#they have so many injuries I feel like the state has launched multiple investigations

[littlewing-52]

I recently learned that before New 52, Guy Gardener was at one point social worker. This got retconned during New 52 as did most of his previous backstory, however while the rest of his backstory got brought back, he's still a fucking cop.

DC is missing out on the opportunity to do the funniest shit.

Just imagine baby Dick meeting Guy for the first time as Robin and instantly ruining the secret identity thing by immediately shouting "MR. GARDNER????" Because Guy was the social worker assigned to Dick after his parents died.

When the league finds out Billy is just a child, everyone else is freaking out about how young he is while Guy is simultaneously going full social worker, asking Billy questions to make sure his uncle isn't facilitating this, and also trying to figure out why so many of his kids are in the Justice League.

He also quit being a social worker to teach children with disabilities, imagine Bruce S T R E S S I N G when this happens because having a superhero social worker made everything so much easier.

[toldnews-blog]

New Post has been published on https://toldnews.com/world/the-boy-who-survived-a-plane-crash-in-alaska/

The boy who survived a plane crash in Alaska

Willy Phillips Jr was 13 years old when he survived a plane crash that killed his father in 2010. Almost nine years on, he explains how he is still coming to terms with how he survived.

The weather in Alaska on 9 August 2010 was awful – raining and foggy. The group had planned a fishing trip, travelling by plane, but Willy says “the likelihood of us getting out was not very high”.

Willy was in Alaska with his father William “Bill” Phillips, and former US senator, Ted Stevens. Bill had previously worked for Senator Stevens, who had represented Alaska for more than 40 years, and was known by many in the state as “Uncle Ted”.

“After an hour or so we finally got the heads up that we would be able to make it out,” Willy remembers, “so that was pretty exciting. So everybody is running around and getting their things together”.

They would use a de Havilland Canada DHC-3 Otter, an amphibious float-plane. Willy had been on it before and knew how it worked. But this time for some reason he didn’t put his seatbelt on.

“I was sitting on the window seat and I was dozing in and out of the reality around me.

“One of the last things I remember before the accident was that there was a bunch of rain on the window, and I remember sitting there and there was a big drop of water that was snaking it’s way down the window. Right as it got to the bottom – that’s when I fell asleep.”

Image copyright US National Transportation Safety Board

Image caption The wreckage of the plane on an Alaskan mountainside

At about 14:30 Alaska Daylight Time the plane crashed into the side of a mountain. The weather was bad, visibility was poor. But the exact reasons for the crash are still unknown.

An investigation by the US National Transportation Safety Board couldn’t say for sure what happened. It speculated that the pilot, who was one of five people killed, may have fallen asleep or had a seizure, but there was no direct evidence to support these theories.

Willy says he thought it had been a dream: “I was sitting there for probably an hour or so. Every five minutes I would try to fall back asleep and then I’d wake up and then I’d think OK maybe I’ll try again. And I would close my eyes and then open them up again and I’m still in this place.”

‘I wasn’t in my seat’

Eventually he realised he had to move.

“I wasn’t in my seat. Had I actually been wearing my seatbelt I could have been in a much worse situation. Because I ended up being in the cockpit of the plane. I sustained most of my injuries making impact with the front of the plane as we had come into contact with the mountain.

“Right in front of me were a few broken bushes and glass everywhere. I ended up pretty much sitting on the lap of the person who’d been in the co-pilot’s seat for the duration of that flight. I was looking at a 50% gradient on the mountain.”

Image copyright US National Transportation Safety Board

Image caption It’s still not clear what caused the plane to crash

There were nine passengers and crew on the plane. Five lost their lives.

“You kind of assume the worst at this point,” Willy says. “I heard some rustling around and some voices so I definitely had some hope that I could be going to an area full of people.

“I went around the side of the plane… right down the side of [the] mountain and kind of made my way to the spot where I was originally sitting. And it was actually quite morbid.

“It was just a group of lifeless people and then other people who were just scattered among them, who were alive at that point.”

Willy says what he’d learned from his father was key in keeping him calm.

“He had a role in keeping my head level,” he says. “For my entire life he had taught my brothers and I that by getting overly frustrated or anxious in a moment doesn’t help the resolution. My first instinct was to be the calmest there. I didn’t really see another option, it didn’t feel right to talk about how bad a situation we were in, that didn’t seem helpful to anybody.”

Willy saw one of his father’s best friends, who had survived: “He was one of the first people to bring me down to earth a little bit. He was like ‘Willy you know we’re going to need your help, but do you know that your father is dead?’ But I knew right then was not the time to have this moment of breakdown. It was something I was told then, but not something I came to terms with until we got out of there.”

Treacherous conditions

As soon as it was reported that the aircraft hadn’t landed as scheduled, other pilots launched a search. But Willy says the authorities assumed the plane had crashed and everybody on board had died. Nobody was looking at a rescue operation.

“The focus was on getting us out the next day because with no survivors and the weather not good, it didn’t make sense to rescue a plane full of bodies,” he says.

The wreckage of the plane was found at 18:30 local time on a 40-degree slope in the mountainous Dillingham region of Alaska.

“I could just hear very faint fluttering of a helicopter somewhere in the distance so I scrambled out of the fuselage of the plane. I had on a white sweatshirt and I started throwing that around and waving my hands around. I think it was at that moment that we turned from a ‘recovery the next morning’ to a ‘rescue immediately’.”

Within half-an-hour of Willy’s white sweatshirt being spotted, rescue teams were on the ground – a doctor and a handful of local responders were airlifted in to help the survivors. But the with the weather conditions deteriorating, it was seen as too treacherous to get the casualties out that night, and the full scale rescue didn’t start until the next morning.

Willy had multiple injuries on his left side, including a broken ankle requiring 13 surgeries, plus injuries to his shoulder, wrist and nose.

As he says, “It’s been a long process”.

Image copyright Family photo

Image caption Willy Phillips was in hospital for 10 days in Alaska before being transferred to Washington

The crash was front page news across the US. One of America’s longest serving politicians, Senator Ted Stevens, had died. Statements poured in commemorating the late senator, including from President Obama, who said: “Michelle and I extend our condolences to the entire Stevens family and to the families of those who perished alongside Senator Stevens in this terrible accident.”

For Willy and his family, the news coverage meant recovery was even harder: “It complicated things when there would be reporters showing up at the end of our driveway or coming and knocking on our front door. Any time my mum went to the grocery store she would be accosted by somebody. It was years of somebody trying to get a story. “

It’s been almost nine years since the crash, and Willy is philosophical.

“It’s one of those things that had to happen to somebody – it happened to me. It was obviously an unfortunate thing, but exposed me to so many finer idiosyncrasies of life that I don’t think I would ever have had an appreciation for in the same way… Every day when I wake up I think this is so infinitely better to waking up on the side of that mountain so today is probably going to be a pretty good day.”

‘Crippling anxiety’

Willy is currently studying environmental science and in particular, water.

“I used to have this crippling anxiety every time it would rain because that was the last thing that I remember when everything was normal. The last thing I remember before waking up on the mountain was seeing the rain on the side of that window and so for years it scared the hell out of me. It would rain and I would feel it raining and I would just kind of collapse.”

He says he’s since taken rain, which he called his biggest weakness, to be his biggest source of motivation.

“Maybe I think about my Dad when I do that stuff. I learn from him every single day. I think about how my outward actions and expressions are influenced by him and I think I take after him quite a bit.

“Alaska and the natural environment were things that he always had an appreciation for and he definitely passed that down to me, and that’s probably part of my reason in being so invested in what I study.

“There’s something to it that I just can’t get enough of.”

Listen to Emma Barnett’s full interview with Willy Phillips on BBC Sounds.

[gordonwilliamsweb]

NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”

Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.

“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”

The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.

Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.

Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.

If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.

A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.

Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.

The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.

More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.

In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.

Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.

“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”

Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.

FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.

It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.

Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.

“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.

AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.

But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.

“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”

The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.

“There are also potential consequences if you stop a study,” Goodman said.

If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.

“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”

Schaffner said researchers need to remember that vaccine research is unpredictable.

“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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This story can be republished for free (details).

NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial published first on https://nootropicspowdersupplier.tumblr.com/

[stephenmccull]

NIH and FDA Examine Serious Side Effect That Surfaced in COVID Vaccine Trial

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”

Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.

“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”

The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.

Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.

Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.

If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.

A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.

Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.

The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.

More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.

In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.

Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.

“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”

Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.

FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.

It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.

Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.

“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.

AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.

But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.

“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”

The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.

“There are also potential consequences if you stop a study,” Goodman said.

If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.

“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”

Schaffner said researchers need to remember that vaccine research is unpredictable.

“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

USE OUR CONTENT

This story can be republished for free (details).

NIH and FDA Examine Serious Side Effect That Surfaced in COVID Vaccine Trial published first on https://smartdrinkingweb.weebly.com/

[dinafbrownil]

NIH and FDA Examine Serious Side Effect That Surfaced in COVID Vaccine Trial

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”

Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.

“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”

The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.

Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.

Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.

If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.

A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.

Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.

The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.

More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.

In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.

Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.

“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”

Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.

FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.

It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.

Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.

“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.

AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.

But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.

“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”

The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.

“There are also potential consequences if you stop a study,” Goodman said.

If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.

“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”

Schaffner said researchers need to remember that vaccine research is unpredictable.

“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

USE OUR CONTENT

This story can be republished for free (details).

from Updates By Dina https://khn.org/news/nih-and-fda-examine-serious-side-effect-that-surfaced-in-covid-vaccine-trial/

[soccernetghana]

FEATURE: Ghana’s failure in youth football: The growth we need

Poor pitches with no touch of green in sight, No flood lights or lamp poles, so they play till the night. And no touchlines, just their imagination of where to call it quits. Yes, the bumpy pitches make control difficult when the balls take flight, But the tenacity and strength they build makes them commit. Essien, Muntari, Appiah; yes we admit, Grassroots football was helpful but it’s now pointless.   Now, it’s difficult to be scouted and it makes me hopeless, I wanted to play in the top tier and make mummy speechless but now I’m helpless. Some academies gave me an opportunity but I had to support my family, Picking an injury would have been a calamity so Mummy said “focus on reality”. She made me believe I was chasing a “fantasy”. Yes, I should have tried, but who was I kidding! I had to choose a path that was more certain, Education and football couldn’t find a middle ground. With this trade-off, I had to choose one that was sound Maybe if a better talent development strategy was launched, I could have been the shining light the Black Star needs. Some context:

There are numerous problems in Ghana’s football industry today. From lack of professionalism to administrative issues, to dire financial problems. These problems are affecting the performance of the football leagues and the national teams in international competitions. Ghana’s best performance from her youth national teams dates as far back as 2009 (i.e. Winning the U-20 World Cup in Egypt). Hence we have a lot of foundational work to do.

The neglect of grassroots football (commonly called colts football in Ghana) over the years has crippled the image of the Black Stars and the best clubs in Ghana’s premier league.

As it is impossible to ignore a flat tire, so it is impossible to ignore youth national teams. The words of the poetic piece above highlights the depth of this argument.

For my undergraduate thesis, I interacted with some football stakeholders. I collated data from retired coaches and players to grassroots coaches and players, to help investigate how youth football can be improved in Ghana.

This post will explore the problems from the perspective of the youth football players I interacted with.

Some of the main problems the colt team players battle with include; the worries and drawbacks of “football age”, the trade-off between schooling and a pro-career, and poor training infrastructure.

I gathered these problems from interacting with 10 players across 5 colts teams; Great Corinthians, F.C Glory, Hope Soccer Academy and Biribi (all colts teams in Accra).

Football Age

I witnessed a conversation between a colts team player and a scouting manager from an academy, during an exhibition match earlier this year.

“How old are you?” the Scout asked. “I am 12” said the young boy. “Are you sure?” “I know your Headmaster, if I go to your school and they tell me something different I will sack you!”, the Scout said. The young boy afraid to lose his only shot said, “please I am 14.”

Lying about your age to benefit from opportunities is prevalent in many underdeveloped countries because of poor documentation and accountability. Too prevalent in Africa that, FIFA introduced MRI scans in 2009 to help identify which players were qualified to participate in the U-17 Africa Cup of Nations which took place in Tanzania.

In football, age is very important. Players who indulge in this fraudulent act do so to outperform younger opponents in age-restricted competitions, and help them attract club contracts.

According to one of the colts team coaches I interacted with, academy scouts and foreign club scouts are mostly looking for players between the ages of 8–15. Therefore, when the players are above 18, they become a “burden” to their coaches. A burden because such players are usually not attractive to scouts, hence they cannot be traded. The coaches then try to fix the players in local league teams in the lower divisions.

From the data I gathered, most players easily pass off as younger than their actual age because of imbalanced nutrition in their diets. Notwithstanding our poor culture of documentation.

This has cost some “right-aged” children the opportunity to be scouted even when they tick all the right boxes. Luckily, some players are registered with colts teams at the regional level, hence it is easy to refer to their records. That is a good step by the FA. Yet more work needs to be done.

With regards to the size of the pitch, ball size, number of field players, the distance between the goal posts, match duration and many other rules concerning the game, may differ from different age categories (i.e. U8’s, U10’s, U12’s, U13s, U16s U18s and Seniors (18+)).

For example, U7s in England do not have strict referees officiating their games, they do not have to face the disappointment of an offside or a poor goal kick from the goalie, they get 2 attempts to correct a foul-throw and more interestingly they play 5 a-side for 10 minutes a half with unlimited substitution of players. This sounds fun and structured right?! That is what organisation looks like.

In England, there are development matches and competitive matches. An U7s game falls under development matches. The focus is on learning basic skills in football such as passing in close spaces, decision-making, increased attentiveness and increased ball-time. The objective usually does not include “the number of goals scored”.

This ties in with the idea of some colts teams using one brick as a goal post with no goalie, or slippers/stones as a goal post with no goalies.

From what I observed during my research, this is mostly not the case in Ghana. A 12-year-old could be playing against an 8-year-old. In terms of physicality and skill they are most likely not on the same level and it makes evaluations biased and inefficient.

The “inescapable” trade-off

If you are a Ghanaian and you want to make the most of your education and football talent, especially when you are not well connected or “lucky”, you will have to choose between the possibility of dedicating money and time to successfully secure a football career, or focus on schooling for a more certain future.

Considering the special attention young footballers require in developing the fundamental skills a footballer needs, Ghana’s current educational system is not supportive of youth football development.

Most students in Ghana spend 8–9 hours in school from Monday to Friday. Several students in the rural areas support their parents’ trades before and after school. Also, some students in the rural areas must travel long distances to attend school. Others face both problems and discouragement from their parents about their football dreams. Though parents are aware of the success stories of some football stars, they believe the chances are very rare.

Though most colts team coaches encourage their players to go to school, they hesitate to insist when the children’s parents cannot afford. Thanks to Free-SHS, the players can now afford to attend school. Nevertheless, in cases where the location of their schools is far from their training grounds, the players are unable to consistently attend training sessions.

Additionally, most parents in the informal sector would want their children to support them with house chores and their family trades after school. This makes it difficult for young talents to get the attention they deserve from their coaches. How then can we get the next Abedi Pele, Tony Yeboah or Asamoah Gyan?

But are the parents to be blamed?

Some of the players are made to believe that when they make it, education will not matter. Hence, most players quit school after Junior High School and train intensively with their coaches hoping to be scouted to Europe.

From the qualitative research I conducted, some grassroots coaches scout for players across Ghana and camp them away from the children’s parents. One of these teams is Great Corinthians at Abokobi. Some responsible coaches create partnerships with private schools to provide education to their players. Hence, they call themselves “mini academies”. When the players in these mini academies fail to be scouted in football trials or “exhibition matches”, the coaches feel indebted to the children’s parents. The coaches then try to fix the players in local league teams in the lower divisions. As we know, the local league clubs are not well-funded. This pushes most players to take up multiple jobs with the aim of earning a little above their cost of living.

One of the scandalous issues I discovered was that young players had to pay “a small fee” to be enrolled in some football academies in Ghana, after they displayed exceptional skills during their trials or exhibition matches.

From a personal experience in High School, during inter-school competitions, I had to miss classes while my colleagues studied ahead. This trade-off will continue to exist if the relevant stakeholders do not find a well-fortified bridge between education and football talent development.

Poor Training Infrastructure:

In an interview with a retired goalkeeper of the Black Stars, he stated that, “investing heavily in the national teams has affected youth football in the country and the narrative has to be changed to improve football at the grassroots level”. I cannot argue with that.

With the increasing rate of developmental and real estate projects in our communities, the availability of pitches or unoccupied lands are very limited.

The needed infrastructure; quality football turf/fields, top-notch training facilities and stadiums that attract tourists.

It is difficult for colts teams to have access to these infrastructure especially when the local clubs cannot afford such “luxury”. Though some colts teams are funded by foreign scout teams, they still lack some basic but modern football training equipment and accessories like agility equipment, soccer tennis sets, rebounders, crowd barriers, pop up goals and the speed chute.

The amount of sprinting in the English Premier League has increased by 50% in the last 10 years. The matches are infused with high intensity sprinting and increased physicality. The new direction of elite football requires players to have stronger muscles and a higher recovery rate which makes them accelerate and decelerate quickly. This requires special training sessions to suit the individual differences of players. Hence the need for these “modernised” accessories to remain competitive on global grounds.

This is the core problem out of the 3 problems stated above, which limits the progress of Ghana’s youth football. In the interim, I think more investments should be made in the youth teams as compared to the senior national teams.

Some young talents are lucky to be scouted to European clubs through academies. The greater number who do not make the cut, should be most likely to get an opportunity to play in the youth national teams and consequently make up the senior national team. Unfortunately, these local players do not get access to premium training facilities for talent development. Making them unattractive to national team coaches.

Some of these players become a burden to society as most of them do not complete school, hence cannot get descent well-paid jobs. It contributes to a big vicious cycle.

It might sound cliché, but if the foundation is weak, the building can only go as high. Therefore, the Football Association and relevant parties need to seriously consider a talent development strategy, which incorporates honing football skills and providing quality education. This will benefit everyone. People may guess that we should adopt an academy system. Frankly, that is not far from the right path.

In subsequent posts, I will explore more problems grassroots teams face from the different perspective of football stakeholders in Ghana, and how I believe Ghana’s youth football can be elevated to everyone’s benefit.

By Nana Ama B. Ayenor 

source: https://ghanasoccernet.com/

[douchebagbrainwaves]

REALLY

A few years before by a big company it's necessarily the dominant one. Most of the people. There is only one real advantage to being a member of most exclusive clubs: you know you wouldn't be missing much if you weren't. They'd have sacrificed hundreds of thousands of dollars. So it is with colleges. Hackers should do this even if they don't plan to start startups, because it could be. I'm always delighted to find I've forgotten the details of disputes, because that is the future, places that don't have startups will be a tendency to push it back to their offices to implement them. Hackers are unruly. So if you can achieve the same level of performance with less effort, surely that's more impressive, not less. That was why they'd positioned themselves as a media company, or portal, or whatever we were, search could safely be allowed to wither and drop off, like an umbilical cord.1 033600237 programming 0.

If you keep the company moving forward—releasing new features, increasing traffic, doing deals, getting written about—those investor meetings are more likely to be productive. This one may not always be true. And strangely enough, the leaders now are European countries like Belgium, which has a capital gains tax rate of zero. As a little piece of debris, the rational thing for you to do everything.2 If you let the difficulty of raising money, but connections and advice. The difference between design and research seems to be mobile devices, but that they lack examples. And probably the only people who will notice. But they all said no, so I didn't do it. 4 month interruption. The only way a startup makes sense.3 If you're writing something that you'll be able to sign up a lot of people working for them.

It's this pattern that makes them; idleness is lonely and demoralizing. Like many of the half-truths adults tell us, this one contradicts other things they shared in common with us. One reason Europe pulled ahead was that the valuation wasn't just the value of our ideas, which turned out to be the same. They can be considered in this algorithm by treating them as virtual words. Is it just a coincidence that they used the same word, or is there some overlap in what they can say to you. And I think that's precisely why people put it off.4 Editorials quote this kind of statistic with horror. A word like shortest is almost as much evidence for innocence as a word like that is effectively a kind of whitelist and blacklist because they are based on entire messages, including the headers.5 Put them all in a building in Silicon Valley face an unpleasant choice: either live in the boring sprawl of the valley proper, or live in San Francisco and endure an hour commute each way.

There is a lot more in common than this, of course. Most adults looking at art worry that if you take a vote.6 If companies started doing that, they'd learn some frightening things. There is only one real advantage to being a member of most exclusive clubs: you know you have to know who you should be able to test in an hour, then you only have one meeting a day with investors, somehow that one meeting will burn up your whole day.7 I'm talking about filtering my mail based on a half-page agreement. Every engraver since Durer has had to live in them. The problem was not the 14 pages, but the other half you're thinking as deeply as most people only get to sitting alone on a Sunday morning.8 99 respectively, and a dial to control each. And thought you should check out the following: http://www.9 In the US things are more haphazard. Oddly enough, the better an idea it seems. Milan at the time, a lot of valuable advice about business, and also did all the legal work of getting us set up as a depressing, undifferentiated heap.

The added confidence that comes from the controversial topic of wealth, no one will know. So I don't think you should always be collecting data about investors' intentions. Among companies, the best opportunities are where things suck more than in corporate IT departments. In 1938 Buckminster Fuller coined the term ephemeralization to describe the atmos. IBM developing what they expected to be the right kind of vibe. The idea is to judge you, not more sophisticated. For the first 100 years or so of its existence, it was Stripe.10 All the unfun kinds of wealth creation slow dramatically in a society where I was the richest, but much less costly if you discover them early. The good news is, all you have to design what the user needs, not simply what he says he wants. Lately hackerliness seems rather frowned upon. This is harder to do than it sounds.11

Someone who does you an injury hurts you twice: first by the injury itself, and second by taking up your time afterward thinking about it afterward. I learned something valuable from that.12 Any wealth a serf created belonged to his master.13 That would have led to disaster, because our software was so complex. CEOs, it's hard to see how little launches matter. It might be a good one. It would cost something to run, and since 2001 there has been an unprecedented opportunity for learning how to pick winners. And if the idea of good art, then people who liked it would have meant taking on a newscaster—someone who, as they say yes. But this can't be an intrinsically European quality; previous generations of Europeans were as ambitious as Americans. And being charming and confident counts for nothing with users. Who made the wealth it represents?14 It assumes good technical people have college degrees, and that the weight of a few carefully observed and solidly modelled objects will tend to make filtering easier, because you'd only have to find your peers, which is the worst sort of strip development.

Notes

Survey by Forrester Research reported in their early twenties compressed into the sciences, even though you tend to use some bad word multiple times. Several people have historically done to painting may be some part you can say I need to fix once it's big, messy canvases that philistines see and say that's not directly, but Javascript now works. Whereas the value of a handful of companies used consulting to generate all the worse if you're measuring usage you need to, but this could be ignored. The downside is that the middle of the reason this trick works so well is that the government, it was wiser for them, not like soccer; you don't know which name will stick.

The main one was drilling for oil, over fairly low heat, till onions are glassy.

If we had high hopes for doesn't do well, but for different things from different types of people who start these supposedly local seed firms.

On the other hand, a lot of classic abstract expressionism is doodling of this process but that's a pyramid scheme. A knowledge of human anatomy.

At two years investigating it.

This argument seems to have been Andrew Wiles, but for the same thing, because you have to worry about the smaller investments you raise as you can control. It wouldn't cut their overall returns tenfold, because it aggregates data from so many people work with me there. Paul Buchheit points out, if you turn out to be vigorously enforced. This is one of the word procrastination to describe the worst.

There's not much use, because such companies need huge numbers of users to recruit manually—is probably no accident that the government and construction companies. If you have significant expenses other than salaries that you could get a poem published in The New Industrial State to trying to work for Gillette, but delusion strikes a step further.

Yes, actually: dealing with the other by adjusting the boundaries of what investment means; like any investor, than to call you about it. Google is much like the one the Valley use the name Homer, to the founders' advantage if it gets presumptuous for a year, they will come at an academic talk might appreciate a joke, they were beaten by iTunes and Hulu.

If a big factor in high school football game that will sign up quickest and those are guaranteed in the body or header lines other than those I mark. 8%, Linux 11. Historically, scarce-resource arguments have been a good way to do that.

This is one of the world population, and one VC. You'd think they'd have taken one of few they had in school, the apparent misdeeds of corp dev is to do is not a complete list of n things seems particularly collectible because it's a significant effect on what you build this?

Ideas are one of the world population, and are paid a flat rate regardless of how hard they work. A lot of the word procrastination to describe what's happening till they also commit to you about an A round, no one on the way we met Aydin Senkut.

My feeling with the government. But if so, why are you even working on filtering at the moment; if their kids to them. So what ends up happening is that intelligence is surprisingly recent.

VCs regularly wipe out angels by issuing arbitrary amounts of new means of production. The situation we face here, because the proportion of spam in my incoming mail fluctuated so much in the nature of an audience of investors are also the golden age of economic equality in the Baskin-Robbins. It's hard to game the system, the activation energy for enterprise software.

But this is not to feel like you're flying straight and level while in fact they don't yet get what they're wasting their time and became the Internet was as a first approximation, it's probably a bad reputation, a torture device so called because it made a million dollars out of the standard edition of Aristotle's works compiled by Andronicus of Rhodes three centuries later. Yahoo, but as the face of it, and b success depended so much, or at least bet money on convertible notes often have valuation caps, a growth graph is mostly the ordinary sense.

[gordonwilliamsweb]

NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”

Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.

“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”

The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.

Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.

Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.

If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.

A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.

Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.

The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.

More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.

In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.

Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.

“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”

Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.

FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.

It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.

Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.

“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.

AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.

But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.

“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”

The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.

“There are also potential consequences if you stop a study,” Goodman said.

If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.

“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”

Schaffner said researchers need to remember that vaccine research is unpredictable.

“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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