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Johnson & Johnson pauses COVID vaccine trial over sick participant

Washington — Johnson & Johnson said Monday that it had temporarily halted its COVID-19 vaccine trial because one of its participants had become sick.

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“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement.

The pause means the enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.

J&J said that serious adverse events (SAEs), such as accidents or illnesses, are “an expected part of any clinical study, especially large studies.” Company guidelines allow them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.

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The J&J Phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the U.S. and around the world, the company and the U.S. National Institutes for Health (NIH), which is providing funding, said.

FDA coronavirus vaccine guidelines raise doubts over approval by Election Day



The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

J&J was the tenth maker globally to conduct a Phase 3 trial against COVID-19, and the fourth in the U.S. The U.S. government has given J&J about $1.45 billion in funding under Operation Warp Speed to develop its vaccine candidate.

The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

J&J used the same technology in its Ebola vaccine which received marketing approval from the European Commission in July.

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Pre-clinical testing on rhesus macaque monkeys that were published in the journal Nature showed it provided complete or near-complete protection against virus infection in the lungs and nose. Like several other Phase 3 trials that are underway, its primary objective is to test whether the vaccine can prevent symptomatic COVID-19.

In September, trials on the coronavirus vaccine developed by AstraZeneca and Oxford University were paused after a U.K. volunteer developed an unexplained illness.

The vaccine is one of the most advanced Western projects, having already been tested on tens of thousands of volunteers worldwide. Trials resumed earlier this month in Japan but not the United States, where AstraZeneca is still working with regulators.

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400-pound bear found sick in Colorado restaurant’s dumpster has to be ‘humanely euthanized’

A 400-pound bear had to be euthanized after it was found in a Colorado restaurant’s dumpster earlier this week.

On Wednesday, the Colorado Parks and Wildlife (CPW) Southeast Region tweeted about the incident that happened in Woodland Park, Colorado.

According to the agency, the bear was able to get into the restaurant’s trash because the dumpster wasn’t locked.


Bill Vogrin, a CPW public information officer, told Fox News that the bear — which was estimated to be between 18 and 19 years old — was first found in the dumpster around midnight, but wildlife officers hoped the bear would find its way out overnight.

However, when an officer returned to the dumpster in the morning, the bear was still inside and was struggling to get out.

After wildlife officers tranquilized it and tipped the dumpster over, they saw the bear was having trouble breathing and “was in serious distress,” Vogrin said.


The officers determined the bear was probably too old to recover, so they “humanely euthanized” the bear and performed a necropsy — or autopsy — right there.

“Its stomach was full of garbage, a lot of plastic,” Vogrin said. “[It] was suffering from having spent the night gorging itself in this garbage.”

This 400-pound bear had to be euthanized after it was found struggling to get out of a dumpster in Woodland Park, Colorado, on Wednesday morning. (Colorado Parks and Wildlife)

This 400-pound bear had to be euthanized after it was found struggling to get out of a dumpster in Woodland Park, Colorado, on Wednesday morning. (Colorado Parks and Wildlife)


Vogrin said the restaurant has never been cited for leaving its dumpster unsecured before, so it will not be fined.

“But they are being cited with a written warning and we’ll be watching them because really, there’s no excuse for this up here,” he said.


“We preach this constantly,” Vogrin said. “‘Garbage kills bears’ is one of our catchphrases.”

He added that securing garbage is especially important for residents and businesses in the fall months because bears are going through something called hyperphagia, which is an increase in feeding that happens as they prepare for hibernation.


Vogrin said during hyperphagia, bears eat 20 hours a day and are trying to consume 20,000 calories a day. Unsecured dumpsters are easier places for bears to get those calories than their typical diet of berries and acorns — but the garbage inside is also deadly.

“It’s a human problem,” Vogrin said. “It’s not a bear problem. We don’t have bad bears, but we have bad humans teaching bears bad habits, to look to humans for food.”


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Opinion | A Sick Donald Trump Takes His Own Medicine. How Will That Go?

He wants you to believe that the worst of his infection has passed because he was strong enough to sit at a table and be photographed signing a document. He wants you to believe that he is getting better because he took a ride in a Secret Service SUV. He wants you to believe he’s out of the woods because he’s getting out of the hospital. “Don’t be afraid of Covid,” he wrote in his tweet Monday afternoon. “Don’t let it dominate your life”—an easy thing to say if you’re the recipient of the best (and free) 24-7 health care in the world. He wants you to believe that all is well because he’s “getting great reports from the doctors,” as he said in a Sunday video from Walter Reed. If he’s really getting such great reports from the docs, he must be the first sick person in history to conceal the actual evidence that he’s getting better.

As with Trump’s let’s-sweep-it-under-the-rug policy toward Covid-19, his decision to throttle the flow of information about his illness to a dribble has only encouraged speculation and criticism from the press and the medical establishment. His doctors continue to give us upbeat news about Trump’s health but decline to answer questions that might reflect poorly on his recovery. Consider: We know he contracted Covid-19, but we don’t know precisely when or the date of his last negative Covid-19 test. We know he had a fever on Friday but not how high it was. We know he was administered oxygen on Friday and that his blood-oxygen level dropped again on Saturday but his doctors won’t clarify if he was given oxygen again. We don’t know if he suffered lung damage or if he had pneumonia. We don’t know how or where he contracted the disease but we know that at least 30 people (and counting) recently in his immediate orbit—wife Melania, White House and campaign staffers, senators, White House journalists, former Gov. Chris Christie, the president of Notre Dame, and others—have also tested positive. We also don’t know exactly why doctors treated Trump with the steroid dexamethasone, which is usually reserved for severe Covid-19 cases, or why doctors dosed him with experimental drugs. Has he lost the senses of taste and smell? And that’s only the overview (see Science magazine for more details).

As Trump returns to the White House, presumably still infectious, the press corps will meet him with a new round of questions. Will the president quarantine himself to the White House’s upstairs living quarters to prevent the contagion from spreading? Will Trump be isolated or will he be domiciled with his wife, who also has Covid-19? Who will be allowed to visit him, and what medical precautions will they take? How wise is it for him to return to the White House, which seems to be the center of an environmental cluster of infections? Are the experimental treatments continuing? When will we learn more about his medical history? Would Trump have

The Cost of Medical Bias When You’re Sick, Black, and Female

This is Race and Medicine, a series dedicated to unearthing the uncomfortable and sometimes life-threatening truth about racism in healthcare. By highlighting the experiences of Black people and honoring their health journeys, we look to a future where medical racism is a thing of the past.

Being a doctor is a unique role. It involves knowing some of the most intimate things about a person, but not really knowing them as a person at all.

The patient’s job is to be transparent about their health, and the doctor’s job is to listen objectively to symptoms and fears to choose the most logical diagnosis. 

Racial bias in the medical field disrupts the trust needed for this relationship to function. 

A biased doctor might disbelieve symptoms or their severity and misdiagnose a condition.

A patient may come to mistrust the doctor, not attend appointments, not follow instructions, or stop sharing key information because history tells them they aren’t taken seriously. 

Reducing bias is critical to eliminating health disparities, especially for Black women.

My run-in with bias

Several years ago, I experienced medical bias when I started having headaches multiple times per week. I had had migraine before, but this was different. 

I felt like I was dragging my body through heavy resistance, like encountering an undertow. I was losing weight. No matter how much water I drank, I was always thirsty and rushing to the bathroom around the clock. 

It seemed I could never eat enough to feel full. When I tried to avoid overeating, I became fatigued, my vision blurred, and I had so much trouble focusing it was hard to drive.

My primary care physician (PCP) cut me off when I tried to explain.

She congratulated me for losing weight and said I just needed to let my brain adjust to food deprivation. When I explained I wasn’t dieting, she sent me to a headache specialist. 

The headache specialist prescribed a medication that didn’t help. I knew they weren’t migraine headaches, but no one listened, even as my fatigue and disorientation increased. 

Once, I even had trouble finding my own house.

By my sixth visit, the symptoms were massively disrupting my life. I wondered if I had type 2 diabetes because of family history. My symptoms seemed to match. 

I knew of a test called HbA1c that provides a snapshot of blood sugar levels. I insisted on being tested. My doctor said she would order labs based on my demographics. 

I thought I was finally getting somewhere — but when the receptionist at the lab printed the list of tests, HbA1c wasn’t present. Instead, it was tests for common STDs. 

I was humiliated, overwhelmed, and no closer to having answers. In the parking lot, I broke down and cried. 

Subtle racism

When Black people share instances of racism, it’s often disregarded as playing the ‘race card’ or as an isolated incident. It’s much more difficult to explain subtle racism than it is to explain blatant acts like burning crosses and