NEW BRUNSWICK, N.J. — A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot.

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This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot, the company announced Monday. Cheryl Gerber/Courtesy of Johnson & Johnson via Associated Press

The company said in a statement Monday evening that illnesses, accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies,” but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.

The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S.

The company declined to reveal any more details about the illness, citing the participant’s privacy.

Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.

Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Given that such tests are done on tens of thousands of people, some medical problems are a coincidence. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.

The halt was first reported by the health news site STAT.

Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.

Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.

Patriots show no positive virus tests, hope to practice Wednesday

The New England Patriots returned no coronavirus positives on Monday, according to reports, and the team is now hoping to begin a second round of preparation for the Denver Broncos with a Wednesday afternoon practice.

After a wild nine-day stretch during which two games had to be rescheduled due to positive COVID-19 tests, the Patriots were given Monday and Tuesday off by Coach Bill Belichick.

The team is now scheduled to be back at Gillette Stadium on Wednesday to begin what the Patriots hope will be a normal week leading up to Sunday’s 1 p.m. game against the Broncos in Foxborough – unless further positive tests would change those plans.

The teams were supposed to play this past Sunday, but due to the lack of practice time for the Patriots after Stephon Gilmore’s positive test, the game was moved to Monday at 5 p.m. When defensive lineman Byron Cowart tested positive over the weekend, the NFL switched the game to next Sunday.

Read the full story here.

UK unveils 3-level lockdown plan

LONDON — The British government carved England into three tiers of coronavirus risk on Monday in a bid to slow a resurgent outbreak, putting the northern city of Liverpool into the highest risk category and shutting its pubs, gyms and betting shops.

Prime Minister Boris Johnson said the three-tier national system was designed to “simplify and standardize” a confusing patchwork of local rules, as the country faces a “crucial phase” in which hospitals are now filling up with more COVID-19 patients than in March, when he ordered a national lockdown.

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Britain’s Prime Minister Boris Johnson ponders his message during a coronavirus briefing in Downing Street, London, on Monday. Toby Melville/Pool Photo via Associated Press

“These figures are flashing at us like dashboard warnings in a passenger jet, and we must act now,” he said.

Shops, schools and universities would remain open in all areas. Johnson told lawmakers that the goal of the new system was to save lives and prevent hospitals becoming overwhelmed without “shuttering our lives and our society” through a new national lockdown.

But pubs, restaurants and other hospitality businesses pushed back, with some industry leaders threatening a legal challenge against the rules and arguing that they are not to blame for rising infections.

After falling during the summer, coronavirus cases are rising in the U.K. as winter approaches, with northwest and northeast England seeing the steepest increases. Liverpool has one of the country’s most severe outbreaks, with about 600 cases per 100,000 people, even more than the hard-hit European cities of Madrid and Brussels.

Under the new measures, areas in England are classified at medium, high or very high risk, and placed under restrictions of varying severity.

Areas in the lowest tier will follow existing national restrictions, including a 10 p.m. curfew on pubs and restaurants and a ban on more than six people gathering. In areas at high risk, members of different households are barred from meeting indoors.

The “very high” risk tier will face restrictions including closing pubs — apart from those that serve meals — and, if local authorities want, other venues such as gyms and casinos.

Liverpool was the only area put into the top category Monday, but Johnson said authorities were still talking with other local leaders across the north of England.

Pubs, gyms, leisure centers, betting shops and casinos in Liverpool will close beginning Wednesday.

Read the full story about the United Kingdom here.

China vows to test all 9 million people in eastern city

BEIJING — China’s government says all 9 million people in the eastern city of Qingdao will be tested for the coronavirus this week after nine cases linked to a hospital were found.

The announcement Monday broke a string of weeks without any locally transmitted infections reported in China.

The National Health Commission said authorities were investigating the source of the infections found in eight patients at Qingdao’s Municipal Chest Hospital and one family member. The commission said the whole city will be tested within five days.

China, where the pandemic began in December, has reported 4,634 deaths and 85,578 cases, plus nine suspected cases that have yet to be confirmed.

The last reported virus transmissions within China were four patients found on Aug. 15 in the northwestern city of Urumqi in the far western Xinjiang region. All the cases reported since then were in travelers from outside the mainland.

WHO leader warns against herd immunity solution

LONDON — The head of the World Health Organization warned against the idea that herd immunity might be a realistic strategy to stop the pandemic, calling such proposals “unethical.”

WHO director-general Tedros Adhanom Ghebreyesus said at a press briefing on Monday that health officials typically aim to achieve herd immunity — where the entire population is protected from a virus when the majority are immune — by vaccination. Tedros noted that to obtain herd immunity from measles, for example, about 95% of the population must be vaccinated.

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In this photo released by WHO, World Health Organisation on Monday, Oct. 5, 2020, WHO Director-General, Dr Tedros Adhanom Ghebreyesus, wearing a mask to protect against coronavirus, gestures during a special session on the COVID-19 response. Christopher Black/WHO via AP

“Herd immunity is achieved by protecting people from a virus, not by exposing them to it,” he said. “Never in the history of public health has herd immunity been used as a strategy for responding to an outbreak,” he said, calling the strategy “scientifically and ethically problematic.”

Tedros said that WHO estimates less than 10% of the population has any immunity to the coronavirus, meaning the vast majority of the world remains susceptible.

Tedros also noted countries had reported record-high daily figures of COVID-19 to the U.N. health agency for the last four days, citing surges in Europe and the Americas in particular.

Wisconsin judge upholds mask order for enclosed spaces

MADISON, Wis. — A Wisconsin judge on Monday allowed the state’s mask mandate to stand, rejecting an attempt by the Republican-controlled Legislature and a conservative law firm to overturn it, even as cases are spiking.

The judge noted in his ruling that the Legislature could vote to overturn the order from Democratic Gov. Tony Evers if they wanted to, but they haven’t so far.

Republican legislative leaders and a spokesman for the Wisconsin Institute for Law and Liberty, which brought the case, did not immediately return messages seeking comment. The Legislature filed a brief in support of the lawsuit. The ruling is expected to be appealed.

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Nursing assistant Monica Brodsky, right, hands McKensie Burreson, of Madison, a funnel and vial for a saliva test that tests for COVID-19 at a drive-thru testing site in the parking lot at the UW Health Administrative Office Building in Middleton, Wis., Monday, Oct. 5. Amber Arnold/Wisconsin State Journal via AP

The lawsuit argued that Evers overstepped his authority by issuing multiple emergency orders to curb the coronavirus pandemic. Evers defended the mask order, saying it was within his power to impose the requirement and that he followed the recommendations of public health experts.

St. Croix County Circuit Judge R. Michael Waterman said in his ruling that nothing prevents a governor, as Evers did in this case, from issuing multiple emergency declarations “when the emergency conditions continue to exist.”

“And, if the Legislature is unconvinced that a state of emergency does exist, the Legislature has the ultimate power to terminate it,” the judge said.

The judge also noted that overturning the mask mandate, in place since August, would “affect every person in Wisconsin by a judicial act that usurps the governor’s power to declare a state of emergency and the Legislature’s power to end one.”

Evers first declared a public health emergency in March and renewed it in July after the Legislature declined to extend it. The July order mandated the wearing of masks starting in August for anyone aged 5 and up in all enclosed spaces except at home. He issued another order in September that extended the mask mandate until Nov. 21. Violators could be subject to a $200 fine.

The lawsuit argues that Evers can issue only one emergency declaration per crisis. Attorney Anthony LoCoco said during a hearing last week t hat the multiple declarations amount to a power grab and that the mask mandate is an “invasion” of personal liberty.

The lawsuit also argued that masks are ineffective since Wisconsin’s infection numbers have continued to rise since Evers’ mandate was imposed.

Assistant Attorney General Colin Hector argued for the state that the three orders were designed to address the growing pandemic.

Wisconsin is among the worst COVID-19 hot spots in the country, topping more than 150,000 positive cases on Sunday. Medical experts have attributed Wisconsin’s spike to colleges and K-12 schools reopening and general fatigue with precautions such as wearing masks and socially distancing.

Carnival Cruise Line cancels Florida, Australia trips

MIAMI — Carnival Cruise Line said Monday it was canceling its remaining cruises scheduled for November out of two Florida ports, as well as five cruises from Australia at the beginning of next year.

The cruise line had previously announced it was canceling for the rest of the year all U.S. cruises except for trips out of Port Canaveral and Port Miami following an extension of a no-sail order until Oct. 31 by the U.S. Centers for Disease Control. But Monday’s announcement nixed trips in November on the six ships operating out of the two Florida ports.

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Carnival cruise line ship Carnival Magic is docked at Port Canaveral, in Cape Canaveral, Fla. in April. Carnival Cruise Line is canceling most U.S. sailings through the end of this year. AP Photo/John Raoux, File

Cruises are still planned for December out of the two Florida ports.

“Carnival continues to work on protocols and procedures that would allow for the resumption of cruise operations, with a gradual, phased-in approach, designating Miami and Port Canaveral as the first two homeports for embarkations,” the cruise line said in a statement.

The cruise line said it was notifying guests that five cruises on Carnival Splendor out of Sydney, Australia next January and February have been canceled.

Guests can either get credit or a full refund.

EU nations to adopt traffic light virus system

BRUSSELS — European Union countries are getting ready to adopt a common traffic light system to coordinate traveling across the 27-nation bloc amid the coronavirus pandemic.

To ensure that member states do not close their borders to one another and avoid a repeat of the cacophony witnessed in March when the virus first struck, the EU commission came up with proposals that have been amended before their scheduled approval by EU nations on Tuesday.

The key measure is a common map of infections drawn up by the European Centre for Disease Prevention and Control. It will sort European regions into green, orange and red zones according to the severity of coronavirus outbreaks. Under the latest proposal, red zones should be areas where the total number of newly notified COVID-19 cases is more than 50 per 100,000 people during a 14-day period and the percentage of positive tests reaches at least 4%.

Regions with a lower positive rate but where the total number of cases is more than 150 per 100,000 will also be classified red.

In light of the very high level of infections across the continent now, most of the bloc should be classified as red or orange.

Vatican says 4 Swiss Guards tested positive

VATICAN CITY — The Vatican says four Swiss Guards have tested positive for the coronavirus, as the surge in infections in surrounding Italy enters the Vatican walls.

The four are all symptomatic and are in isolation while their contacts are being traced, the Vatican said Monday. They join three other Vatican residents who tested positive in recent weeks plus the dozen or so Holy See officials who tested positive during the first wave of the outbreak.

Despite the positive cases among his own bodyguards, 83-year-old Pope Francis continued Monday to shun a mask. He was seen warmly greeting Cardinal George Pell in his private studio, and neither man wore a mask.

Francis decision to shun a mask during his Wednesday audience, held last week indoors, drew criticism on social media.

Italy is seeing a sharp surge in COVID-19 cases, with the Lazio region around the Vatican among the worst-hit in this second wave of the pandemic.

The Vatican last week amended its mask mandates to conform to that of Italy, requiring them indoors and out. The Vatican didn’t immediately respond when asked why Francis wasn’t wearing one to receive Pell.

Far-right Spanish party protest restrictions

MADRID — Supporters of Spain’s far-right Vox party have staged protests by car across Spain against restrictions introduced to help stem the spread of COVID-19.

The protests Monday coincided with the Fiesta Nacional de España and aimed to “turn our National Day into a cry for freedom.”

Scores of cars jammed traffic in Madrid on the Paseo de la Castellana, one of the capital’s main roads. Protesters, wearing face masks, honked horns and waved Spanish flags out of their car windows.

Vox has lawmakers in the Spanish and European parliaments, as well as many town councillors across Spain.

Spain has officially recorded more than 861,000 COVID-19 cases and has attributed almost 33,000 deaths to the new coronavirus, making it one of Europe’s worst-hit countries.

Belgian officials warn of alarming rise in infections

BRUSSELS — Authorities in Belgium, one of the European countries hit hardest by the coronavirus, are warning that the number of cases is rising at a “quite alarming” rate and that 10,000 people could be catching the virus each day by the end of the week.

Yves Van Laethem, a spokesman for Belgium’s COVID-19 crisis center, says that “all the indicators continue to rise, it must be said, in a quite alarming way, in all provinces and all age groups.”

An average of 4,145 new cases were being recorded every day in Belgium in the week of Oct. 2-8, an increase of 89% over the previous week, according to data released Monday. Van Laethem said “if this rise continues at the same rate, we could see 10,000 new cases a day at the end of this week.”

Since the start of the pandemic, more than 162,200 people have been infected with the virus in Belgium, which has a population of around 11.5 million. As of Monday, 10,191 people were reported to have died from the disease in Belgium.

Last week, the government tightened its coronavirus restrictions. Close contacts are limited to a maximum of three people outside of a household. In the capital, Brussels, which is seeing more than 800 new cases each day, bars and cafes were ordered to close for at least a month.

British officials order field hospitals reopened

LONDON — British health officials have ordered three temporary COVID-19 hospitals in northern England that were mothballed when the outbreak receded over the summer to prepare to reopen as new infections surge.

Stephen Powis, medical director of the National Health Service in England, said Monday that the “Nightingale” hospitals in Manchester, Sunderland and Harrogate were being readied to admit new patients if needed.

The temporary facilities were set up rapidly inside conference centers and other venues earlier this year to treat coronavirus patients if hospitals became overwhelmed. Most were not needed during the initial peak of the U.K. outbreak in the spring.

Coronavirus infections are on the rise again across the U.K., with northwest and northeast England seeing the biggest surges.

Prime Minister Boris Johnson is due to announce new restrictions for the worst-hit areas later Monday.

Italians reduce quarantine time to 10 days

ROME — Scientific advisers to the Italian government have modified Italy’s coronavirus quarantine rules, reducing to 10 days the 14-day minimum quarantine for people who test positive or have come into contact with someone who tested positive.

The shift, which follows reductions taken by other European countries, was an acknowledgement of the impracticability of asking tens of thousands of people to remain isolated for two weeks as a precaution, even as infections are rising sharply. In addition, in a bid to reduce pressure on Italy’s overwhelmed laboratories, the advisers also decided that only one negative test is required to get out of quarantine, rather than two.

The scientific committee issued revised guidelines late Sunday as Italy is seeing a surge in new infections, averaging more than 5,000 a day. While still far fewer than the daily increases in Spain, France or Britain, Italy’s surge is prompting the government to consider new restrictions.

According to Italian news reports, they could include nighttime curfews for bars, restrictions on drinking outside bar venues and limitations on the size of parties and other social gatherings. Public health authorities say three quarters of Italy’s current active clusters were spread within families.

Indian infections top 7 million

NEW DELHI — India has reported 66,732 new coronavirus cases, driving the country’s overall tally to more than 7.1 million.

The Health Ministry on Monday also reported 816 deaths in the past 24 hours, taking total fatalities to 109,150.

India is second in the world in number of infections, behind only the U.S., which has reported more than 7.7 million cases.

Maharashtra in the south continues to be the worst-hit Indian state, with over 1.5 million cases. Andhra Pradesh, Karnataka, Tamil Nadu and Uttar Pradesh are the next four worst-hit states, followed by the Indian capital, New Delhi, according to the Health Ministry.

India has seen the spread of the virus slow down since mid-September, when daily infections touched a record high of 97,894 cases. It’s averaging more than 70,000 cases daily so far this month.

Kentucky’s governor goes into isolation after contact

FRANKFORT, Ky. — Kentucky’s governor says he will be in isolation after a member of his security detail who drove with his family tested positive for the coronavirus.

Gov. Andy Beshear said Sunday that he and his family feel fine and have tested negative for the virus. Beshear’s wife and their two children also will stay isolated.

The governor has stressed the importance of following the advice of health experts to limit the virus’s spread and says that by going into isolation he will be “walking the walk, not just talking the talk.”

Beshear says his family was not in contact with anyone else following the exposure. He says that his family and the state police trooper who accompanied his family all wore facial coverings.

Florida reports 3,700 new cases in 24 hours

MIAMI — Florida officials have reported the state’s biggest one-day total of confirmed coronavirus cases since late August, a day after not releasing any pandemic data because of a problem with a private testing laboratory.

The Florida Department of Health said Sunday there were 3,700 new cases in the previous 24 hours and 1,790 for the day before that. It said there were 180 COVID-19 over both days.

Health officials say they received 400,000 previously reported test results late Friday from Helix Laboratory, which prevented them from processing and releasing the daily data report Saturday. Epidemiologists needed to verify results to make sure cases weren’t counted more than once.

Florida has reported 734,491 known cases of coronavirus since the beginning of the pandemic and 15,552 deaths.


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