
Newton381779
Grenada3707108
Stone360364
Tishomingo359792
Attala331589
Jasper329965
Winston314291
Clay308076
Chickasaw300367
Clarke292494
Calhoun279446
Holmes267987
Smith264050
Yalobusha234047
Tallahatchie228051
Greene219348
Walthall218763
Lawrence212940
Perry205556
Amite205156
Webster202946
Noxubee186740
Montgomery179656
Jefferson Davis171743
Carroll169138
Tunica159839
Benton148838
Kemper141941
Choctaw133426
Claiborne132737
Humphreys129538
Franklin120228
Quitman106428
Wilkinson105139
Jefferson94534
Sharkey64120
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 819597

Reported Deaths: 15406
CountyCasesDeaths
Jefferson1147901924
Mobile725791338
Madison52306697
Shelby37597350
Baldwin37245552
Tuscaloosa35101612
Montgomery34106740
Lee23526246
Calhoun22225488
Morgan20941378
Etowah19825500
Marshall18361304
Houston17384412
St. Clair16054339
Cullman15443293
Limestone15343199
Elmore15241286
Lauderdale14302295
Talladega13836283
DeKalb12649261
Walker11202370
Blount10192176
Autauga10043148
Jackson9871184
Coffee9210191
Dale8897185
Colbert8860201
Tallapoosa7084198
Escambia6772134
Covington6712183
Chilton6641162
Russell636659
Franklin5959105
Chambers5607142
Marion5005127
Dallas4973200
Pike4795106
Clarke475584
Geneva4571127
Winston4516103
Lawrence4321117
Bibb425186
Barbour357776
Marengo338090
Monroe331464
Randolph329764
Butler326396
Pickens316284
Henry312666
Hale311388
Cherokee302860
Fayette292880
Washington251551
Cleburne247760
Crenshaw245275
Clay243368
Macon234663
Lamar224147
Conecuh186153
Coosa180240
Lowndes175164
Wilcox168839
Bullock151644
Perry138840
Sumter133038
Greene126744
Choctaw88527
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