Tag Archives: Coronavirus

Pfizer is first to apply for U.S. emergency use for COVID-19 vaccine

By Vishwadha Chander

(Reuters) – Pfizer Inc. said it will apply to U.S. health regulators on Friday for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus.

The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.

Pfizer’s shares rose 1.6% and BioNTech climbed 6% on the news that a vaccine could soon be available, raising hopes for the end of a pandemic that has claimed more than a quarter of a million lives in the United States and over 1.3 million worldwide.

The application also includes safety data on about 100 children 12-15 years of age. The company said 45% of U.S. trial participants are 56-85 years old.

If the data is solid, “we literally could be weeks away from the authorization of a 95% effective vaccine,” U.S. Health Secretary Alex Azar said on CBS’ “This Morning”.

The companies expect the FDA to grant the EUA by mid-December and said they will begin shipping doses almost immediately. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.

An FDA advisory committee tentatively plans to meet Dec. 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change.

The final trial data showed the vaccine provided a similar level of protection across different ages and ethnicities – an encouraging result as the disease disproportionately hurts the elderly and minorities.

Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving over 43,000 people, 162 had received only a placebo, meaning the vaccine was 95% effective, far higher than originally expected. U.S. FDA had set minimum bar for efficacy of 50%.

Pfizer said nearly 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds.

“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Moderna Inc. is expected to be the next company to seek a U.S. emergency use nod for a COVID-19 vaccine. An initial analysis of data from its late-stage trial showed the vaccine was 94.5% effective. Final results and safety data are expected in the coming days or weeks.

Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines.

Of dozens of drugmakers and research institutions racing to develop COVID-19 vaccines, the next late-stage data is expected to come from AstraZeneca Plc, which is working with the University of Oxford, in November or December.

Johnson & Johnson said it expects to have data needed to seek U.S. authorization for its experimental vaccine by February.

(Reporting by Vishwadha Chander in Bengaluru, additional reporting by Ankur Banerjee in Bengaluru and Doina Chiacu in Washington; Editing by Bill Berkrot, Shinjini Ganguli and Chizu Nomiyama)

Tyson Foods suspends employees after lawsuit alleges managers bet on workers catching COVID-19

By Tom Polansek

CHICAGO (Reuters) – Tyson Foods Inc. said on Thursday it suspended employees without pay and hired former U.S. Attorney General Eric Holder to conduct an investigation in response to a wrongful death lawsuit that alleges managers at an Iowa pork plant took bets on how many employees would catch COVID-19.

The coronavirus pandemic has ravaged the meatpacking industry, infecting thousands of workers since the spring and forcing companies like Tyson, Smithfield Foods and JBS to shut slaughterhouses hit by outbreaks.

The son of a worker at a Tyson facility in Waterloo, Iowa, who died in April of complications from the virus, filed a lawsuit that claims plant managers misled workers about COVID-19 and allowed sick employees to continue working.

The worker, Isidro Fernandez, got sick because of his job, according to the lawsuit that was amended on Nov. 11.

The Waterloo facility is Tyson’s largest U.S. pork plant, processing 19,500 hogs a day, or about 5% of total U.S. pork production.

COVID-19 infected more than 1,000 employees out of about 2,800 at the plant, and five died, the lawsuit says. Tyson idled the plant in late April because of an outbreak.

Earlier that month, manager Tom Hart “organized a cash buy-in, winner-take-all meatpacking industry for supervisors and managers to wager how many employees would test positive for COVID-19,” according to the lawsuit.

Hart could not immediately be reached for comment.

Tyson said it suspended employees involved in the accusations and retained the law firm Covington & Burling to conduct an independent investigation led by Holder.

“If these claims are confirmed, we’ll take all measures necessary to root out and remove this disturbing behavior from our company,” the company said.

The Iowa Capital Dispatch first reported on the betting allegations in the lawsuit on Wednesday.

“This shocking report of supervisors allegedly taking bets on how many workers would get infected, pressuring sick workers to stay on the job, and failing to enforce basic safety standards, should outrage every American,” said Marc Perrone, president of the United Food & Commercial Workers International Union.

(Reporting by Tom Polansek; Editing by Bill Berkrot)

U.S. coronavirus wildfire hitting jobs as broad recovery trudges on

By Howard Schneider

WASHINGTON (Reuters) – The most intense U.S. coronavirus outbreak yet appears to have slowed hiring and may have begun to drag on retail spending on the cusp of the holiday shopping season, even as overall economic activity proves more resilient than in the spring.

But that uneasy coexistence – wildfire-like spread of a deadly disease with an economy that remains largely open – may be tested in coming weeks if face mask mandates and lighter-touch restrictions imposed by local governments fail to curb the spread of COVID-19. Infections are growing by more than 1 million a week, according to data from the COVID Tracking Project, and the week-to-week percentage change is rising too.

Some local governments are taking more aggressive steps, with New York City again closing schools, and in a rare federal response from the “lame-duck” administration of President Donald Trump, the U.S. Centers for Disease Control and Prevention urged Americans not to travel for next week’s Thanksgiving holiday, which typically sees tens of millions on the move.

Most states, though, are moving gingerly, curbing restaurant hours or seating capacity, but not shuttering nonessential businesses like during the early months of the U.S. outbreak in the spring.

Still, the surge in cases appears to have capped the U.S. economic rebound, according to high-frequency data tracked by economists for real-time evidence about the recovery.

Employment at a sample of mostly small businesses from time management firm Homebase declined for a fourth week, and shifts worked across different industries fell, according to time management firm UKG.

“The uncertainty that exists right now and has existed really since mid-summer is making it really hard for business owners to think about growth,” said David Gilbertson, UKG vice president for strategy and operations. “We seem to take one step forward, and then one step back.”

The decline in shifts from mid-October to mid-November likely points to a weakening jobs report in November, he said.

LOOKING ‘GRIM’

Since the spring’s catastrophic drop in employment, the economy has clawed back about half of the more than 20 million lost positions. But momentum is slowing, and last week the number of new claims for unemployment insurance rose for the first time in about a month.

An index of new job postings from analytics firm Chmura as of August had reached a high of 85% of the level predicted in the absence of the pandemic, but is now at 67%.

Workers may be in for a “grim” period, said AnnElizabeth Konkel, economist at Indeed Hiring Lab, whose index of job postings remains 13% below 2019 levels. Holiday hiring is largely complete, and unemployment benefits are expiring for many of those out of work since the spring, a lapse that may finally be weighing on national data.

Initially, the flood of government support increased incomes for many families and supported consumer spending. Data on 30 million JPMorgan debit- and credit-card customers, however, showed spending fell “notably” in early November from a level just 2.7% below 2019 to 7.4% below last year, said JPMorgan economist Jesse Edgerton.

Declines were sharper in places where COVID-19 was spreading more rapidly but were still widespread, suggesting “a broader pullback in spending,” Edgerton wrote. U.S. retail sales in October also grew less than expected.

That and other data indicate an outright decline in jobs in November versus October, Edgerton said, evidence that millions left jobless by the pandemic face a long road back to normal.

SOME IMPROVEMENTS

Vaccine prospects, however, “represent a ray of light at the end of the tunnel,” said Gregory Daco, chief U.S. economist at Oxford Economics. Oxford recovery tracker rose slightly last week, snapping a five-week skid, a sign that the scale of economic collapse seen in the spring is not in the offing.

Data from OpenTable showed a slight rise in diners seated at restaurants over the past week even as new limits were imposed.

Some Federal Reserve officials have noted how businesses, particularly in manufacturing, construction and some parts of the retail sector, have adapted to operating during the pandemic. A New York Fed weekly index projecting growth in gross domestic product has risen steadily since the recession began.

But Oxford’s index and other data have also remained largely stalled, well below pre-pandemic levels. Data tracking cellphone movement from Unacast, for example, has shown no upward trend since summer.

That may remain the case until vaccines are rolled out to enough people to make a difference.

Meanwhile, “the recovery is becoming entrenched in a low-growth mode, and we are worried about signs of lasting economic damage,” Daco wrote.

(Reporting by Howard Schneider; Editing by Dan Burns and Paul Simao)

U.S. disease experts: Don’t travel for Thanksgiving

By Rebecca Spalding and Manojna Maddipatla

(Reuters) – The Centers for Disease Control and Prevention on Thursday urged Americans not to travel during next week’s Thanksgiving holiday to mitigate the spread of the coronavirus as cases of COVID-19 spike around the United States.

The travel advice is a “strong recommendation,” not a requirement, CDC official Henry Walke said on a call with reporters. The federal agency said it was making the recommendation after many states across the country experienced a surge in coronavirus cases in recent weeks.

“We’re alarmed with the exponential increase in cases, hospitalizations, and deaths,” Walke said.

The CDC advised against gathering with anyone who has not lived in the same household for at least 14 days, the incubation period for the coronavirus. Officials said they were also posting recommendations on their website on how to stay safe during the holidays for those Americans who do choose to travel.

“It is the right advice. We are in a major surge in the U.S. with hospitals inundated,” Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said at a Reuters forum. “There are some that will travel nonetheless, but, hopefully, they will put in place some common-sense measures to limit the damage the virus can cause.”

While the CDC recommended virtual gatherings, for those who do gather in person, guests should bring their own food and utensils and celebrate outdoors if possible, it said.

If celebrating indoors, it recommends that Americans open windows and put fans in front of open windows to pull fresh air into the room where guests are sitting. It also suggests limiting the number of people near where food is being prepared.

The Wednesday before Thanksgiving is typically the busiest travel day of the year in the United States, as Americans gather with friends and family around the country. Shares in airlines and hotel companies have plummeted since the outbreak began as government officials have advised against unnecessary travel.

The AAA travel agency has said it anticipates at least a 10 percent drop in the number of travelers this Thanksgiving, the largest single-year drop since 2008. Based on its October models, it forecasts 50 million Americans will travel for the holiday, compared with 55 million in 2019.

With the CDC recommendations, it expects that number now to be even lower.

United Airlines, American Airlines and Southwest Airlines each said on Thursday that bookings were weakening due to the spike in COVID-19 cases, and United said cancellations were rising.

(Reporting by Rebecca Spalding, Tracy Rucinski, David Shepardson and Lisa Pauline Mattackal; Editing by Chizu Nomiyama, Jonathan Oatis and Peter Henderson)

AstraZeneca COVID-19 vaccine shows promise in elderly, trial results by Christmas

By Kate Kelland and Alistair Smout

LONDON (Reuters) – AstraZeneca and Oxford University’s potential COVID-19 vaccine produced a strong immune response in older adults, data published on Thursday showed, with researchers expecting to release late-stage trial results by Christmas.

The data, reported in part last month but published in full in The Lancet medical journal on Thursday, suggest that those aged over 70, who are at higher risk of serious illness and death from COVID-19, could build robust immunity.

“The robust antibody and T-cell responses seen in older people in our study are encouraging,” said Maheshi Ramasamy, a consultant and co-lead investigator at the Oxford Vaccine Group.

“We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”

Late-stage, or Phase III, trials are ongoing to confirm the findings, researchers said, and to test whether the vaccine protects against infection with SARS-CoV-2 in a broad range of people, including people with underlying health conditions.

Results of those trials should definitely be known by Christmas, the Oxford Vaccine Group’s director, Andrew Pollard, said, adding it was too early to know whether and how well the vaccine works in preventing COVID-19 disease.

“We’re still waiting to get to the point where we can do the analysis to just work out how well the vaccine can protect people, and we’re getting ever closer to that,” he told journalists.

“We are optimistic that we’ll be able to do that before Christmas, and obviously we’ll share that with you as soon as we can at that point.”

The Oxford-AstraZeneca COVID-19 vaccine candidate, called AZD1222 or ChAdOx1 nCoV-19, had been among the front-runners in global efforts to develop shots to protect against infection with the novel coronavirus, or SARS-CoV-2.

But rival drugmakers Pfizer Inc, BioNTech and Moderna Inc have in the past 10 days edged ahead, releasing data from late-stage COVID-19 vaccine trials that shows more than 90% efficacy.

“We’re not in a rush. We and it’s not a competition with the other developers,” Oxford’s Pollard said, adding that AstraZeneca would release headline efficacy data before it was published in an academic journal.

Oxford University has set a target of 53 infections to start the interim analysis of its late-stage trial results, though “lots of cases” in its trial arms in Britain, South Africa and Brazil mean the exact number of infections reported could differ.

Unlike the Pfizer-BioNTech and Moderna shots, both of which use new technology known as messenger RNA (mRNA), AstraZeneca’s is a viral vector vaccine made from a weakened version of a common cold virus found in chimpanzees.

The Phase II trial reported in The Lancet involved a total of 560 healthy volunteers, with 160 aged 18-55, 160 aged 56-69, and 240 aged 70 or over.

Volunteers got two doses of the vaccine or a placebo, and no serious side effects related to the AZD1222 vaccine were reported, the researchers said.

AstraZeneca has signed several supply and manufacturing deals with companies and governments around the world.

(Reporting by Kate Kelland; Additional reporting by Alistair Smout; Editing by Matthew Lewis, Alexander Smith and Nick Macfie)

U.S. travel restrictions at Canada, Mexico borders set to be extended until Dec. 21 — official

By David Shepardson

WASHINGTON (Reuters) – The United States’ land borders with Canada and Mexico are expected to remain closed to non-essential travel until Dec. 21 at the earliest amid a rising number of U.S. coronavirus cases, a Homeland Security Department official told Reuters.

The current restrictions expire on Saturday and the three countries are expected to approve another 30-day extension, the official said on Wednesday. The United States leads the world in COVID-19 cases and deaths.

The restrictions were first put in place in March to control the spread of COVID-19.

Canada’s CTV News also reported that the travel restrictions in place at the Canada-U.S. land border were expected to remain in effect for at least another month.

The DHS official told Reuters the agency was “continuing to look at appropriate public health criteria for a future re-evaluation of existing restrictions.”

The restrictions are particularly painful for U.S. and Canadian towns along the border that are tightly intertwined.

Statistics Canada said earlier that U.S. visits to Canada by automobile had plummeted by more than 95% in August from August 2019.

(Reporting by David Shepardson; Editing by Chizu Nomiyama and Peter Cooney)

COVID-19 survivors may have long lasting immunity; Pfizer vaccine is 95% effective in trial

COVID-19 survivors may have long lasting immunity; Pfizer vaccine is 95% effective in trial
By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Immune protection against severe reinfection appears lasting

Regardless of their detectable antibody levels, most COVID-19 survivors are likely to have lasting protection against severe COVID-19 if they become re-infected, thanks to other components of the body’s immune response that remember the new coronavirus in different ways, researchers say. In a study of 185 patients, including 41 who had been infected more than six months earlier, scientists at La Jolla Institute for Immunology in California found that multiple branches of the immune system – not just antibodies – recognized the novel coronavirus for at least eight months. For example, so-called memory B cells that could recognize the virus and produce antibodies to fight it were more abundant six months after infection than at one month, they reported in a paper posted on Monday on bioRxiv ahead of peer review. The new findings “suggest that the immune system can remember the virus for years, and most people may be protected from severe COVID-19 for a substantial time,” said study leaders Shane Crotty and Alessandro Sette.

Final data from Pfizer vaccine trial shows 95% efficacy

Final results from Pfizer Inc’s pivotal COVID-19 vaccine trial show it had a 95% success rate – even higher than an earlier analysis – and two months of follow-up data without serious side effects, the company said on Wednesday. In the study involving about 43,000 volunteers, 162 of the 170 who contracted COVID-19 had received a placebo, not the vaccine. Of the 10 participants who had severe COVID-19, only one had received the vaccine. The final analysis of the trial’s data comes a week after interim results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine, showing 94.5% effectiveness. Pfizer said the efficacy its two-dose vaccine, developed with German partner BioNTech SE, was consistent across different age and ethnic groups. Efficacy in adults over age 65 was over 94%. Pfizer said it expects to make up to 50 million vaccine doses this year – enough to inoculate 25 million people – and up to 1.3 billion doses in 2021.

Respiratory muscle damage linked to severe COVID-19

Critically ill COVID-19 patients develop virus-induced damage of respiratory muscles, scientists at Amsterdam UMC in The Netherlands reported on Monday in JAMA Internal Medicine. They performed autopsy studies of the diaphragm, the main respiratory muscle, in 26 COVID-19 patients who died in the intensive care unit (ICU) and 8 ICU patients who died without COVID-19. In everyone, the diaphragm muscle cell membranes contained a protein called ACE2, which the new coronavirus uses as an entryway into cells. The researchers found genetic evidence of the virus in diaphragm muscle cells in some of those who died from COVID-19, and microscopy analyses showed much more connective tissue scarring (fibrosis) in COVID-19 patients’ diaphragms, indicating damage, study coauthor Coen Ottenheijm told Reuters. He said the diaphragm damage may help explain why it is often difficult for COVID-19 patients to breathe on their own again after they have been on mechanical ventilators in the ICU. It may also explain the persistent shortness of breath in patients recovering from COVID-19.

Cardiac arrest survival is down during the pandemic

U.S. data from early this year suggest the pandemic has led to decreased survival rates after “out-of-hospital” cardiac arrest. Based on nationwide data, the proportion of patients whose hearts could be restarted was 21% lower in March-April 2020 than in the same period in 2019, researchers reported on Saturday at the annual American Heart Association meeting, held virtually this year, and in JAMA Cardiology. The proportion of patients who survived to be discharged from hospitals was also lower in 2020, at 6.6%, versus 9.8% in 2019. Survival rates after out-of-hospital cardiac arrest had nearly doubled in the last 20 years, and “we want to make sure we don’t lose those gains,” said coauthor Dr. Paul Chan of St. Luke’s Mid-America Heart Institute in Missouri. Dr. Clifton Callaway of the University of Pittsburgh, who viewed the presentation but was not involved in the study, said other viewers noted it is more difficult for paramedics to work wearing full personal protective gear as it takes time to put on and can impede emergency care. Furthermore, some patients may have delayed calling for help over concerns of becoming infected with the coronavirus. And some may have also had COVID-19, making their medical condition more severe.

(Reporting by Nancy Lapid, Linda Carroll and Michael Erman; Editing by Bill Berkrot)

U.S. death toll from COVID-19 nears quarter million as infection rates soar

By Gabriella Borter and Anurag Maan

(Reuters) – The death toll from COVID-19 in the United States approached 250,000 on Wednesday, the day after the country recorded the highest number of victims in nearly four months, a chilling sign for a healthcare system already struggling to cope.

On Tuesday, the pandemic claimed 1,596 lives in the United States, more than on any single day since July 27, contributing to a total of 248,898 confirmed deaths since the pandemic began, according to a Reuters tally.

For weeks, health officials and healthcare workers have warned that hospitals in all regions could soon become overwhelmed, with widespread community transmission of the virus evident in many places.

“I’m the most concerned I’ve been since this pandemic started,” Dr. Tom Inglesby, director of Johns Hopkins Center for Health Security, told CNN on Wednesday.

Nationwide, the number of patients hospitalized with COVID-19 topped 75,000 on Tuesday, setting a new record. The Midwest has become the epicenter, reporting almost a half-million cases in the week ending on Monday. In Wisconsin, 90.6% of Intensive Care Unit beds were occupied as of Wednesday, state data showed.

Forty-one U.S. states have reported daily record increases in COVID-19 cases in November, 20 have registered new all-time highs in coronavirus-related deaths from day to day, and 26 have reported new peaks in hospitalizations, according to a Reuters tally of public health data.

Government officials in at least 18 states, representing both sides of the U.S. political divide, have issued sweeping new public health mandates this month. These range from stricter limits on social gatherings and non-essential businesses to new requirements for wearing masks in public places.

Even officials who initially bristled at the idea of the government imposing social restrictions have changed tune as the virus has spread.

In South Dakota, about 2% of residents currently have COVID-19, according to state data. The city of Sioux Falls voted to institute a mask mandate on Tuesday night, a week after Mayor Paul TenHaken voted the mandate down. TenHaken shifted to supporting the ordinance after the South Dakota State Medical Association urged the city council to mandate masks. State Governor Kristi Noem, a Republican, has continued to oppose government restrictions to curb COVID-19.

White House spokeswoman Kayleigh McEnany on Wednesday called the wave of new restrictions an overreach by state and local officials.

“The American people know how to protect their health,” she told Fox News in an interview. “We don’t lose our freedom in this country. We make responsible health decisions as individuals.”

(Reporting by Gabriella Borter in New York and Anurag Maan in Bengaluru; additional reporting by Susan Heavey and Maria Caspani; Editing by Rosalba O’Brien)

U.S. judge blocks expulsions of unaccompanied children under Trump’s pandemic-related border rules

By Ted Hesson and Mica Rosenberg

WASHINGTON (Reuters) – A U.S. district court judge on Wednesday blocked expulsions of unaccompanied children caught crossing into the United States, a setback for the outgoing Trump administration, which said the policy was aimed at limiting the spread of the coronavirus.

U.S. District Judge Emmet Sullivan in the District of Columbia ruled that the minors were likely to suffer irreparable harm because they could be subject to sexual abuse and other violence, as well as face the possibility of torture and death if summarily returned to their home countries.

President Donald Trump has made immigration curbs a central part of his four-year term in office and enacted a series of sweeping immigration restrictions during the pandemic.

President-elect Joe Biden, has vowed to reverse many of the Republican president’s hardline immigration policies.

Biden has not yet commented on how he would handle the emergency border rules that allow for rapid deportations. A Biden campaign official told Reuters that he would defer to health experts on such restrictions.

A U.S. Border Patrol official said in a September court filing that 8,800 unaccompanied minors were expelled under the border rules between their enactment on March 20 and Sept. 9.

Overall, the United States has expelled roughly 197,000 migrants caught crossing the U.S.-Mexico border from March through the end of September, though those figures include migrants who may have crossed multiple times.

Lee Gelernt, an attorney with the American Civil Liberties Union (ACLU), which represented plaintiffs in the lawsuit, said the policy was a “pretext” for Trump to close the border to children and asylum seekers from Central America.

The U.S. Department of Justice, U.S. Department of Homeland Security and White House did not immediately respond to requests for comment.

(Reporting by Ted Hesson in Washington and Mica Rosenberg in New York; Editing by Chizu Nomiyama and Nick Macfie)

FDA approves first COVID-19 test kit for home use

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.

The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn said.

The kit can also be used at hospitals and point-of-care settings but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.

Although a recent string of positive news from Moderna Inc and Pfizer Inc on their potential vaccines has raised hopes in combating the disease, testing still is a key factor in controlling the spread of the virus.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” said Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health.

The United States crossed 11 million total infections on Sunday, just eight days after reaching the 10 million mark.

(Reporting by Shubham Kalia in Bengaluru; Editing by Anil D’Silva)