Virus

University staff members found the first-year students hanging out last week in a room at a Westin Hotel in downtown Boston, which Northeastern is using as a temporary dorm for about 800 students, according to a university statement. Officials instructed them to take a coronavirus test, then leave campus within 24 hours.
The students, who were part of a study-abroad program that was held in Boston this semester, will not be reimbursed for their $36,500 tuition payments, according to the university. They will be allowed back on campus in the spring. In the meantime, the university said, they can appeal the punishment in an expedited hearing.

EXCLUSIVE

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

By REBECCA ROBBINS @rebeccadrobbins, ADAM FEUERSTEIN @adamfeuerstein, and HELEN BRANSWELL @HelenBranswell

SEPTEMBER 8, 2020

A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.

A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

It was not immediately clear who placed the hold on the trial, though it is possible it was placed voluntarily by AstraZeneca and not ordered by any regulatory agency. The nature of the adverse reaction and when it happened were also not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. 

The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.

Related: ‘An unchartered situation for all of us’: From shipping containers to security concerns, a Covid-19 vaccine supply chain takes shape
Clinical holds are not uncommon, and it’s unclear how long AstraZeneca’s might last. But the progress of the company’s trial — and those of all Covid-19 vaccines in development — are being closely watched given the pressing need for new ways to curb the global pandemic. There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold.

Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.

AstraZeneca only began its Phase 3 trial in the U.S. in late August. The U.S. trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the U.K., Brazil, and South Africa.

There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death. It was also not immediately clear which clinical trial the adverse reaction occurred in, though a clear possibility is the Phase 2/3 trial underway in the U.K.

While it’s still unclear how severe and rare the adverse event may be, the finding could impact how quickly efficacy data from the U.K. trial will be available. Those data are considered integral to any bid to seek an emergency use authorization for the vaccine from the U.S. Food and Drug Administration — and potentially jeopardize President Trump’s efforts to fast-track a vaccine ahead of the November election.

A Phase 1/2 study published in July reported that about 60% of 1,000 participants given the vaccine experienced side effects. All of the side effects, which included fever, headaches, muscle pain, and injection site reactions, were deemed mild or moderate. All of the side effects reported also subsided during the course of the study. 

The vaccine  — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus. 

The Phase 3 trial in the U.S. aims to enroll about 30,000 participants at 80 sites across the country, according to a release last week from the National Institutes of Health. 

It was not immediately clear what steps were being taken at study sites across the U.S. in response to the hold. Clinical holds in ongoing studies often involve a pause in recruiting new participants and dosing existing ones, unless it’s deemed in the interest of participant safety to continue dosing.

In the statement from AstraZeneca, the company spokesperson noted that “in large trials illnesses will happen by chance but must be independently reviewed to check this carefully.” The spokesperson also said the company is “committed to the safety of our participants and the highest standards of conduct in our trials.”

Eric Feigl-Ding
2h, 12 tweets, 3 min read

Not fake news— Jamain Stephens, a football player at California University of Pennsylvania has died at the age of 20 of #COVID19 complications.

This was why football was cancelled— in addition to myocarditis found in 15% of Big 10 players (not 30%)

College football player Jamain Stephens dies at age 20 of COVID-19 complications - ProFootballTalk

Jamain Stephens, a football player at California University of Pennsylvania and the son of a former Steelers first round-draft pick, has died at the age of 20 of COVID-19 complications. Stephens had p…

https://profootballtalk.nbcsports.com/2020/09/09/college-football-player-jamain-stephens-dies-at-age-20-of-covid-19-complications/

2) Earlier study: “cardiac M.R.I.s, an expensive and sparingly used tool, revealed an alarmingly high rate of myocarditis — heart inflammation that can lead to cardiac arrest with exertion — among college athletes who had recovered from the coronavirus...”

3) ...”The survey found myocarditis in close to 15% of athletes who had the virus, almost all of whom experienced mild or no symptoms, perhaps shedding more light on the uncertainties about the short- & long-term effects the virus may have on athletes.”

Doctors Enter College Football’s Politics, but Maybe Just for Show

Universities have had mixed messages, competing agendas and a lack of transparency as they consider whether to hold college football in the fall, with billions of dollars at stake.

https://www.nytimes.com/2020/08/23/sports/ncaafootball/college-football-myocarditis-coronavirus.html#click=https://t.co/S9eF85bJfR

4) Another study: “And [myocarditis] is not age-specific: In The Lancet, doctors recently reported on an 11-year-old child with multisystem inflammatory syndrome (MIS-C)—a rare illness—who died of myocarditis and heart failure.”

5) ...”At autopsy, pathologists were able to identify coronavirus particles present in child’s cardiac tissue, helping to explain the virus’ direct involvement in her death.”

6) “In fact, researchers are reporting the presence of viral protein in the actual heart muscle, of six deceased patients.”

COVID-19 Can Wreck Your Heart, Even if You Haven’t Had Any Symptoms

A growing body of research is raising concerns about the cardiac consequences of the coronavirus

https://www.scientificamerican.com/article/covid-19-can-wreck-your-heart-even-if-you-havent-had-any-symptoms/#click=https://t.co/3cMEBQLO0A

7) “Of note is the fact that these patients were documented to have died of lung failure, having had neither clinical signs of heart involvement, nor a prior history of cardiac disease.”

8) “Ossama Samuel, associate chief of cardiology at Mount Sinai Beth Israel in New York, told me about a cluster of younger adults developing myocarditis, some of them a month or so after they had recovered from COVID-19.”

9) “One patient, who developed myocarditis four weeks after believing he had recovered from the virus, responded to a course of steroid treatment only to develop a recurrence in the form of pericarditis (an inflammation of the sac surrounding the heart).”

10) “A second patient, in her 40s, now has reduced heart function from myocarditis, and a third—an athletic man in his 40s—is experiencing recurring and dangerous ventricular heart rhythms, necessitating that he wear a LifeVest defibrillator for protection.”

11) “His MRI also demonstrates fibrosis and scarring of his heart muscle, which may be permanent, and he may ultimately require placement of a permanent defibrillator.”

12) Again, not fake news.

GEN: Cal U mourns the loss of senior football player Jamain Stephens https://t.co/yrL45ndo9k

— Cal U Athletics (@calvulcans) September 8, 2020

Međutim, "Njujork tajms" prenosi da se kod dobrovoljca u britanskoj grupi ispitanika pojavio upalni sindrom koji pogađa kičmenu moždinu i koji može biti rezultat virusne infekcije ili razbuktavanja neke autoimune bolesti.

Ova bolest podrazumeva kompletan poprečni presek kičmene moždine, koji sprečava komunikaciju između mozga i tela ispod nivoa upale. Simptomi se ispoljavaju samo u delu tela ispod linije upale i odnose se na otežano kretanje i senzorne probleme.

Vreme postavljanja dijagnoze, kao i to da li je ona povezana sa primljenom vakcinom, i dalje je nepoznato. Nezavisna istraga će tek utvrditi da li je bolest posledica reakcije na vakcinu.

паће wrote:Те болести које подразумевају су врло зајебане. Откуд знаш на шта мисле.

А тек ово ми није јасно, "време постављања дијагнозе ... је непознато". Шта, не знају кад ће дијагноза бити постављена? Тј не знају шта је а ни кад ће знати, или је дијагноза већ била постављена ама колега није уписао датум и време?

Не морају новинари да знају медицину. Не морају ни преводиоци. Ал' могли би понекад да погледају шта су написали и да ли то има смисла.

buffalo bill wrote:Međutim, "Njujork tajms" prenosi...

A person familiar with the situation, who spoke on the condition of anonymity, said that the participant who experienced the suspected adverse reaction had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is still unknown.

Transverse myelitis can result from a number of causes that set off the body’s inflammatory responses, including viral infections, said Dr. Gabriella Garcia, a neurologist at Yale New Haven Hospital. But, she added, the condition is often treatable with steroids.

AstraZeneca declined to comment on the location of the participant and did not confirm the diagnosis of transverse myelitis. “The event is being investigated by an independent committee, and it is too early to conclude the specific diagnosis,” the company said.

Transverse myelitis ( TM ) is a rare neurological condition in which the spinal cord is inflamed.
...
TM is characterized by weakness and numbness of the limbs, deficits in sensation and motor skills, dysfunctional urethral and anal sphincter activities, and dysfunction of the autonomic nervous system that can lead to episodes of high blood pressure. Signs and symptoms vary according to the affected level of the spinal cord.

AstraZeneca’s CEO, Pascal Soriot, said the woman who suffered the suspected adverse effect is recovering and is expected to leave hospital today.

Mr Soriot added that the trials had also been paused in July after a different participant experienced neurological symptoms. However, these were proven to be unrelated to the vaccine and the individual was diagnosed with multiple sclerosis. 

bemty wrote:

паће wrote:Те болести које подразумевају су врло зајебане. Откуд знаш на шта мисле.

А тек ово ми није јасно, "време постављања дијагнозе ... је непознато". Шта, не знају кад ће дијагноза бити постављена? Тј не знају шта је а ни кад ће знати, или је дијагноза већ била постављена ама колега није уписао датум и време?

Не морају новинари да знају медицину. Не морају ни преводиоци. Ал' могли би понекад да погледају шта су написали и да ли то има смисла.

AstraZeneca ne daje takve informacije jer postuju privatnost osobe uljucene u klinicku studiju. ovo je neki 'izvor blizak porodici' ili tako nesto, nije zvanicna dijagnoza i pitanje je koliko je tacna.

[size=32]Transiting through Hungary[/size]

lalinea wrote:Zna li neko da li Madjarska dopusta tranzit ljudima sa boravisnim dozvolama EU/EEA/Swiss? Tj. moze li se autom za Swiss iz Srbije kroz Madjarsku?