Chicagoans told to stay home, Detroit moves school online as COVID-19 cases surge

By Brendan O’Brien and Maria Caspani

CHICAGO (Reuters) – Chicago issued a stay-at-home advisory and Detroit stopped in-person schooling on Thursday to staunch the coronavirus outbreak as more than a dozen states reported a doubling of new COVID-19 cases in the last two weeks.

Officials in the Midwestern cities along with New York, California, Iowa and other states were re-imposing this week restrictions that had been eased in recent months. The moves were driven by surging infection rates and concern that the onset of winter, when people are more likely to gather indoors, will worsen the trends.

Chicago Mayor Lori Lightfoot on Thursday issued a 30-day advisory calling upon residents to stay at home and have no visitors, even during Thanksgiving festivities. The third- largest city in the United States could see 1,000 more COVID-19 deaths by the end of 2020 if residents do not change behaviors to stop the spread of the virus, Lightfoot said.

Lightfoot set a 10-person limit on gatherings, including indoor and outdoor events, and said travelers from out of the state needed to quarantine for 14 days or submit a negative coronavirus test.

“None of us can keep maintaining the status quo in the face of this very stark reality,” the mayor told reporters, noting the average number of cases have gone from 500 to 1,900 per day over the last month and the city’s positivity rate shot up to 15% from 5%.

Illinois has emerged as the pandemic’s new epicenter in the region as well as across the country. In the past two weeks, the state reported about 130,000 cases, the highest in the country and more than hard-hit Texas and California.

A Reuters tally showed coronavirus cases more than doubling in 13 states in the past two weeks.

In Michigan, the Detroit public school system – the state’s largest – said on Thursday it would suspend of in-person education until Jan. 11, with the infection rate in the city rising rapidly. The district will hold all classes online starting Monday.

New York City Mayor Bill de Blasio said on Thursday that the country’s largest school system was preparing for a possible shutdown but closure might still be averted.

“We’re not there yet, and let’s pray we don’t get there,” de Blasio told reporters. De Blasio has said schools will close if the percentage of city residents testing positive, now at a seven-day average of 2.6%, surpasses 3%.

Total COVID-19 cases across the United States hit an all-time daily high for a second day in a row on Wednesday at 142,279 and crossed the 100,000 mark for an eighth consecutive day, Reuters data showed.

The number of people hospitalized with the virus surged to at least 64,939 by late Wednesday, the highest ever for a single day during the pandemic, increasing by more than 41% in the past two weeks. The death toll rose by 1,464 to a total of 241,809.

Vaccine developers have offered some good news this week, with Pfizer and BioNTech trumpeting successful early data from a large-scale clinical trial of a coronavirus vaccine.

Health experts are hopeful that a vaccine might become available in the coming months for the most vulnerable populations and for healthcare providers.

But with a more lengthy timeline for the general public, many are urging strict adherence to well-known virus mitigation measures like wearing a face covering, washing hands and maintaining a safe social distance.

“We hope that by the time you get into the second quarter, end of April, early May, May-June – somewhere around that time, the ordinary citizen should be able to get it,” Dr. Anthony Fauci, a top U.S. health official, told the ABC “Good Morning America” program on Thursday.

“What we need to do is what we’ve been talking about for some time now but really doubling down on it.”

(Reporting by Maria Caspani in New York and Anurag Maan in Bengaluru and Brendan O’Brien in Chicago, additional reporting by Peter Szekely in New York and Doina Chiacu in Washington; Editing by Howard Goller and Cynthia Osterman)

Migrant smugglers see boost from U.S. pandemic border policy

By Laura Gottesdiener and Sarah Kinosian

MONTERREY, Mexico (Reuters) – These days, Martin Salgado’s migrant shelter in the city of San Luis Rio Colorado on Mexico’s border with the United States feels more like an hourly hotel. His guests, many of them from Central America, often don’t even bother to spend the night.

Salgado said he has never seen people cycle through as repeatedly as he has in recent months, after the United States began expelling almost all migrants caught on the Mexican border rather than returning them to their homelands. Now, human smugglers often attempt to get migrants back across the border the very same day they are deported, he said.

Previously, Central American migrants apprehended at the border would be processed in the U.S. immigration system and would often be held for weeks, if not months, before being deported back to their home country.

“We never saw this before,” said Salgado, who runs the shelter near Arizona’s western limits founded by his mother in the 1990’s. Some Central Americans who arrive at the shelter after being deported “eat, bathe, and suddenly they disappear.”

U.S. President Donald Trump’s administration in March announced that it would begin to quickly expel nearly all migrants caught at the border under the authority of an existing federal public health act, known as Title 42, saying the move was necessary to prevent coronavirus spreading into the United States.

But the order appears to be having unintended effects.

It’s led to an increase in repeated border crossing attempts, data from U.S. Customs and Border Protection shows. And it’s benefiting the illegal networks that move people from Central America to the United States, according to interviews with more than a dozen migration experts, shelter directors, immigrant advocates and human smugglers.

That is because U.S. authorities are depositing the migrants on the border, rather than returning them home, which allows smugglers to eliminate some of the costs of repeat border crossings, said three smugglers working with transnational networks. The price migrants pay smugglers, which can be $7,000, or double that, often includes two or three attempted border crossings to offset the risks of being intercepted by Mexican or U.S. authorities, according to the three smugglers, as well as migration experts.

Not all migrants travel with smugglers, but even those braving the dangerous journey alone or in small groups often turn to coyotes at the border for the final stretch of the journey. Since they too are now being returned at the Mexican border when caught they now often pay for a second or third try, in another boon for the smuggling networks, said migrant experts and a guide tied to a smuggling network in the Sonora region.

U.S. border officials say the program, which has resulted in migrants being returned in an average of less than two hours, is crucial for protecting U.S. agents, health care workers and the general public from COVID-19 by avoiding the potential spread of coronavirus if migrants were apprehended, processed, and then sent to U.S. detention centers, as per previous policy.

“It would take just a small number of individuals with COVID-19 to infect a large number of detainees and CBP personnel and potentially overwhelm local healthcare systems along the border,” the U.S. Customs and Border Protection (CBP) said in a statement.

Joe Biden clinched the U.S. presidency following the Nov. 3 election, though Trump has not acknowledged defeat and has launched an array of lawsuits to press claims of election fraud for which he has produced no evidence. The president elect has not laid out specific plans about the Title 42 program. A senior advisor to the Biden campaign in August told Reuters that Biden would look to public health officials for guidance on pandemic-related border closures.

“MAKING MORE MONEY”

Seeking safe passage on the perilous trek north, migrants often pay thousands of dollars to smugglers – known as ‘coyotes’ – linked to gangs that control territory in Mexico.

The three men who identified themselves as smugglers from different transnational networks told Reuters they save about $1,000 or more each time U.S. Border Patrol expels one of their Central American clients at the Mexican border rather than returning them back by plane to their home countries.

“It’s great for us,” said Antonio, a Salvadoran smuggler who is part of a network that he said charges migrants $14,000 a head for three runs at getting from Central America to the United States.

Antonio, like the others involved in the smuggling trade that Reuters interviewed, declined to give his last name.

He said his network spends at least $800 per migrant paying off drug cartels for the right to transit through their turf, then there are additional costs such as food, shelter, transportation, and occasional bribes to Mexican authorities.

In the past, when Central American migrants were caught by U.S. Border Patrol and sent home, his network would have to pick up that tab again on migrants’ second or third attempts.

Mexico’s immigration agency in August vowed to “eradicate the collusion between public servants and human smugglers” as it ousted hundreds of officials for work-related offenses.

Pablo, a Guatemalan who ferries migrants across Guatemala’s border into Mexico, estimated that the network he works for saves at least $1,300 for every Central American who is returned at the U.S. border rather than sent back to their homeland.

“We’re making more money because we don’t have to pay the mafia again in Mexico,” he said. “So, there’s an advantage.”

REPEATED ATTEMPTS

Migration numbers are returning to pre-pandemic levels, following steep declines this spring after Central American countries slammed their borders shut in an effort to halt the spread of coronavirus. The U.S. Customs and Border Protection agency said it conducted nearly 55,000 expulsions and apprehensions of migrants at the southwest border in September. That is more than triple the figure for April and is slightly higher than the 40,507 a year earlier, according to CBP data.

And, apprehensions and expulsions continued to climb in October, said a U.S. official with knowledge of the numbers.

Still, migration numbers for the 12-month period ended in September were down from the previous year. The Title 42 order does not change deportation policy for Mexicans, who made up about two thirds of people expelled by the United States during August and September, according to the CBP. Hondurans, Guatemalans, and Salvadorans account for the next three largest groups.

Meanwhile, the number of repeated attempts has sharply increased, indicating that fewer people are migrating than last year but more of those who are trying to cross the border multiple times.

Between April and September, the proportion of people caught crossing the border more than once surged to 37%, up from 7% for the 12-month period ended in September 2019, according to the CBP.

The president of the Border Patrol union in Laredo Texas, border agent Hector Garza, said the Title 42 order was helping limit the exposure of the border workforce to COVID-19 and avoid overwhelming local hospitals in communities in Texas, which are already experiencing a surge of coronavirus cases.

“But with any benefit there is a downside, and in this case, we’re seeing people coming back and forth, trying to cross multiple times within a 24-hour period,” he told Reuters.

In the border city of Ciudad Juarez on Oct. 31, across from the Texas city of El Paso, Cuban Alexander Garcia stood by the port of entry to the United States. Garcia, who identified himself as a doctor, said he had just been deported after his sixth attempt at crossing the border without authorization.

“They’re returning us in less than three hours!” exclaimed García. “We cross, and they just grab us and push us back into Juarez.”

U.S. Border Patrol Chief Rodney Scott, during a news conference last month, said the pandemic had reduced the ability and willingness of authorities to prosecute because detaining people potentially involved additional risk of spreading COVID-19 in the United States.

“IT MOTIVATES YOU”

About 125 miles east of Salgado’s shelter, Jesus, a guide linked to a local smuggling network, and his Guatemalan girlfriend, Yolanda, have been biding their time in a chilly trailer serving as a migrant stash house along the Mexican border.

They said nearby clashes between rival gangs have delayed Yolanda’s departure across the Sonoran desert into the United States.

But Jesus said he’s heartened by the new U.S. policy – and so are the town’s smugglers that he’s worked for over the years.

“It’s better because if people get caught, they come right back,” he said. “So it’s like, we’re still in business.”

Yolanda was also encouraged when, upon reaching the border, she found out that if she was caught, she would only be sent to Mexico, rather than likely being deported back home.

“It motivates you,” she said, explaining that she left Guatemala after she was forced to close her clothing shop when pandemic restrictions crippled the economy.

She racked up debts, fell behind on her mortgage, and lost her home, she said, joining a small but growing number of Central Americans fleeing the economic crisis triggered by pandemic-related restrictions across the region.

While Title 42 has encouraged some people to risk the crossing after being turned back, some human rights organizations say it erodes migrants’ rights because they are being rapidly returned to Mexico before having an opportunity to explain why they fled their countries or to present a case for why they would qualify for asylum under U.S. law.

CBP said in a statement the agency “remains committed to our obligations to provide safe haven to those who claim persecution.”

(Reporting by Laura Gottesdiener in Monterrey, Sarah Kinosian in Caracas, and Lizbeth Diaz in Mexico City; Additional reporting by Jose Luis Gonzalez in Ciudad Juarez; Editing by Dave Graham, Frank Jack Daniel and Cassell Bryan-Low)

U.S. airlines caution on winter challenges as COVID-19 cases rise

(Reuters) – Delta Air Lines and Southwest Airlines on Thursday cautioned that the recent surge in COVID-19 cases may have a negative impact on travel over the winter holidays, a period the sector had hoped would see improved bookings.

The United States on Wednesday reported new COVID-19 infections reached an all-time daily high for a second day in a row and the number of people hospitalized also surged to the highest ever during the pandemic.

“With the U.S. hitting a grim milestone of 10 million positive cases and outbreaks in Europe and other parts of the world, all signs point to a challenging winter ahead,” Delta Chief Executive Ed Bastian said in a memo to employees on Thursday.

Earlier, low-cost carrier Southwest said an improvement in revenues in the past few months was losing steam in recent weeks, prompting caution about December trends.

“While the company expected the election to impact trends, it is unclear whether the softness in booking trends is also a direct result of the recent rise in COVID-19 cases,” Southwest said.

“As such, the company remains cautious in this uncertain revenue environment.”

The COVID-19 pandemic brought travel to a near halt earlier in the year, forcing airlines to scale back operations and seek government aid.

(Reporting by Tracy Rucinski; Editing by Sonya Hepinstall)

Fauci stresses on need for equitable access of COVID-19 vaccines

(Reuters) – U.S. infectious disease expert Anthony Fauci said on Thursday vaccine developers should push to make billions of their COVID-19 vaccines to ensure access to all parts of the world, instead of focusing on the rich countries.

Fauci’s comments come days after Pfizer Inc said its COVID-19 vaccine candidate was more than 90% effective based on initial results from a large-scale trial, securing a lead in the race to develop a safe and effective vaccine for the respiratory illness.

Pfizer has a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year, as well as a deal with the European Union to supply up to 300 million doses.

“Now a number of different companies are talking about the ability to make billions of doses. That’s what we need. We don’t need hundreds of millions for the rich countries,” Fauci said at a webinar conducted by British think tank Chatham House.

“We need billions (of vaccine doses), so whether you live in the darkest part of the developing world, or if you live in London, you should have the same access.”

Experts have also raised doubts about access to the vaccine, especially in the developing countries, as it needs to be stored at temperatures of minus 70 degrees Celsius (-94 F) or below, posing infrastructure challenges.

“Certainly it is not going to be pandemic for a lot longer, because I believe the vaccines are going to turn that around,” Fauci said, while adding that there may be a need to re-vaccinate people intermittently, if COVID-19 becomes endemic.

Fauci said efforts were underway in the United States to push for the development of antivirals and other therapies for early intervention during the course of the COVID-19 respiratory illness.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta)

Fears of COVID-19 resurgence spread to East Coast as grim U.S. records mount

By Maria Caspani and Anurag Maan

NEW YORK (Reuters) – As COVID-19 infections, hospitalizations and deaths surge across the United States, more signs emerged that a second wave could engulf areas of the Northeast, which managed to bring the pandemic under control after being battered last spring.

In New Jersey, one of the early U.S. hotspots, a spike in cases in Newark, the state’s largest city, prompted Mayor Ras Baraka to implement aggressive measures, including a mandatory curfew for certain areas, to contain the spread of the virus.

New York state and city officials also reported a worrying rise in the seven-day average infection rate that raised the specter of stricter mitigation measures adopted at the height of the pandemic.

“This is our LAST chance to stop a second wave,” New York City Mayor Bill de Blasio wrote on Twitter on Wednesday as he announced the seven-day average positivity rate citywide was 2.52%. The city’s public school system, the largest in the country, would have to shut down if that figure reached 3%.

“We can do it, but we have to act NOW,” he said.

The United States as a whole reported more than 1,450 deaths on Tuesday, the highest single-day count since mid-August, according to a Reuters analysis.

U.S. COVID-19 cases climbed for seven days straight to reach more than 136,000 as of late Tuesday while hospitalizations, a key metric of the pandemic, crossed 60,000 for the first time since the pandemic began.

In Newark, the positivity rate hovered at 19%, more than double the state’s 7.74% seven-day average, Baraka said in a statement released on Tuesday.

“Stricter measures are required in the city’s hotspots in order to contain the virus and limit the spread,” he said.

New Jersey Governor Phil Murphy announced some restrictions on Monday in response to a rise in COVID-19 cases in the state, and outbreaks among bartenders.

New York Governor Andrew Cuomo said in a press release on Tuesday that New York’s positivity rate had climbed above 3% for the first time in weeks.

In Maryland, where the positivity rate stood at 5.6% on Wednesday, officials warned about rising COVID-19 hospitalizations. More than 800 people were being treated for the coronavirus at state hospitals as of Wednesday, according to Mike Ricci, the communications director of Governor Larry Hogan, the highest daily count since April, a Reuters tally showed.

A record number of people died of coronavirus in several Midwest and western states on Tuesday, including in Alaska, Indiana, Missouri, North Dakota, Wisconsin and Wyoming.

Officials in states hardest-hit by the virus pleaded with residents to stay home as much as possible and heed the advice of experts by wearing masks, washing their hands and social distancing.

“It’s not safe to go out, it’s not safe to have others over — it’s just not safe. And it might not be safe for a while yet,” Wisconsin Governor Tony Evers said during a primetime address on Tuesday. “So, please, cancel the happy hours, dinner parties, sleepovers and playdates at your home.”

(Reporting by Maria Caspani in New York and Anurag Maan in Bengaluru, Editing by Nick Macfie)

Russia says its Sputnik V COVID-19 vaccine is 92% effective

By Polina Ivanova

MOSCOW (Reuters) – Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on Wednesday, as Moscow rushes to keep pace with Western drugmakers in the race for a shot.

Russia’s results are only the second from a late-stage human trial, following on swiftly from data released on Monday by Pfizer Inc. and BioNTech, which said their shot was also more than 90% effective.

While experts said the Russian data was encouraging and reinforced the idea the pandemic could be halted by vaccines, they warned that the results were only based on a small number of trial volunteers who had contracted COVID-19.

The analysis was conducted after 20 participants developed the virus and examined how many had received the vaccine versus a placebo. That is significantly lower than the 94 infections in the trial of the vaccine being developed by Pfizer and BioNTech.

“I assume there was political pressure after the press release from Pfizer and BioNTech earlier in the week to now draw level with their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the Mainz University. “What is missing for now is an analysis of statistical significance.”

To confirm the efficacy rate of its vaccine, Pfizer said it would continue its trial until there were 164 COVID-19 cases.

The Russian Direct Investment Fund (RDIF), which has been backing Sputnik V’s development, said the Russian trial would continue for six months.

Alexander Gintsburg, director of the Gamaleya Institute which developed the vaccine, said the interim results demonstrated that Sputnik V was effective and mass vaccinations would be rolled out in Russia in the coming weeks.

European stocks and U.S. stock futures extended their gains slightly after Russia’s announcement though the reaction was far more muted than after Pfizer’s results.

China’s Sinopharm, which is running large-scale late-stage clinical trials for two COVID-19 vaccine candidates, said on Wednesday that its data was better than expected, though it did not give further details.

‘NOT A COMPETITION’

Successful vaccines are seen as crucial to restoring daily life around the world by helping end the pandemic that has killed more than 1.26 million people, shuttered businesses and put millions out of work.

However, experts said knowledge about the Russian trial’s design was sparse, making it hard to interpret the data.

Scientists have raised concerns about the speed at which Moscow has worked, giving the regulatory go-ahead for the shot and launching mass vaccinations before full trials to test its safety and efficacy had been completed.

“This is not a competition. We need all trials to be carried out to the highest possible standards and it is particularly important that the pre-set criteria for un-blinding the trial data are adhered to avoid cherry picking the data,” said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh.

“Anything less than this risks a public loss of trust in all vaccines, which would be a disaster.”

The results are based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine.

“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the sort of news that the vaccine’s developers would talk about one day with their grandchildren.

The so-called Phase III trial of the shot is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.

The chances of contracting COVID-19 were 92% lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said.

That’s well above the 50% effectiveness threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.

The RDIF said data from the study would be published in a leading medical journal following a peer review. The results of the early-stage Russian trials were peer reviewed and published in September in The Lancet medical journal.

Experts said that as with the Pfizer results, it was not yet clear how long immunity would last after taking the Russian vaccine, nor how efficient it would be for different age groups.

“We certainly need longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer’s and BioNTech’s numbers,” said Plachter in Mainz.

As Moscow seeks partners abroad to boost output, China’s Tibet Rhodiola Pharmaceutical Holding announced a deal soon after the results to released to make, sell and test the shot in China.

SPUTNIK V

The Russian drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for Russian President Vladimir Putin.

Russia registered the vaccine for public use in August, the first country to do so, ahead of the start of the large-scale trial in September.

So far, it has inoculated 10,000 members of the public considered at high risk of contracting COVID-19 such as doctors and teachers, outside of the trial.

The vaccine is designed to trigger a response from two shots administered 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.

Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is on the cusp of registering a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective.

RDIF said as of Nov. 11 no serious side effects had been reported during the Sputnik V Phase III trial.

Some volunteers had short-term minor adverse events such as pain at the injection site, flu-like syndrome including fever, weakness, fatigue, and headache, it said.

In late October, the vaccination of new volunteers was temporarily paused due to high demand and a shortage of doses.

Russia’s deputy prime minister said on Wednesday that the Vector Institute vaccine was expected to start post-registration trials on Nov. 15.

She also said that Russia would produce 500,000 doses of Sputnik V in November, lower than a previous forecast of 800,000 doses given by Trade and Industry Minister Denis Manturov.

Russia reported 19,851 new coronavirus infections in the past 24 hours and a record high of 432 deaths. At 1,836,960, its overall case tally is the fifth largest in the world, behind the United States, India, Brazil and France.

(Reporting by Polina Ivanova; Additional reporting by Kate Kelland, Ludwig Burger, Josephine Mason and Thyagaraju Adinarayan; Editing by David Clarke)

In blow to WHO, EU seeks powers to declare health emergencies

By Francesco Guarascio

BRUSSELS (Reuters) – The European Commission on Wednesday proposed rules which would give the EU the power to declare a health emergency and stress test national plans to tackle pandemics, in a potential blow to the World Health Organization.

The move follows an often uncoordinated reaction by the 27 EU governments to the COVID-19 pandemic, which at the beginning of the crisis led to competition on vital medical gear and export bans on medicines.

It also comes after the WHO was criticized for having declared the pandemic, which first emerged in China at the end of last year, too late. The U.N. agency has repeatedly denied the accusation.

Under the proposals, the EU would be able to declare an EU-level public health emergency, which would in turn trigger more coordination among EU states.

Currently, the EU relies on the WHO to declare such an emergency.

“The new rules will enable the activation of EU emergency response mechanisms (..) without making it contingent upon the WHO’s own declaration of a Public Health Emergency of International Concern,” an EU document says, adding that such a move would be coordinated with the WHO.

If adopted, the overhaul would partly take away a major power from the WHO, as EU states call for reform of the organization to address shortfalls in emergencies.

“We relied too much on the WHO for the COVID-19 pandemic,” Peter Liese, a top EU lawmaker from German Chancellor Angela Merkel’s party, said.

“Under pressure from China, the WHO declared the health emergency too late. It is therefore very important to have the possibility to act at European level in future similar situations.”

The WHO, which the Trump administration has labelled a puppet of China, was not immediately available to comment.

COORDINATION ON VACCINES

Under the commission’s proposals, the EU would help governments prepare pandemic plans and would audit and stress test them, an EU document says.

EU states have traditionally been reluctant to give more powers to Brussels on the matter.

During the pandemic, they have applied different national measures on a series of issues, including testing policies for COVID-19 cases, quarantine rules and travel restrictions.

But they have shown good coordination on procuring vaccines.

If approved by EU governments and EU lawmakers, the commission said the proposals would be immediately applicable and could strengthen EU powers to tackle the current pandemic, in which most European countries are seeing a surge in cases.

Brussels wants to strengthen the EU public health agency, the European Centre for Disease Prevention and Control, whose non-binding advice, such as on the length of quarantine after contact with an infected person, has often been ignored.

It also wants more power for the EU Medicines Agency to prevent risks of shortages of medicines and medical devices.

Brussels also said it would unveil by the end of next year plans for a new health authority modelled after the U.S. Biomedical Advanced Research and Development Authority, which has played a vital role in procuring experimental dugs and vaccines.

(Reporting by Francesco Guarascio @fraguarascio; Editing by Alison Williams and Nick Macfie)

Moderna on track to report COVID-19 vaccine data later this month

By Manas Mishra and Dania Nadeem

(Reuters) – Moderna Inc. said on Wednesday it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file for U.S. emergency use authorization in early December.

The company may have to wait for a two-month follow up safety data to apply for U.S. emergency use authorization, even after reporting positive interim data on the vaccine’s effectiveness.

Moderna said it expects the safety data in the second half of this month.

Hopes of the world soon getting an effective vaccine against the virus that has killed over a million people were raised on Monday after Pfizer Inc. said its COVID-19 vaccine was more than 90% effective based on interim trial results.

There are no vaccines that have gained global approval yet, although a handful, including Moderna’s, are in late-stage studies.

It was too early to guess how effective Moderna’s vaccine could be, Chief Executive Officer Stephane Bancel said at a Credit Suisse conference.

The world would have to wait for more data to understand whether use of a particular vaccine would be more widespread, Bancel said.

Moderna, which uses a technology similar to Pfizer’s, finished enrolling 30,000 volunteers in its late-stage study last month.

Public health experts have said it is likely that more than one vaccine would be needed to control the pandemic.

(Reporting by Manas Mishra and Dania Nadeem in Bengaluru; Editing by Krishna Chandra Eluri, Saumyadeb Chakrabarty and Sriraj Kalluvila)

Q&A: Where are we in the COVID-19 vaccine race?

(Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over 1.26 million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc and German partner BioNTech SE were the first to release data showing on Monday that their vaccine worked in a large, late-stage clinical trial.

Russia’s sovereign wealth fund published interim late-stage trial results for its Sputnik V vaccine on Wednesday showing the shot is 92% effective at protecting people from COVID-19.

The next data releases will likely be from U.S. biotech firm Moderna Inc, possibly in November, and from Britain-based AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why is Pfizer ahead with its data?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer said its interim analysis was conducted after 94 participants in the trial developed COVID-19 while Russia’s examination was conducted after 20 participants in the trial developed the disease.

AstraZeneca said last week a slowdown in infections during the summer is delaying data analysis for its UK trial.

COVID-19 cases, however, soared in October and early November, setting daily records in the United States and Europe.

How well are the vaccines supposed to work?

The World Health Organization has recommended a minimum standard for effectiveness of at least 50%. The United States and some other regulators are following that guideline – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

Pfizer and Russia both said their vaccines are more than 90% effective against COVID-19.

When will regulators rule on safety and efficacy?

Regulators review vaccines after companies submit applications seeking either emergency use authorization (EUA) or formal approval.

The earliest the U.S. Food and Drug Administration could make a decision is in December because Pfizer/BioNTech and Moderna do not expect to have enough safety data until the second half of November. The FDA has asked companies to watch trial participants for side effects for two months after receiving a final vaccine dose.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to conduct expedited reviews as well. It is not clear when companies will submit efficacy data to these agencies or when the agencies would make a decision.

Could these be the first widely available coronavirus vaccines?

Yes, although China is on a similar timeline. The country launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people.

At least four vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November.

Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.

In late October, the director of the Gamaleya Institute, Alexander Gintsburg, said 20,000 volunteers had received the first shot so far and 9,000 the second.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanova in Moscow; Editing by Caroline Humer, Bill Berkrot, Edwina Gibbs, David Clarke and Josephine Mason)

Alarmed by soaring COVID-19 hospitalizations, some U.S. states tighten curbs

By Sharon Bernstein and Maria Caspani

SACRAMENTO (Reuters) – Several U.S. states on Tuesday imposed restrictions to curb the spread of the coronavirus as hospitalizations soared, straining hospitals and medical resources across much of the country.

The number of patients hospitalized with COVID-19 in California has risen by 32% over the past two weeks, and intensive-care admissions have spiked by 30%, Dr. Mark Ghaly, the state’s health and human services secretary, told reporters.

As a result, Ghaly announced that three counties that are home to about 5.5 million people – San Diego, Sacramento and Stanislaus – must reverse their reopening plans and go back to the most restrictive category of regulations under which indoor dining in restaurants is not allowed and gyms and religious institutions are also not permitted to hold indoor activities.

“We anticipate if things stay they way they are … over half of California counties will have moved into a more restrictive tier” by next week, Ghaly said.

In Minnesota, Governor Tim Walz announced new restrictions as the Midwestern state reported a fresh record high in daily COVID-19 hospitalizations, and medical systems in Minnesota expressed concerns about their ability to cope with the surge.

The state reported 1,224 coronavirus hospitalizations on Tuesday, up from 1,084 the previous day and a new daily record, according to a Reuters tally.

Beginning Friday, restaurants and bars in Minnesota must close dine-in services between 10 p.m. and 4 a.m., and keep the number of patrons below 50% of capacity. The governor’s order also includes private social gatherings, which must be limited to 10 people from three households or less.

“We’ve turned our dials, we’re going to have to turn them back a little bit today,” Walz told a briefing.

In Illinois, which recorded its highest number of daily cases on Tuesday with 12,626 new infections, Governor J.B. Pritzker told reporters the majority of the state’s regions were seeing higher hospitalization rates than last spring.

Faced with rampant coronavirus infections and a strained healthcare system, Iowa Governor Kim Reynolds also took steps to curb the disease’s spread by limiting the size of social gatherings and imposing a targeted mask-wearing requirement for certain situations.

U.S. Health Secretary Alex Azar expressed concern about rising hospitalizations that were straining medical facilities in areas hardest hit by the surge, and said health officials will work to set up temporary medical facilities where they might be needed.

“As you get more cases, you get more hospitalizations,” Azar said in an interview with MSNBC. “It’s just simple math.”

There were just over 59,000 COVID-19 patients in hospitals across the United States on Monday, the country’s highest number ever of in-patients being treated for the disease. Daily new infections exceeded 100,000 for the sixth consecutive day.

Hospitalizations are a key metric of how the pandemic is progressing because, unlike case counts, they are not influenced by the number of tests performed.

The harsh statistics tallied by Reuters cemented the United States’ position as the country worst affected by the coronavirus pandemic, even as drugmaker Pfizer Inc. on Monday provided some hope: successful late-stage tests of its vaccine.

U.S. infectious disease expert Anthony Fauci welcomed the Pfizer vaccine announcement but warned the winter months promise to bring more infections as people stay indoors.

Fauci said health officials were reporting more infections from small gatherings, an indication the virus is being spread by asymptomatic people.

“There are people out there, innocently and unwittingly, who are infected, don’t have any symptoms, who are infecting others,” he told MSNBC on Tuesday. “So, much more widespread testing of asymptomatic individuals is going to be very important as we enter, and go into, these months of indoor-type gathering.”

The American Health Care Association and National Center for Assisted Living warned about a spike in COVID-19 cases in nursing homes.

“As we feared, the sheer volume of rising cases in communities across the U.S., combined with the asymptomatic and pre-symptomatic spread of this virus, has unfortunately led to an increase in new COVID cases in nursing homes,” Mark Parkinson, president and chief executive of the American Health Care Association and National Center for Assisted Living, said in a statement.

Nursing homes in the hard-hit Midwest saw a 120% increase in weekly COVID-19 cases since mid-September, the group said.

(Reporting by Doina Chiacu in Washington, Anurag Maan in Bengaluru, Sharon Bernstein in Sacramento, California; additional reporting by Maria Caspani, Peter Szekely and Gabriella Borter in New York; writing by Maria Caspani; editing by Jonathan Oatis)