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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: 341862

Reported Deaths: 7533
CountyCasesDeaths
Hinds23783441
DeSoto23180283
Harrison20365329
Rankin15307290
Jackson15087251
Madison10917227
Lee10674179
Jones8969169
Forrest8621159
Lauderdale7839243
Lowndes7016151
Lamar696289
Lafayette6535124
Washington5589139
Pearl River5141152
Bolivar4949134
Oktibbeha491698
Panola4766112
Warren4709127
Marshall4691106
Pontotoc446273
Union432579
Monroe4322137
Neshoba4268181
Hancock423788
Lincoln4171116
Pike3650113
Leflore3619125
Tate352888
Alcorn349574
Sunflower347194
Adams340588
Scott340176
Yazoo338575
Copiah323468
Simpson322090
Itawamba314180
Coahoma313385
Tippah304768
Prentiss297863
Covington291883
Leake284675
Marion283681
Wayne276143
George270551
Grenada268888
Newton261564
Tishomingo239370
Winston236584
Jasper229548
Attala225973
Stone225337
Chickasaw218760
Holmes199274
Clay196754
Clarke186280
Tallahatchie183742
Calhoun181232
Smith178935
Yalobusha171340
Walthall145348
Lawrence141626
Greene139734
Amite136943
Noxubee134835
Perry133238
Montgomery132244
Carroll125931
Webster121032
Jefferson Davis116234
Tunica113427
Benton106225
Claiborne105031
Kemper102329
Humphreys100133
Franklin87723
Quitman84619
Choctaw82319
Wilkinson77732
Jefferson71128
Sharkey51618
Issaquena1736
Unassigned00

Alabama Coronavirus Cases

Cases: 577463

Reported Deaths: 11510
CountyCasesDeaths
Jefferson841981589
Mobile47171860
Madison37047533
Tuscaloosa26915465
Shelby26873256
Montgomery25918625
Baldwin24499328
Lee16949181
Calhoun15252332
Morgan15017290
Etowah14778370
Marshall12933235
Houston11774292
Elmore10761217
St. Clair10617252
Limestone10574158
Cullman10363205
Lauderdale10083254
DeKalb9382191
Talladega8836188
Walker7681287
Autauga7479114
Jackson7317117
Blount7266139
Colbert6635142
Coffee6163132
Dale5453117
Russell470642
Chilton4682117
Covington4649125
Franklin450081
Tallapoosa4440156
Escambia427882
Chambers3898125
Dallas3717163
Clarke367763
Marion3427106
Pike327879
Lawrence3225101
Winston294973
Bibb284565
Geneva276383
Marengo259967
Barbour246261
Pickens240062
Butler238272
Hale232778
Fayette225264
Henry209245
Monroe197241
Randolph196744
Cherokee196348
Washington180139
Macon168752
Crenshaw165558
Clay163759
Cleburne160245
Lamar149938
Lowndes144854
Wilcox130531
Bullock126142
Conecuh119630
Coosa116929
Perry109928
Sumter109032
Greene98736
Choctaw64325
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