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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: 156868

Reported Deaths: 3851
CountyCasesDeaths
DeSoto10409104
Hinds10279202
Harrison7313112
Jackson6566128
Rankin5887106
Lee529496
Madison5014107
Forrest389786
Jones369088
Lauderdale3594147
Lafayette338253
Washington3246108
Lamar297850
Oktibbeha252362
Lowndes247064
Bolivar244384
Panola232653
Neshoba2249121
Marshall222851
Leflore208591
Monroe206778
Pontotoc204231
Lincoln197366
Sunflower192655
Warren180258
Tate177751
Union171926
Copiah167940
Pike165359
Yazoo160140
Scott159430
Itawamba157635
Alcorn155628
Pearl River155368
Coahoma152743
Simpson152653
Prentiss151331
Adams144752
Grenada143345
Leake139744
Holmes133461
Covington128639
Tippah128430
George128325
Winston125526
Hancock124341
Wayne121323
Marion119446
Attala119334
Tishomingo112443
Chickasaw109432
Newton108229
Tallahatchie98127
Clay94727
Clarke93653
Jasper85223
Stone80615
Calhoun78713
Walthall77629
Montgomery76926
Carroll74115
Lawrence73814
Smith73216
Yalobusha73128
Noxubee72717
Perry68326
Tunica62619
Greene61522
Jefferson Davis59017
Claiborne58916
Amite56615
Humphreys54719
Benton50018
Quitman5007
Webster46714
Kemper45018
Wilkinson40522
Jefferson37112
Choctaw3617
Franklin3555
Sharkey32417
Issaquena1204
Unassigned00

Alabama Coronavirus Cases

Cases: 252900

Reported Deaths: 3638
CountyCasesDeaths
Jefferson33526501
Mobile20103365
Madison13723151
Tuscaloosa13366154
Montgomery12552236
Shelby1079677
Baldwin9051137
Lee787266
Morgan696451
Calhoun6598121
Etowah656167
Marshall647357
Houston541038
DeKalb498137
Cullman462443
St. Clair441956
Limestone440445
Lauderdale426754
Elmore421164
Walker3735111
Talladega370157
Jackson340423
Colbert332042
Blount306140
Autauga281842
Franklin257434
Coffee250015
Dale239054
Dallas231532
Chilton228939
Russell22663
Covington225034
Escambia202331
Tallapoosa187291
Chambers182750
Pike161514
Clarke161019
Marion144736
Winston137523
Lawrence133436
Pickens126518
Geneva12508
Marengo123424
Bibb120418
Barbour118911
Butler118642
Randolph105522
Cherokee105124
Hale98131
Fayette94616
Washington93219
Clay92824
Henry8896
Monroe83011
Lowndes80929
Cleburne78814
Macon75522
Crenshaw72230
Bullock70119
Lamar7018
Conecuh70014
Perry6916
Wilcox64818
Sumter58622
Greene43518
Choctaw43114
Coosa3664
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