Tag Archives: Pandemic

Global coronavirus deaths exceed 700,000, one person dies every 15 seconds on average

By Lisa Shumaker

(Reuters) – The global death toll from the coronavirus surpassed 700,000 on Wednesday, according to a Reuters tally, with the United States, Brazil, India and Mexico leading the rise in fatalities.

Nearly 5,900 people are dying every 24 hours from COVID-19 on average, according to Reuters calculations based on data from the past two weeks.

That equates to 247 people per hour, or one person every 15 seconds.

President Donald Trump said the coronavirus outbreak is as under control as it can get in the United States, where more than 155,000 people have died amid a patchy response to the public health crisis that has failed to stem a rise in cases.

“They are dying, that’s true,” Trump said in an interview with the Axios news website. “It is what it is. But that doesn’t mean we aren’t doing everything we can. It’s under control as much as you can control it. This is a horrible plague.”

In Brazil, President Jair Bolsonaro has minimized the gravity of the pandemic and opposed lockdown measures, even as he and several of his cabinet tested positive for the virus.

The pandemic was initially slower to reach Latin America, which is home to about 640 million people, than much of the world. But officials have since struggled to control its spread because of the region’s poverty and densely packed cities.

More than 100 million people across Latin America and the Caribbean live in slums, according to the United Nations Human Settlements Program. Many have jobs in the informal sector with little in the way of a social safety net and have continued to work throughout the pandemic.

Even in parts of the world that had appeared to have curbed the spread of the virus, countries have recently seen single-day records in new cases, signaling the battle is far from over.

Australia, Japan, Hong Kong, Bolivia, Sudan, Ethiopia, Bulgaria, Belgium, Uzbekistan and Israel all recently had record increases in cases.

Australia also reported a record number of new deaths on Wednesday, taking the country’s total to 247.

(Reporting by Lisa Shumaker; editing by Jane Wardell)

Special Report: Local governments ‘overwhelmed’ in race to trace U.S. COVID contacts

By Benjamin Lesser, Dan Levine, Jaimi Dowdell and Andrea Januta

(Reuters) – The soaring number of COVID-19 cases in the United States has far outstripped many local health departments’ ability to trace the contacts of those infected, a step critical in containing the virus’ spread.

With the pandemic claiming about a thousand American lives a day, many city and county departments say they lack the money and staff to expeditiously identify people who have been exposed, according to a Reuters survey of 121 local agencies, as well as interviews with dozens of state and local officials, epidemiologists and tracers.

The United States badly lags other wealthy countries in contact tracing, including South Korea and Germany, which ramped up their programs months ago. Contributing to the faltering U.S. response is the government’s failure to provide accurate and timely diagnostic testing, something other countries were able to roll out much faster and more broadly.

On Alabama’s hard-hit Gulf Coast, health department staffers are stretched so thin they are directing individuals who test positive to notify any contacts themselves, said Rendi Murphree, director of Mobile County’s Bureau of Disease Surveillance and Environmental Services.

“Everything is overwhelmed,” she said.

Adding to the challenge has been a sharp politicization of the COVID-19 response, with many Americans, from President Donald Trump on down, often portraying mask-wearing and other measures as an infringement of personal liberty.

The United States has by far the world’s largest COVID-19 caseload, with over 4.6 million confirmed infections and more than 155,000 deaths. Yet public health measures during the pandemic have been largely decentralized, coming down to patchwork efforts by state, and especially local, governments. Federal funding has proved unreliable, caught up in fierce debate over the crisis.

Now, as part of log-jammed negotiations over new relief legislation, Republicans and Democrats in Congress are arguing over funding proposals for testing and tracing that are tens of billions of dollars apart. As of June, U.S. Centers for Disease Control and Prevention director Robert Redfield said the country had 27,000 contact tracers – about a quarter of what has been recommended.

Although some local health departments told Reuters their efforts have proved successful – and many said they were worthwhile – several researchers described U.S. contact tracing overall as too little, too late.

“You don’t clean up an oil spill with paper towels,” said Marc Lipsitch, a professor of epidemiology at the Harvard public health school.

On this point, the Trump administration does not disagree. Admiral Brett Giroir, Assistant Secretary for Health at the U.S. Department of Health and Human Services, told Reuters that given the spread of the disease, mask wearing and other prevention measures are more effective.

“It is really impossible to contact trace,” Giroir said, until the numbers come down.

The agencies responding to the Reuters survey serve at least 27 million residents in large cities such as Minneapolis, Boston, and Cleveland, as well as smaller communities including Allentown, Pennsylvania, and Dare County, North Carolina. Collectively, as of last week, they accounted for at least 230,000 COVID-19 cases and 7,300 deaths. The responses cover the week ending June 22. Reuters followed up in late July with several departments, such as Las Vegas and Kansas City, Kansas, where officials said circumstances had not improved.

Among the findings:

• The 40 local health departments with the highest caseloads have fallen far short in their efforts to reach patients who tested positive. Only about half the departments with more than 1,000 cases had reached close to all infected people at the time of the survey. The CDC recommends that newly positive cases be interviewed within 24 hours.

“It’s just impossible with the kind of numbers that we are seeing,” said Devin Raman, a senior disease investigator at the Southern Nevada Health District, including Las Vegas.

• Nearly half of the local departments said they lacked sufficient staff and funds. In Missouri, many said they hadn’t received any additional money for contact tracing. “Some of them are literally running out of money right now,” Diane Weber, executive director of the Missouri Association of Local Public Health Agencies, said in July.

• Local health officials in six states complained that efforts to create statewide contact tracing systems have been hampered by issues including technical problems and poor coordination. In some cases, this has led to tension and a costly duplication of efforts, with state and local tracers calling the same people.

“We’re not going to drop the ball on tracing in our county and leave it to the state. If we did that, we’d probably all be dead,” said Joni Wise, administrator of the Vigo County Health Department in Indiana.

A spokesperson for the Indiana Department of Health acknowledged that people are more likely to answer a local call from a municipal health department than an “833” number from the state’s centralized call center.

• More than three dozen public health departments said they were hindered by some residents’ failure to answer their phones or to provide accurate information when they did. Several departments said people they called had objected to contact tracing as an infringement on their privacy rights.

“We get a variety of responses from yelling and hanging up, to those telling us that they have already contacted all of their friends and will not give us those names,” said Kenosha County health director Jen Freiheit in Wisconsin.

‘A LAME EXCUSE’

From the early days of the pandemic, public health experts emphasized the importance of contact tracing, a decades-old strategy aimed at interrupting infectious disease transmission. It involves interviewing infected people, identifying people whom they may have exposed to infection and trying to keep those individuals from passing the virus to someone else.

“If any country is saying contact tracing is difficult, it is a lame excuse,” World Health Organization Chief Tedros Adhanom Ghebreyesus said in June. He pointed to the WHO’s success in halting an Ebola outbreak in eastern Congo by tracing 25,000 contacts a day in a remote area, where some 20 armed groups were fighting.

Under the best of circumstances, contact tracing is not a panacea. It is only one of many public health tools commonly deployed against infectious disease. The approach is particularly challenging during a fast-moving epidemic in which people may be infectious but don’t fall sick right away. In addition, a culture of individualism and legal protections inhibit U.S. authorities from forcing people to stay inside and divulge their social relationships.

Still, some other democracies have devised a more coordinated testing and tracing strategy than the United States.

In Germany, a country with about 400 public health offices, contact tracing early on was part of a collaborative effort. Workers from other municipal government offices lent a hand. The national Robert Koch Institute said it deployed hundreds more “containment scouts” – mostly medical students – to help. Daily confirmed cases in Germany now number in the hundreds. Deaths per day are down to the single digits, from a peak of over 300 on April 16.

In the United States, daily case counts that had been falling since mid-April began climbing again in July, reaching a peak of 77,299 July 16.

The federal government has largely taken a hands-off approach to contact tracing, as well as other public health measures during the pandemic. Though the CDC has issued guidance for contact tracing, it is not deeply involved. And though Congress authorized billions of dollars in aid that could pay for tracing, the money is not required to be used that way.

Trump and many of his fellow Republicans in Congress have often downplayed the threat posed by COVID-19. In July, the White House tried to block new funding for testing and contact tracing – something the White House later disavowed amid opposition even from Trump’s own party. Since then, Senate Republican leaders have proposed a relief bill that would dedicate $16 billion for the effort, while a bill passed by the Democrat-dominated House would provide $75 billion for testing, tracing and hospital support. Negotiations are at a crawl.

A senior CDC official told Reuters in a statement that the agency has provided more than $12 billion across the country to address the COVID 19 crisis, including a recent grant of $10.25 billion for testing and other activities such as contact tracing. In addition, the official said, the CDC has provided staff and extensive technical support to states.

“Contact tracing is most effective when local communities embrace it and drive it,” said the official, who declined to be named. “The Administration has empowered states with funding to lead these efforts.”

REALITY SINKS IN

A few days before Las Vegas casinos reopened in June, state health officials in Nevada predicted a wave of coronavirus cases.

The state should have as many as 700 people working on contact tracing to meet the surge, the officials wrote in a May 29 COVID-19 “plan of operations,” which Reuters obtained under a Freedom of Information Act request. Referring to the roughly 100 tracing staffers then aboard, the plan said staffing “falls short of what is needed to effectively manage the need.”

It took two months to staff up. As of July’s end, Nevada had 744 staffers statewide, a Nevada Health and Human Services department spokeswoman said.

Still, Las Vegas and surrounding areas have struggled. The Southern Nevada Health District (SNHD) saw about 1,000 new cases a day by mid-July, up ten-fold from the first week of June (although new cases have dropped precipitously in recent days).

A SNHD official told legislators last week that the district had less than half the tracing staff needed to serve Clark County, home to Las Vegas.

Raman, the senior investigator in the southern district, estimated in mid-July that her department was able to interview between 25% and 40% of people who recently tested positive.

“Right now, unfortunately, we are just trying to keep our heads above water.,” she told Reuters.

It was a similar story in other hotspots. Health officials for Harris County, Texas, who serve the Houston suburbs, have reported about 550 cases a day since July 1, up from about 200 a day during the first half of June.

Harris County reported reaching about 60% of the newly positive people to interview about contacts. In general, epidemiologists told Reuters, the goal should be at least 75%.

Martha Marquez, a county spokesperson, described the 60% figure as “good” but said the county was “looking into how to grow our success rate.”

Other departments struggle to keep potentially infectious people in quarantine. Ideally, a tracer notifies contacts, refers them for testing and advises them to stay home and away from others. Then someone in the department follows up to see if they need anything to stay indoors – house-cleaning supplies or food, for instance. It’s no guarantee they won’t go out, but tracers say it can make a difference.

In Alabama’s Mobile County, with case counts exploding to more than 1,000 cases a week by mid-July, follow-up was next to impossible. “It is not going well,” said Murphree, the disease surveillance director.

For months, the health department in Mobile relied only on existing health staff for contact tracing – as well as a few volunteers. It took until mid-July for the department to hire two people dedicated to that work, positions that the federal government has promised to fund, Murphree said.

The county has not yet received the money, she said.

This lack of resources is being felt across the country.

Despite pleas for assistance, local health departments in Missouri have received little to no COVID-19 funding from the state. Meanwhile, the state recently announced a $15 million package to help support tourism, using funding from the federal CARES Act – a $2.2 trillion COVID-19 relief package passed by Congress in March.

“Tourism is a major employer and a major boon to the economy of Missouri,” said Scott Clardy, assistant director of the Columbia/Boone County Department of Public Health and Human Services. “That being said, here we are not being able to investigate cases, but we’re giving $15 million to the tourism industry to bring in more people.”

Clardy said, however, that he was expecting almost $1.8 million in CARES Act funding for contact tracing and testing to become available as early as this week.

Contact tracing efforts are strained not just by the sharp rise in cases but by the long delays in getting COVID-19 test results back.

David Holcombe, the director of the Louisiana Department of Health for the central portion of that state, said that, as of mid-July, the turnaround was as long as 14 days.

The lag time makes “contact tracing virtually useless,” he said. That’s because by the time positive results come back, the infected person has potentially had many more contacts, who have potentially infected others themselves.

KEEPING UP

Not all contact-tracing efforts are in disarray.

In San Francisco, cases are rising but not spiking to the level seen in other places in the country. So far, contact tracers say they have been able to keep up – largely through the efforts of redirected city workers.

Before the pandemic, program manager Jana De Brauwere could be found at San Francisco’s main public library, using one of the four languages she speaks to help patrons without computers apply for jobs and other services online.

Since April, dozens of librarians, attorneys and other San Francisco city workers have been redeployed to trace COVID-19 contacts – though at some cost to the city’s other public services.

After about 20 hours of training, De Brauwere started calling people exposed to the disease, arranging for supplies to help them quarantine, and referring them for testing. Soon she was promoted to team leader.

A typical shift now starts at 7 am, when De Brauwere parcels out roughly 100 contacts for her eight-tracer team to interview that day. De Brauwere has given up all her library work. “This is the priority,” she said.

The city’s contact tracing program, which is getting help from nonprofit organizations, reported reaching over 80% of people with positive tests through the third week of July, an exceptionally high rate. Similarly, health officials in Vigo County, Indiana, report being able to interview nearly all positive cases. Wise, the county health administrator, said local contact tracers have been more successful at reaching people than those at the state level.

The state’s tracers often are contractors who don’t understand the area, she said. That unfamiliarity can alienate residents and make them less likely to share critical health information, she said.

‘A THREAT TO OUR PRIVACY’

Even with sufficient money and staff, health departments often have trouble convincing people to pick up the phone and cooperatively answer questions.

Playing into that problem are political divisions throughout the country over how seriously to take the pandemic and what responsibilities the government should or should not impose on the public.

In Texas, a Republican state representative in June called for ending the contact tracing program as “a threat to our privacy and individual liberties.” The Republican-controlled Kansas legislature in June passed a COVID-19 bill with bipartisan support ensuring that no civil or criminal penalties would apply to anyone who refuses to provide information to a tracer. Such penalties, to the limited extent they are allowed under public health laws, are rarely enforced.

People may be reluctant to engage with tracers for a variety of other reasons, including embarrassment for exposing themselves to infection or fear they’ll lose their job.

Sometimes, contact tracers are hindered by misunderstandings.

In early June, in Berrien County, Michigan, contact tracer Karen Kortebein received a call from a public health nurse in a neighboring county. An employee of a long-term care facility there – a resident of Kortebein’s county – had contracted the virus. Kortebein knew the woman. She’d been speaking with her since her husband tested positive in May.

Kortebein had asked the woman then if she was working outside her home. The woman said no. But in reality she had been working – possibly while infectious – with a particularly vulnerable population until her husband became ill, something contact tracers needed to know as soon as possible.

It turned out the woman, whose first language is not English, had misunderstood the question. Also, she was confused about the risk she posed because she’d had conflicting test results and had yet to develop symptoms.

For Kortebein, it was a lesson in how easily wires can get crossed.

“I was kind of blown away,” she said.

(Benjamin Lesser and Andrea Januta reported from New York, Dan Levine from San Francisco, and Jaimi Dowdell from Los Angeles. Additional reporting by Douglas Busvine in Berlin and Alexandra Alper in Washington, D.C. Editing by Michele Gershberg, Janet Roberts and Julie Marquis)

State attorneys general urge U.S. government to increase supply, lower price of remdesivir

(Reuters) – A bipartisan coalition of attorneys general on Tuesday urged the U.S. government to use its legal authority to increase the availability and lower the price of Gilead Sciences’ COVID-19 treatment, remdesivir.

Gilead has priced remdesivir, the antiviral drug at the forefront of the battle against the pandemic, at $2,340 per patient for wealthier nations and said will charge U.S. patients with commercial insurance, $3,120 per course, or $520 per vial.

The United States signed a deal with Gilead in June for more than 500,000 courses of the treatment, which shortened hospital recovery time in a U.S. trial, making up most of the company’s output through September.

In a letter sent to the U.S. health agencies, the coalition led by Louisiana Attorney General Jeff Landry and California Attorney General Xavier Becerra urged the federal government to ensure Americans can afford and have reasonable access to sufficient supply of remdesivir during this pandemic.

Under the Bayh-Dole Act, the National Institutes of Health and the U.S. Food and Drug Administration have the authority to license remdesivir to third-party manufacturers to scale up production and distribution and ensure its availability at a reasonable price, according to the letter.

Gilead was not immediately available for comment.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

Stacey Abrams warns not to expect a U.S. presidential winner on Election Night

By Alessandra Galloni

(Reuters) – Voting rights advocate Stacey Abrams warned Americans on Tuesday not to expect to learn the winner of the White House on Election Night Nov. 3, as problems delivering and counting an expected flood of mail-in ballots prompted by the coronavirus pandemic could delay the result and draw a flurry of legal challenges.

“The sheer volume of people who will be voting by mail is going to preclude the ability to count those ballots and adjudicate the outcome of the election by 11 p.m. on Election Night,” Abrams, a Democrat and former leader in Georgia’s state legislature, said in a virtual Reuters Newsmaker event.

The public health crisis has drawn litigation in dozens of states from both major parties. Democrats and voting rights groups have pushed voting by mail as a safer option to cast ballots during the pandemic, while President Donald Trump and his allies have proclaimed without evidence that expanded voting by mail will lead to widespread fraud.

Abrams, once considered a possible running mate for Democratic presidential candidate Joe Biden, said cuts in Postal Service overtime imposed by Louis DeJoy, a new Trump-appointed postmaster general, may cause delays in service as voting by mail ramps up.

“And so my admonition is that we have to approach Nov. 3 with patience,” Abrams said.

A Postal Service spokesman said last week the agency was taking steps to increase operational efficiency and ensure prompt and reliable service.

Several primaries this year experienced long delays in counting and naming winners because of the mail-in ballots. Ballots from New York’s June 23 primary are still being counted in some undecided races, including a congressional contest.

Abrams said states hurt by the economic collapse lack the resources to handle a deluge of mail-in ballots, and are going to need to determine whose ballot should be questioned and who needs to provide additional information.

“But we also can’t ignore that the president has put in place a postmaster general who is slowing down the essential delivery of mail… We know that’s going to lead to a number of legal challenges,” Abrams said.

Abrams, 46, gained national prominence after narrowly losing her 2018 bid in Georgia to become the country’s first Black female governor. She accused Republican opponent Brian Kemp of voter suppression after he refused to resign as the state’s top elections officer while campaigning for governor.

Abrams, who later formed a voting rights group, Fair Fight, called on Trump and other Republicans to fund more than $3 billion in assistance to state election officials in the coronavirus relief bill being negotiated in the U.S. Senate.

Trump, who trails Biden in opinion polls, has raised a series of questions about the integrity of the election. Last week he suggested delaying the election due to the likelihood of fraud, though he does not have the authority to do so.

‘VOTER SUPPRESSION’ THE ISSUE

Election experts say voter fraud of any kind, including incidents related to mail-in ballots, is extremely rare.

“Voter fraud is not the issue. Voter suppression is the issue,” Abrams said.

She said the election funding would help state officials deal with an expected crush of mail-in ballots, as well as provide adequate polling sites for in-person Election Day voting to resolve some of the problems seen in recent primaries in Wisconsin, Georgia and elsewhere.

“The United States knows how to run elections, we just have to agree to do it properly,” she said. “Our bottom line is we have to have a full toolbox of methods of voting.”

Asked whether she had been interviewed by the Biden campaign as a potential running mate, Abrams declined to comment, referring questions on the process to the campaign. But she said she feels qualified for the job and would serve if Biden asked.

Her chances at the spot have faded in recent months as other candidates emerged as more likely selections, according to conversations with Democratic officials and Biden allies. Biden is expected to announce his running mate next week, ahead of the Democratic National Convention.

Abrams said Black voters were motivated to defeat Trump in November. They became a focus in the campaign after the racial and social justice protests in American streets sparked by the death of George Floyd, a Black man, under the knee of a white police officer.

The first dip in Black voter turnout in 20 years contributed to Democrat Hillary Clinton’s upset loss to Trump four years ago.

“Even if people don’t necessarily feel enthusiastic about the person that is Joe Biden, they are enthusiastic about the policies that are Joe Biden, and that’s what I think is going to matter in November,” Abrams said.

(Reporting by Alessandra Galloni, Joseph Ax and Colleen Jenkins; Writing by John Whitesides; Editing by Soyoung Kim and Howard Goller)

California governor says COVID-19 cases, hospitalizations, trending down

By Dan Whitcomb

LOS ANGELES (Reuters) – The rates of new COVID-19 cases, hospitalizations and intensive care unit admissions were all trending downward in California in the latest counts, the governor said on Monday.

Governor Gavin Newsom, a Democrat, said that despite that good news, the state’s Central Valley agricultural region was still being hit hard by the coronavirus. He said the data had yet to reach a point for lifting pandemic restrictions.

“This virus is not going away,” Newsom said at a daily coronavirus briefing. “It’s not going to take Labor Day weekend off or Halloween off or the holidays off. Until we have a vaccine we are going to be living with this virus.”

California, the country’s most populous state with some 40 million residents, has recorded a total of 514,901 confirmed COVID-19 infections and 9,388 deaths, according to the governor’s office.

The state’s seven-day average of infections has dropped more than 21 percent, compared to the previous period, Newsom said, and hospitalizations are down 10 percent in a 14-day average.

California has administered more than 8 million tests for COVID-19, and the rate of positive results has declined to seven percent over the last 14 days, compared to 7.5 percent in the previous two weeks.

(Reporting by Dan Whitcomb; Editing by Sandra Maler and Howard Goller)

U.S. House panel to hold Postal Service hearing amid 2020 election concerns

By David Shepardson

WASHINGTON (Reuters) – A U.S. House of Representatives committee plans to hold a Sept. 17 hearing with new Postmaster General Louis DeJoy to examine operational changes to the U.S. Postal Service amid concerns about the 2020 election and recent reports of a slowdown in some deliveries.

The House Committee on Oversight and Reform invited DeJoy “to examine recent changes to U.S. Postal Service operations and standards and the need for on-time mail delivery during the ongoing pandemic and upcoming election, which as you know may be held largely by mail-in ballot,” said Representative Carolyn Maloney, who chairs the panel.

Maloney and other senior House Democrats warned in a July 20 letter that “increases in mail delivery timing would impair the ability of ballots to be received and counted in a timely manner — an unacceptable outcome for a free and fair election.”

A spokesman for DeJoy declined to comment on the hearing.

The Postal Service will report third-quarter financials on Friday when the board holds a virtual meeting.

A group of senators last week raised concerns that delaying mail deliveries could hinder attempts to mail in ballots for the 2020 election by Americans fearful about voting in person during a pandemic.

U.S. President Donald Trump threatened to sue Nevada after Democratic lawmakers passed a bill on Sunday that would send mail-in ballots to every voter ahead of November’s presidential election in light of the coronavirus pandemic.

Trump, who has claimed without evidence that voting by mail will lead to rampant fraud, wrote on Twitter on Monday that the legislation approved on Sunday was an “illegal late night coup.”

If the state’s Democratic governor, Steve Sisolak, signs the bill as expected, Nevada would become the seventh state to send ballots to all registered voters for the Nov. 3 election.

(Reporting by David Shepardson)

Trump threatens to sue Nevada to block universal mail-in ballots

By Joseph Ax

(Reuters) – President Donald Trump threatened to sue Nevada after Democratic lawmakers passed a bill on Sunday that would send mail-in ballots to every voter ahead of November’s presidential election in light of the coronavirus pandemic.

Trump, who has claimed without evidence that voting by mail will lead to rampant fraud, wrote on Twitter on Monday that the legislation approved on Sunday was an “illegal late night coup.”

“Using Covid to steal the state,” he added. “See you in Court!”

If the state’s Democratic governor, Steve Sisolak, signs the bill as expected, Nevada would become the seventh state to send ballots to all registered voter for the Nov. 3 election. Utah, Colorado, Hawaii, Oregon and Washington already conduct their elections entirely by mail, while California and Vermont have decided to do so this year due to the pandemic.

A Trump campaign spokeswoman did not immediately comment on Trump’s threat. But the ongoing public health crisis has prompted litigation in dozens of states between Democrats and Republicans over issues like absentee ballots, postmark deadlines and signature requirements.

Most states have sought to expand mail-in voting to avoid spreading the coronavirus at polling places on Election Day.

Nevada mailed ballots to voters ahead of its primary election in June and encouraged residents not to risk in-person voting. Most of the state’s polling places were closed, leading to waits of as much as seven hours in Las Vegas.

Sisolak’s office did not immediately respond to a request for comment on Trump’s tweet.

Election experts say voter fraud of any kind, including incidents related to mail-in ballots, is vanishingly rare.

Last week, Trump suggested delaying the election due to the likelihood of fraud, though he does not have the authority to do so.

(Reporting by Joseph Ax; Editing by Steve Orlofsky)

Next big COVID-19 treatment may be manufactured antibodies

By Deena Beasley

(Reuters) – As the world awaits a COVID-19 vaccine, the next big advance in battling the pandemic could come from a class of biotech therapies widely used against cancer and other disorders – antibodies designed specifically to attack this new virus.

Development of monoclonal antibodies to target the virus has been endorsed by leading scientists. Anthony Fauci, the top U.S. infectious diseases expert, called them “almost a sure bet” against COVID-19.

When a virus gets past the body’s initial defenses, a more specific response kicks in, triggering production of cells that target the invader. These include antibodies that recognize and lock onto a virus, preventing the infection from spreading.

Monoclonal antibodies – grown in bioreactor vats – are copies of these naturally-occurring proteins.

Scientists are still working out the exact role of neutralizing antibodies in recovery from COVID-19, but drugmakers are confident that the right antibodies or a combination can alter the course of the disease that has claimed more than 675,000 lives globally.

“Antibodies can block infectivity. That is a fact,” Regeneron Pharmaceuticals executive Christos Kyratsous told Reuters.

Regeneron is testing a two-antibody cocktail, which it believes limits the ability of the virus’ to escape better than one, with data on its efficacy expected by late summer or early fall. “Protection will wane over time. Dosing is something we don’t know yet,” said Kyratsous.

The U.S. government in June awarded Regeneron a $450 million supply contract. The company said it can immediately begin production at its U.S. plant if regulators approve the treatment.

Eli Lilly and Co, AstraZeneca, Amgen, and GlaxoSmithKline were cleared by the U.S. government to pool manufacturing resources in order to scale up supplies if any of these drugs prove successful.

Even with that unusual cooperation among rivals, manufacturing these medicines is complex and capacity is limited. There is also a debate over whether a single antibody will be powerful enough to stop COVID-19.

AstraZeneca said it plans to start human trials of its dual-antibody combination within weeks.

Lilly, which began human testing in June of two antibody candidates in separate trials, is focusing on a one-drug approach.

“If you need a higher dosage or more antibodies, fewer people can be treated,” Lilly Chief Scientific Officer Dan Skovronsky said.

‘INSTANT IMMUNITY’

Unlike vaccines, which activate the body’s own immune system, the impact of infused antibodies eventually dissipates.

Still, drugmakers say monoclonal antibodies could temporarily prevent infection in at-risk people such as medical workers and the elderly. They could also be used as a therapeutic bridge until vaccines become widely available.

“In a prophylactic setting we think we may achieve coverage for up to six months,” said Phil Pang, chief medical officer of Vir Biotechnology, which aims to start testing an antibody in non-hospitalized patients next month with partner GSK.

“The advantage of an antibody is that it is basically instant immunity,” said Mark Brunswick, senior vice president at Sorrento Therapeutics, which aims to begin human trials next month of a single antibody candidate.

Safety risks for monoclonal antibodies are considered low, but their cost can be quite high. These type of drugs for cancer can cost over $100,000 a year.

There is also concern that the coronavirus could become resistant to specific antibodies. Researchers are already at work on second-generation compounds with targets other than the crown-like spikes the virus uses to invade cells.

“We are trying to develop something that is complementary,” Amgen research chief David Reese said. Amgen is working with Adaptive Biotechnologies Corp.

Researchers in a recent paper published in the journal Nature said they had discovered several new, very potent, antibodies directed to an area where the virus attaches to human cells and to a region of the spike that has not attracted attention.

“To avoid development of resistance you want to target different sites,” study author and Columbia University professor David Ho told Reuters.

There are also questions about when in the course of the illness it might be best to employ these new weapons.

“Giving an antibody later on after infection might not be that helpful, said Florian Krammer, microbiology professor at New York’s Icahn School of Medicine. “Given early, they probably work well.”

(Reporting By Deena Beasley, editing by Peter Henderson and Bill Berkrot)

Large U.S. COVID-19 vaccine trials will exclude pregnant women for now

By Julie Steenhuysen

CHICAGO (Reuters) – The first two COVID-19 vaccines to enter large-scale U.S. trials will not be tested in pregnant women this year, raising questions about how this vulnerable population will be protected from the coronavirus, researchers told Reuters.

Moderna and Pfizer, which has partnered with Germany’s BioNTech, this week separately launched clinical trials that use a new and unproven gene-based technology. Both companies are requiring proof of a negative pregnancy test and a commitment to using birth control from women of childbearing age who enroll.

Drugmakers say they first need to make sure the vaccines are safe and effective more generally. In addition, U.S. regulators require that drugmakers conduct safety studies in pregnant animals before the vaccines are tested in pregnant women to ensure they don’t harm the fetus or lead to miscarriage.

Bioethicists, vaccine and maternal health experts have argued for years that pregnant women should be included early in trials of pandemic vaccines so they would not need to wait until long after a successful candidate emerges. That debate fell on deaf ears in recent outbreaks of Ebola and Zika, but has taken on new urgency in the era of COVID-19, as studies show pregnant women are at increased risk of severe disease from the new coronavirus.

“It’s a problem because if (vaccines) are not tested in pregnancy, then they may not be available or people may not be comfortable offering them,” said Dr. Denise Jamieson, chief of gynecology and obstetrics for Emory Healthcare in Atlanta.

According to the 2012 Census, 75.4 million U.S. women were of childbearing age, defined as 15 to 50 years old. Currently, pregnant women are recommended to take flu and whooping cough vaccines and certain others depending on individual circumstances, but none of these have been specifically tested and proven safe for pregnant women.

“We have an enormous number of women of childbearing age and potentially getting pregnant, and what’s the safest vaccine for them?” said Dr. Larry Corey, a vaccine expert at Fred Hutchinson Cancer Center in Seattle who is helping oversee vaccine trials conducted by Moderna and other drugmakers in collaboration with the U.S. government.

Doctors may want to see even more data for completely new vaccine technologies, such as those used by Moderna and Pfizer, compared with one that has already been used in pregnant women.

Such differences highlight why “we need multiple vaccines” to best address the needs of specific populations, Corey said.

A PRECEDENT IN PREGNANCY

Johnson & Johnson, which kicked off a small-scale safety trial for its COVID-19 vaccine this week, is using the same underlying technology that it used with its Ebola vaccine, which has been used in 1,000 pregnant women in Democratic Republic of Congo. Larger studies with that vaccine are now under way.

J&J’s chief scientific officer, Dr. Paul Stoffels, told Reuters the company has done many years of “extensive” pre-clinical study with the Ebola vaccine, including on pregnant animals, and “has not see any challenges.”

Stoffels said J&J would decide in the next few weeks whether it will include pregnant women in its large Phase 3 late-stage trial for a COVID-19 vaccine due to start in September. Pfizer expects to start toxicology studies in pregnant animals shortly, with data ready for review by the U.S. Food and Drug Administration in the first quarter of 2021. Studies in pregnant women could start some time afterward.

“We continue to explore potential ways to shorten the time to studies in pregnant women,” Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told Reuters.

Of course, unplanned pregnancies can happen even when women are using reliable contraception. Based on past experiences in such trials, Gruber said he expects about 1% of women in Pfizer’s Phase 3 trial, or about 150 women, will become pregnant. And those women and their babies will be followed closely.

Moderna said in an emailed statement that the company launched its safety study in pregnant animals at the end of June and expects results by the end of this year.

“Once we have generated additional safety data for our vaccine, and importantly demonstrated that it is efficacious, we intend to conduct additional studies in this important population,” a Moderna spokesperson said.

Sanofi, whose coronavirus vaccine is based on its flu vaccine platform, is doing reproductive toxicology in animals, but those results won’t be ready before the start of the company’s large Phase 3 trials, expected to start by year-end.

Sanofi may establish a pregnancy registry after the vaccine is approved to track outcomes in pregnant women, as has been done in the past.

Merck & Co. said it has not made any decisions yet on when to test its vaccine candidate in pregnant women. Novavax and AstraZeneca Plc declined to comment on their plans.

Dr. Flor Munoz, an expert in maternal use of vaccines at Baylor College of Medicine, said companies have been reluctant to test anything in pregnant women since the 1950’s and 60’s, after the drug thalidomide, which was used to treat nausea in pregnancy, caused widespread birth defects. She agrees that preliminary testing is needed.

The vaccines “need to be reasonably safe and reasonably effective,” she said. “We don’t necessarily have to finish the Phase 3 trials.”

(Reporting by Julie Steenhuysen; editing by Michele Gershberg and Leslie Adler)

There is no ‘zero risk’ in easing travel restrictions, WHO says

By Bhargav Acharya and Kanishka Singh

(Reuters) – There is no “zero risk” strategy for countries easing international travel restrictions during the COVID-19 pandemic, and essential travel for emergencies should remain the priority, the World Health Organization (WHO) said.

In a long-awaited update to its guidance on travel, the United Nations global health agency said cross-border trips for emergencies, humanitarian work, the transfer of essential personnel and repatriation would constitute essential travel.

“There is no ‘zero risk’ when considering the potential importation or exportation of cases in the context of international travel,” it said in the updated guidance posted on its website on Thursday.

A surge of new infections in many parts of the world has prompted some countries to reintroduce some travel restrictions, including testing and quarantining incoming passengers.

The WHO had said in June it would update its travel guidelines before the northern hemisphere summer holidays.

The WHO’s guidance can be used by governments and industries to help shape policies, but is not enforceable.

The updated travel advice is little changed from previous guidance, which also included infection control advice applicable to other settings such as social distancing, wearing masks, washing hands and avoiding touching the face.

The WHO urged each country to conduct its own risk-benefit analysis before lifting any or all travel restrictions. Authorities should take into account local epidemiology and transmission patterns, it said, as well as national health and social distancing measures already in place.

Countries that choose to quarantine all travelers on arrival should do so after assessing the risks and consider local circumstances, the WHO said.

“Countries should continuously plan for and assess their surge capacities for testing, tracking, isolating and managing imported cases and quarantine of contacts,” it said.

The WHO said this week that international travel bans cannot stay in place indefinitely, and countries will have to do more to reduce the spread of the novel coronavirus within their borders.

(Reporting by Bhargav Acharya and Kanishka Singh in Bengaluru; Writing by Kate Kelland, editing by Diane Craft, Marguerita Choy, Grant McCool and Timothy Heritage))