Johnson & Johnson has paused the large late-stage clinical trial of its coronavirus vaccine because of an “unexplained illness” in one of the volunteers, the company said on Monday.
The company did not say whether the sick participant had received the experimental vaccine or a placebo. The pause was first reported by the health news website Stat.
Johnson & Johnson, which just began the so-called Phase 3 trial of its vaccine last month, was behind several of its competitors in the vaccine race, but its vaccine had some advantages over others. It does not need to be frozen, and it could need just one dose instead of two. It would also be the largest trial, with a goal of enrolling 60,000 volunteers.
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in a statement. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
Trial pauses are often lifted quickly after the illness is investigated and deemed not to be a serious safety risk.
“It’s actually a good thing that these companies are pausing these trials when these things come up,” said Dr. Phyllis Tien, an infectious disease physician at the University of California, San Francisco, a trial site for Johnson & Johnson and AstraZeneca. “We just need to let the sponsor and the safety board do their review and let us know their findings.”
“It doesn’t mean that the adverse event is related to the vaccine, but it needs to be investigated thoroughly,” said Dr. Luciana Borio, who oversaw public health preparedness for the National Security Council under President Trump and was acting chief scientist at the Food and Drug Administration under former President Barack Obama. Depending on the findings, she said, additional data may be collected, trial rules may be modified, or other steps may be taken to ensure safety.
Johnson & Johnson’s is not the first trial to be paused because of safety concerns. Two participants in AstraZeneca’s trial became seriously ill after getting its vaccine. That trial was halted twice — most recently last month — and has still not resumed in the United States, though locations abroad swiftly broke the pause.
Both Johnson & Johnson and AstraZeneca developed their vaccines using adenovirus vectors, modified viruses engineered to carry coronavirus genes into human cells. AstraZeneca’s vaccine used an adenovirus that causes common colds in chimpanzees. Johnson & Johnson’s used another adenovirus, called Ad26, which has also been used in its approved vaccine for Ebola.
Experts say safety issues must be investigated and are one reason late-stage trials cannot be rushed — even for a president who has repeatedly claimed that a vaccine will be ready before the U.S. election on Nov. 3. “This kind of event epitomizes why vaccine development can’t be influenced by artificial timelines such as an election,” said John Moore, a virologist at Weill Cornell Medicine.
The United States may be within months of a profound turning point in the country’s fight against the coronavirus: the first working vaccine.
Demonstrating that a new vaccine is safe and effective in less than a year would shatter the record for speed, the result of seven-day workweeks for scientists and billions of dollars of investment by the government.
The path has not been without bumps. Johnson & Johnson announced Monday night that it was halting its Phase 3 trial after a volunteer got sick. And AstraZeneca also paused its trial, last month, after two participants became ill.
Still, it’s tempting to look at the first vaccine as President Trump does: an on-off switch that will bring back life as we know it. “As soon as it’s given the go-ahead, we will get it out, defeat the virus,” he said at a September news conference.
Instead, vaccine experts say, we should prepare for a perplexing, frustrating year.
The first vaccines may provide only moderate protection, low enough to make it prudent to keep wearing a mask. By next spring or summer, there may be several of these so-so vaccines.
Because of this array of options, makers of a superior vaccine in early stages of development may struggle to finish clinical testing. And some vaccines may be abruptly withdrawn from the market because they turn out not to be safe.
“It has not yet dawned on hardly anybody the amount of complexity and chaos and confusion that will happen in a few short months,” said Dr. Gregory Poland, the director of the Vaccine Research Group at the Mayo Clinic.
President Trump, eager to prove he is healthy and energetic despite his recent hospitalization for Covid-19, returned to the campaign trail on Monday night in Florida, telling supporters he was fully recovered and therefore immune to the coronavirus — a claim for which there is no conclusive scientific backing.
Onstage at a hangar at the Orlando Sanford International Airport, Mr. Trump said he felt “so powerful” and offered to wade into the crowd.
“I’ll kiss everyone in that audience,” he said. “I’ll kiss the guys and the beautiful women. Just give you a big fat kiss.”
The president spoke for about an hour. Many supporters in the crowd did not wear masks, including some of those chosen to stand behind the president’s lectern and within the camera shot.
Mr. Trump claimed that vaccines against the virus “are going to be distributed very shortly,” although the Food and Drug Administration has not yet approved one. The president also implied without evidence that the agency was deliberately holding back on vaccine approvals to hurt his chances of re-election. (Read a fact check of Mr. Trump’s claims on Monday here.)
“Frankly, it’s a big political deal going on where they don’t want it to be before the election,” the president said.
Mr. Trump, whose response to a pandemic that has killed more than 214,000 Americans remains the biggest threat to his re-election, also claimed without evidence that his Democratic rival, former Vice President Joseph R. Biden Jr., would delay the vaccine and “prolong the pandemic.”
Mr. Trump’s arrival in Florida took place only hours after the White House physician, Dr. Sean P. Conley, said the president had tested negative “on consecutive days” using a rapid coronavirus test not intended for that purpose.
Experts cautioned that the test’s accuracy has not yet been investigated enough to be sure that the president is virus-free or, as his doctor claimed, “not infectious to others.”
With three weeks left in the race, Mr. Trump is running behind Mr. Biden. His polling numbers with seniors, a crucial constituency that has been disproportionately harmed by the coronavirus, have been flagging.
Hours before Monday’s rally, the nation’s top infectious disease expert, Dr. Anthony S. Fauci, warned that holding large rallies was “asking for trouble” with cases of the virus surging in many states.
Dr. Fauci, in an interview with CNN, said that Americans needed to be more cautious in the fall and winter months, and warned that rising rates of infections in a number of states suggested Americans should be “doubling down” on precautions rather than casting them aside.
Major news organizations have become increasingly wary of sending journalists to travel with President Trump to White House events and campaign rallies, as the president and his aides continue to shun safety protocols after an outbreak of the virus within their ranks.
The New York Times, The Wall Street Journal and The Washington Post are among the major outlets that have declined to assign reporters to travel with Mr. Trump as he returns to the trail this week, saying they do not have assurance that basic precautions will be taken to protect reporters’ health.
Foremost among the flouters is Mr. Trump himself, who, despite recently contracting the virus and spending three nights in the hospital, has shown little willingness to change his habits: On Saturday, he said the virus would soon “disappear,” and on the way to a rally in Florida on Monday, he boarded Air Force One — where reporters were seated in the cabin — without wearing a mask.
At least three White House correspondents have tested positive for the coronavirus in the past two weeks, including a Times reporter who had traveled on Air Force One, Michael D. Shear.
Safety concerns may also complicate Mr. Trump’s tentative NBC town hall on Thursday. NBC executives have asked the White House for proof that their employees will not face undue risks at the event, according to two people familiar with discussions.
Among the concerns raised by reporters: Many flight attendants and Secret Service agents on Air Force One have not worn masks; White House aides who tested positive for the coronavirus, or were potentially exposed, are returning to work before the end of a two-week quarantine; and the campaign has instituted few restrictions at the raucous rallies that Mr. Trump is now pledging to hold.
The White House press secretary, Kayleigh McEnany — who briefed reporters last weekend without wearing a mask, shortly before she tested positive for the virus — said on Monday that the Trump campaign would distribute masks but would not require attendees to wear them.
Global Roundup
The Czech Republic, now battling the highest rate of coronavirus infection in Europe, will close schools Wednesday, joining Slovakia as the first countries on the Continent to impose sweeping school closures in an effort to curb the spread of the virus.
“We only have one shot at this, and it has to be successful to make sure that our nation overcomes the pandemic this time as well,” Prime Minister Andrej Babis told the nation Monday night.
The school closures are an expansion of measures that had already been put in place last month as the number of cases started to grow in August before exploding in September.
On Monday, all theaters, cinemas and zoos were closed for at least two weeks. Restaurants and bars will have to close on Wednesday, but will be allowed to serve food and drinks to go until 8 p.m.
Even before the official decision to close schools, dozens were forced to suspend classes after teachers and students fell ill.
The health minister, Roman Prymula, an epidemiologist who was appointed last month to direct the fight against the virus, said that the country’s health care system could soon be overwhelmed, forcing the country to take the painful step of closing schools.
“We have to do it, because we do not have another chance, we are forced to take such a measure that will within two to three weeks reverse the trend, because otherwise we will exhaust the hospital capacity,” he said.
As of Friday, the country recorded 451.2 coronavirus cases per 100,000 inhabitants over a 14-day period, according to statistics from European Center for Disease Control and Prevention. The death toll reached 1,045 on Monday, with more than half the deaths — 618 — coming since September, according to the health ministry.
The Czech Republic’s neighbor Slovakia is now regularly reporting over 1,000 new cases per day and announced the closure of high schools on Monday. Most universities had already moved online.
Prime Minister Igor Matovic called the development “a serious moment for Slovakia.”
The country is considering limiting travel to its neighbor, which would be an extraordinary development for the two countries, which until 1993 formed one nation, Czechoslovakia.
In other global developments:
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Officials in Qingdao, China, where all 9.5 million residents are being tested for the coronavirus amid a new outbreak, said Tuesday that there were no positive tests among the more than 1.1 million results that have come back so far. The five-day testing drive was ordered on Monday after the city reported China’s first locally transmitted cases of the virus in almost two months.
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European Union countries on Tuesday adopted guidelines aimed at coordinating their varying coronavirus travel measures. The bloc will now use a single map with a color-coded system to denote the scale of outbreaks: green at the low end of risk, orange in the middle and red at the high end. Other measures include unifying how quarantines and testing are done to smooth travel between E.U. countries and ensuring ample warning when national travel advisories are about to change to ensure travelers don’t get stranded. The measures are not mandatory, however, and individual member states said they wanted to reserve the right to take unilateral action, including stepping up travel restrictions or changing the risk category for regions, based on their own assessments.
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Poland’s prime minister, Mateusz Morawiecki, is self-isolating after having been in contact with someone who tested positive for the coronavirus. Mr. Morawiecki is not experiencing any symptoms, a government spokesman said in a statement. “From today on I will be working remotely,” Mr. Morawiecki said in a video message posted on Facebook. “Look after yourselves and be responsible. I am wishing good health to everyone!” Mr. Morawiecki’s announcement comes two days before a planned summit meeting of European leaders in Brussels.
The Italian government continued to tighten restrictions in an effort to stem a resurgence in virus cases, announcing on Tuesday a ban on informal amateur contact sports, parties and school trips.
The decree, signed by Italy’s prime minister Giuseppe Conte, represents a second crackdown in less than a week as the second wave of the coronavirus, which seemed to have hit Italy less violently than other European countries, is now gaining strength, with 4,619 new cases registered on Monday.
The new decree introduces a general ban on parties and recommends private gatherings be limited to no more than six people inside homes. It also sets a limit of 30 guests for banquets organized after religious or civil ceremonies. To avoid crowds, Mr. Conte also ordered restaurants, bars and ice-cream sellers to stop serving non-seated customers after 9 p.m.
While contact sports, such as soccer or basketball, are now banned in informal contexts, trainings and matches organized by clubs are still permitted.
Italy is still in a better position compared with countries such as Spain or France, and while the number of daily infections is similar to those reached in Italy during the spring, the number of deaths and of patients in intensive care units remains lower. But in Italy, the first and one of the worst-hit countries in Europe, the level of alert and the fear of a new lockdown remain high.
“I would exclude a new lockdown,” Mr. Conte told reporters on Monday, “We specifically worked to prevent a new generalized lockdown.”
Prime Minister Boris Johnson of Britain has brushed aside advice from an influential group of scientists to lock down the economy for a brief period to try to halt a surge in coronavirus cases.
The recommendation, contained in newly published minutes from the government’s Scientific Advisory Group for Emergencies, or Sage, has intensified the debate in Britain over whether Mr. Johnson’s government is doing enough to avert a second wave of the pandemic.
On Monday, Mr. Johnson ordered pubs and gyms in the city of Liverpool to close, part of a new three-tiered system of restrictions targeting places hardest hit by the virus. But he has resisted pressure to impose a so-called “circuit breaker” lockdown — a brief national shutdown designed to stop the exponential increase in infections — saying it would come at too high an economic and social cost.
In the minutes of its Sept. 21 meeting, posted online late Monday night, Sage recommended a brief lockdown as one of several measures to stop what it warned could be a “very large epidemic with catastrophic consequences.” The scientists also advised closing restaurants, gyms and hairdressers, urging people to work from home, and converting universities to remote learning. And they expressed doubts about the effectiveness of one of the measures Mr. Johnson has imposed: closing pubs and restaurants at 10 p.m.
The politics of lockdowns are fraught for Mr. Johnson. He has long pledged to be guided by scientific advice. But he faces fierce opposition from members of his own Conservative Party and from local and regional officials in the north of England, who contend that the measures are crippling their economies.
Jesse Katayama had planned to end a journey around the world 8,000 feet above sea level at Machu Picchu, the sprawling 15th-century Inca citadel high in the Andes Mountains.
Then the coronavirus happened, stranding Mr. Katayama, a 26-year-old Japanese citizen, in Peru and shutting down tourism sites as a lockdown was imposed across the country.
On Sunday, after a wait of seven months, Mr. Katayama finally got to visit the UNESCO world heritage site. And aside from a few guides, he got it all to himself.
“After the lockdown, the first man to visit Machu Picchu is meeeeeee,” he wrote in a post on Instagram that included photos of him with a park representative.
Alejandro Neyra, Peru’s culture minister, said in a virtual news conference on Monday that Mr. Katayama had been granted special access to the site in recognition of his patience.
“He had come to Peru with the dream of being able to enter,” Mr. Neyra said. “The Japanese citizen has entered together with our head of the park so that he can do this before returning to his country.”
Before the pandemic, Machu Picchu welcomed thousands of visitors a day. Tourists typically have to apply months in advance for permits to enter an Inca trail that leads to the ancient fortress.
When the coronavirus pandemic closed offices around the United States in March, many companies told their employees that it would be a short hiatus.
Workers, they said, would be back in cubicles within a matter of weeks. Weeks turned into September. Then September turned into January. And now, with the virus still surging in some parts of the country, a growing number of employers are delaying return-to-office dates once again, to the summer of 2021.
Google was one of the first to announce that July 2021 was its return date. Uber, Slack and Airbnb soon followed. In the past week, Microsoft, Target, Ford Motor and The New York Times said they, too, had postponed the return of in-person work to next summer and acknowledged the inevitable: The pandemic isn’t going away anytime soon.
Many more companies are expected to delay their return-to-office dates to keep workers safe. And workers said they were in no rush to go back, with 73 percent of U.S. employees fearing that being in their workplace could pose a risk to their personal health and safety, according to a study by Wakefield Research commissioned by Envoy, a workplace technology company.
More companies are also saying that they will institute permanent work-from-home policies.
In May, Facebook was one of the first to announce that it would allow many employees to work remotely even after the pandemic. Twitter, Coinbase, Shopify and Microsoft have also said they would do so.
The postponement of return dates is a “psychological blow for those who expected this to be a transition phase,” said Tsedal Neeley, a Harvard Business School professor who studies remote work. “The reality is hitting that, ‘There won’t be a vaccine as I expected very quickly. This is going to be my life, and I’d better learn how to do this.’”
Tourism is undergoing a downturn all over the world, but several factors make Iceland particularly vulnerable to the industry’s crash: geographic isolation, a small domestic population, strict border measures and an economy that — after an extraordinary, decade-long tourism boom — had come to depend heavily on foreign tourists. A recent surge in coronavirus cases has added to Iceland’s challenges.
But while visitor numbers are low, Iceland is positioning itself for a major tourism rebound after the pandemic. The government is investing more than $12 million in tourism infrastructure, while improving roads and harbors across the country.
To keep the tourism industry afloat in the short term, the government is also investing more than $9 million in a program that distributes free travel vouchers to Icelandic citizens and residents. A marketing campaign targeting domestic tourists was rolled out in the late spring; an international version will be unveiled as soon as travel restrictions are lifted.
The voucher campaign helped to jump-start demand for hotels, restaurants and attractions. So far, Icelanders have used more than $1.2 million worth of their free travel vouchers, which are valid through the end of the year.
The summer was “pretty good, considering everything,” said Bjarnheidur Hallsdottir, the chairwoman of the board of the Icelandic Travel Industry Association and the chief executive of two tourism companies. “And then suddenly out of nowhere, the government decided to change the rules at the borders. Since then, everyone is crying.”
Under the new rules, which took effect in August, arriving passengers may choose either to submit to two screening tests for the virus, separated by five days’ self-quarantine, or to skip border screening and self-quarantine for 14 days after arrival.
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