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Pharmaceutical company AstraZeneca on Tuesday canceled global trials of its coronavirus vaccine because of a serious and unexpected suspected side effect from a participant.

The trial freeze, first reported by Stat News, enables the British-Swedish company to conduct a security review. How long the hold will last is unclear.

In a statement, the company described the stop as a "routine action to be taken if any of the studies have a potentially unexplained disease while it is being investigated to ensure we are maintaining the integrity of the studies".

Officials in the US and Europe said the hiatus was a sign that the process was working as planned and assured that a vaccine that had passed all stages of clinical trials would be safe.

In an e-mail response to a Reuters query, the World Health Organization said, "We are pleased that vaccine developers ensure the scientific integrity of studies and adhere to standard guidelines and rules for vaccine development."

In an interview on "CBS This Morning", Dr. Anthony S. Fauci, the government's foremost infectious disease expert, shared that feeling.

"That is why you have different phases of trials to see if these candidates are actually safe," said Dr. Fauci, adding that such a stop was "not at all unusual". The problems may not be directly related to the vaccine, he said, but "you can't guess so."

"It really is one of the safety valves that you have in such clinical trials," he said.

The news that AstraZeneca was pausing its study came on the same day the company and eight other drug makers jointly pledged to commit to coronavirus vaccines, reiterating that they would not develop such products until they thoroughly checked them out and effectiveness checked.

President Trump has repeatedly claimed that a vaccine could be available before Election Day, November 3, adding to fears that his administration is politicizing the race by scientists to develop a vaccine and possibly public trust in an approved vaccine undermines.

One person who was familiar with the AstraZeneca study and spoke on condition of anonymity said the participant had taken part in a phase 2/3 study based in the UK. The person also said that one volunteer in the UK study was diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections. The timing of diagnosis and whether it was linked to the vaccine was unclear.

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

AstraZeneca's vaccine is currently in phase 2/3 in the UK and India, as well as phase 3 in Brazil, South Africa and in more than 60 locations in the US. The company intended to enroll 30,000 US members.

AstraZeneca is one of three companies whose vaccines are in late-stage clinical trials in the United States.

The director of the N.I.H. and the surgeon general answers the senators' questions.

The director of the National Institutes of Health and the surgeon general appeared before the Senate Health Committee Wednesday morning amid growing concerns that Mr Trump was pressuring his administration to approve a coronavirus vaccine ahead of the November election, before there is evidence for sure and effective.

Dr. Francis Collins, director of the National Institutes of Health, shot at an angle at Mr Trump, who on Monday told reporters that a vaccine could be approved by election day.

"Trying to predict whether this will happen in a certain week before or after a certain date in early November is way beyond anything a scientist could tell you right now, and you can be sure they know what they are saying" said Dr. Collins. He was "cautiously optimistic" that a safe and effective approach would emerge by the end of this year.

The panel's witnesses – Dr. Collins and Surgeon General Jerome Adams – are not controversial. The hearing should be tense, however, as the Democrats are grilling the two Doctors and Republicans, trying to stave off the idea that Mr. Trump is planning an "October surprise" – a vaccine approval that could give him an advantage – an election offer against former Vice President Joseph R. Biden Jr.

But one vaccine study has already hit the streets. On Tuesday, AstraZeneca halted major global trials of its late-stage vaccine over a serious suspicion of side effects in a participant, the company said. It is not yet known whether the vaccine caused the reaction directly.

Dr. Collins said the discontinuation of the AstraZeneca trial is "a concrete example of how a single case of unexpected illness is enough to conduct a clinical trial in multiple countries" – and proof that "we cannot compromise on safety" .

Dr. Adams said the Trump administration will allow state-licensed pharmacists to give Covid-19 vaccines to people ages three and up. The Federal Ministry for Health and Human Services will issue guidelines later on Wednesday, he said.

global summary

Britain prohibits gatherings of more than six people.

Britain, which is seeing a surge in new coronavirus cases, will ban most gatherings of more than six people starting next week, Prime Minister Boris Johnson said on Wednesday.

"I wish we didn't have to take this step" Mr Johnson said. "As your prime minister, I must do what is necessary to stop the virus from spreading."

Emphasizing hand washing and wearing face coverings, he said the new rule would only apply "as long as necessary".

He said the arrangement, which he called the "rule of six", replaced old guidelines and would apply to public and private gatherings.

Government Chief Medical Officer Professor Chris Whitty said the boom in the country wasn't just a matter of testing more people, comparing the situation in the UK to France, where cases are on the rise.

Restaurants and other eateries are now also legally obliged to use the personal data of customers for the purposes of contact tracking. And Mr Johnson said there will be stronger enforcement of quarantine rules for those entering the country.

The new rules go into effect on Monday and anyone who violates them can be fined and potentially arrested.

"They are not allowed to meet socially in groups of more than 6 people," said Mr Johnson. "If you do that, you will break the law."

Around 3,000 new cases were reported on both Sunday and Monday this week, the highest daily numbers in the UK since May. An additional 2,500 new cases and 32 deaths were reported Tuesday.

In other developments around the world:

  • A fast moving fire destroyed most of the largest European refugee camp the Greek island of LesbosThe 12,000 residents became homeless just days after the collective quarantine due to a coronavirus outbreak.

  • IndiaThe Ministry of Health announced Tuesday that it plans to voluntarily open classrooms for students starting September 21, only with parental consent. The vast majority of students will continue to study online. The Taj Mahal will also open to tourism on September 21st. Access is limited to 5,000 people per day. India has recorded more than 4.3 million cases, second only to the US. Almost 90,000 new infections were reported on Tuesday.

  • OntarioCanada's most populous province said Tuesday it would take a four-week "hiatus" before considering easing restrictions or allowing further economic reopening. Ontario Minister of Health Christine Elliott admitted that schools that reopened across the province on Tuesday would most likely become carriers of the virus and said the province's top priority is to prevent it from spreading in the country Protect community. Ontario has reported at least 43,000 coronavirus cases, including 852 in the past week, according to a New York Times database.

  • Viral infections are increasing the NetherlandsHugo de Jonge, the country's health minister, said Wednesday that 1,140 confirmed cases have been reported in the past 24 hours. "This is the highest number in months," said de Jonge. Hospital stays are also increasing, he said.

  • China's largest air show will take place in November, the organizer said on Wednesday, going back to an earlier announcement that the event had been canceled due to the pandemic. The biennial International Aerospace Exhibition takes place amid a sharp downturn in the industry.

  • Germany extended a general travel warning to all countries outside Europe until September 30th. However, the Foreign Ministry stated that from October individual non-European targets would be assessed on a case-by-case basis instead of issuing another blanket warning. Germans can travel within the European Union and to other countries within the European Schengen Zone for passport-free travel, as well as to Great Britain, Andorra, Monaco, San Marino and the Vatican without violating the warning, which is a notice and not a mandate. For the many Germans who travel on package tours, the warning In general, you can cancel bookings free of charge.

  • A photo of an elderly man having a meal in a pub in Galway, Ireland, began a national conversation about virus regulations and the simple joys in life.

Mnuchin expressed little optimism about another stimulus bill.

Treasury Secretary Steven Mnuchin on Wednesday expressed doubts about the likelihood of another stimulus package being passed this year, and said his current focus is on a move to extend government funding later this month.

The comments come from the fact that Republicans and Democrats in Congress are far apart in their views on the scope and cost of another bailout bill and that Mr Trump has been largely excluded from the negotiations.

When asked about the prospect of a further bill, Mr Mnuchin showed little optimism.

"I don't know," said Mr. Mnuchin outside the White House. "We'll see. I hope there is. It's important to a lot of people out there."

The Treasury Secretary said he was in talks with spokeswoman Nancy Pelosi on a "clean" bill to help the government financially until after the election and avoid government shutdowns. He has also had discussions with Senator Richard Shelby of Alabama, the Republican chief on the Senate Appropriations Committee, about such a bill.

"It doesn't seem promising for incentives at the moment," Shelby said Tuesday after speaking with Mnuchin about a stopgap solution, formally known as the rolling resolution. "So if we don't get an incentive, the only game in town would be a couple of nominations and the CR, which the government funds."

Mr Mnuchin has also reached out to Senate Republicans to discuss the scaled-back stimulus plan, tabled Tuesday, to provide federal aid to the unemployed, schools, farmers, the postal service and small businesses. Legislation, which saves billions of dollars from the original Republican $ 1 trillion proposal unveiled in July, does not provide for another round of $ 1,200 economic reviews or additional funding for state and local governments.

A vote on this bill, slated for Thursday in the Senate, is unlikely to reach the required 60-vote threshold as Democrats continue to push for a more robust and costly package.

When asked if he was frustrated by Trump's exposed rallies, Fauci said: "We want to set an example."

On Wednesday morning, the day after Mr. Trump held a major rally in North Carolina without a mask, Anthony S. Fauci, the nation's chief infectious disease official, expressed concern about the example of this set.

Dr. Fauci appeared on CBS This Morning to discuss the hunt for a coronavirus vaccine and was asked if he was frustrated to see such rallies.

"Well, and I've said that many times," he said. "We want to set an example."

Dr. Fauci, whose differences with the president were noted over the course of the pandemic, said public health measures such as wearing masks, maintaining physical distance, avoiding crowds, and engaging in outdoor rather than indoor activities "are the most important Are kind of things that change around surges and also prevent us from getting surges. "

"So I would definitely like to see mask wearing universal," he said.

While Mr. Trump's recent rallies have been outdoors or in airport hangars, they are certainly crowded, with little evidence of physical distancing. And even in places where there is an official mask requirement, such as North Carolina, there are few masks at the rallies. The Republican chairman of the district commission, where the rally was held on Wednesday, previously said the president should wear a mask in view of the nationwide order on face coverings. Mr. Trump didn't.

It is estimated that hundreds of thousands of sailors are trapped at sea fighting against exhaustion and despair.

When the borders were closed because of the pandemic, seafarers on ships around the world suddenly had no way home. For cargo ships around the world, the process known as crew change, where seafarers are replaced with new ones when their contracts expire, has almost stalled.

Six months later, there is no solution in sight.

In June the United Nations called the situation "a growing humanitarian and security crisis".

Last month, the International Transport Workers 'Federation, a seafarers' union, estimated that 300,000 of the 1.2 million crew members at sea were essentially stranded on their ships, working after their original contracts expired, battling isolation, insecurity and fatigue.

Some crew members have started to refuse to work, forcing ships to stay in port. And many in the shipping industry fear that stress and exhaustion will lead to accidents, perhaps catastrophic.

"There's nothing I can do," said Ralph Santillan, a merchant seaman from the Philippines, late last month from his ship, a 965-foot bulk carrier off South Korea. "I have to leave whatever could happen here to God."

France's Prime Minister Jean Castex is self-isolating and will hold his meetings remotely after meeting the Tour de France director on Saturday who tested positive.

Mr Castex's isolation comes from the fact that France will revive in the past seven days with a daily average of 7,000 cases and an increase in the number of ICU patients after months of decline.

Mr Castex tested negative on Tuesday but he will isolate until he is retested seven days after contact. As a result, France's weekly cabinet meeting will be held via videoconference on Wednesday for the first time since the country's two-month lockdown ended in May.

President Emmanuel Macron also tested negative after visiting Lebanon and Iraq last week, and Interior Minister Gérald Darmanin is being tested after spending time with Mr Castex on Tuesday.

"We do for ourselves what we ask of all our fellow citizens," Macron told reporters on Tuesday.

However, Mr Macron admitted that the situation was "worrying" and urged French citizens to be "more vigilant" in their private lives in the face of the epidemic.

Mr Macron said new measures to fight the virus would be discussed in a health protection council on Friday.

In particular, the government will discuss the widespread adoption of antigen testing, believed to be easier and faster, as the country faces increasing delays in test results, hindering its fight against the spread of the virus.

In the United States, colleges that have reopened for face-to-face classes are struggling to contain the spread of the virus among tens of thousands of students. Perhaps the most complex problem is what to do with students who test positive or who they come into contact with someone who has.

Many have set up special dormitories or rent apartments or hotel rooms off campus in order to provide isolation beds and separate quarantine units for infected students for potentially sick people.

However, some students and epidemiologists say the guidelines have collapsed, often in ways that could put students and college staff at risk.

At the University of Alabama at Tuscaloosa and Notre Dame University, students have reported their classmates for violating quarantine and outdoor hiking. At Iowa State University, a student waiting for his virus test results said he was sent back to his regular dorm room where he could have infected his roommate.

And in many locations, students with confirmed or potential infections have flooded social media platforms describing dirty rooms, meager food rations, missing furniture, messy procedures, and minimal surveillance by their universities.

The breakdown of the guidelines reflects the chaotic nature of this extraordinary semester, with schools struggling to offer both personal and remote classes. Identify, isolate, and treat coronavirus outbreaks; and to maintain safe behavior among sometimes unruly students.

At the University of North Carolina at Chapel Hill, Brianna Hayes developed a fever after a week at school, went to the on-campus health service and was immediately placed in a quarantine dormitory for students at risk of viruses. Two days later, the university informed Ms. Hayes, a freshman, that she had tested positive and had to move again, this time to a Covid-19 isolation home.

But there were no university staff in the dormitory to help sick students, Ms. Hayes said, and no one came from university to check on her during her week in isolation.

"I felt like everyone was just interested in how I influenced others, how who I came in contact with, and then I just got sick," she said.

Amy Johnson, vice chancellor for student affairs at U.N.C., said the school worked hard "to make transition easy and convenient for students" and "to keep lines of communication open". With more than 900 cases of student virus in the last month, the university switched to online classes in mid-August, but it has allowed some students with proven needs to stay on campus.

Elsewhere in the US:

  • in the New York CityMayor Bill de Blasio said Wednesday that an update on indoor dining in the city, which is currently banned, could come "as early as this week". He added that the city must set a threshold to stop activity in certain cases in the event of a surge. His remarks came when Governor Andrew M. Cuomo raised concerns about compliance, enforcement and safety standards. "We are trying our best to see if there is any way to bring clarity to the restaurant industry so that they have the opportunity to move on," said the mayor.

Former Italian Prime Minister Silvio Berlusconi was in Sardinia in August, as was his friend, club owner Flavio Briatore. Now both are among hundreds of island-related events, a favorite of the rich party-goers.

It is unclear when or how Mr Berlusconi and Mr Briatore got the virus. However, it is known that the number of cases on the island has increased from a few dozen before summer to over 1,000 per month.

Mr Berlusconi, 83, lies in a Milan hospital with pneumonia. Mr Briatore, who stopped by to pay him a visit to his Sardinian property and who publicly complained about a government overreaction to the pandemic, is being quarantined.

In March, as cases and deaths exploded in northern Italy, South Island Governor Christian Solinas asked authorities in Rome to ban entry into Sardinia. The government obliges. The island held the worst off for months.

But August has been Sardinia's hot season since the 1960s, and even the pandemic couldn't stop it.

Roberto Ragnedda, the mayor of the Sardinian city of Arzachena, said that "10 days of madness" in August had "done enormous damage to our image and our economy".

Some of the perpetrators who were caught without a mask had to lie in a coffin. Others were ordered to sit in the back of a hearse.

With coronavirus numbers rising above 200,000 in Indonesia, some officials are finding creative ways to get home the message that wearing a mask is required to prevent new infections.

In East Jakarta, the authorities punished several people with time in a coffin.

"The coffin is a symbol to remind people not to underestimate the coronavirus," said Budhy Novian, head of the public order agency in east Jakarta. "We try to get the message across to people: The Covid-19 number is high and leads to death."

But officials halted the practice after critics pointed out viewers violating social distancing rules by pushing themselves to gawk and take photos.

Indonesia, fourth in the world Most populous country, passed 200,000 reported cases as of Tuesday. According to a New York Times database, an average of more than 3,000 cases per day has occurred for the past two weeks, and the death toll is the highest in East Asia at 8,230.

Indonesia has one of the lowest testing rates in the world, and its positivity rate is close to 14 percent, slightly higher than Sweden's and well above the 5 percent the World Health Organization has cited as a rough benchmark for easing social distancing measures. (An increasing rate of positivity can indicate an uncontrolled outbreak; it can also indicate that not enough tests are being done.)

Some independent experts suggest that the real number of cases in Indonesia is many times higher than 200,000.

In Jakarta, the capital, officials erected a coffin-themed monument last week to highlight the rising death toll and remind people to follow coronavirus protocols.

Failure to comply with the obligation to wear a mask in public in Jakarta is punishable by a fine of up to US $ 67 for repeat offenders, which is a significant sum for many residents.

Coverage was by Aurora Almendral, Troy Closson, Emily Cochrane, Jason Horowitz, Mike Ives, Patrick Kingsley, Constant Méheut, Claire Moses, Richard C. Paddock, Alan Rappeport, Christopher F. Schütze, Sheryl Gay Stolberg, Natasha Singer and Karan Deep written by Singh, Kaly Soto, Megan Specia, Muktita Suhartono, Katie Thomas, Katherine J. Wu, and Elaine Yu.


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