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)

Teachers protest across U.S. over re-opening schools in pandemic

By Brendan O’Brien

CHICAGO (Reuters) – Teachers and support staff at more than 35 school districts across the United States on Monday are protesting the re-opening of schools while COVID-19 is surging in many parts of the country.

They are demanding in-person classes not be held until scientific data supports it, safety protocols such as lower class sizes and virus testing are established, and schools are staffed with adequate numbers of counselors and nurses, according to a website set up for the demonstrations.

On Twitter, the Milwaukee Teachers’ Education Association showed protesters making fake gravestones that said “Here lies a third grade student from Green Bay who caught COVID at school” and “RIP Grandma caught COVID helping grand kids with homework.”

Teachers are also demanding financial help for parents in need, including rent and mortgage assistance, a moratorium on evictions and foreclosures and cash assistance.

Many of these issues are at the center of a political tussle in Washington, where Congressional Democrats and Trump administration officials will resume talks on Monday aimed at hammering out a coronavirus economic relief bill after missing a deadline to extend benefits to tens of millions of jobless Americans.

The coronavirus, which first appeared in China late last year, has infected 4.6 million people in the United States and killed more than 155,000 Americans since February, according to a Reuters tally. Deaths rose by over 25,000 in July and cases doubled in 19 states during the month.

President Donald Trump has made school re-openings for classroom instruction, as they normally would in August and September, part of his re-election campaign. The Republican president is trailing in opinion polls against Democratic candidate Joe Biden ahead of the Nov. 3 election.

“Cases up because of BIG Testing! Much of our Country is doing very well. Open the Schools!” Trump tweeted on Monday.

While reported case numbers may be linked to more testing, recent increases in hospitalizations and deaths have no connection to more people being tested for the virus.

The United States is in a new phase of the outbreak with infections in rural areas as well as cities, Deborah Birx, the coordinator of Trump’s coronavirus task force, said on Sunday.

“What we are seeing today is different from March and April. It is extraordinarily widespread,” Birx said on CNN’s “State of the Union” program.

On Monday, Trump lashed out at Birx for her comments. Trump accused Birx of capitulating to criticism from Democrats that the federal government’s response to the pandemic has been ineffective.

“So Crazy Nancy Pelosi said horrible things about Dr. Deborah Birx, going after her because she was too positive on the very good job we are doing on combating the China Virus, including Vaccines & Therapeutics. In order to counter Nancy, Deborah took the bait & hit us. Pathetic!” Trump wrote.

House of Representatives Speaker Pelosi said on CNN on Monday that Birx has “enabled” Trump, who played down the seriousness of the virus in the early stages and pushed for a quick reopening of the economy and schools following weeks of lockdowns.

“I don’t have confidence in anyone who stands there while the President says swallow Lysol and it’s going to cure your virus,” Pelosi said in a reference to Trump at a coronavirus briefing in April with Birx present.

Trump had asked whether injecting disinfectant into the body could be a treatment for the virus, leading makers of those products to issue warnings against doing so.

(Reporting by Brendan O’Brien in Chicago, Gabriella Borter in New York; writing by Grant McCool; Editing by Bill Berkrot)

New Jersey governor re-tightens restrictions on indoor gatherings after COVID-19 surge

By Maria Caspani

(Reuters) – New Jersey Governor Phil Murphy on Monday announced he was re-tightening restrictions on indoor gatherings after a recent surge in coronavirus cases in the state that officials have, in part, linked to house parties and indoor events.

Murphy said such events will now be limited to 25% of a room’s capacity with a maximum of 25 people, down from the previous limit of 100.

“The actions of a few knuckleheads leaves us no other course,” Murphy said at a news briefing. “We have to go back and tighten these restrictions once again until we begin to see the numbers of cases decrease.”

The restrictions will not apply to weddings, funerals and memorial services, and religious and political activities protected under the First Amendment, Murphy said.

The rate of COVID-19 transmission has climbed to 1.48 in New Jersey, the governor said, compared with 0.87 about a month ago, while cases have also been on the rise.

“Let me reiterate, we remain in a public health emergency,” Murphy said. “Over the past week we saw numbers of cases that we had not seen in eight weeks, our rate of transmission is now more than double where it was a few weeks ago. Everyone needs to get it together folks.”

Murphy also sought to clarify previously provided guidance on schools reopening and announced that all students will be required to wear face coverings at all times when inside a school building, excepts for health reasons.

(Reporting by Maria Caspani, Editing by Jonathan Oatis and Marguerita Choy)

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)

Long-term complications of COVID-19 signals billions in healthcare costs ahead

By Caroline Humer, Nick Brown and Emilio Parodi

NEW YORK (Reuters) – Late in March, Laura Gross, 72, was recovering from gall bladder surgery in her Fort Lee, New Jersey, home when she became sick again.

Her throat, head and eyes hurt, her muscles and joints ached and she felt like she was in a fog. Her diagnosis was COVID-19. Four months later, these symptoms remain.

Gross sees a primary care doctor and specialists including a cardiologist, pulmonologist, endocrinologist, neurologist, and gastroenterologist.

“I’ve had a headache since April. I’ve never stopped running a low-grade temperature,” she said.

Studies of COVID-19 patients keep uncovering new complications associated with the disease.

With mounting evidence that some COVID-19 survivors face months, or possibly years, of debilitating complications, healthcare experts are beginning to study possible long-term costs.

Bruce Lee of the City University of New York (CUNY) Public School of Health estimated that if 20% of the U.S. population contracts the virus, the one-year post-hospitalization costs would be at least $50 billion, before factoring in longer-term care for lingering health problems. Without a vaccine, if 80% of the population became infected, that cost would balloon to $204 billion.

Some countries hit hard by the new coronavirus – including the United States, Britain and Italy – are considering whether these long-term effects can be considered a “post-COVID syndrome,” according to Reuters interviews with about a dozen doctors and health economists.

Some U.S. and Italian hospitals have created centers devoted to the care of these patients and are standardizing follow-up measures.

Britain’s Department of Health and the U.S. Centers for Disease Control and Prevention are each leading national studies of COVID-19’s long-term impacts. An international panel of doctors will suggest standards for mid- and long-term care of recovered patients to the World Health Organization (WHO) in August.

YEARS BEFORE THE COST IS KNOWN

More than 17 million people have been infected by the new coronavirus worldwide, about a quarter of them in the United States.

Healthcare experts say it will be years before the costs for those who have recovered can be fully calculated, not unlike the slow recognition of HIV, or the health impacts to first responders of the Sept. 11, 2001 attacks on the World Trade Center in New York.

They stem from COVID-19’s toll on multiple organs, including heart, lung and kidney damage that will likely require costly care, such as regular scans and ultrasounds, as well as neurological deficits that are not yet fully understood.

A JAMA Cardiology study found that in one group of COVID-19 patients in Germany aged 45 to 53, more than 75% suffered from heart inflammation, raising the possibility of future heart failure.

A Kidney International study found that over a third of COVID-19 patients in a New York medical system developed acute kidney injury, and nearly 15% required dialysis.

Dr. Marco Rizzi in Bergamo, Italy, an early epicenter of the pandemic, said the Giovanni XXIII Hospital has seen close to 600 COVID-19 patients for follow-up. About 30% have lung issues, 10% have neurological problems, 10% have heart issues and about 9% have lingering motor skill problems. He co-chairs the WHO panel that will recommend long-term follow-up for patients.

“On a global level, nobody knows how many will still need checks and treatment in three months, six months, a year,” Rizzi said, adding that even those with mild COVID-19 “may have consequences in the future.”

Milan’s San Raffaele Hospital has seen more than 1,000 COVID-19 patients for follow-up. While major cardiology problems there were few, about 30% to 40% of patients have neurological problems and at least half suffer from respiratory conditions, according to Dr. Moreno Tresoldi.

Some of these long-term effects have only recently emerged, too soon for health economists to study medical claims and make accurate estimates of costs.

In Britain and Italy, those costs would be borne by their respective governments, which have committed to funding COVID-19 treatments but have offered few details on how much may be needed.

In the United States, more than half of the population is covered by private health insurers, an industry that is just beginning to estimate the cost of COVID-19.

CUNY’s Lee estimated the average one-year cost of a U.S. COVID-19 patient after they have been discharged from the hospital at $4,000, largely due to the lingering issues from acute respiratory distress syndrome (ARDS), which affects some 40% of patients, and sepsis.

The estimate spans patients who had been hospitalized with moderate illness to the most severe cases, but does not include other potential complications, such as heart and kidney damage.

Even those who do not require hospitalization have average one-year costs after their initial illness of $1,000, Lee estimated.

‘HARD JUST TO GET UP’

Extra costs from lingering effects of COVID-19 could mean higher health insurance premiums in the United States. Some health plans have already raised 2021 premiums on comprehensive coverage by up to 8% due to COVID-19, according to the Kaiser Family Foundation.

Anne McKee, 61, a retired psychologist who lives in Knoxville, Tennessee and Atlanta, had multiple sclerosis and asthma when she became infected nearly five months ago. She is still struggling to catch her breath.

“On good days, I can do a couple loads of laundry, but the last several days, it’s been hard just to get up and get a drink from the kitchen,” she said.

She has spent more than $5,000 on appointments, tests and prescription drugs during that time. Her insurance has paid more than $15,000 including $240 for a telehealth appointment and $455 for a lung scan.

“Many of the issues that arise from having a severe contraction of a disease could be 3, 5, 20 years down the road,” said Dale Hall, Managing Director of Research with the Society of Actuaries.

To understand the costs, U.S. actuaries compare insurance records of coronavirus patients against people with a similar health profile but no COVID-19, and follow them for years.

The United Kingdom aims to track the health of 10,000 hospitalized COVID-19 patients over the first 12 months after being discharged and potentially as long as 25 years. Scientists running the study see the potential for defining a long-term COVID-19 syndrome, as they found with Ebola survivors in Africa.

“Many people, we believe will have scarring in the lungs and fatigue … and perhaps vascular damage to the brain, perhaps, psychological distress as well,” said Professor Calum Semple from the University of Liverpool.

Margaret O’Hara, 50, who works at a Birmingham hospital is one of many COVID-19 patients who will not be included in the study because she had mild symptoms and was not hospitalized. But recurring health issues, including extreme shortness of breath, has kept her out of work.

O’Hara worries patients like her are not going to be included in the country’s long-term cost planning.

“We’re going to need … expensive follow-up for quite a long time,” she said.

(Reporting by Caroline Humer and Nick Brown in New York; Emilio Parodi in Milan and Alistair Smout in London; editing by Michele Gershberg and Bill Berkrot)

Anxious WHO implores world to ‘do it all’ in long war on COVID-19

By Michael Shields and Emma Farge

GENEVA (Reuters) – The World Health Organization warned on Monday that there might never be a “silver bullet” for COVID-19 in the form of a perfect vaccine and that the road to normality would be long, with some countries requiring a reset of strategy.

More than 18.14 million people around the world are reported to have been infected with the disease and 688,080​ have died, according to a Reuters tally, with some nations that thought they were over the worst experiencing a resurgence.

WHO Director-General Tedros Adhanom Ghebreyesus and WHO emergencies head Mike Ryan exhorted nations to rigorously enforce health measures such as mask-wearing, social distancing, hand-washing and testing.

“The message to people and governments is clear: ‘Do it all’,” Tedros told a virtual news briefing from the U.N. body’s headquarters in Geneva. He said face masks should become a symbol of solidarity round the world.

“A number of vaccines are now in phase three clinical trials and we all hope to have a number of effective vaccines that can help prevent people from infection. However, there’s no silver bullet at the moment – and there might never be.”

The WHO head said that, while the coronavirus was the biggest health emergency since the early 20th century, the international scramble for a vaccine was also “unprecedented”.

But he underscored uncertainties. “There are concerns that we may not have a vaccine that may work, or its protection could be for just a few months, not more. But until we finish the clinical trials, we will not know.”

“THE WAY OUT IS LONG”

Ryan said countries with high transmission rates, including Brazil and India, needed to brace for a big battle: “The way out is long and requires a sustained commitment,” he said, calling for a “reset” of approach in some places.

“Some countries are really going to have to take a step back now and really take a look at how they are addressing the pandemic within their national borders,” he added.

Asked about the U.S. outbreak, which White House coronavirus experts say is entering a “new phase,” he said officials seemed to have set out the “right path” and it was not the WHO’s job to do so.

The WHO officials said an advance investigation team had concluded its China mission and laid out the groundwork for further efforts to identify the origins of the virus.

The study is one of the demands made by top donor the United States which plans to leave the body next year, accusing it of being too acquiescent to China.

A larger, WHO-led team of Chinese and international experts is planned next, including in the city of Wuhan, although the timing and composition of that was unclear. Ryan said China had already given some information but knowledge gaps remained.

(Reporting by Michael Shields, Emma Farge and Francesco Guarascio; Writing by Andrew Cawthorne; Editing by Kevin Liffey)

WHO reports record daily increase in global coronavirus cases, up over 292,000

(Reuters) – The World Health Organization reported a record increase in global coronavirus cases on Friday, with the total rising by 292,527.

The biggest increases were from the United States, Brazil, India and South Africa, according to a daily report. Deaths rose by 6,812. The four countries have dominated global headlines with large outbreaks.

The previous WHO record for new cases was 284,196 on July 24. Deaths rose by 9,753 on July 24, the second largest one-day increase ever. Deaths have been averaging 5,200 a day in July, up from an average of 4,600 a day in June.

Nearly 40 countries have reported record single-day increases in coronavirus infections over the last week, around double the number that did so the previous week, according to a Reuters tally showing a pick-up in the pandemic in every region of the world.

Cases have been on the rise also in Australia, Japan, Hong Kong, Bolivia, Sudan, Ethiopia, Bulgaria, Belgium, Uzbekistan and Israel, among others.

Last week, cases in Latin America for the first time surpassed the combined infections in the United States and Canada, a Reuters tally showed. Infections are surging in Brazil, which is second in the world behind the United States in cases and deaths.

Globally there are over 17.4 million infections and nearly 675,000 deaths, according to a Reuters tally.

(Reporting by Lisa Shumaker; Editing by Howard Goller)

Coronavirus child care pinch in U.S. poses threat to economic gains of working women

By Jonnelle Marte and Rachel Dissell

CLEVELAND (Reuters) – Most days, Zora Pannell works from her dining room table, sitting in front of her computer, turning off the video on Zoom calls to nurse her one-year-old daughter, Savannah.

Pannell has balanced working from home and caring for her daughter and son Timothy, aged 2, since March when she started a new job as a manager for a language services company the same week that Ohio issued a “stay at home” order to stop the spread of the coronavirus.

Working from home is an exhausting daily juggle but she’s more worried about being told it’s time to return to the office. Her husband cannot watch the children during the day because he has a job at a local steel mill and the couple have been unable to find a daycare center they deemed safe and affordable close to their Shaker Heights apartment on the eastern fringe of Cleveland.

“I’ve already felt penalized for being a working mother,” said Pannell, 30, who is worried she would have to quit if she is not allowed to keep working from home. “Now it’s like I’m in purgatory.”

The pandemic upended child care plans for many parents in the United States, forcing them – particularly mothers – to grapple with tough choices that are only becoming more difficult as states push return-to-work policies to try to revive the battered economy.

Do they hunt for expensive and hard-to-find child care that could expose their families to COVID-19, which is still raging across much of the country? Or do they scale back on work, or even quit, threatening their financial stability?

The barriers risk stalling or reversing the economic gains of recent years made by working women, who are more likely to take a career hit than men when they are unable to find child care, studies show.

A survey by Northeastern University between May 10-June 22 found that 13% of working parents had to resign or reduce their work hours because of a lack of child care during the health crisis, with women impacted significantly more than men. In all, of those who said they had lost a job due to child care problems, 60% were women, the survey found.

“If women don’t have child care, they can’t go back to work,” said Karen Schulman, Child Care and Early Learning Research Director for the National Women’s Law Center. If that doesn’t happen, “you end up creating a system that is going to result in vast gender inequities”.

Prior to the pandemic, the labor force participation rate for women aged 25-54 touched 77% in February, rising from 73% in September 2015 and close to the peak reached in 2000, when the share of women in the labor force began to plateau, in part because of challenges accessing affordable child care, experts say.

LIMITED OPTIONS

Pressure looks certain to mount on families in the coming weeks, as various aid programs and protections that offered relief to jobless parents expire, including enhanced unemployment benefits, eviction moratoriums and a freeze on student loan payments.

“There’s this fragile, invisible thread holding the lives of our moms, holding the lives of our economy together,” said Chastity Lord, president and chief executive of the Jeremiah Program, a Minneapolis-based nonprofit organization that supports single mothers and their children.

Finding a way to broaden access to child care will be pivotal to helping the U.S. labor market heal from the economic devastation caused by the pandemic, with latest data showing the economy contracting an annualized 32.9% in the second quarter of 2020 and approximately one out of five workers claiming unemployment insurance in the week ending July 11.

Child care was already scarce before the coronavirus led to the shuttering of thousands of centers. More than half of all Americans lived in a child care “desert” as of 2018, defined by the Center for American Progress, a liberal nonprofit group in Washington, as an area with no licensed child care providers or less than one slot for every three children under five.

Now, in many states, care centers accept only limited numbers of children to prevent the virus from spreading. Additionally, families that relied on grandparents or other older relatives or neighbors must weigh up the risks of asking for their help again and perhaps exposing them to a disease that has proved especially deadly for the elderly.

Chantel Springer, 24, worked at Starbucks in Manhattan during the early months of the pandemic but has been on furlough since June, when the store cut back on staff to adjust to lower demand and social distancing requirements. Now that her unemployment benefits could shrink as low as $325 a week, Springer is making arrangements to get back to her job as a shift manager.

“I feel like I have to work,” said Springer, explaining that the reduced benefits would not be enough to cover the rent, food, diapers and other costs.

This month, Springer transferred to a store in Brooklyn so she could be closer to her apartment and her two-year-old. But finding someone to babysit her son is a challenge. Springer can no longer leave the toddler with her mother, who recently moved to take care of a disabled sister whose husband died from Covid-19. For now, she is looking to coordinate schedules with her son’s father, who has also returned to work at a retail store.

HOME ALONE

Under the CARES Act passed in late March, parents who lost access to child care because of the pandemic became eligible for unemployment benefits. But the process of qualifying for the program, which varies from state to state, became less clear cut as the school year ended and some day care centers began to re-open with limited capacity.

The Labor Department sought to clarify with guidance that parents should resort to their typical summer child care plans.

Many states, including New York, Missouri and Louisiana, allow parents to self-certify each week, under penalty of perjury, that their child care center was closed and that they met the requirements to continue receiving benefits. Other states, like California and Texas, make such decisions on a “case-by-case” basis.

While child care places are hard to find for toddlers, they are even scarcer for school-age children and many summer programs for this age-group went online, leaving parents facing a quandary.

Sarah Sapp is hatching plans to rig up an old cell phone for her 11-year-old son, Avery.

The 37-year-old waitress from North Olmsted, a western suburb of Cleveland, fears her son, who sometimes struggles to pay attention to instructions, isn’t quite mature enough to be left home alone while she serves food and drinks at a high-end tavern. But she feels she has little choice.

When Ohio initially ordered restaurants and bars to close in March, Sapp qualified for state unemployment. But when the state told people it was safe to return to work in May, she was informed that she would no longer be eligible. Sapp tried to sign her son up for a day camp at her local recreation center but it got canceled.

More problems are piling up on the horizon. Sapp’s school district has told parents they must choose between all online lessons or a hybrid of two days shortened days in school and three days at home when classes resume in September. Neither of these options would allow her to work her lunchtime shift.

“I feel stuck,” Sapp said. “There doesn’t seem to be a right choice no matter how I look at things.”

(Rachel Dissell is a contributing reporter with The Fuller Project, a global nonprofit newsroom reporting on issues that impact women.; Jonnelle Marte reported for this story from New York; Editing by Heather Timmons and Crispian Balmer)

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)