COVID-19 long haulers on months of debilitating symptoms: ‘They don’t know how to make me better’

https://www.yahoo.com/lifestyle/covid-19-long-haulers-debilitating-symptoms-210633981.html

COVID-19 'long-haulers' complain of symptoms lasting weeks and ...

SARS-CoV-2, the virus that causes COVID-19, has prompted more questions than science can answer. But of the many puzzles that remain, few are more perplexing — or urgent — than this one: Why do some people get sick and never get better?

This group of individuals, nicknamed the “long haulers,” are people of all ages, races and genders. Survivors of the virus who, months later, find themselves battling a constellation of debilitating side effects that disrupt their ability to function. In a study released by Indiana University School of Medicine this August, in partnership with COVID-19 nonprofit Survivor Corps, long haulers describe nearly 100 side effects, from fatigue and body aches to night sweats and neuropathy.

The study casts doubt on the idea that the COVID-19 is a respiratory illness that lasts only a few weeks, suggesting instead that it may be a vascular disease capable of wreaking havoc on the eyes, skin, heart and brain, long after the sore throat goes away. While some hospitals, such as Mount Sinai in New York, have launched recovery centers for post-COVID care, the Centers for Disease Control and Prevention has released little data on the longterm prognosis for those who survive.

In the interim, it’s the long haulers themselves who are helping demystify their strange new world. Karyn Bishof, a firefighter paramedic in Florida, is one of them. After coming down with sore throat, nausea and fatigue in late March, she tested positive for COVID-19 and was told her case was mild. But as the weeks went on, the symptoms didn’t go away. Over four months later, the fatigue remains constant and along with it, a host of other exhausting side effects.

“I’m dealing with drastic changes in heart rate … My oxygen levels drop into the low 90, sometimes even the low eighties, I’m still dealing with headache, memory issues. I have a lot of trouble recalling things or sometimes finding my words,” Bishof tells Yahoo Life. “I’m still dealing with a runny and stuffy nose on and off. And then just a ton of other neurological issues, cardiac issues, chest pain, shortness of breath. I mean, the list goes on.”

Jessica Hulett, a writer in New York, has been battling similar effects. “The fatigue has been really persistent … All I want to do is go to sleep from like two o’clock on every day, and some days I have to,” says Hulett. “I’ve also started having a lot of like cognitive difficulties. Like I can’t remember things, I can’t focus on things.

Both Hulett and Bishof have struggled to find answers from doctors about what’s happening. “I’ve been talking a lot to my primary care doctor … she has kind of admitted, she’s like, ‘We don’t know, like we don’t know how long you’re going to be sick,’” says Hulett. “We don’t know what’s gonna make you better. We don’t know why you’re still sick.”

Luis Santos, a native-New Yorker who’s been experiencing “crushing fatigue,” cognitive issues and an unexplained spike in his cholesterol since getting COVID-19 in March, is too. “I have a team of about seven or eight doctors … and it’s a very scary thing that all these physicians are saying they don’t know. They don’t know how to make me better,” says Santos. “They’re hoping that with time they get better.”

Natalie Lambert, an associate research professor at IU School of Medicine and the lead author of the long haulers study, says this reaction is common. “I feel like this is a huge problem in health care around the world...We’re just kind of a society where you’re healthy until you can prove that you’re sick,” Lambert tells Yahoo Life. “If you’re experiencing something that’s outside of the standard of medical care, it can be really hard to get answers.”

Lambert, who began talking to patients after seeing a “wide range of COVID-19 symptoms” early on, says she doesn’t blame doctors for the gap in knowledge. “They can only treat you with the appropriate and approved standard treatments,” says Lambert. “They can’t experiment on people — so it’s understandable. But if there’s no answer to your question, what can you do?”

Survivor Corps, a grassroots movement connecting COVID-19 survivors, is trying to figure out just that — hosting webinars, sharing research and creating a Facebook group nearly 100,000 people strong. It’s from this group that Lambert pulled information about side effects, using an open-ended survey that allowed long haulers to add their symptoms.

She says the importance of these individuals, and their stories, can’t be overstated. “They are the world’s experts in the disease at this point in time,” Lambert tells Yahoo Life. “I mean, these patients know more about the disease than the medical community does.”

She hopes her research will serve as validation to long haulers — and proof that they’re not alone. “If you’re experiencing any of these symptoms, lots of people are experiencing these symptoms,” says Lambert. “And if your doctor won’t treat them, continue to advocate for yourself to try to get medical care because some of these can result in very serious health consequences.”

When it comes to the long haulers themselves, they’re urging others not to overlook the seriousness of this virus. “Right now the science for long haulers is showing that [COVID-19] doesn’t care about your age. It doesn’t care about your fitness level,” says Bishof. “It doesn’t care if you’re a firefighter-paramedic, or if you work on your computer from home … Do everything you can to protect yourself and others. This is not just a cold or a flu.”

 

 

 

The two sides of America’s coronavirus response

https://www.axios.com/us-coronavirus-vaccine-testing-science-b656e905-67d1-4836-863e-c91f739cfd1e.html

The two sides of America's coronavirus response - Axios

America’s bungled political and social response to the coronavirus exists side-by-side with a record-breaking push to create a vaccine with U.S. companies and scientists at the center.

Why it matters: America’s two-sided response serves as an X-ray of the country itself — still capable of world-beating feats at the high end, but increasingly struggling with what should be the simple business of governing itself.

What’s happening: An index published last week by FP Analytics, an independent research division of Foreign Policy, ranked the U.S. 31st out of 36 countries in its assessment of government responses to COVID-19.

  • That puts it below developed countries like New Zealand and Denmark, and also lower than nations with fewer resources like Ghana, Kenya and South Africa.
  • The index cited America’s limited emergency health care spending, insufficient testing and hospital beds and limited debt relief.

By the numbers: As my Axios colleague Jonathan Swan pointed out in an interview with President Trump, the U.S. has one of the worst per-capita death rates from COVID-19, at 50.29 per 100,000 population.

Yes, but: Work on a COVID-19 vaccine is progressing astonishingly fast, with the Cambridge-based biotech company Moderna and the National Institutes of Health announcing at the end of July that they had begun Phase 3 of the clinical trial.

  • Their efforts are part of a global rush to a vaccine, and while companies in the U.K. and China are jockeying for the lead, U.S. companies and the NIH’s resources and expertise have been key to the effort.
  • Anthony Fauci has said he expects “tens of millions” of doses to be available by early 2021, a little over a year after the novel coronavirus was discovered.
  • If that turns out to be the case, “the Covid-19 vaccine could take a place alongside the Apollo missions as one of history’s greatest scientific achievements,” epidemiologist Michael Kinch recently wrote in STAT.

So which is the real American response to COVID-19? The bungled testing policies, the politically driven rush to reopen, the tragic racial divide seen in the sick and the dead? Or the warp-speed work to develop a vaccine in a year when most past efforts took decades?

Be smart: It’s both.

The bottom line: It can often feel as if there are two Americas, and not even a virus that has spread around the world seems capable of bridging that gap.

 

 

 

 

Fauci: ‘I seriously doubt’ Russia’s coronavirus vaccine is safe and effective

https://thehill.com/policy/healthcare/511615-fauci-seriously-doubt-russias-coronavirus-vaccine-is-safe-and-effective?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-08-12%20Healthcare%20Dive%20%5Bissue:29035%5D&utm_term=Healthcare%20Dive

The White House has pushed Fauci into a little box on the side

Anthony Fauci, the nation’s top infectious diseases expert, said Tuesday that he has serious doubts about Russia’s announcement that it has a vaccine ready to be used for the novel coronavirus.

“Having a vaccine and proving that a vaccine is safe and effective are two different things,” Fauci said during a panel discussion with National Geographic.

The comments came just hours after Russian President Vladimir Putin said that the country had become the first in the world to gain regulatory approval for a COVID-19 vaccine.

Putin said that the vaccine went through clinical testing and that it had proven to offer immunity to the deadly disease, which has infected more than 20 million people worldwide, according to a Johns Hopkins University database.

However, phase three trials for the drug have reportedly not been completed, triggering skepticism from international health experts about its usefulness. 

Fauci, the director of the National Institute of Allergy and Infectious Diseases and a key member of the White House coronavirus task force, said that he had seen no evidence supporting Putin’s position. 

“I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they’ve done that,” he said, adding that Americans need to understand that the process for gaining vaccine approval requires safety and efficacy. 

More than 100 possible vaccines are being developed around the world as part of efforts to offer immunity protection for the coronavirus. Moderna, in collaboration with the National Institutes of Health, launched a phase three trial for a vaccine in July, making it the first U.S. candidate to reach that stage.

Fauci has said that he’s “cautiously optimistic” that a COVID-19 vaccine will be ready by the end of the year. He told a House committee on July 31 that he was encouraged by everything he’s seen in the early data but that “there’s never a guarantee that you’re going to get a safe and effective vaccine.”

The World Health Organization said Tuesday that it was monitoring Russia’s progress in developing a COVID-19 vaccine. Progress in combating the virus “should not compromise safety,” the health agency said.

Former Food and Drug Administration Commissioner Scott Gottlieb echoed Fauci’s skepticism earlier Tuesday, noting in a tweet that Russia has been behind disinformation campaigns related to the pandemic. 

“Today’s news that they ‘approved’ a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines,” he said.

Russia is reportedly planning to offer its COVID-19 vaccine to medical personnel as soon as this month. It will be made available to the general public in October, according to Reuters

 

 

 

Dr. Anthony Fauci says chance of coronavirus vaccine being highly effective is ‘not great’

https://www.cnbc.com/amp/2020/08/07/coronavirus-vaccine-dr-fauci-says-chances-of-it-being-highly-effective-is-not-great.html?utm_source=&utm_medium=email&utm_campaign=32192

KEY POINTS
  • White House coronavirus advisor Dr. Anthony Fauci that the chances of scientists creating a highly effective vaccine — one that provides 98% or more guaranteed protection — for the virus are slim.
  • Scientists are hoping for a coronavirus vaccine that is at least 75% effective, but 50% or 60% effective would be acceptable, too, he said.
  • The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective.

White House coronavirus advisor Dr. Anthony Fauci said Friday that the chances of scientists creating a highly effective vaccine — one that provides 98% or more guaranteed protection — for the virus are slim.

Scientists are hoping for a coronavirus vaccine that is at least 75% effective, but 50% or 60% effective would be acceptable, too, Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a Q&A with the Brown University School of Public Health. “The chances of it being 98% effective is not great, which means you must never abandon the public health approach.”

“You’ve got to think of the vaccine as a tool to be able to get the pandemic to no longer be a pandemic, but to be something that’s well controlled,” he said.

The Food and Drug Administration has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. Dr. Stephen Hahn, the FDA’s commissioner, said last month that the vaccine or vaccines that end up getting authorized will prove to be more than 50% effective, but it’s possible the U.S. could end up with a vaccine that, on average, reduces a person’s risk of a Covid-19 infection by just 50%.

“We really felt strongly that that had to be the floor,” Hahn said on July 30, adding that it’s “been batted around among medical groups.”

“But for the most part, I think, infectious disease experts have agreed that that’s a reasonable floor, of course hoping that the actual effectiveness will be higher.”

A 50% effective vaccine would be roughly on par with those for influenza, but below the effectiveness of one dose of a measles vaccination, which is about 93% effective, according to the Centers for Disease Control and Prevention.

Public health officials and scientists expect to know whether at least one of the numerous potential Covid-19 vaccines in development worldwide is safe and effective by the end of December or early next year, though there is never a guarantee. Drug companies Pfizer and Moderna both began late-stage trials for their potential vaccines last week and both expect to enroll about 30,000 participants.

Fauci has previously said he worries about the “durability” of a coronavirus vaccine, saying if Covid-19 acts like other coronaviruses, it may not provide long-term protection.

Health officials say there is no returning to “normal” until there is a vaccine. Fauci’s comment came a day after the World Health Organization cautioned about the development of vaccines, reiterating that there may never be a “silver bullet” for the virus, which continues to rapidly spread worldwide. The phase three trials underway do not necessarily mean that a vaccine is almost ready to be deployed to the public, the agency said.

“Phase three doesn’t mean nearly there,” Mike Ryan, executive director of the WHO’s emergencies health program, said during a virtual panel discussion with “NBC Nightly News” Anchor Lester Holt hosted by the Aspen Security Forum. “Phase three means this is the first time this vaccine has been put into the general population into otherwise healthy individuals to see if the vaccine will protect them against natural infection.”

While there is hope scientists will find a safe and effective vaccine, there is never a guarantee, WHO Director-General Tedros Adhanom Ghebreyesus said.

“We cannot say we have vaccines. We may or may not,” he said.

On Friday, Fauci reiterated that he is “cautiously optimistic” scientists will find a safe and effective vaccine. He also reiterated that the coronavirus may never be eliminated, but world leaders can work together to bring the virus down to “low levels.”

Some of Fauci’s comments have been at odds with President Donald Trump, who has repeatedly said the virus would “disappear.”

Trump, who is seeking reelection, said Thursday that it’s possible the United States could have a safe and effective vaccine for the coronavirus before the upcoming presidential election on Nov. 3.

 

 

 

 

 

A Viral Epidemic Splintering into Deadly Pieces

Once again, the coronavirus is ascendant. As infections mount across the country, it is dawning on Americans that the epidemic is now unstoppable, and that no corner of the nation will be left untouched.

As of Wednesday, the pathogen had infected at least 4.3 million Americans, killing more than 150,000. Many experts fear the virus could kill 200,000 or even 300,000 by year’s end. Even President Trump has donned a mask, after resisting for months, and has canceled the Republican National Convention celebrations in Florida.

Each state, each city has its own crisis driven by its own risk factors: vacation crowds in one, bars reopened too soon in another, a revolt against masks in a third.

“We are in a worse place than we were in March,” when the virus coursed through New York, said Dr. Leana S. Wen, a former Baltimore health commissioner. “Back then we had one epicenter. Now we have lots.”

To assess where the country is heading now, The New York Times interviewed 20 public health experts — not just clinicians and epidemiologists, but also historians and sociologists, because the spread of the virus is now influenced as much by human behavior as it is by the pathogen itself.

Not only are American cities in the South and West facing deadly outbreaks like those that struck Northeastern cities in the spring, but rural areas are being hurt, too. In every region, people of color will continue to suffer disproportionately, experts said.

While there may be no appetite for a national lockdown, local restrictions must be tightened when required, the researchers said, and governors and mayors must have identical goals. Testing must become more targeted.

In most states, contact tracing is now moot — there are simply too many cases to track. And while progress has been made on vaccines, none is expected to arrive this winter in time to stave off what many fear will be a new wave of deaths.

Overall, the scientists conveyed a pervasive sense of sadness and exhaustion. Where once there was defianceand then a growing sense of dread, now there seems to be sorrow and frustration, a feeling that so many funerals never had to happen and that nothing is going well. The United States is a wounded giant, while much of Europe, which was hit first, is recovering and reopening — although not to us.

“We’re all incredibly depressed and in shock at how out of control the virus is in the U.S.,” said Dr. Michele Barry, the director of the Center for Innovation in Global Health at Stanford University.

With so much wealth and medical talent, they asked, how could we have done so poorly? How did we fare not just worse than autocratic China and isolated New Zealand, but also worse than tiny, much poorer nations like Vietnam and Rwanda?

“National hubris and belief in American exceptionalism have served us badly,” said Martha L. Lincoln, a medical anthropologist and historian at San Francisco State University. “We were not prepared to see the risk of failure.”

Since the coronavirus was first found to be the cause of lethal pneumonias in Wuhan, China, in late 2019, scientists have gained a better understanding of the enemy.

It is extremely transmissible, through not just coughed droplets but also a fine aerosol mist that is expelled when people talk loudly, laugh or sing and that can linger in indoor air. As a result, masks are far more effective than scientists once believed.

Virus carriers with mild or no symptoms can be infectious, and there may be 10 times as many people spreading the illness as have tested positive for it.

The infection may start in the lungs, but it is very different from influenza, a respiratory virus. In severely ill patients, the coronavirus may attach to receptors inside the veins and arteries, and move on to attack the kidneys, the heart, the gut and even the brain, choking off these organs with hundreds of tiny blood clots.

Most of the virus’s victims are elderly, but it has not spared young adults, especially those with obesity, high blood pressure or diabetes. Adults aged 18 to 49 now account for more hospitalized cases than people aged 50 to 64 or those 65 and older.

Children are usually not harmed by the virus, although clinicians were dismayed to discover a few who were struck by a rare but dangerous inflammatory versionYoung children appear to transmit the virus less often than teenagers, which may affect how schools can be opened.

Among adults, a very different picture has emerged. Growing evidence suggests that perhaps 10 percent of the infected account for 80 percent of new transmissions. Unpredictable superspreading events in nursing homes, meatpacking plants, churches, prisons and bars are major drivers of the epidemic.

Thus far, none of the medicines for which hopes were once high — repurposed malaria drugs, AIDS drugs and antivirals — have proved to be rapid cures. One antiviral, remdesivir, has been shown to shorten hospital stays, while a common steroid, dexamethasone, has helped save some severely ill patients.

One or even several vaccines may be available by year’s end, which would be a spectacular achievement. But by then the virus may have in its grip virtually every village and city on the globe.

Some experts, like Michael T. Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy, argue that only a nationwide lockdown can completely contain the virus now. Other researchers think that is politically impossible, but emphasize that localities must be free to act quickly and enforce strong measures with support from their state legislators.

Danielle Allen, the director of Harvard University’s Edmond J. Safra Center for Ethics, which has issued pandemic response plans, said that finding less than one case per 100,000 people means a community should continue testing, contact tracing and isolating cases — with financial support for those who need it.

Up to 25 cases per 100,000 requires greater restrictions, like closing bars and limiting gatherings. Above that number, authorities should issue stay-at-home orders, she said.

Testing must be focused, not just offered at convenient parking lots, experts said, and it should be most intense in institutions like nursing homes, prisons, factories or other places at risk of superspreading events.

Testing must be free in places where people are poor or uninsured, such as public housing projects, Native American reservations and churches and grocery stores in impoverished neighborhoods.

None of this will be possible unless the nation’s capacity for testing, a continuing disaster, is greatly expanded. By the end of summer, the administration hopes to start using “pooling,” in which tests are combined in batches to speed up the process.

But the method only works in communities with lower infection rates, where large numbers of pooled tests turn up relatively few positive results. It fails where the virus has spread everywhere, because too many batches turn up positive results that require retesting.

At the moment, the United States tests roughly 800,000 people per day, about 38 percent of the number some experts think is needed.

Above all, researchers said, mask use should be universal indoors — including airplanes, subway cars and every other enclosed space — and outdoors anywhere people are less than six feet apart.

Dr. Emily Landon, an infection control specialist at the University of Chicago Pritzker School of Medicine, said it was “sad that something as simple as a mask got politicized.”

“It’s not a statement, it’s a piece of clothing,” she added. “You get used to it the way you got used to wearing pants.”

Arguments that masks infringe on personal rights must be countered both by legal orders and by persuasion. “We need more credible messengers endorsing masks,” Dr. Wen said — just before the president himself became a messenger.

“They could include C.E.O.s or celebrities or religious leaders. Different people are influencers to different demographics.”

Although this feels like a new debate, it is actually an old one. Masks were common in some Western cities during the 1918 flu pandemic and mandatory in San Francisco. There was even a jingle: “Obey the laws, wear the gauze. Protect your jaws from septic paws.”

“A libertarian movement, the Anti-Mask League, emerged,” Dr. Lincoln of San Francisco State said. “There were fistfights with police officers over it.” Ultimately, city officials “waffled” and compliance faded.

“I wonder what this issue would be like today,” she mused, “if that hadn’t happened.”

Images of Americans disregarding social distancing requirements have become a daily news staple. But the pictures are deceptive: Americans are more accepting of social distancing than the media sometimes portrays, said Beth Redbird, a Northwestern University sociologist who since March has conducted regular surveys of 8,000 adults about the impact of the virus.

“About 70 percent of Americans report using all forms of it,” she said. “And when we give them adjective choices, they describe people who won’t distance as mean, selfish or unintelligent, not as generous, open-minded or patriotic.”

The key predictor, she said in early July, was whether or not the poll respondent trusted Mr. Trump. Those who trusted him were less likely to practice social distancing. That was true of Republicans and independents, “and there’s no such thing as a Democrat who trusts Donald Trump,” she added.

Whether or not people support coercive measures like stay-at-home orders or bar closures depended on how scared the respondent was.

“When rising case numbers make people more afraid, they have more taste for liberty-constraining actions,” Dr. Redbird said. And no economic recovery will occur, she added, “until people aren’t afraid. If they are, they won’t go out and spend money even if they’re allowed to.”

As of Wednesday, new infections were rising in 33 states, and in Puerto Rico and the District of Columbia, according to a database maintained by The Times.

Weeks ago, experts like Dr. Anthony S. Fauci, the director of the National Institute for Allergy and Infectious Diseases, were advising states where the virus was surging to pull back from reopening by closing down bars, forbidding large gatherings and requiring mask usage.

Many of those states are finally taking that advice, but it is not yet clear whether this national change of heart has happened in time to stop the newest wave of deaths from ultimately exceeding the 2,750-a-day peak of mid-April. Now, the daily average is 1,106 virus deaths nationwide.

Deaths may surge even higher, experts warned, when cold weather, rain and snow force Americans to meet indoors, eat indoors and crowd into public transit.

Oddly, states that are now hard-hit might become safer, some experts suggested. In the South and Southwest, summers are so hot that diners seek air-conditioning indoors, but eating outdoors in December can be pleasant.

Several studies have confirmed transmission in air-conditioned rooms. In one well-known case cluster in a restaurant in Guangzhou, China, researchers concluded that air-conditioners blew around a viral cloud, infecting patrons as far as 10 feet from a sick diner.

Rural areas face another risk. Almost 80 percent of the country’s counties lack even one infectious disease specialist, according to a study led by Dr. Rochelle Walensky, the chief of infectious diseases at Massachusetts General Hospital in Boston.

At the moment, the crisis is most acute in Southern and Southwestern states. But websites that track transmission rates show that hot spots can turn up anywhere. For three weeks, for example, Alaska’s small outbreak has been one of the country’s fastest-spreading, while transmission in Texas and Arizona has dramatically slowed.

Deaths now may rise more slowly than they did in spring, because hospitalized patients are, on average, younger this time. But overwhelmed hospitals can lead to excess deaths from many causes all over a community, as ambulances are delayed and people having health crises avoid hospitals out of fear.

The experts were divided as to what role influenza will play in the fall. A harsh flu season could flood hospitals with pneumonia patients needing ventilators. But some said the flu season could be mild or almost nonexistent this year.

Normally, the flu virus migrates from the Northern Hemisphere to the Southern Hemisphere in the spring — presumably in air travelers — and then returns in the fall, with new mutations that may make it a poor match for the annual vaccine.

But this year, the national lockdown abruptly ended flu transmission in late April, according to weekly Fluview reports from the Centers for Disease Control and Prevention. International air travel has been sharply curtailed, and there has been almost no flu activity in the whole southern hemisphere this year.

Assuming there is still little air travel to the United States this fall, there may be little “reseeding” of the flu virus here. But in case that prediction turns out be wrong, all the researchers advised getting flu shots anyway.

“There’s no reason to be caught unprepared for two respiratory viruses,” said Tara C. Smith, an epidemiologist at Kent State University’s School of Public Health.

Experts familiar with vaccine and drug manufacturing were disappointed that, thus far, only dexamethasone and remdesivir have proved to be effective treatments, and then only partially.

Most felt that monoclonal antibodies — cloned human proteins that can be grown in cell culture — represented the best hope until vaccines arrive. Regeneron, Eli Lilly and other drugmakers are working on candidates.

“They’re promising both for treatment and for prophylaxis, and there are companies with track records and manufacturing platforms,” said Dr. Luciana Borio, a former director of medical and biodefense preparedness at the National Security Council. “But manufacturing capacity is limited.”

According to a database compiled by The Times, researchers worldwide are developing more than 165 vaccine candidates, and 27 are in human trials.

New announcements are pouring in, and the pressure to hurry is intense: The Trump administration just awarded nearly $2 billion to a Pfizer-led consortium that promised 100 million doses by December, assuming trials succeed.

Because the virus is still spreading rapidly, most experts said “challenge trials,” in which a small number of volunteers are vaccinated and then deliberately infected, would probably not be needed.

Absent a known cure, “challenges” can be ethically fraught, and some doctors oppose doing them for this virus. “They don’t tell you anything about safety,” Dr. Borio said.

And when a virus is circulating unchecked, a typical placebo-controlled trial with up to 30,000 participants can be done efficiently, she added. Moderna and Pfizer have already begun such trials.

The Food and Drug Administration has said a vaccine will pass muster even if it is only 50 percent effective. Experts said they could accept that, at least initially, because the first vaccine approved could save lives while testing continued on better alternatives.

“A vaccine doesn’t have to work perfectly to be useful,” Dr. Walensky said. “Even with measles vaccine, you can sometimes still get measles — but it’s mild, and you aren’t infectious.”

“We don’t know if a vaccine will work in older folks. We don’t know exactly what level of herd immunity we’ll need to stop the epidemic. But anything safe and fairly effective should help.”

Still, haste is risky, experts warned, especially when opponents of vaccines are spreading fear. If a vaccine is rushed to market without thorough safety testing and recipients are hurt by it, all vaccines could be set back for years.

No matter what state the virus reaches, one risk remains constant. Even in states with few Black and Hispanic residents, they are usually hit hardest, experts said.

People of color are more likely to have jobs that require physical presence and sometimes close contact, such as construction work, store clerking and nursing. They are more likely to rely on public transit and to live in neighborhoods where grocery stores are scarce and crowded.

They are more likely to live in crowded housing and multigenerational homes, some with only one bathroom, making safe home isolation impossible when sickness strikes. They have higher rates of obesity, high blood pressure, diabetes and asthma.

Federal data gathered through May 28 shows that Black and Hispanic Americans were three times as likely to get infected as their white neighbors, and twice as likely to die, even if they lived in remote rural counties with few Black or Hispanic residents.

“By the time that minority patient sets foot in a hospital, he is already on an unequal footing,” said Elaine Hernandez, a sociologist at Indiana University.

The differences persist even though Black and Hispanic adults drastically altered their behavior. One study found that through the beginning of May, the average Black American practiced more social distancing than the average white American.

Officials in ChicagoBaltimore and other communities faced another threat: rumors flying about social media that Black people were somehow immune.

The top factor making people adopt self-protective behavior is personally knowing someone who fell ill, said Dr. Redbird. By the end of spring, Black and Hispanic Americans were 50 percent more likely than white Americans to know someone who had been sickened by the virus, her surveys found.

Dr. Hernandez, whose parents live in Arizona, said their neighbors who had not been scared in June had since changed their attitudes.

Her father, a physician, had set an example. Early on, he wore a mask with a silly mustache when he and his wife took walks, and they would decline friends’ invitations, saying, “No, we’re staying in our bubble.”

Now, she said, their neighbors are wearing masks, “and people are telling my father, ‘You were right,’” Dr. Hernandez said.

There was no widespread agreement among experts about what is likely to happen in the years after the pandemic. Some scientists expected a quick economic recovery; others thought the damage could persist for years.

Working at home will become more common, some predicted, while crowded, open-plan offices may be changed. The just-in-time supply chains on which many businesses depend will need fixing because the processes failed to deliver adequate protective gear, ventilators and test materials.

A disease-modeling system like that used by the National Weather Service to predict storms is needed, said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. Right now, the country has surveillance for seasonal flu but no national map tracking all disease outbreaks. As Dr. Thomas R. Frieden, a former C.D.C. director, recently pointed out, states are not even required to track the same data.

Several experts said they assumed that millions of Americans who have been left without health insurance or forced to line up at food banks would vote for politicians favoring universal health care, paid sick leave, greater income equality and other changes.

But given the country’s deep political divisions, no researcher was certain what the outcome of the coming election would be.

Dr. Redbird said her polling of Americans showed “little faith in institutions across the board — we’re not seeing an increase in trust in science or an appetite for universal health care or workers equity.”

The Trump administration did little to earn trust. More than six months into the worst health crisis in a century, Mr. Trump only last week urged Americans to wear masks and canceled the Republican convention in Florida, the kind of high-risk indoor event that states have been banning since mid-March.

“It will probably, unfortunately, get worse before it gets better,” Mr. Trump said at the first of the resurrected coronavirus task force briefings earlier this month, which included no scientists or health officials. The briefings were discontinued in April amid his rosy predications that the epidemic would soon be over.

Mr. Trump has ignoredcontradicted or disparaged his scientific advisers, repeatedly saying that the virus simply would go away, touting unproven drugs like hydroxychloroquine even after they were shown to be ineffective and sometimes dangerous, and suggesting that disinfectants or lethal ultraviolet light might be used inside the body.

Millions of Americans have lost their jobs and their health insurance, and are in danger of losing their homes, even as they find themselves in the path of a lethal disease. The Trump presidency “is the symptom of the denigration of science and the gutting of the public contract about what we owe each other as citizens,” said Dr. Joia S. Mukherjee, the chief medical officer of Partners in Health in Boston.

One lesson that will surely be learned is that the country needs to be better prepared for microbial assaults, said Dr. Julie Gerberding, a former director of the C.D.C.

“This is not a once-in-a-century event. It’s a harbinger of things to come.”

 

 

 

Three Predictable Covid Nightmares — and How Congress Can Help Prevent Them

https://www.politico.com/news/agenda/2020/07/29/states-congress-covid-nightmare-vaccine-385217?mkt_tok=eyJpIjoiTVRNNU0yWXpNMlk1TVRsaiIsInQiOiJ1Vlg3dlBCYytaWTdtcGtMd3ZaUVh6TTBZRlMxXC9MaW9UMk9MRHhpdkFpSFFJMHFVWWpocUhWR1ZEZTM2NFBXb0xOVUZTSXNJMzYxWk90Yld

Opinion | Three Predictable Covid Nightmares — and How Congress ...

The good news is that they aren’t partisan, and they’re fixable.

In our response to the Covid-19 pandemic, the United States has all too often been caught flat-footed. Our public officials have tried to avoid or deny problems until they have been right on top of us, and legislative measures have tended to react to major challenges rather than avert them.

That has left policymakers with a lot to react to. And the relief and assistance bill now being worked out in the Senate will need to do that on several fronts. But to do better in the future, that bill should also take on several predictable problems that will face our country over the remainder of the year and which could benefit enormously from some advance attention and action.

Three sets of such predictable problems stand out above all, and in all three cases there are measures that can be taken now that should be able to attract bipartisan support.

First, states are going to face a monumental fiscal crisis.

The pandemic and the ensuing shutdowns of economic activity have left state governments with immense revenue shortages. Balanced-budget amendments in all but one state severely restrict their capacity to run deficits, in many cases even in major emergencies. That means states will have to either find other ways to raise revenue quickly or make major cuts to basic services. Such cuts in spending, jobs and public assistance would exacerbate the deep recession we are in and leave millions who need help in the lurch.

Most state fiscal years begin in July, so in many cases budgets designed or enacted before the severity of the crisis was clear are now starting to take effect, leaving states facing gaps they can easily predict but haven’t formally accounted for. In fact, 16 states are now starting the second year of biennial budgets enacted in 2019, before anyone could have imagined the sort of crisis we now face. Over the coming months, there will be no avoiding the fiscal crunch.

The states have already begun pleading with Congress for help, and sooner or later Congress will need to provide it. Taking steps sooner rather than later would make an enormous difference. The federal government has often been called on to serve as a fiscal backstop for states in extreme emergencies, since its borrowing power vastly exceeds that of the states. And that role is particularly appropriate in a truly national—indeed global—crisis of this magnitude.

But to provide such help responsibly, Congress will need to clearly delineate what kinds of assistance it can offer and on what terms. Congressional Republicans are not wrong to be wary of state efforts to use the emergency to fill fiscal holes dug over decades of irresponsible state policies. Yet that can’t mean that they deny state governments the help they need to contend with this crisis. Rather, it means they must draw some distinctions.

As I’ve argued elsewhere, Congress would do well to divide state needs into three tranches: direct pandemic spending (which should be covered by federal dollars), lost state revenue (which states should be given the opportunity to make up with federally guaranteed loans on favorable terms), and longstanding obligations like pension and retiree health costs made untenable by the recession (for which affected states should be given options only for strictly conditional support, like a new state bankruptcy code or federal support conditioned on major pension reforms).

To be effective, that sort of response would need to take shape now, before states have truly hit the wall. It should be part of the bill the parties are now beginning to negotiate.

Second, this fall’s election is going to be seriously complicated by the pandemic.

There is pretty much no way around that. We’ll be voting while the virus is still spreading, which means that far more people than usual will vote by mail. Only a few states have real experience with voting by mail in large numbers, and the logistics involved are not simple. Primary elections in many states have already made the challenge clear.

To take just one example among many, mailed ballots require signature verification. In states that haven’t spent years building the required infrastructure, such verification will probably need to be done by hand, creating huge risks of confusion and error. States will need to develop new processes to handle this, to train election workers to use unfamiliar equipment, and to take on problems in real time. Signature verification also requires a process for notifying voters whose handwriting is challenged and giving them time to respond. All that, and similar challenges on other election administration fronts, makes it easy to imagine that many races will be impossible to call on election night, and perhaps for quite some time afterward.

Particularly in an era already overflowing with cynical mistrust and conspiracy mongering, such problems raise the prospect of a legitimacy crisis around the election. And policymakers need to take steps now to reduce the risk of such a crisis.

The first step must be to prepare the public. Elected officials, candidates, journalists and others must start speaking plainly about the likelihood of logistical challenges around the election so that voters are not shocked if things don’t go smoothly. People must know in advance that we should not expect every race to be called straight away and that results which take days or even weeks to determine are not therefore illegitimate.

But beyond setting voter expectations, policymakers should also be looking for ways to reduce the strain on the system and to deal with predictable problems. One simple step Congress could take now is to push back the deadlines involved in the work of the Electoral College, to give the states more time to count votes in the presidential race if they need it. A simple change in the federal law governing these dates, which wouldn’t give either party an advantage, could give every state about three more weeks to count. Such a change would be essentially impossible after the election—when partisans looking at partial results would argue over which side it would advantage. But it could easily be done today, it would just take a few sentences of legislative language, and it too should be part of the relief bill now being worked out.

Opinion | Three Predictable Covid Nightmares — and How Congress ...

Finally, if we’re lucky, we’re going to need to figure out how to distribute a Covid-19 vaccine early next yearThat would be a good problem to have, of course, but a huge problem nonetheless. And getting it wrong could catastrophically undermine the effort to defeat the virus.

Vaccine development itself is one area where our country has not been behind the curve: The federal government has invested heavily in the effort, the National Institutes of Health has played a key coordinating role, and the administration is prepared to pay for “at risk” manufacturing of millions of doses of any vaccine that makes it into Phase III trials, so that if a vaccine is found to be safe and effective there will immediately be doses to provide to high-risk individuals. But who will be first in line to get these early doses? And who will decide?

Here, too, there is an enormous danger of a legitimacy crisis. Both public fear about the safety of a vaccine (building on decades of anti-vaccine conspiracy theories on the right and left alike) and the danger of corruption, or at least perceived corruption, in the distribution of doses could undermine the potential of effective vaccination to end the nightmare of this pandemic.

Widespread uptake is essential to the effectiveness of any vaccine. It is not so much by protecting each vaccinated individual as by vaccinating enough Americans to achieve broad-based communal (or “herd”) immunity that a vaccine could truly change the game. That means public trust in the process and wholesale vaccination across our society will be crucial.

To achieve that, it is essential that both the safety of the vaccine-development process and the basic fairness of the ultimate distribution formula be established in advance, and in a very public way. Congress has a crucial role to play here, too. Hearings should begin very soon to put before the public all available information about the efforts taken by the Food and Drug Administration to ensure the safety of the vaccine-development process, even as that process proceeds with unprecedented speed. And Congress should establish, ideally in this next relief bill, a public commission to develop a formula for equitable distribution of early vaccine doses: setting out tiers of priority (for front-line health workers, vulnerable populations, the elderly, and those with particular preexisting conditions), and seeking out ways to make sure that economic and other disadvantages do not translate into lesser or later access to vaccination.

The work of such a group should be reasonably transparent and would need to begin very soon if it is to bear fruit in time to be useful. Policymakers must not underestimate the danger of a loss of public confidence in a Covid-19 vaccine, and must take steps now to avoid such a foreseeable disaster.

The same is true on all three of these fronts. These may not be the greatest problems we confront in the remainder of this dark and difficult year, but they share some features that ought to make them high priorities: All three are predictable and serious, each would amount to a disaster if left unchecked, but each could be made much easier to handle with some straightforward preparation. The relief bill being negotiated this summer could easily, without sparking a partisan war, take concrete steps on all three fronts.

Leadership in a crisis demands a combination of planning for foreseeable difficulties and responding to the unexpected. Getting the former right can make the latter far more doable. To make the rest of this year less disastrous, our leaders need to look ahead.

 

Grim statistics mount in the battle with COVID

https://mailchi.mp/9075526b5806/the-weekly-gist-july-24-2020?e=d1e747d2d8

Coronavirus US: Cases rise in 40 states though death rate falls ...

It was a week of unhappy milestones in the nation’s battle with the coronavirus. On Thursday, the US crossed the threshold of 4M confirmed COVID cases, just 15 days after it hit the 3M cases mark. That’s three times as fast as it took to go from 2M to 3M cases, with daily new case counts now hovering near 70,000.

As the virus proliferates across the country, California has now overtaken New York as the epicenter of the outbreak, with more than 422,000 total cases reported since the beginning of the pandemic, versus New York’s 413,000.

Of greater concern, the daily US death toll from COVID stayed stubbornly above 1,000 for most of the week, the highest it’s been since late MayMore Americans are currently hospitalized with COVID than at any time since the middle of April, with the Gulf Coast states showing some of the highest per-capita hospitalization rates in the country. For good reason, Secretary of Health and Human Services (HHS) Alex Azar officially renewed the Trump administration’s declaration of a public health emergency for another 90 days, clearing the way for the nation’s hospitals to receive more emergency financial assistance in battling the virus, and for continued relaxation of regulations that have allowed them to provide care virtually, and in non-traditional settings.

Meanwhile, as part of its Operation Warp Speed initiative to accelerate the development of a COVID vaccine, the Trump administration inked a $1.95B deal with pharmaceutical firm Pfizer and a German biotech company, BioNTech, to purchase 100M doses of the vaccine those companies are developing, with an option to buy an additional 500M doses. That’s in addition to contracts already in place to purchase 100M doses of a vaccine from Novavax, and 300M doses from AstraZeneca.

Americans would have free access to the Pfizer vaccine under the new arrangement, with the government subsidizing the entire cost of each dose, estimated to be about $19.50. Similar deals struck by the British government with AstraZeneca and GlaxoSmithKline carry a much lower per dose price tag—between $4 and $10—raising concerns of “profiteering” by pharmaceutical companies in the US vaccine hunt.

The forward purchasing of millions of doses, coupled with rapid progress on vaccine development (at least 25 of the 150 potential vaccines being developed are already in human trials), raises hopes that help is on the way in our battle with the virus. On Friday, however, top White House science advisor Dr. Anthony Fauci said that he doesn’t expect a vaccine to be “widely available” to the American public until the second half of next year. Until then, our hand-to-hand combat with the virus—using non-pharmaceutical interventions such as mask wearing, social distancing, hand hygiene, testing, and contact tracing—must intensify, particularly in light of increasingly worrisome data on the spread and impact of the disease.

US coronavirus update: 4.0M cases; 144K deaths; 48.8M tests conducted.

 

 

Six reasons to be optimistic amid COVID-19

Six reasons to be optimistic amid COVID-19

Being more optimistic lowers the risk of CVD and early death: JAMA

Although COVID-19 cases, hospitalizations, and deaths are rising, there is also some positive news on the horizon, according to Joseph Allen of Harvard T.H. Chan School of Public Health.

In a July 14, 2020 Washington Post op-ed, Allen, assistant professor of exposure assessment science and director of the Healthy Buildings program, wrote that progress is being made in treatments, testing, and vaccines, and that there’s growing agreement about ways to curb the spread of infection.

Among positive developments, Allen cited:

  • Therapeutic treatments, such as cloned antibodies, are showing to be effective both to treat and prevent COVID-19.
  • Rapid, low-cost saliva tests for COVID-19 are being developed and could be a game-changer.
  • Universal mask-wearing is catching on.
  • Consensus has emerged that airborne spread of the coronavirus is happening, and the World Health Organization and other organizations are now recommending the use of healthy building strategies such as higher ventilation, better filtration, and the use of air-cleaning devices.
  • Several studies suggest that past exposure to common-cold coronaviruses may help protect some people from COVID-19 infection.
  • Vaccine trials seem to be working and drug makers have said they may be able to deliver doses as early as October.

“For the first time in history, nearly every scientist in the world is focused on the same problem,” Allen wrote. “This is starting to pay real dividends.”

Read Joseph Allen’s Washington Post op-ed: Need some good news about covid-19? Here are six reasons for optimism.

 

 

 

 

The state of the global race for a coronavirus vaccine

https://www.axios.com/race-for-coronavirus-vaccine-us-china-oxford-eace8d13-59b6-404f-9dd9-569d00e01f58.html

The state of the global race for a coronavirus vaccine - Axios

Vaccines from the U.K., U.S. and China are sprinting ahead in a global race that involves at least 197 vaccine candidates and is producing geopolitical clashes even as it promises a possible pandemic escape route.

Driving the news: The first two candidates to reach phase three trials — one from the University of Oxford and AstraZeneca, the other from China — both appear safe and produce immune responses, according to preliminary results published today in The Lancet.

  • A vaccine from Moderna, the U.S. biotech firm, is heading into phase three trials after similarly encouraging initial results.
  • There are at least 16 other vaccines currently in clinical trials in Australia, France, Germany, India, Russia, South Korea, the U.K., the U.S. and China, which is experimenting with a variety of vaccine types and has five candidates already in trials.

What they’re saying: Experts are increasingly confident that it’s no longer a question of if but when vaccines will be available.

  • “Absolutely, for sure, we will get more than one vaccine,” Barry Bloom, a professor of public health at Harvard, told reporters today.
  • He cautioned that it’s not yet clear which vaccines will win the race and that we won’t know how effective they are in protecting against COVID-19 — and for how long — until after phase three trials.

Pressed on when a vaccine could be approved, Bloom said that while it seemed “utterly crazy seven months ago,” January was looking increasingly realistic.

  • Richard Horton, The Lancet‘s editor-in-chief, is more cautious: “If we have a vaccine by the end of 2021, we will have done incredibly well.”
  • Zeke Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania, splits the difference: “Seven months after we got the genome, to have three vaccines in phase three is literally unprecedented. If in six to eight months we get a license, that will be, again, totally unprecedented in world history.”

But, but, but: “Getting something approved doesn’t protect you from COVID,” Emanuel warns.

  • The challenges of producing, distributing and delivering a vaccine (particularly in two doses, as the Oxford vaccine requires) around the entire world are hard to even fathom.
  • Even distributing a vaccine in one country will require an unprecedented buildup of facilities, materials (like glass vials), personnel and protocols, assuming enough people are even willing to take it.

Illustration of syringe in the earth

The global picture is even murkier. Several countries and pharmaceutical companies have committed to “fair and equitable” distribution.

  • In principle, that would suggest a vulnerable front-line worker in Uganda, say, should get the vaccine before a young, healthy person in the United States.
  • In practice, well … no one really knows.

The bottom line: “It’s very fragmented, and in some ways that’s understandable,” Horton says. “But the danger of that is that many countries will lose out and only the strongest country, the country with the most money, will win.”

  • If countries hoard supplies rather than prioritizing at-risk people elsewhere, Bloom says, “that should be a cause not just of global concern but of global shame.”

For now, governments are prioritizing their own populations.

  • The Trump administration is pouring at least $3.5 billion into the development and manufacture of three leading vaccine candidates, with the promise of hundreds of millions of doses should they prove safe and effective.
  • Even as the homegrown Oxford vaccine takes a global lead, the U.K. is hedging its bets by purchasing 90 million doses being developed by German and French companies.
  • The U.K. and U.S. have both also put in large pre-orders of the Oxford vaccine, though AstraZeneca says 1 billion doses will also be manufactured in India and distributed mainly to other low- and middle-income countries.
  • The WHO and EU are attempting to create a framework for distributing the vaccine globally, though the U.S. has declined to take part.

Illustration of syringes forming a health plus/cross

What to watch: Managing the largest vaccination project in history will clearly require global collaboration — but it’s also becoming a competition between rival powers.

  • Six months from now, we will be in a situation where a few countries will have vaccines, and we believe those countries will be the UK, Russia, China and the US,” Kirill Dmitriev, the head of Russia’s sovereign wealth fund, told the FT.

Between the lines: Others are less certain Russia will be in that group, though Dmitriev says a vaccine bankrolled by his fund and developed by the state-run Gamaleya Institute will move into phase three trials next month.

“Basically other countries will decide, you know, which vaccine to buy … and who do you trust?”

— Kirill Dmitriev

State of play: There’s a clear lack of trust among the competitors.

  • According to the U.S, U.K. and Canada, hackers linked to Russian military intelligence have attempted to steal vaccine research in order to aid their own efforts.
  • The U.S. has also accused China of pilfering American research.
  • House Republican leader Kevin McCarthy will introduce a bill on Tuesday that would sanction foreign hackers attempting to steal U.S. vaccine research, according to a copy of the bill obtained by Axios’ Alayna Treene.

Zoom out: It will be a victory for humanity when the first coronavirus vaccines are approved. But the competition to obtain one early goes beyond national pride.

  • Vaccines will save countless lives, drive economic recoveries, and could provide rare opportunities to generate goodwill and influence abroad.
  • “There’s a huge soft power advantage to the U.S. ensuring that other countries can get the vaccine and protect themselves,” Emanuel says. The same would, of course, be true for China.

The bottom line: The race is on, but it won’t end when the first vaccine is approved.

 

 

 

We’re still in the early stages of the vaccine race

https://www.axios.com/newsletters/axios-vitals-a91eb4fb-e10d-46cf-b919-96e1e6e08b22.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Oxford and CanSino released coronavirus vaccine data. It's still ...

New clinical trial data from two experimental coronavirus vaccines — one from Oxford University and AstraZeneca in the U.K., and the other from CanSino Biologics in China — are providing cautious optimism in the race to combat the pandemic, Axios’ Bob Herman reports.

The big picture: Science has never moved this fast to develop a vaccine. And researchers are still several months away from a clearer idea of whether the leading candidates help people generate robust immune responses to this virus.

Driving the news: The Oxford and CanSino vaccines didn’t lead to any severe adverse reactions or hospitalizations, according to the results released yesterday.

  • Safety — not efficacy — was the main thing these studies were supposed to be testing. And they performed well enough to move on to further trials.
  • Competing candidates from Moderna and Pfizer/BioNTech have also performed well in safety trials.

Yes, but: Future trials will be the ones that tell us whether any of these potential vaccines actually trigger patients’ immune systems to respond to the virus.

  • In the results released yesterday, Oxford researchers gave their vaccine to 543 people but only tested 35 for “neutralizing antibodies.” A separate, nonrandomized group of 10 people got a booster dose of the Oxford vaccine a month after the initial dose.
  • Preliminary antibody responses from CanSino’s vaccine were “disappointing” to several experts.

The bottom line: There are 23 coronavirus vaccines in clinical testing right now, according to the World Health Organization.

  • We now have data on the first four, but the studies mostly are confirming that the vaccines aren’t severely harmful and that large-scale studies are warranted — not that they definitely work yet.
  • “It is good and hopeful news indeed, but we’ll only know when the large trials are done,” tweeted Robert Califf, a former FDA commissioner under President Obama.