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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 3:40 PM
Updated: 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: 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: 813481

Reported Deaths: 15179
CountyCasesDeaths
Jefferson1139971910
Mobile722271323
Madison51970686
Shelby37279341
Baldwin37069540
Tuscaloosa34934599
Montgomery33953725
Lee23142240
Calhoun22142470
Morgan20639372
Etowah19758496
Marshall18245300
Houston17302405
St. Clair15912337
Cullman15306290
Limestone15202198
Elmore15075284
Lauderdale14143294
Talladega13715272
DeKalb12569259
Walker11085366
Blount10094174
Autauga9893146
Jackson9789180
Coffee9182189
Dale8859181
Colbert8789200
Tallapoosa7044195
Escambia6732127
Covington6682179
Chilton6587160
Russell625958
Franklin5930105
Chambers5559142
Marion4955126
Dallas4882199
Clarke472782
Pike4719105
Geneva4564126
Winston4473101
Lawrence4264117
Bibb421686
Barbour355475
Marengo334089
Monroe330262
Randolph327063
Butler324794
Pickens313882
Henry310965
Hale309187
Cherokee299957
Fayette290679
Washington250951
Cleburne246958
Crenshaw243575
Clay240367
Macon230562
Lamar215846
Conecuh185652
Coosa178538
Lowndes173761
Wilcox167438
Bullock151744
Perry138040
Sumter131038
Greene125544
Choctaw86927
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A cold front passing through our area overnight will bring into our area some of the coolest temperatures of the season so far. We will see most of the highs this weekend only in the upper 60s to lower 70s. While overnight lows will drop off down into the 40s Saturday night.
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