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J&J says review of illness that led to pause of coronavirus vaccine trial could take days

(Reuters) – Johnson & Johnson said on Tuesday it would take a few days at least to hear from a safety monitoring panel about its review of the company’s late-stage COVID-19 vaccine trial after announcing that the large study had been paused due to an unexplained illness in one participant.

The pause comes around a month after AstraZeneca Plc also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill. That trial remains on pause.

U.S.-based J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as its own clinical and safety team. The data board is then required to submit its findings to the U.S. Food and Drug administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo.

J&J said such pauses are normal in big trials, which can include tens of thousands of people. The company said the trial is still on track to continue adding patients over the coming months.

It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.

Former FDA chief said on Twitter the trial said that the oversight of safety boards for the COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Experts and officials have voiced concerns that U.S. President Donald Trump could put pressure on vaccine makers to rush an unsafe or ineffective vaccine to market.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines both use modified, harmless versions of adenoviruses to deliver genetic instructions to human cells in order to spur an immune response to the target virus, in this case the novel coronavirus.

FILE PHOTO: The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid/File Photo

They are both also

J&J says review of illness that led to coronavirus vaccine trial pause could take days

By Carl O’Donnell and Manas Mishra

(Reuters) – Johnson & Johnson said on Tuesday it would take at least a few days for an independent safety panel to evaluate an unexplained illness of a study participant that led to a pause in the company’s COVID-19 vaccine trial.

J&J shares fell more than 2% following news of the pause and safety review. Rival AstraZeneca Plc’s U.S. trial for its coronavirus vaccine candidate – which uses a similar technology – has remained on hold for more than a month after a participant in the company’s UK trial fell ill.

J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as by its own clinical and safety team.

The data board, which is also reviewing AstraZeneca’s U.S. trial, is required to submit its findings to the U.S. Food and Drug Administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo. Mammen added that J&J remains on track to complete recruitment for its 60,000-person trial in the next two to three months.

EVIDENCE OF ‘INTEGRITY’

The company said such pauses are not unusual in large trials.

It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.

J&J has said it expects to have enough data to apply for U.S. regulatory clearance by the end of the year. Pfizer Inc and Moderna Inc have said they expect to be able to apply for FDA clearance for their vaccine candidates even sooner.

Former FDA chief Scott Gottlieb said on Twitter that the oversight of safety boards for COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Health experts have voiced concerns that U.S. President Donald Trump could put pressure on the FDA and drugmakers to rush an unsafe vaccine to market to bolster his re-election prospect. He has repeatedly said a vaccine could be available prior to the Nov. 3 election.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant. While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial remains on hold.

China Qingdao city says it tested 3m people for COVID-19 in 2 days

  • The Chinese city of Qingdao says it has tested 3 million people for COVID-19 in just 48 hours.
  • After finding 12 new coronavirus cases on Sunday, health authorities pledged to test all 9 million residents within a week.
  • Qingdao’s reaction shows how seriously China still takes the virus, and the scale of the drive is unheard of in the US and Europe. 
  • Authorities in many US cities and European countries have struggled to roll out comprehensive testing schemes.
  • Visit Business Insider’s homepage for more stories.

A Chinese city says it has tested 3 million people for COVID-19 in just 48 hours, the latest example of just how far the US and much of Europe lag behind in terms of testing capability. 

On Sunday, the eastern city of Qingdao announced it would test all 9 million residents after identifying 12 cases of coronavirus linked to a local hospital. Officials said everyone would be tested within five days.

In a Tuesday update, the Municipal Health Commission of Qingdao said none of the 1.1 million tests that had returned so far were positive, according to the Associated Press.

However, China’s National Health Commission said Tuesday that there were six new cases of the virus in Qingdao recorded in the past 24 hours, according to the AP. The reason for the discrepancy is not clear so far.

China effectively rid itself of the coronavirus in August, having recorded its first day without a new locally transmitted case on May 23. 

The news from Qingdao after a dozen new cases shows just how seriously the country is still taking the virus.

Testing 3 million people in 48 hours is a feat that would be unheard of in cities across Europe and North America.

xi jinping china poster

A woman with a protective face mask walks past a portrait of Chinese President Xi Jinping in Shanghai, China, on March 12, 2020.

Aly Song/Reuters


Many authorities in US cities, who struggled to roll out comprehensive testing programs during the worst weeks of the outbreak in July, are still failing to do so in the face of another surge in cases this autumn and winter.

“One of the biggest obstacles to containment has been the fact that we don’t have a testing strategy and people don’t know their status,” Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, told Business Insider in August.

“When you look at countries that have been able to contain [the virus], they didn’t do anything out of the ordinary. They tested, traced, and isolated.”

Dr. Carolyn Cannuscio, a social epidemiologist who leads the contact-tracing program at the University of Pennsylvania, also told Business Insider: “We have a broken testing system, and that sets us up for failure in contact tracing because people are waiting so long to get their test results that we have missed a critical period for counseling those people to stay home and avoid infecting others.”

At one point in May the US was testing more people than

Studies find COVID-19 coronavirus can survive 28 days on some surfaces, 11 hours on skin

The coronavirus that causes COVID-19 can survive on items such as banknotes and phones for up to 28 days in cool, dark conditions, according to a study by Australia’s national science agency. Researchers at CSIRO’s disease preparedness centre tested the longevity of SARS-CoV-2 in the dark at three temperatures, showing survival rates decreased as conditions became hotter, the agency said Monday.

The scientists found that at 68 degrees Fahrenheit, SARS-CoV-2 was “extremely robust” on smooth surfaces — like cell phone and other touch screens — surviving for 28 days on glass, steel and plastic banknotes.

At 86 degrees Fahrenheit, the survival rate dropped to seven days and plunged to just 24 hours at 104 degrees Fahrenheit.


Alarming spike of COVID-19 cases across the U…

01:37

The virus survived for shorter periods on porous surfaces such as cotton — up to 14 days at the lowest temperatures and less than 16 hours at the highest — the researchers said. This was “significantly longer” than previous studies which found the disease could survive for up to four days on non-porous surfaces, according to the paper published in the peer-reviewed Virology Journal.

A separate piece of research published this week by Kyoto Prefectural University of Medicine in Japan found the new coronavirus  is unusually durable on human skin, too, surviving for up to 11 hours. That compares to about two hours of expected longevity for the influenza A (flu) virus on skin. The Japanese researchers said this durability “may increase the risk of contact transmission… thus accelerating the pandemic.”

The authors said in their study, published in the journal Clinical Infectious Diseases, that the findings underscore the importance of hand-washing and disinfecting. 

Trevor Drew, director of the Australian Centre for Disease Preparedness, said their study involved drying samples of the virus on different materials before testing them, using an “extremely sensitive” method that found traces of live virus able to infect cell cultures.

“This doesn’t mean to say that that amount of virus would be capable of infecting someone,” he told public broadcaster ABC.

He added that if a person was “careless with these materials and touched them and then licked your hands or touched your eyes or your nose, you might well get infected upwards of two weeks after they had been contaminated.”

Critical for “risk mitigation”

Drew said there were several caveats including that the study was conducted with fixed levels of virus that likely represented the peak of a typical infection, and there was an absence of exposure to ultraviolet light, which can rapidly degrade the virus.

Humidity was kept steady at 50 percent, the study said, as increases in humidity have also been found as detrimental to the virus.

According to the CSIRO, the virus appears to primarily spread through the air but more research was needed to provide further insights into the transmission of the virus via surfaces.


CDC says COVID-19 is “sometimes” airborne

04:15

“While the precise role of surface transmission, the degree of surface contact and

One-third of Chinese city of 9 million swabbed for virus in two days

More than three million swabs have been taken in a matter of days in Qingdao, the Chinese port city where a minor coronavirus outbreak elicited a sweeping health response.

Queues for testing stretched deep into Monday night across the eastern city, which detected six virus cases the day before but swiftly swung into action to head off a wider outbreak.

In scenes which contrast with the fumbled efforts of other nations to establish effective testing regimes, Qingdao health workers in protective gear set up tents to take samples across neighbourhoods, where parents brought toddlers for testing.

Residents said on social media that community representatives informed them of their nearest testing stations, with local districts helping to organise sample collection for mass testing.

“As of 8 am… our city has taken 3.08 million samples for nucleic testing, with 1.11 million results received,” Qingdao’s health commission said in a statement Tuesday.

In addition to six people with symptoms, there six asymptomatic cases have been detected so far.

The city declared it aims to test its entire population — around 9.4 million — within five days of the detection of the first cases at a hospital on Sunday.

It was not immediately clear how fast results could be processed, although China has paraded its rapid testing capacities during previous minor outbreaks.

China’s ruling Communist Party is desperate to show its ability to manage the pandemic to its citizens — as well as to foreign audiences — after it emerged in the central city of Wuhan.

The country has bounced back since the virus emerged late last year and forced widespread lockdowns that hammered the world’s second-largest economy.

China is also desperate to be the first nation to produce a coronavirus vaccine, with several companies in final-stage trials.

burs-apj-bys/am/qan

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Trump doctor says president ‘has tested negative’ for COVID-19 on consecutive days, won’t reveal when

President Donald Trump tested negative for COVID-19 at some point in the “recent” past, his personal doctor said Monday, though he didn’t specify what that meant.

Dr. Sean Conley, the White House doctor who has continued to offer misleading or incomplete information about Trump’s COVID-19 diagnosis, offered the latest confusing update in a memo released shortly before the president was set to hold an evening campaign rally in Florida.

“In response to your inquiry regarding the president’s most recent COVID-19 tests, I can share with you that he has tested NEGATIVE, on consecutive days,” Conley wrote in the memo.

A White House spokesman did not return a request for clarity.

Conley wrote in the memo that Trump’s negative results came back using the so-called “Abbott BinaxNOW antigen card” — a rapid test known to not be as accurate as more sensitive swab tests.

However, Conley said the team of White House physicians also relied on “clinical and laboratory data” in assessing that “the president is not infectious to others.”

Since Trump was diagnosed with COVID-19 on Oct. 1, Conley and White House officials have refused to say when he took his last negative test.

The obfuscation has raised concern that Trump could still be contagious.

The Centers for Disease Control and Prevention says COVID-19 patients who experience severe symptoms — which Trump did — can be contagious for “up to 20 days.”

Nonetheless, Trump was not wearing a face mask as he boarded Air Force One on Monday afternoon for a rally in Sanford, Florida — his first public campaign event since being diagnosed with the virus that’s killed more than 215,000 Americans.

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Coronavirus can last 28 days on glass and currency, study finds

MELBOURNE/SYDNEY (Reuters) – The virus that causes COVID-19 can survive on banknotes, glass and stainless steel for up to 28 days, much longer than the flu virus, Australian researchers said on Monday, highlighting the need for frequent cleaning and handwashing.

FILE PHOTO: Commuters ride a train in Sydney, Australia, August 19, 2020. REUTERS/Loren Elliott

Findings from the study by Australia’s national science agency, CSIRO, appear to show that in a very controlled environment the virus remained infectious for longer than other studies have found.

CSIRO researchers found that at 20 degrees Celsius (68 Fahrenheit), the SARS-CoV-2 virus remained infectious for 28 days on smooth surfaces such as plastic banknotes and the glass found on mobile phone screens. The study was published in Virology Journal.

By comparison, the influenza A virus has been found to survive on surfaces for 17 days.

“It really reinforces the importance of washing hands and sanitising where possible and certainly wiping down surfaces that may be in contact with the virus,” said the study’s lead researcher, Shane Riddell.

The World Health Organization (WHO) said that the study built on previous experimental studies used to draw up its existing guidance on handwashing and disinfection of surfaces.

“The persistent detection of SARS-CoV-2 … in the experimental conditions from this study is not unexpected and informs our understanding of virus survivability,” April Baller, a WHO infection prevention and control expert, said in an emailed response to Reuters, adding that this would not change WHO recommendations at this time.

INFECTIOUS TRACES MEASURED

Paul Digard, a virology specialist at Britain’s Edinburgh University Roslin Institute, said it was significant that the researchers had measured infectious virus, not just detectable bits of virus, but added that it was also key to remember that the infectivity decays over time.

“So the amount of virus surviving at 28 days is very low and is therefore likely to be much less likely to infect someone than the higher amounts present when the virus is freshly deposited,” he said in an emailed comment.

The study involved drying virus in an artificial mucus on a range of surfaces at concentrations similar to samples from COVID-19 patients and then recovering the virus over a month.

Experiments done at 20, 30 and 40 degrees Celsius showed the virus survived longer at cooler temperatures, longer on smooth surfaces than on complex surfaces such as cotton and longer on paper banknotes than on plastic banknotes.

All the experiments were done in the dark to remove the impact of ultraviolet light because research has shown that direct sunlight can kill the virus.

“So in the real world, results would likely be shorter than what we were able to show,” Riddell told Reuters.

Researchers said, given that proteins and fats in body fluids can also sharply increase virus survival times, their study may help to explain the apparent persistence and spread of the virus in cool environments such as meat-packing plants.

Additional reporting by Kate Kelland in London

Trump campaign manager returns to office 10 days after positive COVID-19 test

President TrumpDonald John TrumpDes Moines mayor says he’s worried about coronavirus spread at Trump rally Judiciary Committee Democrats pen second letter to DOJ over Barrett disclosures: ‘raises more questions that it answers’ Trump asks campaign to schedule daily events for him until election: report MORE‘s campaign manager Bill StepienBill StepienTrump Jr. returning to campaign trail after quarantining The Memo: Trump searches for path to comeback Bob Dole claims no Republicans on debate commission support Trump MORE resumed working at the campaign’s Virginia headquarters on Monday, 10 days after he tested positive for COVID-19.

Stepien told reporters on a conference call that he was back in the office after his recent positive test, “in full accordance with” Centers for Disease Control and Prevention (CDC) guidelines.

The CDC guidelines say adults with mild to moderate COVID-19 cases can be around others 10 days after the onset of symptoms so long as they have gone 24 hours without a fever and other symptoms are improving. Severe cases require longer isolation periods. Public health experts have also encouraged individuals to obtain two negative tests before resuming regular activities.

Stepien, 42, tested positive on Oct. 2 and dealt with mild flu-like symptoms, the campaign said at the time. He went into quarantine and worked from home until Monday.

Stepien did not say on Monday’s call whether he had tested negative for the virus but cited being beyond the 10 day window from the onset of symptoms for his decision to return to the office.

“We take a lot of precautions here at the headquarters every single day,” Stepien said, pointing to signage about health protocols and noting that the campaign has a nurse on staff to ensure everyone is healthy.

Stepien’s decision to resume working in-person reflects the broader attitude of the president and his team toward the virus, which has killed more than 210,000 people in the U.S. and infected nearly 8 million.

Trump, who revealed that he had tested positive for the coronavirus on Oct. 2, is set to resume campaign rallies on Monday night in Florida despite the White House refusing to say when he last tested negative, and some top White House officials, such as chief of staff Mark MeadowsMark Randall MeadowsAdministration officials call on Congress to immediately pass bill to spend unused PPP funds Trump claims he is ‘immune’ from coronavirus, defends federal response Senate Republicans rip new White House coronavirus proposal MORE, have continued to work from the building despite being in close contact with the president, press secretary Kayleigh McEnany and others who have tested positive. 

The president’s physician said late Saturday that Trump is no longer a risk to spread the virus but stopped short of saying he had tested negative.

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Study finds COVID-19 coronavirus can survive 28 days on some surfaces

The coronavirus that causes COVID-19 can survive on items such as banknotes and phones for up to 28 days in cool, dark conditions, according to a study by Australia’s national science agency. Researchers at CSIRO’s disease preparedness centre tested the longevity of SARS-CoV-2 in the dark at three temperatures, showing survival rates decreased as conditions became hotter, the agency said Monday.

The scientists found that at 68 degrees Fahrenheit, SARS-CoV-2 was “extremely robust” on smooth surfaces — like cell phone and other touch screens — surviving for 28 days on glass, steel and plastic banknotes.

At 86 degrees Fahrenheit, the survival rate dropped to seven days and plunged to just 24 hours at 104 degrees Fahrenheit.


Alarming spike of COVID-19 cases across the U…

01:37

The virus survived for shorter periods on porous surfaces such as cotton — up to 14 days at the lowest temperatures and less than 16 hours at the highest — the researchers said.

This was “significantly longer” than previous studies which found the disease could survive for up to four days on non-porous surfaces, according to the paper published in the peer-reviewed Virology Journal.

Trevor Drew, director of the Australian Centre for Disease Preparedness, said the study involved drying samples of the virus on different materials before testing them, using an “extremely sensitive” method that found traces of live virus able to infect cell cultures.

“This doesn’t mean to say that that amount of virus would be capable of infecting someone,” he told public broadcaster ABC.

He added that if a person was “careless with these materials and touched them and then licked your hands or touched your eyes or your nose, you might well get infected upwards of two weeks after they had been contaminated.”

Critical for “risk mitigation”

Drew said there were several caveats including that the study was conducted with fixed levels of virus that likely represented the peak of a typical infection, and there was an absence of exposure to ultraviolet light, which can rapidly degrade the virus.

Humidity was kept steady at 50 percent, the study said, as increases in humidity have also been found as detrimental to the virus.

According to the CSIRO, the virus appears to primarily spread through the air but more research was needed to provide further insights into the transmission of the virus via surfaces.


CDC says COVID-19 is “sometimes” airborne

04:15

“While the precise role of surface transmission, the degree of surface contact and the amount of virus required for infection is yet to be determined, establishing how long this virus remains viable on surfaces is critical for developing risk mitigation strategies in high contact areas,” CSIRO’s Debbie Eagles said.

The main message remains that “infectious people are far, far more infectious than surfaces”, Drew told the ABC.

“But nevertheless, it may help to explain why even when we got rid of the infectious people, we do occasionally get these breakouts again, sometimes even in a country which is considered to be free,” he

Coronavirus can last 28 days on glass, currency, study finds

MELBOURNE/SYDNEY (Reuters) – The virus that causes COVID-19 can survive on banknotes, glass and stainless steel for up to 28 days, much longer than the flu virus, Australian researchers said on Monday, highlighting the need for frequent cleaning and handwashing.

Findings from the study done by Australia’s national science agency, CSIRO, appear to show that in a very controlled environment, the virus remained infectious for longer than other studies have found.

CSIRO researchers found that at 20 degrees Celsius (68 Fahrenheit), the SARS-COV-2 virus remained infectious for 28 days on smooth surfaces such as plastic banknotes and the glass found on mobile phone screens. The study was published in Virology Journal.

By comparison, the influenza A virus has been found to survive on surfaces for 17 days.

“It really reinforces the importance of washing hands and sanitising where possible and certainly wiping down surfaces that may be in contact with the virus,” said the study’s lead researcher, Shane Riddell.

Paul Digard, a virology specialist at Britain’s Edinburgh University Roslin Institute, said it was significant that the researchers had measured infectious virus, not just detectable bits of virus, but added it was also key to remember that the virus’ infectivity decays over time.

“So the amount of virus surviving at 28 days is very low and is therefore likely to be much less likely to infect someone than the higher amounts present when the virus is freshly deposited,” he said in an emailed comment.

The study involved drying virus in an artificial mucus on a range of surfaces at concentrations similar to samples from COVID-19 patients and then recovering the virus over a month.

Experiments done at 20, 30 and 40 degrees C showed the virus survived longer at cooler temperatures, longer on smooth surfaces than on complex surfaces such as cotton, and longer on paper banknotes than on plastic banknotes.

All the experiments were done in the dark to remove the impact of ultraviolet light, as research has shown direct sunlight can kill the virus.

“So in the real world results would likely be shorter than what we were able to show,” Riddell told Reuters.

Researchers said given that proteins and fats in body fluids can also sharply increase virus survival times, their study may help explain the apparent persistence and spread of the virus in cool environments like meat-packing facilities.

Australia has fared much better than most other rich nations in combating COVID-19, with about 27,000 infections and 898 deaths in a population of 25 million.

The epicentre of the country’s second wave of infection, Victoria state, reported 15 new cases on Monday, well shy of a target of less than five which the government has set for the easing of a hard lockdown in the state capital Melbourne.

Additional reporting by Kate Kelland in London, editing by Stephen Coates and Giles Elgood

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