Jul 14. 2020File photo of cover-19 patient in U.S.
By The Washington Post · Carolyn Y. Johnson · NATIONAL, HEALTH, SCIENCE-ENVIRONMENT
WASHINGTON – New treatment options for covid-19 could arrive months before even the most optimistic timeline for a vaccine, senior Trump administration officials said at a briefing Monday. But limited supply could outstrip demand if the pandemic continues to rage, creating a national tug-of-war over limited doses.
“Vaccines are the permanent hope for controlling this outbreak, but even with success, some people may not respond to vaccines and some may not get vaccinated, so we are always going to need therapeutics,” said Janet Woodcock, who is leading the therapeutics effort under “Operation Warp Speed” and is a senior adviser to the Food and Drug Administration commissioner. Warp Speed is a federal government initiative to speed up the development of countermeasures against the coronavirus.
Unlike vaccines, Woodcock said, therapeutics have to be developed against multiple facets of the infection, including antiviral treatments.
Woodcock urged Americans who have recently recovered from the coronavirus to donate blood plasma, rich with virus-fighting antibodies, to help other patients.
“We need donors. There are blood drives ongoing, and the U.S. government will be trying to accelerate these drives for convalescent plasma,” Woodcock said. “We need to get the word out nationally, this is something people can do. I think people feel very helpless in the face of this – and this is something everyone can contribute who has been infected.”
Although it is not yet clear whether the plasma transfusions are effective, they have been shown to be safe in large numbers of patients and evidence suggests they may help, particularly if given to hospitalized patients early in the disease. Convalescent plasma has been viewed as a bridge to the development of pharmaceutical treatments and vaccines, but there is a relatively narrow window for donation, six to eight weeks after illness, which limits the ability to make it widely available.
Woodcock also emphasized the prospects for monoclonal antibodies, biotechnology drugs that can block the coronavirus and that are moving into large-scale trials this summer, in hopes of learning whether they are effective by fall. Monoclonal antibodies can be used as a treatment or a preventive measure that may be of particular utility in groups of people who don’t respond as well to vaccines, such as older people.
Last week, the federal government’s Biomedical Advanced Research and Development Authority announced a $450 million investment to scale up production of experimental monoclonal antibody drugs being developed by Regeneron Pharmaceuticals, a New York company. That will help the company produce 70,000 to 300,000 doses of treatment, depending on what final dose is shown to be effective.
At least 50 monoclonal antibody drugs are in development, Woodcock said. But with the United States reporting more than 50,000 new coronavirus cases a day, the demand for treatments could quickly outstrip the supply.
“Obviously, we are trying to get as many doses available as possible, for as many people,” Woodcock said. “This requires, of course, scale-up of manufacturing, and even worldwide, there’s a limited number of facilities that can do biotech fermentation at the scale necessary.”
By The Washington Post · Toluse Olorunnipa · NATIONAL, HEALTH, POLITICS
WASHINGTON – President Donald Trump wore a mask in public for the first time Saturday, more than three months after public health officials from his own administration recommended that all Americans cover their face when social distancing was not possible.
Trump’s decision to don a mask during a trip to Walter Reed National Military Medical Center followed several months of controversy over his reluctance to abide by public health guidelines even as novel coronavirus cases surged nationwide. Before wearing the navy-colored mask Saturday, Trump had disparaged his Democratic rival, Joe Biden, for wearing a mask and publicly downplayed the importance of face coverings.
While the president said in recent interviews that he had no problem with masks, Saturday’s public appearance was the first tangible example of him following through on that with action.
“I’ve never been against masks, but I do believe they have a time and a place,” Trump said Saturday at the White House before leaving for Walter Reed.
While visiting wounded veterans and health-care workers at the facility, Trump wore a dark mask that covered most of his face. It featured the presidential seal.
For months, health officials and several Republican lawmakers have urged Trump to model good safety practices by wearing a mask in public, even though he is in an uncommon situation because he is regularly tested for the coronavirus. Trump resisted, and the concept of mask-wearing became part of the country’s partisan political battles as the coronavirus spread rapidly in America and other countries gained control of the pandemic.
“Unfortunately this simple lifesaving practice has become part of a political debate that says: If you’re for Trump, you don’t wear a mask. If you’re against Trump, you do,” Sen. Lamar Alexander, R-Tenn., said last month during a Senate hearing. “That is why I have suggested the president should occasionally wear a mask even though there are not many occasions when it is necessary for him to do so. The president has millions of admirers. They would follow his lead.”
Trump instead chose to set a different example, holding several mass gatherings in recent weeks in which most participants did not wear masks. Trump defied local ordinances and guidelines in Michigan, Oklahoma, Florida, Arizona and elsewhere as he traveled the country maskless.
His explanations varied over the course of three months as he opted against mask-wearing and as the White House staff implemented and then quickly abandoned a universal mask policy. In recent weeks, Trump and the White House staff photographed around him have not worn masks.
Trump has attacked Biden on Twitter for wearing a mask and told Fox News on Thursday that Biden’s mask was the “the largest mask I think I have ever seen. It covers up a big proportion of his face.”
Biden’s campaign criticized Trump on Saturday for waiting so long to wear a mask publicly.
“Donald Trump spent months ignoring the advice of medical experts and politicizing wearing a mask, one of the most important things we can do to prevent the spread of the virus,” said Biden campaign spokesman Andrew Bates.
“Rather than taking responsibility and leading, he wasted four months that Americans have been making sacrifices by stoking divisions and actively discouraging people from taking a very basic step to protect each other,” Bates said. “By contrast, Joe Biden has led by example from the start and as president will make decisions informed by science to protect the American people and defeat the virus.”
As health officials in the Trump administration have tried to persuade Americans to wear masks to slow the spread of the coronavirus, Trump has repeatedly focused on the aesthetics of face coverings and social distancing – adding to the politicization of the issue.
“I just don’t want to wear one myself,” Trump said in early April when asked if he’d wear a mask. “It’s a recommendation; they recommend it. I’m feeling good. I just don’t want to be doing – I don’t know, somehow sitting in the Oval Office. . . . I think wearing a face mask as I greet presidents, prime ministers, dictators, kings, queens, I don’t know. Somehow, I don’t see it for myself. I just – I just don’t.”
After he toured a factory in Michigan in May, Trump told reporters that he did not wear a mask in front of cameras because he “didn’t want to give the press the pleasure of seeing” him with his face covered.
By Saturday, with coronavirus cases in the United States hitting records on a daily basis, Trump was willing to wear the mask in front of cameras – strolling through Walter Reed surrounded by several men who were also wearing masks.
Trump said it made sense for him to wear the mask because he was in a hospital and “in that particular setting where you’re talking to a lot of soldiers and people that in some cases just got off the operating tables.”
Walter Reed’s website includes guidance that says visitors “are expected to wear a cloth face covering over their nose and mouth upon entering and while moving about the facility . . . when not able to maintain 6 feet of social distancing.”
In explaining his about-face on face coverings this month, Trump still focused on superficial rationale, not the public health benefits.
“Actually, I had a mask on. I sort of liked the way I looked, okay? I thought it was okay,” Trump told Fox Business Network on July 1. “It was a dark, black mask, and I thought it looked okay. Looked like the Lone Ranger. But, no, I have no problem with that. I think – and if people feel good about it, they should do it.”
Several Trump campaign aides and White House officials posted images of Trump wearing his mask on Saturday, with most commenting on how he looked rather than on the public health issue.
Jul 10. 2020Mask-wearing mannequins at a store in Austin’s South Congress neighborhood. Texas is among the states that have rolled back their reopenings amid a spike in coronavirus cases. Florida also reversed course on loosened restrictions after Gov. Ron DeSantis, a Republican, pushed for a quick recovery. MUST CREDIT: Photo by Tamir Kalifa for The Washington Post
By The Washington Post · Griff Witte · NATIONAL, BUSINESS, HEALTH, POLITICS, SCIENCE-ENVIRONMENT They raced to shut down their economies in March, and many opened them just as quickly in May.
Now, governors across the country are facing growing pressure from public health experts and local leaders to reimpose stay-at-home orders as the only way to regain control of coronavirus outbreaks that threaten to overwhelm hospitals and send the death count spiraling.
The push appeared to receive a boost from Anthony Fauci, the nation’s top infectious-disease official, who suggested in comments released late Wednesday that struggling states “should seriously look at shutting down.”
He took a more measured approach on Thursday, emphasizing that stay-at-home orders should remain a last resort and suggesting a pause in reopening plans instead.
So far, that has been the preferred method for governors seeking to arrest climbing caseloads while not alienating a virus-weary public. Yet, with scant evidence of progress in states across the Sun Belt – and beyond – experts are increasingly concluding that more drastic measures are necessary.
“Stay-at-home is a blunt instrument,” said Farshad Fani Marvasti, director of public health at Arizona State University. “But when you’re leading the world in new cases and things don’t seem to be getting better, you may have to use that blunt instrument.”
Studies have found that orders that closed nonessential businesses and forbid nonessential travel or gatherings prevented millions of coronavirus cases nationwide when they were imposed this spring. Researchers have also found such orders could have saved tens of thousands of lives had they been implemented earlier.
But with the economy reeling from a prolonged shutdown, and President Donald Trump agitating for a quick reopening, governors across the country lifted restrictions in May. That was despite the fact that most had not met the White House’s own criteria for determining when it was safe to ease up.
Now, with caseloads hitting new peaks, the process for some states has been thrown in reverse.
Nationwide, more than a dozen states have paused their reopenings this summer as case numbers have climbed. Another half-dozen have rolled back previously announced reopenings. Several have reimposed bans on bars, which have been particularly hospitable spots for the virus to circulate.
Yet the majority of states have pressed ahead with reopenings.
As case numbers in the U.S. surge, that has unnerved public health experts who see a disaster in the making.
Fauci told the Wall Street Journal in a podcast released Wednesday that some states “went too fast” with their reopenings and suggested that the solution may be to go back to square one.
“I think any state that is having a serious problem, that state should seriously look at shutting down,” he said in remarks that appeared to contradict Trump’s push for the country’s reopening to continue.
During an appearance Thursday, Fauci dialed back his remarks, saying that a “complete shutdown” would be “obviously an extreme.”
“I would hope we don’t have to resort to shutdown,” he said at an event hosted by the Hill newspaper. “I think it would not be viewed very, very favorably, even by the states and the cities involved. So rather than think in terms of reverting back down to a complete shutdown, I would think we need to get the states pausing in their opening process.”
But other public health specialists insist a pause is not enough, and that the U.S. won’t be able to reopen to the extent that many other countries have until it learns how to do so safely.
“We see the hurricane coming. In some places, it’s already here,” said Thomas Tsai, a Harvard health policy researcher and surgeon. “The question is whether you’re going to evacuate your citizens from the path.”
The evidence so far, Tsai said, suggests not.
“We’re watching this unfold and we’re frozen,” he said.
At the Harvard Global Health Institute, with which Tsai is affiliated, researchers recently put together a national tracker to assess the severity of the outbreak in all 50 states.
As of Thursday, 15 of them were in a state of “accelerated spread,” meaning that stay-at-home orders should at least be considered, along with aggressive testing and tracing programs.
Another five – Arizona, Florida, Louisiana, South Carolina and Georgia – were flashing red. In those states, the outbreaks are so advanced that researchers say stay-at-home is no longer optional. It should be mandatory.
In all five, however, governors have waved off suggestions that people should be again told to stay at home, citing the economic costs of keeping people out of work.
In Arizona, cumulative deaths topped 2,000 on Thursday and daily hospitalizations hit another high. Gov. Doug Ducey, a Republican, has urged people to stay home when possible, and he has reinstated closures of bars, water parks, movie theaters and gyms.
But so far, that hasn’t been sufficient. The case counts continue to rise in a way that public health experts say is reminiscent of the exponential growth that the world’s worst-hit places experienced earlier this year, before stay-at-home orders kicked in.
“We don’t want to become another New York, another Italy,” said Marvasti. “But that’s where we’re headed. We need to learn our lesson from these places.”
Steve Adler, the mayor of Austin, has come to the same conclusion. In Texas’s capital city, cases have been surging and hospitals have been filling up.
This week, new coronavirus admissions surpassed an average of 70 per day – the low end of the trigger that health authorities had set for shutting down nonessential businesses, ending indoor restaurant dining and banning gatherings outside the home.
The situation, Adler said, is “precarious in terms of our ability to meet the intensive care surge that we could be facing.”
A slowed growth rate has bought the city more time to consider whether a shutdown is truly necessary. But Adler said it remained an option he would need to consider.
“I have to do everything I can to protect the city,” he said.
Authorities in Houston and Dallas have also asked for the authority to shut down, citing the pressure on hospitals and concern that there may not be enough medical staff to treat the sick.
Standing in their way, however, is Texas Gov. Greg Abbott, a Republican, who has maintained that he alone has the authority to issue stay-at-home orders. And he has been a steadfast opponent, despite record caseloads – more than 10,000 new cases of the virus were reported Tuesday.
“To shut things down completely back into lockdown mode, that would really force Texans into poverty,” Abbott said this week.
A return to stay-at-home orders could have severe political consequences. Although surveys showed strong support for such measures in the spring, a second round would inevitably spawn a backlash.
“People are tired of this and they’re tired of the same message and they’re tired of this disease,” said Karen Landers, assistant state health officer in Alabama. “The weather looks nice and it’s, ‘Why should I be worried about sickness?’ “
Alabama is one of at least five states that hit a single-day high of new cases Thursday. Nationally, the seven-day average was 52,820, up more than 7,100 cases from the same time last week, according to data tracked by The Post.
Many governors, Abbott included, have argued that targeted measures will be more effective than a blanket shutdown.
In Missouri, which reopened rapidly in early May, case numbers have risen sharply since mid-June. At least some of that increase has stemmed from increased testing. But there have also been significant outbreaks, including at meat processing plants in the state’s southwest – with cases extending into the broader community.
But state health director Randall Williams said that rather than focus on shutdowns, the state’s attention has been on “boxing in” hot spots with aggressive testing and isolation for those infected. He said promotion of social distancing, hand washing and mask wearing would also help to stem the spread.
In southwest Missouri, a conservative area where resistance to masks has run high, many have cited the president’s example in refusing to wear one. But attitudes may be shifting as the peril posed by covid-19 hits home: The city council in Joplin, the region’s hub, rejected a mandatory mask ordinance last week, only to reverse course Wednesday night and approve one.
Michigan health director Robert Gordon said his office, too, was focused on changing behavior and getting the public to follow medical advice.
“Part of it is what are the rules on the books. Equally important is what are people doing, whatever those rules are,” Gordon said.
Gov. Gretchen Whitmer, a Democrat, who authorized some of the strictest stay-at-home rules nationwide before lifting them in June, has signaled that she won’t be afraid to reimpose restrictions. Last week, she halted the state’s reopening, and ordered bars to again be shuttered for indoor service.
Gordon said the difficulty in bringing down case numbers will only increase, with schools seeking to reopen next month and the weather forcing more people indoors in the fall.
A return to stay-at-home, he said, was the last resort. But it wasn’t unimaginable, either.
“Our job is to do absolutely everything in our power,” he said, “so we don’t have to go back to that.”
Excess cancer mortality is a concern for many Asian countries, according to a new report from the Economist Intelligence Unit (EIU).
Thailand ranks sixth for cancer preparedness in the region with an overall score of 65.2, below the regional average of 66.5, while Australia (92.4), South Korea (83.4) and Malaysia (80.3) lead the region.
Thailand records strong performance for policy and planning but further progress can be made in the care delivery and health systems and governance domains to enhance overall cancer preparedness, especially given the country’s low level of physical activity, says the EIU report “Cancer preparedness in Asia-Pacific: Progress towards universal cancer control”.
Sponsored by Roche, the report examines the findings from the EIU’s Index of Cancer Preparedness and describes the complexities of the cancer challenge facing 10 Asia-Pacific countries: Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, Thailand and Vietnam.
Overall, mechanisms to translate policy and planning to action are lacking in the region and gaps in service provision are of concern, the report said.
Middle-income countries in Asia-Pacific do not meet recommended spending for achieving universal health coverage, the report added.
The report called for prioritising prevention and early detection of cancer.
Asia-Pacific had an estimated 8.8 million new cases and 5.5 million cancer deaths in 2018. As of 2017, cancer was the leading cause of death in Thailand. Changing demographics associated with ageing population and changing lifestyles mean this burden is only set to grow, the report said.
Countries in the vast Asia-Pacific region show great diversity in their healthcare needs, and responses to cancer are highly influenced by their stage of economic development. High-income countries with established healthcare infrastructures are primarily dealing with quality-of-care concerns. Upper-middle-income countries are refining their universal health coverage systems to close access gaps and ensure financial sustainability. Lower-middle-income countries are setting up the foundations for an increasingly important cancer challenge.
The EIU research found a strong association between income level and overall cancer preparedness as measured by the Index of Cancer Preparedness: that is, high-income countries outperform upper- and lower-middle income countries. Furthermore, a strong correlation was seen between overall score in the Index of Cancer Preparedness and cancer control outcomes as measured by the ratio of mortality to cancer incidence in the countries. This demonstrates that, in broad terms, better preparedness to manage the cancer burden equates with achieving better cancer outcomes, the report said
Differences were observed between countries’ ability to address the cancer burden. Given that as many as 70 per cent of cancer cases in low- and middle-income countries in Asia are diagnosed at a late stage, an emphasis on preventive services and moving from opportunistic to population-based screening is needed. “While Indonesia and Malaysia have demonstrated strong growth in health spending, and China has the biggest reduction in out-of-pocket health expenditure in our analysis, it is still only high-income countries that meet World Health Organization-recommended spending for universal health coverage,” the report said.
Jesse Quigley Jones, editor of the report, said: “While there is clear progress at the planning level, the translation of policy into health service delivery and improved cancer outcomes requires more emphasis. While upper-middle- and lower-middle income countries are pulling together more comprehensive cancer control plans, our index showed weaker performance in health system governance and service delivery domains suggesting progress in addressing health infrastructure and service capacity is more limited. A renewed political commitment is needed to address the cancer burden.
“Thailand was recognised for the significant progress made in universal health coverage [UHC] as well as its health technology assessment mechanisms. While the downstream benefits of UHC on improved cancer outcomes is yet to be seen, Thailand should continue focusing its efforts on closing persistent access gaps and ensuring quality of services across the cancer continuum through better infrastructure and service supply while prioritising effective policies on tobacco control and healthy lifestyle promotion.”
By The Washington Post · William Wan · NATIONAL, HEALTH
Health-care workers on the front lines of the coronavirus pandemic are encountering shortages of masks, gowns, face shields and gloves – a frustrating recurrence of a struggle that haunted the first months of the crisis.
Nurses say they are reusing N95 masks for days and even weeks at a time. Doctors say they can’t reopen offices because they lack personal protective equipment. State officials say they have scoured U.S. and international suppliers for PPE and struggle to get orders filled. Experts worry the problem could worsen as coronavirus infections climb, straining medical systems.
“A lot people thought once the alarm was sounded back in March surely the federal government would fix this, but that hasn’t happened,” said Deborah Burger, a California nurse and president of National Nurses United, a union representing registered nurses. Like many health-care workers, Burger blamed the Trump administration for the lack of equipment, noting the administration has insisted the responsibility falls to state and local officials, with the federal government playing only a supporting role.
The specter of equipment shortages comes as other issues that plagued the country’s early response to the pandemic return: surging cases, overwhelmed hospitals, lagging testing and contradictory public health messages. But the inability to secure PPE is especially frustrating, health-care workers say, because it is their main defense against catching the virus.
For weeks, nurses have posted online testimonials about a lack of PPE, with some given surgical masks instead of N95 masks because of shortages. In a video posted last week, a Florida nurse said she breaks the oath she took “to do no harm” every time she goes to work without protection and worries constantly she may be infecting her patients, co-workers and family.
In interviews, White House officials said concerns over PPE shortages are overblown. They said U.S. manufacturing and stockpiles of protective equipment have improved dramatically and are adequate in most states.
“I’m not going to tell you we’re able to meet all demand, but there’s significantly less unfulfilled orders today than in April,” said Rear Adm. John Polowczyk, whom President Donald Trump put in charge of coronavirus-related supplies. “I have not found a hospital system that is in threat of running out. . . . I don’t have the sense of there being severe shortages.”
Polowczyk said the Trump administration has helped increase domestic manufacturing of PPE and that demand continues to outstrip supply because hospitals, states and the federal government are trying to stockpile supplies. He blamed some of the concern about shortages on outdated letters to Congress from March and April.
But the administration’s reassurance contrasts with growing alarm from medical associations, governors, nursing homes and members of Congress – all of whom have pleaded for federal help within the past month.
Demand for protective equipment has soared, but unlike in March, when efforts focused on getting PPE for major hospitals – especially in New York, Detroit and Chicago – supplies now are desperately needed by primary care offices, nursing homes, prisons and psychiatric and disability facilities. As many states continue to reopen their economies, demand has also surged from the construction industry and other sectors. With soaring demand, prices have skyrocketed.
Some hospitals say much of the PPE they have acquired has been exorbitantly priced. At a legislative hearing, a hospital association executive detailed how one Maryland hospital that spent $600,000 on PPE last year expects to spend $10 million this year. The struggles have been especially acute for smaller and rural providers that can’t compete with bigger health systems on price and large-scale orders, experts say.
In a letter last week, the American Medical Association told the Federal Emergency Management Agency that doctor’s offices outside big systems – including those providing primary care, chemotherapy and minor surgeries – have struggled to reopen because they are unable to secure PPE. The association, which pleaded for transparency and a coordinated national strategy, said it is unclear “whether the central problem is in the availability of raw material, production backlogs, gaps in the distribution systems, or some combination of all three.”
In a second letter, the medical association urged the White House to invoke the Defense Production Act to compel manufacturers to increase supplies of N95 masks and gowns.
In a survey of 23,000 registered nurses, National Nurses United found 85 percent were asked to reuse masks designed for single use. A survey of 14,300 nurses by the American Nurses Association, an advocacy group, found 79 percent being asked to reuse masks and 45 percent reporting PPE shortages at their facility.
In Washington state, Gov. Jay Inslee, a Democrat, said state officials have struggled to find domestic and international suppliers. In a letter to Trump last month, Inslee said he has tried to buy $400 million in equipment, but only 10 percent of orders have been filled.
“It is clear that the status quo is not working,” Inslee said, pointing to an inadequate federal stockpile, reliance on foreign suppliers and limited domestic production. He described a counterproductive and “unnecessary, chaotic, 50-state scramble to secure badly needed PPE” and cited the continued lack of a coordinated federal response. “It is akin to fighting a war in which each state is responsible for procuring its own weapons and body armor.”
As the virus has rampaged through America, it has pummeled the ranks of health-care workers, infecting at least 94,000 and killing at least 500, according to an incomplete count by the Centers for Disease Control and Prevention. The true number is believed to be much higher.
A study of U.S. and British medical workers found their risk of testing positive for the coronavirus was 12 times higher than the general public’s. The researchers from Massachusetts General Hospital and King’s College London found that workers with inadequate PPE access were at even higher risk.
“The limited availability of adequate PPE, such as masks, gowns and gloves, has raised concerns about whether our health care system is able to fully protect our health care workers,” senior author Andrew Chan, chief of the Clinical and Translational Epidemiology Unit at Massachusetts General, said in a statement.
Last month, Sen. Maggie Hassan, D-N.H., successfully pressed FEMA to release an internal report that showed alarming shortages of medical gowns and no meaningful increase in their production since March, when nurses and doctors in New York resorted to wearing trash bags. The FEMA report states bluntly, “The demand for gowns outpaces current US manufacturing capabilities.”
The report also suggests health-care workers will need to keep reusing N95 masks for months to come. And it notes there remain no domestic manufacturers of nitrile gloves, meaning hospitals must continue relying on foreign suppliers.
At a congressional hearing last week, House Democrats raised similar concerns and revealed their findings from an investigation into the Trump administration’s handling of supply chain problems. Their report alleged failures to provide data and guidance needed to address shortages in manufacturing and distribution. The report found Trump’s policy of shifting responsibility to state leaders resulted in a disastrous competition for resources.
In interviews with committee staff, large medical equipment companies cautioned that prices for raw materials have risen dramatically. One executive told congressional staff that “raw material for gowns is unavailable at any price, at least in the quantities we need to make gowns” and warned continuing to supply PPE under these conditions is “not sustainable.”
In a 45-minute phone interview Tuesday with The Washington Post, Polowczyk, the administration’s point person on coronavirus-related supplies, defended White House efforts. Its strategy of emphasizing local and state control, bolstered by federal support, is working, he said, with 60 to 70 percent of states having nearly a two-month PPE supply. He said the other states should be okay because they are requiring counties and hospitals to have a month’s worth of supplies.
“I just talked to a hospital system in Houston, Texas, where you would read the mainstream news and think the world is ending and they’re running out of stuff. But multiple hospitals across the region have millions of isolation gowns, masks and also hundreds of thousands of N95 masks,” Polowczyk said.
Nurses at a hospital in Humble, Texas, went on strike Monday, protesting a lack of adequate PPE. Hospitals executives in Houston – where case numbers keep breaking records – have said they have enough PPE for now but expressed worries of running out if cases continue to spike.
Polowczyk said he briefs governors weekly and that FEMA has ensured equitable distribution of supplies. While he acknowledged continuing problems with unmet demand, he said those issues are decreasing.
And he said that since the start of the pandemic, the White House has invoked the Defense Production Act more than 20 times. Critics, however, have noted the Trump administration has routinely invoked the act hundreds of thousands of times for issues outside the pandemic and questioned the administration on its hesitancy to use it to address PPE problems.
When Polowczyk took over the PPE effort in March, the federal government had already given away the 18 million N95 masks in the national stockpile. Since then, the White House said, the national stockpile has been replenished with 36 million N95 masks. Officials want to have 152 million masks by September and 314 million by December.
But health-care workers say they find little evidence shortages have abated.
Doctors throughout the nation created a volunteer organization in March called #GetUsPPE to marshal donations and make bulk purchases. In recent weeks, the number of PPE items requested has surged, said co-founder Megan Ranney, an emergency room doctor and researcher at Brown University. Some of that may reflect greater awareness of their group, Ranney and others said. But a drastic increase in calls for gowns and coveralls tracks with shortages documented by FEMA and industry leaders, and a spike in requests from Texas arrived as cases there surged.
“We thought we were creating this thing that would be around a few weeks, like a temporary fix to this problem others would solve once they saw just how bad it was,” Ranney said. “Here we are months later and it’s like nothing has changed.”
By The Washington Post · Cleve R. Wootson Jr., Isaac Stanley-Becker, Lori Rozsa · NATIONAL, BUSINESS, HEALTH, POLITICS, SCIENCE-ENVIRONMENT
ST. PETERSBURG, Fla. – As the coronavirus savaged other parts of the country, Florida, buoyed by low infection rates, seemed an ideal location for a nation looking to emerge from isolation. The Republican National Convention moved from Charlotte to Jacksonville, the NBA eyed a season finale at a Disney sports complex near Orlando and millions packed onto once-empty beaches.
Weeks later, the Sunshine State has emerged as a coronavirus epicenter. Nearly 1 out of every 100 residents is infected with the virus, hospital intensive care units are full or filling up, and big-name visitors who chose Florida for their first post-isolation events are now mired in questions and controversies about safety.
Amid escalating infections, Florida, once held up by President Donald Trump as a model for how to manage the novel coronavirus, is faring poorly. Residents worry the situation will get much worse. Florida is now one of a handful of states whose spiking numbers are driving a major resurgence of the virus in the United States, which is approaching 3 million cases.
Gov. Ron DeSantis, a Republican, has downplayed the growing outbreak in Florida, saying expanded testing is responsible for more positive results and emphasizing that many new infections are among younger people less likely to experience the worst effects of the virus.
On Tuesday there were 213,794 cases of the coronavirus in Florida, according to Washington Post data. The state has tallied a record number of cases over the past week, averaging 8,766 a day, according to Post data.
In a sign of intensifying trouble, 52 intensive care units across more than a third of the state’s counties had reached capacity by Tuesday, according to data released by the state’s Agency for Health Care Administration. Another 17 hospitals had also run out of regular beds. The state has “abundant capacity,” DeSantis said at a news conference Tuesday.
Some nurses at Good Samaritan Medical Center in West Palm Beach have been working 18 hours instead of the usual 12 because of overnight staffing shortages, according to a nurse who spoke on the condition of anonymity for fear of jeopardizing her job. Patients are being treated in an open area cordoned off by curtains that is typically used for quick medical consultations, she said. The hospital did not respond to a request for comment.
“We’re overfilled and understaffed,” she said. “It’s really bad.”
Florida Education Commissioner Richard Corcoran late Monday ordered that the state’s schools open for in-person instruction next month, igniting fears that a new round of classroom interactions would lead to a new round of infections.
“We want to proceed with caution, but unfortunately the governor continues to deny the science,” said Fedrick Ingram, president of the Florida Education Association. “The trend over the last 30 days has been astronomical. We’re in regression, we’re going backward. In terms of the amount of cases, we are literally going backward as a state.”
Hospital leaders, lawmakers, physicians, epidemiologists, advocates and others familiar with the state’s response said a false sense of security set in when grim predictions about the virus’s spread in Florida did not come to pass in March and April. DeSantis declared victory, attending a laudatory news conference at the White House with President Trump. The editor of National Review wrote an editorial titled “Where does Ron DeSantis go to get his apology?”
But observers maintain the state then failed to prepare for a surge of the virus, which struck as residents were seeking refuge in air-conditioned indoor spaces, where the virus is believed to be most easily transmitted.
Sports leagues that opted to restart their seasons in Florida will now play in a state that is in worse shape than when the pandemic began. Many teams are already in the state, and they face a growing number of critics who believe they should cancel games.
The Republican National Convention, scheduled to take place in Jacksonville next month, faces similar questions about safety. In June, the Republican National Committee announced that it would move its convention from a worried Charlotte to a welcoming Jacksonville. But as cases mount in the city, worries have crept in.
“My concern has grown since a week ago. It has gotten worse,” said Tommy Hazouri, the Democratic president of the city council and a former Jacksonville mayor. Hazouri was initially supportive of his city’s effort to secure the convention.
“It is time to accept reality, and no one can be in denial about what is going on,” he said. “At some point our council and the leaders in this community has to draw a line in the sand on where we need to be going.”
Several hundred doctors have signed a petition that says the convention needs stronger safety measures. Nancy Staats, a retired anesthesiologist who lives in the Jacksonville area, said she hoped a few dozen doctors would sign the petition she helped circulate. Within three days, nearly 500 had added their names.
“We’re really focused on the health and well-being of the citizens of our city and state now. That’s still six or seven weeks off and we’re still climbing scarily, rapidly,” Staats said. “This is about people’s lives, including the attendees of this event.”
NBA and Major League Soccer teams have already landed in Orlando, hoping they play in a coronavirus-free bubble.
A day before resuming summer tournaments, FC Dallas was sent home after a coach and 10 players tested positive for the coronavirus at the same Disney sports complex that will host the NBA later this month. Nashville SC’s first game Wednesday was postponed after five players tested positive for the virus and four tests were inconclusive.
“I am excited to play,” D.C. United midfielder Julian Gressel said. “I’m not excited about the part that obviously puts us at risk.”
At a Fortune magazine virtual forum Tuesday, NBA Commissioner Adam Silver acknowledged that Florida’s situation has significantly deteriorated in recent weeks.
“On paper and dealing with our experts, this should work,” he said. “But we shall see. I’m confident – based on the positive cases we’re seeing from our players and the general public around the country – that it will be safer on this campus than off this campus.”
Still, numerous NBA stars have expressed deep concern about the health situation in Florida. More than a dozen players have decided to sit out the restart for various reasons.
Disney World has announced it would begin to allow visitors back into the Magic Kingdom this week. Disneyland in Anaheim, Calif., said it would remain closed.
The Actors’ Equity Association, a union that represents more than 700 Disney World stage managers and actors, has locked horns with the amusement park, saying it has failed to provide a coronavirus testing plan that would help prevent performers from passing the coronavirus onto others.
“You certainly can’t wave Mickey’s magic wand and say that Florida isn’t a central hot spot right now,” said Kate Shindle, the union’s president. “Personally, as the president of the organization that is fighting for the safety of these performers, I’m mystified by the fact that Disney is attempting to open the park right now.”
The new, high-profile risks threaten to compound problems Florida has faced from the beginning of the pandemic.
There has been a rise in cases affecting older Floridians as well as those living in nursing homes and other long-term care facilities, said Jeff Johnson, Florida director of AARP.
“I don’t see how that doesn’t mushroom at some point,” he said, noting that staff at the facilities live in communities still grappling with the virus, sometimes working second or third jobs that involve interactions with people of diverse age groups.
Testing sites across the state are seeing shortages, and the wait time for results is now as long as 10 days, said U.S. Rep. Ted Deutch, a Democrat representing a swath of the coast stretching from Broward County to Palm Beach County. The problems stem, he said, from the apparent failure to produce a testing plan as required by Congress, or at least to unveil any of its details. He has been asking for details, he said, but has been rebuffed by the state health department, whose deadline was extended from June 15 to Friday. The health department did not respond to requests for comment.
There were also acute shortages of the antiviral drug remdesivir in parts of the state, causing Democratic members of Florida’s congressional delegation to send a letter Tuesday to Health and Human Services Secretary Alex Azar asking him to speed the shipment of emergency supplies.
“Staff capacity is strained; the number of available ICU beds are dwindling; and we are running out of remdesivir . . .” the lawmakers wrote, warning that “people will die without replenished stock.”
Amid the array of old and new concerns, teachers across Florida learned they would have to begin preparing their classrooms for an influx of students.
In Palm Beach County, first-grade teacher Cara Conlogue, who teaches at Coral Reef Elementary School west of Lake Worth Beach, said the messages coming from the state are frightening and confusing.
“The science is going in one direction, and conditions are getting worse, and the politicians are going in the opposite direction,” Conlogue said. “I can’t wrap my head around it. If it wasn’t safe for us when there were 100 cases, how can it be safe for us when we have thousands and thousands of cases? I don’t get that logic.”
“I’ve spoken with a lot of my teacher friends, and a lot of them don’t want to go back,” she continued. “We love our students, we miss them, and we love our jobs. But we don’t feel safe.”
By The Washington Post · Joshua Partlow · NATIONAL, WORLD, HEALTH, SCIENCE-ENVIRONMENT
Amid a resurgent pandemic and rising hospitalizations, President Donald Trump pitted America against the world on Tuesday, moving to pull the United States out of the World Health Organization while his FBI director accused China of hacking U.S. health-care companies that are researching the novel coronavirus.
The virus’s rampage across the South and West continued to drive up hospitalizations, with patients filling intensive care units and federal health officials moving to shore up testing in hot spots. The border-ignoring virus also infected another world leader, Brazilian President Jair Bolsonaro, who has repeatedly dismissed it as a “little cold.”
The Trump administration on Tuesday formally notified the United Nations that it is withdrawing the United States from the WHO, a move that prompted swift criticism from Democrats and showed Trump’s impulse to isolate the country even during a public health crisis. Sen. Robert Menendez, D-N.J., wrote on Twitter that Trump’s decision “leaves Americans sick & America alone.”
FBI Director Christopher Wray, meanwhile, blasted China for its alleged efforts to steal U.S. technology and said China is trying to penetrate companies that are researching how to defeat the virus.
“At this very moment, China is working to compromise American health-care organizations, pharmaceutical companies and academic institutions conducting essential covid research,” Wray said in remarks at the Hudson Institute, a conservative think tank in Washington.
His remarks came as cases and hospitalizations in the United States continued to mount. More than 50 hospitals in Florida said their ICUs are full, according to data from Florida’s Agency for Health Care Administration. In another hot spot, Arizona reported 117 deaths on Tuesday, a daily record for the state, as more than 3,000 people were being treated in hospitals and ICU beds neared capacity. Texas canceled its annual state fair, the longest-running fair in the country, as more than 8,000 Texans were hospitalized on Monday, a third higher than last week.
Ohio Gov. Mike DeWine, a Republican, issued an order Tuesday requiring residents to wear masks in public in seven counties, including those that are home to Cincinnati and Cleveland.
Trump administration health officials announced Tuesday that they are moving medical support into three areas of “recent and intense” outbreaks in Texas, Louisiana and Florida. That includes Jacksonville, Fla., the site of the Republican National Convention, where Trump is expected to be formally nominated next month as the GOP candidate.
Trump’s handling of the pandemic, which has been most extensive and deadliest in the United States, drew renewed criticism from presumptive Democratic presidential nominee Joe Biden on Tuesday. Biden issued a plan for how he would respond to such pandemics, creating a sharp contrast with the Trump administration’s approach.
“Donald Trump needs to do his job,” Biden wrote on Twitter on Tuesday.
Biden’s plan calls for increasing federal stockpiles of medical supplies and requiring companies to develop strategies to address supply chain disruptions, among other measures, as a way to limit the nation’s dependence on other countries in times of crisis.
The blueprint is meant to serve as a rebuttal to Trump’s positioning himself as an “America first” president, according to a senior Biden campaign official who noted the president’s tagline and was critical of his record. Biden’s plan would initiate a 100-day review period upon taking office to “identify critical national security risks across America’s international supply chains.”
The United States has reported nearly 3 million confirmed virus cases to date, meaning nearly 1 in every 110 Americans has been found to have the virus, with large swaths of the country not having been tested.
At least 128,000 deaths have been linked to the virus nationwide, with the United States having more than twice as many reported deaths as any other country and the nation accounting for nearly a quarter of all virus-related deaths worldwide.
More than 890 U.S. deaths were reported Tuesday, the highest total in 12 days, amid signs the country’s death rate might be creeping up after falling for the past three months.
Trump has repeatedly complained that not enough attention is being paid to the country’s death rate.
“We have the lowest Mortality Rate in the World. The Fake News should be reporting these most important of facts, but they don’t!” Trump tweeted.
Scientists say many countries have lower death rates than the United States.
The nation’s top infectious-disease expert, Anthony Fauci, said Tuesday that although the fatality rate of the coronavirus has dropped, Americans should not be complacent.
“It’s a false narrative to take comfort in a lower rate of death,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a Facebook Live news conference with Sen. Doug Jones, D-Ala. “There’s so many other things that are very dangerous and bad about this virus.”
The lower mortality rate is a result of two factors, he said. The country has gotten better at treating people, particularly through therapies that work in the advanced stages of the disease. And, Fauci said, the mean age of those getting infected has dropped by about 15 years.
Compared with the older population, young people generally face less-severe consequences from the virus, unless they have underlying medical complications, he said. Still, some young people have been hospitalized or have required intensive care, and there could be long-term health implications.
“The death rate is lower, I admit that, because people in general who are young are healthier,” Fauci said. “But that doesn’t mean that you could not get seriously ill.”
In Brazil, home to the world’s second-worst outbreak, President Bolsonaro became at least the third world leader to contract the virus. British Prime Minister Boris Johnson was treated in intensive care in April and has since recovered. Honduran President Juan Orlando Hernández, who was hospitalized last month, said last week that he was leaving the hospital and returning to work.
Bolsonaro, 65, has repeatedly played down the seriousness of the pandemic, even as Brazil has reported more than 1.6 million confirmed cases and 65,000 deaths. He has been a skeptic of the pandemic as he has pushed Brazilians to get back to work and saying that with his own “history as an athlete, if I were infected by the virus, I wouldn’t need to worry.”
He was tested after developing symptoms that included a fever.
Tensions about how to handle border-hopping during the outbreak also flared again this week.
New federal guidance that international students must take classes in person to legally stay in the United States this fall has left university officials scrambling to adapt while making students fearful of deportation. The guidance from the U.S. Immigration and Customs Enforcement agency said that foreign students won’t be allowed to have visas for programs that are fully online during the fall semester, nor will they be allowed into the country. Though some universities, including Harvard, have pledged to create an on-campus experience for students – especially those in their first year – many have said classes will be online only even if students are on campus.
The White House, meanwhile, has been pushing for schools to open in the fall. Trump said he would pressure governors to open buildings because in-person education is essential for the well-being of students, parents, and the country. “We want to reopen the schools,” Trump said. “We don’t want people to make political statements or do it for political reasons. They think it’s going to be good for them politically, so they keep schools closed. No way.”
The Trump administration is also seeking to expand testing in hard-hit areas. The Department of Health and Human Services said that it is dispatching private contractors to three communities – Edinburg, Texas; Baton Rouge; and Jacksonville – to administer 5,000 free tests per day in coming weeks.
“The Trump administration is doubling down on support to areas hard hit by covid-19,” the illness caused by the virus, said Brett Giroir, an HHS assistant secretary who is the administration’s coordinator for diagnostic testing for the virus.
The Centers for Disease Control and Prevention also published a study on Tuesday that offered further evidence that the virus disproportionately affects workers of color. The study looked at workers in 329 U.S. meat and poultry facilities across 23 states and found that the majority of cases occurred among Hispanic employees (56 percent), followed by 19 percent in black employees, 13 percent in white employees and 12 percent in Asian employees.
The rates are disproportionate to employee demographics at the facilities. The workforce breakdown is 39 percent white, 30 percent Hispanic, 25 percent black and 6 percent Asian, the report said.
Meat and poultry plant workers are particularly vulnerable to the rapid spread of the virus because of the working and living conditions that are common in the industry: prolonged close contact among co-workers, eight- to 12-hour shifts, shared workspaces, group housing and shared transportation.
Jul 05. 2020Sabrina Hopps works in housekeeping at a hospital in Washington, D.C. When her supervisor announced the room number of the first case of coronavirus at their medical facility, Hopps instantly recognized it as one she had scrubbed earlier in the day. MUST CREDIT: Washington Post photo by Jahi Chikwendiu
By The Washington Post · Justin Jouvenal · NATIONAL, BUSINESS, HEALTH
WASHINGTON – When a Waldorf car dealership advertised discounts for medical workers battling the novel coronavirus, Latasha Currie hoped to eke out a hard-won benefit after months on the front lines.
The medical assistant, 31, didn’t tell the salesman how her 10-year-old cried for days after patients with covid-19, the disease caused by the coronavirus, began to roll into the District of Columbia clinic where she works. “She kept saying she didn’t want mommy to die,” Currie said.
She didn’t mention her employer told her there were only enough smocks for doctors and nurses during the early days of the pandemic. Yet Currie kept taking vitals and triaging patients, worried what an errant sneeze might spread across her clothes.
“I said, ‘Yeah, I’m a front-line worker,’ ” Currie recalled, asking the salesman about the discount. “He said, ‘What do you do?’ I said, ‘I’m a medical assistant.’ And he laughed at me. He said, ‘Are you really on the front lines?’ I took offense and walked out.”
Doctors and nurses have been saluted from front porches and rooftops for their efforts to contain the coronavirus, but more than 80 percent of essential workers who keep medical facilities running labor out of the spotlight like Currie, according to the Brookings Institution.
Housekeepers, cooks, phlebotomists, orderlies and others face many of the same risks as their higher-profile colleagues, but sometimes with less access to protective gear, pay that can fall below a living wage and only a modicum of recognition.
With a median wage of $13.58 an hour, some of the largely female and minority cadre of nearly 7 million across the country worry they are a serious case of covid-19 away from financial ruin.
“I’m risking my life every single day just like the doctors are,” said Currie, who triages patients and takes their temperatures. “I just don’t want people to think that because I’m not a nurse or not a doctor, I’m not essential.”
– – –
Sabrina Hopps was stunned as a supervisor announced the room number of the first patient with covid-19 at the Bridgepoint Hospital in Southwest Washington during an April meeting. Hopps instantly recognized it as one she had scrubbed earlier in the day.
The housekeeper said she had been wearing protective gear, but to be sure she was free of any virus, she went home that night, measured a cup of bleach and dumped it in a warm bath.
Her mind has gone to all the frightening possibilities. There was her health. She had asthma and had recently started carrying an inhaler. What would happen if she came down with a disease that attacks the lungs?
There was also rent on her Washington apartment. Hopps, who makes $14.60 an hour, split it with two of her six adult children. They wouldn’t be able to afford it if she got sick and couldn’t work.
Her doctor recommended she get a coronavirus test. After eight agonizing days, she got the news she was negative.
The days on the job since have been an effort to block every route the virus could take into her body. Hopps follows the same ritual each time she cleans the room of a patient in isolation:
She pulls the gown workers have dubbed the “trash bag” over her uniform of gray cargo pants and blue shirt. She positions her N95 mask and slides a surgical mask over it. She pulls on a face shield. She sanitizes her hands before pulling on a first pair of gloves and then a second. She sanitizes the gloves. She pulls booties over her shoes.
Hopps said she begins to sweat almost immediately as she plunges into cleaning toilets and sinks, sanitizing surfaces and mopping the floor of patients’ rooms because the protective gear is suffocating. She repeats the tiring routine up to 12 times a day.
Still, Hopps said she is dedicated to her work because of the gravity of the pandemic. She said she speaks to patients to keep their spirits up. She said she’s even learned to read lips to communicate with those who are unable to utter words.
“I’m nervous, but I know this is my fight, so I’m going to continue until I can’t anymore,” Hopps said. “God put me at Bridgepoint.”
– – –
Lisa Brown, executive vice president of SEIU Local 1199 for the District and Maryland, said essential workers such as Currie and Hopps have faced a constellation of challenges during the pandemic.
She said union workers in nursing homes and a handful in hospitals had been sickened or killed by the coronavirus, but she couldn’t provide exact numbers because SEIU is not always informed when workers fall ill. The union represents about 10,000 employees locally.
Other figures point to a daunting threat for health-care workers on the job. The Centers for Disease Control and Prevention reports nearly 79,000 health-care workers have contracted the coronavirus and more than 420 have died since the outbreak began. An earlier CDC report said a majority of medical workers who were sickened thought they were exposed at work.
Brown said in the early days of the pandemic, there was a tiered system for distributing protective gear that left many employees who aren’t nurses or doctors without proper masks, smocks and other essentials.
She said most receive basic gear now, but there are still problems. At one Washington-area medical facility, she said, workers are sharing smocks from shift to shift. Other workers are forced to buy their own equipment if employers don’t provide it.
Most workers have health insurance but must use their sick leave and vacation if they contract the virus at work, Brown said. Some have been forced to pay for taxis to get to work because cutbacks to public transit have made commuting slow and difficult.
Brown said few low-level medical workers in the D.C. area have received hazard pay, which has helped workers in other industries weather the unprecedented crisis. It’s something the union has been pushing for.
“Every one of our hospitals received millions of dollars from the Cares Act, but they chose not to spend it to give extra pay or money to the workers,” Brown said, referring to the coronavirus relief package signed by President Trump in March.
The Heroes Act passed by the House of Representatives in May would provide extra pay, but it faces uncertain prospects in the Senate. Essential workers would receive up to $13 an hour in premium pay on top of their regular salary or $25,000 through the end of 2020.
– – –
One of Currie’s greatest fears is bringing the virus home.
Her 10-year-old daughter suffers from severe asthma, while her 6-year-old daughter is so scared of the coronavirus she has balked at coming into their Charles County home with Currie at times. A steady stream of coronavirus news has left them on edge.
“She keeps saying, ‘Mommy got the coronavirus,’ ” Currie said of the 6-year-old. “It takes a toll on them.”
Each day, Currie drops them off at her mom’s house before heading to work. But she doesn’t pick them up at night – at least not immediately. She heads home first, stripping off her clothes on the front porch. She takes a shower and sprays her shoes and car with Lysol.
Only then does she pick up the kids.
Brown said many medical workers are single women, heading up households like Currie, while others live with extended family so they can pool resources to pay rent or make mortgage payments.
That poses major challenges for essential medical workers who have to be on the job whether day cares are open or not and may come home to crowded houses where the virus could spread rapidly.
Some workers potentially exposed to the virus have had to turn to GoFundMe to raise money for hotel rooms or donations of accommodations by Airbnb to quarantine themselves away from family members, Brown said.
Those type of sacrifices are why Robyn Jones, a food and nutrition worker at a D.C. hospital, bristles at the celebrations of front-line workers often featured on TV broadcasts. She says doctors and nurses should be thanked for their work, but so should others.
She rarely hears anyone offer a word about the janitors, security guards or food workers such as herself.
“Since this pandemic came, yes, we are even more invisible in the hospital,” Jones said.
Jul 05. 2020File photo: People in India wear masks.
By Syndication Washington Post, Bloomberg · Bhuma Shrivastava, Bibhudatta Pradhan, Nikhil Patwardhan · BUSINESS, WORLD, HEALTH, ASIA-PACIFIC ·
India has set an ambitious timeline for its first potential coronavirus vaccine — from human trials to general use in six weeks.
Bharat Biotech International Ltd., an unlisted Indian vaccine maker, received regulatory approval to start human clinical trials for its experimental shot earlier this week and it already has India’s apex medical research body expediting the process.
The under-development vaccine is “envisaged” to be rolled out “for public health use by Aug. 15 after completion of all clinical trials,” Indian Council of Medical Research, or ICMR, said in a July 2 letter to clinical trial sites, which was seen by Bloomberg News. It “is one of the top priority projects which is being monitored at the topmost level of the government.”
There’s been no evidence yet that Bharat Biotech’s vaccine is safe for use on humans, not to mention effective. The envisioned timeline is markedly shorter than other front-runner vaccine efforts from American and Chinese drugmakers, most of which started human clinical trials months ago and are now entering the last of three stages of testing.
The bid underscores India’s urgent need for a way to halt the coronavirus, which has sickened more than 640,000 people and killed over 18,600 in the Asian nation — the world’s fourth-largest outbreak. In its letter, ICMR urged the trial sites to enroll volunteers by July 7.
The speediness has alarmed some in the medical fraternity. “Such an accelerated development pathway has not been done EVER for any kind of vaccine, even the ones being tried out in other countries,” Anant Bhan, a medical researcher at India’s Manipal University, said in a Twitter post. “Even with accelerated timelines, this seems rushed and hence, with potential risks.”
After abandoning a costly lockdown that caused tremendous economic suffering without slowing the virus’s spread, Prime Minister Narendra Modi’s government is anxious to project control over the outbreak.
The Aug. 15 deadline for Bharat Biotech’s vaccine may reflect that political pressure: that’s the day India celebrates independence from the British, marked by a nationwide address by Modi.
The letter to investigators of clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and to speed up recruitment of participants, the ICMR said in a statement on Saturday.
“ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel,” according to the statement. “Our trials will be done following the best practices and rigour, and will be reviewed, as required.”
Bharat Biotech plans to enroll 375 people in the first phase of clinical trials and 750 people in the second phase, an ICMR spokesperson said. Whether the vaccine will be approved for general use depends on the outcomes of those trials, he said. A spokeswoman for Bharat Biotech declined to comment on the Aug. 15 timeline in ICMR’s letter.
“They can’t do that,” said Jayaprakash Muliyil, chairman of the Scientific Advisory Committee in National Institute of Epidemiology, referring to the targeted timeline of the vaccine launch. Developing a vaccine is a complicated procedure that involves proving its effectiveness and safety, he said.
While Bharat Biotech’s timeline is ambitious compared to other efforts, India’s mature medical manufacturing sector and its large population, from which human trial volunteers can be easily found, are factors that could help accelerate the usual vaccine development process.
The trial will start “most probably” by Monday, said C. Prabhakar Reddy, a professor in Hyderabad’s Nizam’s Institute of Medical Sciences — one of the trial sites that received ICMR’s letter. “We are all working day and night to meet the deadline but still it will be neck to neck race,” he said, adding that he doesn’t anticipate any shortage of volunteers “in the current scenario.”
A vaccine ready for public use will allow the safe reopening of schools, offices and factories to revive India’s economy, which is hurtling toward its first contraction in more than four decades. It will also tie in with self-reliance — a motto Modi has repeated often in recent weeks.
Developing nations are eager to pare their dependence on other nations and foreign drugmakers in securing vaccines. Called Covaxin, the “inactivated vaccine” candidate has demonstrated safety and immune response in preclinical studies, Bharat Biotech said in a June 29 statement that cited the firm’s “track record in developing vero cell culture platform technologies.”
It has developed vaccines against polio, rotavirus, Japanese encephalitis and Zika, according to the statement.
Bharat Biotech “is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all the clinical trial sites involved in the project,” the ICMR letter said.
By The Washington Post · Loveday Morris, William Glucroft · WORLD, EUROPE
STUTTGART, Germany – While much of the world is aching for a coronavirus vaccine, Lilia Löffler is adamant that her three children won’t be getting any jabs.
Shrugging off light rain to join a two-hour bike protest shutdown restrictions, Löffler said that previously she vaccinated all her kids. But she changed her mind after what she’s been hearing at demonstrations and reading on the Internet during the pandemic. She noted that her 6-year-old son is supposed to get a shot for measles ahead of school in the fall.
“But he won’t get that,” she said. Or any other vaccination.
The possibility that Germany’s anti-vaccination movement may gain new adherents like Löffler has been a concern for health authorities, as the coronavirus unites a mishmash of groups resistant to the prospect of a vaccine, from far-right conspiracy theorists to hippie moms.
Germany already had a fervent anti-vaxx movement, reflecting a historic skepticism of government control and an affinity for alternative medicine. Now, health experts have warned that even if a coronavirus vaccine gets approval, refusals could open the way to a resurgence while threatening efforts to keep other preventable diseases in check.
“With such a bad pandemic, there were people that said it would make anti-vaxxers wake up and see that vaccines are important,” said Heidi Larson, director of the London-based Vaccine Confidence Project. “But it’s actually done the opposite.”
Anti-vaxx groups have become highly “active and aggressive,” she said. “I think we are in a vulnerable spot right now.”
In Germany, conspiracy theories over a vaccine abound. Attila Hildmann, a vegan chef, has become one of the leading voices of the resistance, accusing the health minister of promoting a surveillance state and forced-vaccination program at the behest of Bill Gates.
Amid the fervor, the German government has assured the public that any coronavirus vaccine would be voluntary. “The government is accused of secretly plotting to introduce mandatory vaccination,” representative Ulrike Demmer said. “There will be no obligatory vaccination against the coronavirus.”
That’s different from the approach Germany has taken with measles. To address what health officials warned was one of the worst efforts to combat measles in Europe, Germany last year made the measles vaccine mandatory for children entering preschools or kindergarten. Parents who do not follow the rules face fines of 2,500 euros, about $2,800.
Isolde Piechotowski is an infectious-disease expert with the health ministry in Baden-Württemberg, a southwest German state known for a particularly strong anti-vaxx community. She said her office was inundated with calls and emails after the measles announcement. Since the coronavirus pandemic began, there has been another deluge.
“The messages from these people – they suppose that there will be a mandatory vaccination. That’s the contents of a lot of emails and letters right now,” she said. “They are trying to influence those decisions, even though there is no such decision to be made right now.”
Surveys of Germany conducted by the University of Erfurt found that in late June, 64 percent of respondents said they would be willing to get a hypothetical coronavirus vaccine – down from 79 percent in mid-April. The notion of mandatory vaccination was rejected by 38 percent of respondents.
“Even with a perfectly functioning vaccine, this might not be enough for herd immunity,” said lead researcher Cornelia Betsch.
That echoes a warning for the United States by Anthony S. Fauci, the government’s top infectious-disease specialist. On Sunday, Fauci told CNN that while he’d “settle” for a vaccine that is 70 to 75 percent effective, if a third of Americans are reluctant to get vaccinated, as some opinion polls suggest, achieving herd immunity would be “unlikely.”
Germany’s vaccination rates for childhood diseases appear to be somewhat higher than those for the United States, according to comparative data compiled by the OECD. But Germany’s reported figures may overstate vaccination rates – and underestimate anti-vaxx sentiment.
German health insurer Barmer calculated that, based on its patient databases, 89 percent of 6-year-olds were adequately immunized against measles in 2017, before the measles mandate. That’s far lower than Germany’s reported measles vaccination rate of 97 percent for that year and falls short of the 95 percent target for population herd immunity.
The Robert Koch Institute (RKI), Germany’s federal agency for disease control, acknowledges that its official data reflects only what families indicate on vaccination cards at school entry and excludes those who don’t present a card. Assuming all those without cards are not fully vaccinated would mean a “worst case” rate of 81 percent, health officials said.
RKI says its data from a wider range of health insurance companies estimates full measles coverage at 93 percent at school age – still below the 95 percent target. Health authorities single out late vaccinations as a particular problem, with only 74 percent of children receiving their second measles dose in the recommended time period.
One of the hubs of Germany’s anti-vaxx movement is Baden-Württemberg, a wealthy region bordering France and Switzerland and home to auto giants Daimler and Porsche. During the peak of Germany’s anti-shutdown protests in May, the largest crowds congregated in the regional capital of Stuttgart. More than 5,000 people marched through the streets, bolstered by a contingent of anti-vaxxers.
Those tracking growing resistance to a hypothetical vaccine say people may feel a vaccine has become less urgent since Germany managed to flatten its coronavirus curve.
But vaccine attitudes in Germany are complicated by the country’s political history, with the Third Reich leaving behind a legacy of unease over government mandates.
Resistance is also tied up with the country’s alternative and holistic medicine traditions. Samuel Hahnemann, the father of homeopathy – whose statue sits on Washington’s Scott Circle – was a German from the eastern state of Saxony. And it was in Stuttgart that Rudolf Steiner, an Austrian who devised anthroposophical medicine, opened his first Waldorf School 100 years ago.
While the Waldorf institution has distanced itself from anti-vaxxers, the Steiner philosophy is rooted in free will and independence of thought, and some of his followers are vaccine skeptics. In Baden-Württemberg, infectious-disease specialist Piechotowski said, low vaccination rates can be attributed, in part, to “quite a high number of people who are following the anthroposophic philosophy.”
“It’s become very common, in the past 20 years, to think that typical child illnesses are good for healthy development,” said Natalie Grams, formerly a practicing homeopathic doctor who now speaks out against what she sees as pseudoscience. “People are trying to avoid early vaccinations, and this comes from homeopathic and anthroposophic thinking, very much. There’s a common thought that early vaccinations harm little babies.”
Grams said she is concerned how the movement appears to have expanded in just the past few months.
“The movement is getting far more political influence,” she said. It’s no longer just 2 to 4 percent of the population against vaccines, she added. “It’s far more people. The situation is much more intense than if it was just the anti-vaxx movement spreading disinformation about a coronavirus vaccine.”
The government needs to build support for a coronavirus vaccine even before one exists, she added, so people wary of a hastily developed medical intervention don’t turn to conspiracy theorists or hardcore anti-vaxxers to fill the knowledge gap.
In an interview at Steiner House, Christoph Hueck, a Waldorf educator who has spoken at anti-shutdown demonstrations, said he sees a chance to get his message out and doesn’t mind who is in the audience as long as he speaks his “truth.”
“The only thing is to make my point of view as clear as possible,” he said. “As spread out as possible. I don’t feel like I’m a conspiracy theorist.”
But his talking points touch on conspiracy theories involving Bill Gates, the World Health Organization and vaccine tattoos. The risk of the coronavirus is overblown, he said. He said he hopes people will start to demonstrate and take off their masks.
He said he’s not anti-vaccine but against compulsory vaccination.
“You cannot send your kid to school anymore unless they are vaccinated,” he said. “The state wants to control its citizens. This is the dictatorship of health, which sets itself above the value of freedom.”
Nadine Schmid, 37, who runs a “natural medicine” practice just outside Stuttgart, said she thought carefully about vaccines for her 3- and 7-year-old. The eldest has had a measles shot, the youngest only tetanus.
She said there has been tense discussion in her community since the measles vaccine became mandatory. “Corona has accelerated that debate,” she said. For a vaccine, everyone should be able to choose, she said, but it’s “not for me or my children.”