Category Archives: Vaccine

The first presidential debate: 7 healthcare takeaways

Posted on by • Posted in 2020 Election Issues, ACA, Credibility, Essential Health Benefits, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Executive Orders, Health Insurance Coverage Adequacy, Health Policy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Honesty, Integrity, Out of Pocket Expenses, Personal Protective Equipment (PPE), Preexisting Conditions, Scientists, Social Distancing, Supreme Court, Transparency, Trust, Truth, Vaccine, Vaccine Distribution • Leave a comment

https://www.beckershospitalreview.com/hospital-management-administration/the-first-presidential-debate-7-healthcare-takeaways.html?origin=CFOE&utm_source=CFOE&utm_medium=email&oly_enc_id=2893H2397267F7G

5 key takeaways from Joe Biden and Donald Trump's 1st presidential debate - ABC News

President Donald Trump and former Vice President and Democratic presidential nominee Joe Biden sparred over the future of the ACA, the COVID-19 pandemic and health insurance during a 90-minute debate in Cleveland Sept. 29.

Seven takeaways for healthcare leaders:

The ACA

1. Moderator and Fox News host Chris Wallace opened the debate with the topic of President Trump’s nomination of Judge Amy Coney Barrett of the U.S. Court of Appeals for the 7th Circuit to the U.S. Supreme Court. In the first few minutes of the debate, the discussion turned to the future of the ACA should Ms. Coney Barrett join the Supreme Court. A week after the November presidential election, the Supreme Court is set to hear a lawsuit, supported by the Trump administration, that seeks to overturn the ACA. 

2. If the Supreme Court overturns the ACA, Mr. Biden said 22 million Americans would lose insurance and 100 million would lose protections for preexisting conditions. HHS said in 2017 as many as 133 million Americans have preexisting conditions, and a KFF analysis estimates 54 million Americans have conditions serious enough to lead to coverage denials if the ACA is overturned.

3. Mr. Wallace questioned the president about his promise to repeal and replace the ACA, adding that President Trump hadn’t released a comprehensive plan to replace the health law despite pledges to do so. The president disagreed with that, saying he had gotten rid of the individual mandate. Mr. Wallace said eliminating the mandate was not a comprehensive plan. Mr. Wallace called President Trump’s recent executive orders on preexisting conditions and surprise billing “largely symbolic.” President Trump disagreed, but did not tell how the executive orders would be implemented.

Drug prices 

4. The president said drug prices would be coming down “80 or 90 percent.” The president highlighted insulin, which he said he’s getting so inexpensively, “it’s like water.” Insulin continues to retail for about $300 per vial, according to STAT, but cheaper insulin prices could be coming for some seniors. CMS recently said it is expanding the number of Medicare Advantage plans that provide insulin for a $35 or less monthly copay.

Public option

5. In an exchange with Mr. Biden, President Trump accused the Democratic Party of wanting “socialist medicine,” and claimed Mr. Biden wants to end private insurance. Mr. Biden denied those claims and said his health plan, which includes expanded ACA subsidies and a public option, would allow employees to keep their private health insurance. He has not supported Medicare-for-All proposals.

COVID-19

6. On the topic of the pandemic, Mr. Wallace asked President Trump about differing timelines for a vaccine that have been presented by him versus federal scientists like CDC Director Robert Redfield, MD. The president said he has spoken with Pfizer, Moderna and Johnson & Johnson, who’ve said “they can go faster” on a vaccine, but “it’s a very political thing.” He added that the military is already set up to distribute vaccines. Mr. Biden questioned Americans’ trust in the process. A Sept. 29 poll from the Axios/Ipsos Coronavirus Index found 8 in 10 Americans wouldn’t likely get a first generation COVID-19 vaccine if the president said it was safe.

7. President Trump and Mr. Biden took different stances on masks. Mr. Biden cited Dr. Redfield’s renewed call to wear masks, and said masking up and social distancing would save 100,000 lives between now and January. President Trump responded by saying, “They’ve said the opposite.” He alluded to early in the pandemic when public health experts, including Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, were slow to recommend widespread mask-wearing before scientists better understood how the virus spreads. The CDC currently recommends that every American wear a mask.

 

 

 

U.S. Still in First Wave of COVID-19, Fauci Says

Posted on by • Posted in Asymptomatic Transmission, Centers for Disease Control & Prevention (CDC), Coronavirus, Flu Shot, Infection Control, Infection Control Plan, Infectious Virus, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Social Distancing, Vaccine, Vaccine Distribution, Vaccine Efficacy • Leave a comment

https://www.webmd.com/lung/news/20200925/us-still-in-first-wave-of-covid-19-fauci-says

US still in first Covid-19 wave and should be prepared for 'challenge' of fall and winter, Fauci says

Anthony Fauci, MD, says talk about a second wave of the coronavirus is premature because the United States is still dealing with the first one.

The idea of a second wave is based on the 1918 flu pandemic, when many cases were seen in the spring, he says. The spring cases “literally disappeared” and were followed by a spike in flu cases in the fall, he told CNN’s Sanjay Gupta, MD, on Thursday in an online conversation organized by Emory University.

“Rather than say, ‘A second wave,’ why don’t we say, ‘Are we prepared for the challenge of the fall and the winter?’” said Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force.

Flu shots are an important measure to help the U.S. get through the winter, he said.

He and other health care professionals have observed that the Southern Hemisphere has had a very light flu season, probably because measures to curb the coronavirus, such as social distancing and mask-wearing, have limited the spread of the flu.

“If we listen to the public health measures, not only would we diminish the effect of COVID-19, we might get away with a very, very light flu season if we combine that with getting the flu vaccine,” Fauci said.

In a separate interview, he said the arrival of the coronavirus vaccine will not stop the need for tried-and-true measures such as mask-wearing, hand-washing, and social distancing.

In a Facebook Live conversation with New Jersey Gov. Phil Murphy, Fauci said the coronavirus vaccine will not be 100% effective and won’t be taken by the entire population. That means the virus could still spread.

“So when a vaccine comes, we look at it as an important tool to supplement the public health measures that we do,” he said. “It will allow us to more quickly and with less stringency get back to some degree of normal. But it is not going to eliminate the need to be prudent and careful with our public health measures.”

Fauci said that vaccinating 75% to 80% of the population “would be a really good accomplishment.” He expects 700 million doses to be produced by the end of this year or early 2021.

 

 

 

 

Medicare won’t cover coronavirus vaccines approved under emergency use authorization

Posted on by • Posted in Coronavirus, Dept of Health and Human Services (HHS), Food and Drug Administration (FDA), Health Insurance Coverage Adequacy, Health Policy, Medicare, Out of Pocket Expenses, Pandemic, Vaccine, Vaccine Distribution, Vaccine Efficacy • Leave a comment

https://www.beckershospitalreview.com/pharmacy/medicare-won-t-cover-coronavirus-vaccines-approved-under-emergency-use-authorization.html?utm_medium=email

Medicare Wouldn't Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization - WSJ

Medicare won’t cover the cost of a COVID-19 vaccine if it is approved under an emergency use authorization, according to The Wall Street Journal. 

The White House recently concluded that Medicare’s exclusion of emergency-use drug costs could mean 44 million Americans, or 15 percent of the U.S. population, may have to pay out-of-pocket for a vaccine if it is approved under an emergency use authorization, the Journal reported.

HHS is now exploring coverage options, and a spokesperson told the Journal any vaccine doses bought by the government will be provided free.

The administration of President Donald Trump has pushed for a COVID-19 vaccine to be approved and distributed before the presidential election, which would likely only come with an emergency use authorization, since FDA approvals take more time.

In March, lawmakers passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which ensures no out-of-pocket costs for COVID-19 vaccines for people on Medicare.

HHS also said in August that government health insurance programs, including Medicare and Medicaid, would cover the costs of administering a COVID-19 vaccine. 

 

 

 

 

COVID-19 vaccine verdicts loom as next big market risk

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Testing, Contact Tracing, Coronavirus, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expectations, Food and Drug Administration (FDA), Infection Control, Infection Control Plan, Infectious Virus, Market Outlook, Market Uncertainty, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Scientists, Uncertainty, Vaccine, Vaccine Distribution, Vaccine Efficacy • Leave a comment

https://finance.yahoo.com/news/covid-19-vaccine-verdicts-loom-050615809.html

Optimism that vaccines are on the way to end the coronavirus pandemic has been a major factor in this year’s U.S. stock resurgence. That will face a critical test in coming weeks, as investors await clinical data on whether they actually work.

A UBS analysis found that about 40% of the market’s gains since May can be pegged to hopes for vaccines to protect against COVID-19, which has killed over 960,000 worldwide and rocked the global economy.

Global efforts to develop a vaccine are coming to a head, with late-stage data on trials by companies such as Pfizer Inc <PFE.N> and Moderna Inc <MRNA.O> possible as soon as October or November. Disappointing results could further shake markets that have recently grown turbulent on worries over fiscal stimulus delays and uncertainty around the Nov. 3 U.S. presidential election.

“The anticipation is that this stuff is going to work,” said Walter Todd, chief investment officer at Greenwood Capital in South Carolina. “So any news to the contrary could be a risk to the market.”

The number of vaccines in development could blunt the negative market impact of any single setback. More than a half-dozen vaccines globally are in late-stage trials out of over 30 currently being tested in humans, according to the World Health Organization.

“We are setting ourselves up for success in the sense of if you throw enough spaghetti at the wall, hopefully at least one noodle sticks,” said Liz Young, director of market strategy at BNY Mellon Investment Management.

That could explain why stocks overall barely reacted earlier this month, when AstraZeneca Plc <AZN.L> and partner Oxford University paused global trials of one of the leading vaccine candidates after a participant in its U.K. trial became seriously ill. The trials have resumed in Britain, Brazil and South Africa, but remain on hold in the United States.

Some forecasts on vaccine availability have grown less optimistic. Good Judgment, a company whose forecasters make predictions based on publicly available evidence, put the chances that a vaccine will be widely distributed in the United States by the end of March at 54%. That is up from an estimate of less than 20% in early July, but down from above 70% earlier this month.

Pfizer and Moderna could report initial efficacy results in October or November based on an early read of data, followed by data from companies such as AstraZeneca, Johnson & Johnson <JNJ.N> and Novavax Inc <NVAX.O>.

An approval or emergency use authorization this year could lead to a surge in travel, leisure and other stocks that have been decimated by pandemic-related shutdowns, while also fueling a long-awaited shift into value stocks from tech and other growth names that have led the market for years.

Even if a vaccine is approved, questions persist about how easily and quickly it can be distributed. President Trump and his health officials have issued conflicting predictions about when the general public could have access.

“The potential for market disappointment will likely come from the realization that manufacturing and broad distribution will take longer,” said Art Hogan, chief market strategist at National Securities.

An approved, broadly distributed and accepted vaccine could result in a gain of about 300 points to the S&P 500, or more than 8% at the index’s current level, according to Keith Parker, head of U.S. and global equity strategy at UBS.

If a vaccine is widely distributed in the first quarter, BofA Global Research projects global gross domestic product (GDP) growth of 6.3% in 2021, compared with 5.6% if that does not occur until the third quarter.

Disappointing clinical trial news could result in a loss of 100 points from the S&P 500, or about 3%, Parker estimates.

While the market might be able to handle one vaccine setback “reasonably well,” several setbacks could cause a rethink of the vaccine race, he said.

 

 

 

 

America Is Trapped in a Pandemic Spiral

Posted on by • Posted in 2020 Election Issues, Acceptance, Blame, Change, Change Management, Clinical Testing, Complacency, Complex, Contact Tracing, Coronavirus, Coronavirus Long-Term Complications, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Exceptionalism, Excuses, False Hope, False Narrative, Food and Drug Administration (FDA), Herd Immunity, Ignore, Inaction, Infection Control, Infection Control Plan, Infectious Virus, Lagging Indicator, Lagging Indicators, Leadership Decentralized, Long Term Strategy, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Panacea, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Reactive, Reactive Tendencies, School Reopening, Scientists, Sick Leave, Situational Awareness, Social Distancing, Threats, Uncertainty, Vaccine, Wishful Thinking, World Health Organization (WHO) • Leave a comment

https://www.theatlantic.com/health/archive/2020/09/pandemic-intuition-nightmare-spiral-winter/616204/

America Is Trapped in a Pandemic Spiral - The Atlantic

As the U.S. heads toward the winter, the country is going round in circles, making the same conceptual errors that have plagued it since spring.

Army ants will sometimes walk in circles until they die. The workers navigate by smelling the pheromone trails of workers in front of them, while laying down pheromones for others to follow. If these trails accidentally loop back on themselves, the ants are trapped. They become a thick, swirling vortex of bodies that resembles a hurricane as viewed from space. They march endlessly until they’re felled by exhaustion or dehydration. The ants can sense no picture bigger than what’s immediately ahead. They have no coordinating force to guide them to safety. They are imprisoned by a wall of their own instincts. This phenomenon is called the death spiral. I can think of no better metaphor for the United States of America’s response to the COVID-19 pandemic.

The U.S. enters the ninth month of the pandemic with more than 6.3 million confirmed cases and more than 189,000 confirmed deaths. The toll has been enormous because the country presented the SARS-CoV-2 coronavirus with a smorgasbord of vulnerabilities to exploit. But the toll continues to be enormous—every day, the case count rises by around 40,000 and the death toll by around 800—because the country has consistently thought about the pandemic in the same unproductive ways.

Many Americans trusted intuition to help guide them through this disaster. They grabbed onto whatever solution was most prominent in the moment, and bounced from one (often false) hope to the next. They saw the actions that individual people were taking, and blamed and shamed their neighbors. They lapsed into magical thinking, and believed that the world would return to normal within months. Following these impulses was simpler than navigating a web of solutions, staring down broken systems, and accepting that the pandemic would rage for at least a year.

These conceptual errors were not egregious lies or conspiracy theories, but they were still dangerous. They manifested again and again, distorting the debate around whether to stay at home, wear masks, or open colleges. They prevented citizens from grasping the scope of the crisis and pushed leaders toward bad policies. And instead of overriding misleading intuitions with calm and considered communication, those leaders intensified them. The country is now trapped in an intuition nightmare: Like the spiraling ants, Americans are walled in by their own unhelpful instincts, which lead them round and round in self-destructive circles.

“The grand challenge now is, how can we adjust our thinking to match the problem before us?” says Lori Peek, a sociologist at the University of Colorado at Boulder who studies disasters. Here, then, are nine errors of intuition that still hamstring the U.S. pandemic response, and a glimpse at the future if they continue unchecked. The time to break free is now. Our pandemic summer is nearly over. Now come fall, the season of preparation, and winter, the season of survival. The U.S. must reset its mindset to accomplish both. Ant death spirals break only when enough workers accidentally blunder away, creating trails that lead the spiraling workers to safety. But humans don’t have to rely on luck; unlike ants, we have a capacity for introspection.

The spiral begins when people forget that controlling the pandemic means doing many things at once. The virus can spread before symptoms appear, and does so most easily through five P’s: people in prolonged, poorly ventilated, protection-free proximity. To stop that spread, this country could use measures that other nations did, to great effect: close nonessential businesses and spaces that allow crowds to congregate indoors; improve ventilation; encourage mask use; test widely to identify contagious people; trace their contacts; help them isolate themselves; and provide a social safety net so that people can protect others without sacrificing their livelihood. None of these other nations did everything, but all did enough things right—and did them simultaneously. By contrast, the U.S. engaged in …

1. A Serial Monogamy of Solutions

Stay-at-home orders dominated March. Masks were fiercely debated in April. Contact tracing took its turn in May. Ventilation is having its moment now. “It’s like we only have attention for only one thing at a time,” says Natalie Dean, a biostatistician at the University of Florida.

As often happens, people sought easy technological fixes for complex societal problems. For months, President Donald Trump touted hydroxychloroquine as a COVID-19 cure, even as rigorous studies showed that it isn’t one. In August, he switched his attention to convalescent plasma—the liquid fraction of a COVID-19 survivor’s blood that might contain virus-blocking antibodies. There’s still no clear evidence that this century-old approach can treat COVID-19 either, despite grossly misstated claims from FDA Commissioner Stephen Hahn (for which he later apologized). More generally, drugs might save some of the very sickest patients, as dexamethasone does, or shorten a hospital stay, as remdesivir does, but they are unlikely to offer outright cures. “It’s so reassuring to think that a magic-bullet treatment is out there and if we just wait, it’ll come and things will be normal,” Dean says.

Other strategies have merit, but are wrongly dismissed for being imperfect. In July, Carl Bergstrom, an epidemiologist and a sociologist of science at the University of Washington, argued that colleges cannot reopen safely without testing all students upon entry. “The gotcha question I’ve handled most from reporters since is: This school did entry testing, so why did they get an outbreak?” he says. It’s because such testing is necessary for a safe reopening, but not sufficient. “If you do it and screw everything else up, you’ll still have a big outbreak,” Bergstrom adds.

This brief attention span is understandable. Adherents of the scientific method are trained to isolate and change one variable at a time. Academics are walled off into different disciplines that rarely connect. Journalists constantly look for new stories, shifting attention to the next great idea. These factors prime the public to view solutions in isolation, which means imperfections become conflated with uselessness. For example, many critics of masks argued that they provide only partial protection against the virus, that they often don’t fit well, or that people wear them incorrectly. But some protection is clearly better than no protection. As Dylan Morris of Princeton writes, “X won’t stop COVID on its own is not an argument against doing X.” Instead, it’s an argument for doing X along with other measures. Seat belts won’t prevent all fatal car crashes, but cars also come with airbags and crumple zones. “When we layer things, we give ourselves more wiggle room,” Dean says.

Several experts I’ve talked with have been asked: What now? The question assumes that the pandemic lingers because the U.S. simply hasn’t found the right solution yet. In fact, it lingers because the familiar solutions were never fully implemented. Despite claims from the White House, the U.S. is still not testing enough people. It still doesn’t have enough contact tracers. “We have the playbook, but I think there’s a confusion about what we’ve actually tried and what we’ve just talked about doing,” Dean says. A successful response “is never going to be one thing done perfectly. It’ll be a lot of different things done well enough.” That resilience disappears if we create…

2. False Dichotomies

A world of black and white is easier to handle than one awash with grays. But false dichotomies are dangerous. From the start, COVID-19 has been portrayed as a disease that mostly causes mild symptoms in people who quickly recover, and occasionally causes severe illness that leads to hospitalization and death. This two-sided caricature—severe or mild, sick or recovered—has erased the thousands of “long-haulers” who have endured months of debilitating symptoms at home with neither recognition nor care.

Meanwhile, as businesses closed and stay-at-home orders rolled out, “we presumed a trade-off between saving lives and saving the economy,” says Danielle Allen, a political scientist at Harvard. “That was foolishness of the most profound degree.” The two goals were actually aligned: Epidemiologists and economists largely agree that the economy cannot rebound while the pandemic is still raging. By treating the two as opposites, state leaders rushed to reopen, leading a barely contained virus to surge anew.  

Now, as winter looms and the pandemic continues, another dichotomy has emerged: enter another awful lockdown, or let the virus run free. This choice, too, is false. Public-health measures offer a middle road, and even “lockdowns” need not be as overbearing as they were in spring. A city could close higher-risk venues like bars and nightclubs while opening lower-risk ones like retail stores. There’s a “whole control panel of dials” on offer, but “it’s hard to have that conversation when people think of a light switch,” says Lindsay Wiley, a professor of public-health law at American University. “The term lockdown has done a lot of damage.” It exacerbated the false binary between shutting down and opening up, while offering …

3. The Comfort of Theatricality

Stay-at-home orders saved lives by curtailing COVID-19’s spread, and by giving hospitals some breathing room. But the orders were also meant to buy time for the nation to ramp up its public-health defenses. Instead, the White House treated months of physical distancing as a pandemic-ending strategy in itself. “We squandered that time in terms of scaling up testing and contact tracing, enacting policies to protect workers who get infected on the job, getting protective equipment to people in food-processing plants, finding places for people to isolate, offering paid sick leave … We still don’t have those things,” says Julia Marcus, an infectious-disease epidemiologist at Harvard Medical School and regular Atlantic contributor. The country is now facing the fall with many of the same problems that plagued it through the summer.

Showiness is often mistaken for effectiveness. The coronavirus mostly spreads through air rather than contaminated surfaces, but many businesses are nonetheless trying to scrub and bleach their way toward reopening. My colleague Derek Thompson calls this hygiene theater—dramatic moves that appear to offer safety without actually doing so. The same charge applies to temperature checks, which can’t detect the many COVID-19 patients who don’t have a fever. It also applies to the porous and inefficient travel bans that Trump and his allies still tout as policy successes. These tactics might do some good—let’s not conflate imperfect with useless—but they cause harm when they substitute for stronger measures. Theatricality breeds complacency. And by emphasizing solutions that can be easily seen, it exacerbated the American preference for …

4. Personal Blame Over Systemic Fixes

SARS-CoV-2 spread rapidly among America’s overstuffed prisons and understaffed nursing homes, in communities served by overstretched hospitals and underfunded public-health departments, and among Black, Latino, and Indigenous Americans who had been geographically and financially disconnected from health care by decades of racist policies. Without paid sick leave or a living wage, “essential workers” who earn a low, hourly income could not afford to quarantine themselves when they fell ill—and especially not if that would jeopardize the jobs to which their health care is tied. “The things I do to stay safe, they don’t have that as an option,” says Whitney Robinson, a social epidemiologist at the University of North Carolina at Chapel Hill.

But tattered social safety nets are less visible than crowded bars. Pushing for universal health care is harder than shaming an unmasked stranger. Fixing systemic problems is more difficult than spewing moralism, and Americans gravitated toward the latter. News outlets illustrated pandemic articles with (often distorted) photos of beaches, even though open-air spaces offer low-risk ways for people to enjoy themselves. Marcus attributes this tendency to America’s puritanical roots, which conflate pleasure with irresponsibility, and which prize shame over support. “The shaming gets codified into bad policy,” she says. Chicago fenced off a beach, and Honolulu closed beaches, parks, and hiking trails, while leaving riskier indoor businesses open.

Moralistic thinking jeopardizes health in two ways. First, people often oppose measures that reduce an individual’s risk—seat belts, condoms, HPV vaccines—because such protections might promote risky behavior. During the pandemic, some experts used such reasoning to question the value of masks, while the University of Michigan’s president argued that testing students widely would offer a “false sense of security.” These paternalistic false-assurance arguments are almost always false themselves. “There’s very little evidence for overcompensation to the point where safety measures do harm,” Bergstrom says.

Second, misplaced moralism can provide cover for bad policies. Many colleges started their semester with in-person teaching and inadequate testing, and are predictably dealing with large outbreaks. UNC Chapel Hill lasted just six days before reverting to remote classes. Administrators have chastised students for behaving irresponsibly, while taking no responsibility for setting them up to fail—a pattern that will likely continue through the fall as college clusters inevitably grow. “If you put 10,000 [students] in a small space, eating, sleeping, and socializing together, there’ll be an explosion of cases,” Robinson says. “I don’t know what [colleges] were expecting.” Perhaps they fell prey to …

5. The Normality Trap

In times of uncertainty and upheaval, “people crave a return to familiar, predictable rhythms,” says Monica Schoch-Spana, a medical anthropologist at the Johns Hopkins Center for Health Security. That pull is especially strong now because the pandemic’s toll is largely invisible. There’s nothing as dramatic as ruined buildings or lapping floodwater to hint that the world has changed. In some circles, returning to normal has been valorized as an act of defiance. That’s a reasonable stance when resisting terrorists, who seek to stoke fear, but a dangerous one when fighting a virus, which doesn’t care.

The powerful desire to re-create an old world can obscure the trade-offs necessary for surviving the new one. Keeping high-risk indoor businesses open, for example, helps the virus spread within a community, which makes reopening schools harder. “If schools are a priority, you have to put them ahead of something. What is that something?” says Bill Hanage, an epidemiologist at Harvard. “In an ideal world, they would be the last to close and the first to open, but in many communities, casinos, bars, and tattoo parlors opened before them.” A world with COVID-19 is fundamentally different from one without it, and the former simply cannot include all the trappings of the latter. Cherished summer rituals like camps and baseball games have already been lost; back-to-school traditions and Thanksgiving now hang in the balance. Change is hard to accept, which predisposes people to …

6. Magical Thinking

Back in April, Trump imagined the pandemic’s quick end: “Maybe this goes away with heat and light,” he said. From the start, he and others wondered if hot, humid weather might curb the spread of COVID-19, as it does other coronavirus diseases. Many experts countered that seasonal effects wouldn’t stop the new virus, which was already spreading in the tropics. But, fueled by shaky science and speculative stories, people widely latched on to seasonality as a possible savior, before the virus proved that it could thrive in the Arizona, Texas, and Florida summer.

This brand of magical thinking, in which some factor naturally defuses the pandemic, has become a convenient excuse for inaction. Recently, some commentators have argued that the pandemic will imminently fizzle out for two reasons. First, 20 to 50 percent of people have defensive T-cells that recognize the new coronavirus, because they were previously exposed to its milder, common-cold-causing cousins. Second, some modeling studies claim that herd immunity—whereby the virus struggles to find new hosts, because enough people are immune—could kick in when just 20 percent of the population has been infected.

Neither claim is implausible, but neither should be grounds for complacency. No one yet knows if the “cross-reactive” T-cells actually protect against COVID-19, and even if they do, they’re unlikely to stop people from getting infected. Herd immunity, meanwhile, is not a perfect barrier. Even if the low thresholds are correct, a fast-growing and uncontrolled outbreak will still shoot past them. Pursuing this strategy will mean that, in the winter, many parts of the U.S. may suffer what New York City endured in the spring: thousands of deaths and an untold number of lingering disabilities. That alone should be an argument against …

7. The Complacency of Inexperience

When illness is averted and lives are spared, “nothing happens and all you have is the miracle of a normal, healthy day,” says Howard Koh, a public-health professor at Harvard. “People take that for granted.” Public-health departments are chronically underfunded because the suffering they prevent is invisible. Pandemic preparations are deprioritized in the peaceful years between outbreaks. Even now, many people who have been spared the ravages of COVID-19 argue that the disease wasn’t a big deal, or associate their woes with preventive measures. But the problem is still the disease those measures prevented: The economy is still hurting, mental-health problems are growing, and educational futures have been curtailed, not because of some fearmongering overreaction, but because an uncontrolled pandemic is still afoot.

If anything, the U.S. did not react swiftly or strongly enough. Nations that had previously dealt with emerging viral epidemics, including several in East Asia and sub-Saharan Africa, were quick to take the new coronavirus seriously. By contrast, America’s lack of similar firsthand experience, combined with its sense of exceptionalism, might have contributed to its initial sloppiness. “One of my colleagues went to Rwanda in February, and as soon as he hit the airport, they asked about symptoms, checked his temperature, and took his phone number,” says Abraar Karan, an internist at Brigham and Women’s Hospital and Harvard Medical School. “In the U.S., I flew in July, and walked out of the airport, no questions asked.”

Even when the virus began spreading within the U.S., places that weren’t initially pummeled seemed to forget that viruses spread. “In April, I was seeing COVID patients in the ER every day,” Karan says. “In Texas, I had friends saying, ‘No one believes it here because we have no cases.’ In L.A., fellow physicians said, ‘Are you sure this is worse than the flu? We’re not seeing anything.’” Three months later, Texas and California saw COVID-19 all too closely. The tendency to ignore threats until they directly affect us has consigned the U.S. to …

8. A Reactive Rut

In March, Mike Ryan at the World Health Organization advised, “Be fast, have no regrets … The virus will always get you if you don’t move quickly.” The U.S. failed to heed that warning, and has repeatedly found itself several steps behind the coronavirus. That’s partly because exponential growth is counterintuitive, so “we don’t understand that things look fine until right before they’re very not fine,” says Beth Redbird, a sociologist at Northwestern. It’s also because the coronavirus spreads quickly but is slow to reveal itself: It can take a month for infections to lead to symptoms, for symptoms to warrant tests and hospitalizations, and for enough sick people to produce a noticeable spike. Pandemic data are like the light of distant stars, recording past events instead of present ones. This lag separates actions from their consequences by enough time to break our intuition for cause and effect. Policy makers end up acting only when it’s too late. Predictable surges get falsely cast as unexpected surprises.

This reactive rut also precludes long-term planning. In April, Michael Osterholm, an epidemiologist at the University of Minnesota, told me that “people haven’t understood that [the pandemic] isn’t about the next couple of weeks [but] about the next two years.” Leaders should have taken the long view then. “We should have been thinking about what it would take to ensure schools open in the fall, and prevent the long-term harms of lost children’s development,” Redbird says. Instead, we started working our way through a serial monogamy of solutions, and, like spiraling army ants, marched forward with no sense of the future beyond the next few footsteps.

These errors crop up in all disasters. But the COVID-19 pandemic has special qualities that have exacerbated them. The virus moved quickly enough to upend the status quo in a few months, deepening the allure of the hastily abandoned past. It also moved slowly enough to sweep the U.S. in a patchwork fashion, allowing as-yet-untouched communities to drop their guard. The pandemic grew huge in scope, entangling every aspect of society, and maxing out our capacity to deal with complexity. “People struggle to make rational decisions when they cannot see all the cogs,” says Njoki Mwarumba, an emergency-management professor at the University of Nebraska at Omaha. Full of fear and anxiety, people furiously searched for more information, but because the virus is so new, they instead spiraled into more confusion and uncertainty. And tragically, all of this happened during the presidency of Donald Trump.

Trump embodied and amplified America’s intuition death spiral. Instead of rolling out a detailed, coordinated plan to control the pandemic, he ricocheted from one overhyped cure-all to another, while relying on theatrics such as travel bans. He ignored inequities and systemic failures in favor of blaming China, the WHO, governors, Anthony Fauci, and Barack Obama. He widened the false dichotomy between lockdowns and reopening by regularly tweeting in favor of the latter. He and his allies appealed to magical thinking and steered the U.S. straight into the normality trap by frequently lying that the virus would go away, that the pandemic was ending, that new waves weren’t happening, and that rising case numbers were solely due to increased testing. They have started talking about COVID-19 in the past tense as cases surge in the Midwest.

“It’s like mass gaslighting,” says Martha Lincoln, a medical anthropologist at San Francisco State University. “We were put in a situation where better solutions were closed off but a lot of people had that fact sneak up on them. In the absence of a robust federal response, we’re all left washing our hands and hoping for the best, which makes us more susceptible to magical thinking and individual-level fixes.” And if those fixes never come, “I think people are going to harden into a fatalistic sense that we have to accept whatever the risks are to continue with our everyday lives.”

That might, indeed, be Trump’s next solution. The Washington Post reports that Trump’s new adviser—the neuroradiologist Scott Atlas—is pushing a strategy that lets the virus rip through the non-elderly population in a bid to reach herd immunity. This policy was folly for Sweden, which is nowhere near herd immunity, had one of the world’s highest COVID-19 death rates, and has a regretful state epidemiologist. Although the White House has denied that a formal herd-immunity policy exists, the Centers for Disease Control and Prevention recently changed its guidance to say that asymptomatic people “do not necessarily need a test” even after close contact with an infected person. This change makes no sense: People can still spread the virus before showing symptoms. By effectively recommending less testing, as Trump has specifically called for, the nation’s top public-health agency is depriving the U.S. of the data it needs to resist intuitive errors. “When there’s a refusal to take in the big picture, we are stuck,” Mwarumba says.

The pandemic is now in its ninth month. Uncertainties abound as fall and winter loom. In much of the country, colder weather will gradually pack people into indoor spaces, where the coronavirus more readily spreads. Winter also typically heralds the arrival of the flu and other respiratory viruses, and although the Southern Hemisphere enjoyed an unusually mild flu season, that’s “because of the severe precautions they were taking against COVID-19,” says Eleanor Murray, an epidemiologist at Boston University. “It’s not clear to me that our precautions will be successful enough to also prevent the flu.”

Schools are reopening, which will shape the path of the pandemic in still-uncertain ways. Universities are more predictable: Thanks to magical thinking and misplaced moralism, the U.S. already has at least 51,000 confirmed infections in more than 1,000 colleges across every state. These (underestimated) numbers will grow, because only 20 percent of colleges are doing regular testing, while almost half are not testing at all. As more are forced to stop in-person teaching, students will be sent back to their communities with COVID-19 in tow. “I expect this will blow up outbreaks in places that never had outbreaks, or in places that had outbreaks under control,” Murray says. Further spikes will likely occur after Thanksgiving and Christmas, as people who yearn to return to normal (or who think that the country overreacted) travel to see their family. Despite that risk, the CDC recently dropped its recommendation that out-of-state travelers should quarantine themselves for 14 days.

But many of the experts I spoke with thought it unlikely that “we’ll have cities going full New York,” as Bergstrom puts it. Doctors are getting better at treating the disease. States like Massachusetts, New York, and New Jersey have managed to avoid new surges over the summer, showing that local leadership can at least partly compensate for federal laxity. A new generation of cheap, rapid, paper-based tests will hit the market and make it easier to work out who is contagious. And despite the spiral of bad intuitions, many Americans are holding the line: Mask use and support for physical distancing are still high, according to Redbird, who has been tracking pandemic-related attitudes since March. “My feeling is that while things are going to get worse, I’m not sure they’ll be catastrophic, because of situational awareness,” Bill Hanage says.

Meanwhile, Trump seems to be teeing up a vaccine announcement in late October, shortly before the November 3 election. Moncef Slaoui, the scientific head of Operation Warp Speed, told NPR that it’s “extremely unlikely” a vaccine will be ready by then, and many scientists are concerned that the FDA will be pressured into approving a product that hasn’t been adequately tested, as Russia and China already have. Many Americans share this concern. A safe and effective vaccine could finally bring the pandemic under control, but its arrival will also test America’s ability to resist the intuitive errors that have trapped it so far. Vaccination has long been portrayed as the ultimate biomedical silver bullet, separating an era when masks and social distancing mattered from a world where normality has returned. This is yet another false dichotomy. “Everyone’s imagining this moment when all of a sudden, it’s all over, and they can go on vacation,” Natalie Dean says. “But the reality is going to be messier.”

This problem is not unique to COVID-19. It’s more compelling to hope that drug-resistant bacteria can be beaten with viruses than to stem the overuse of antibiotics, to hack the climate than to curb greenhouse-gas emissions, or to invest in a doomed oceanic plastic-catcher than to reduce the production of waste. Throughout its entire history, and more than any other nation, the U.S. has espoused “an almost blind faith in the power of technology as panacea,” writes the historian Howard Segal.* Instead of solving social problems, the U.S. uses techno-fixes to bypass them, plastering the wounds instead of removing the source of injury—and that’s if people even accept the solution on offer.

A third of Americans already say they would refuse a vaccine, whether because of existing anti-vaccine attitudes or more reasonable concerns about a rushed development process. Those who get the shot are unlikely to be fully protected; the FDA is prepared to approve a vaccine that’s at least 50 percent effective—a level comparable to current flu shots. An imperfect vaccine will still be useful. The risk is that the government goes all-in on this one theatrical countermeasure, without addressing the systemic problems that made the U.S. so vulnerable, or investing in the testing and tracing strategies that will still be necessary. “We’re still going to need those other things,” Dean says.

Between these reasons and the time needed for manufacturing and distribution, the pandemic is likely to drag on for months after a vaccine is approved. Already, the event is exacting a psychological toll that’s unlike the trauma of a hurricane or fire. “It’s not the type of disaster that Americans specifically are used to dealing with,” says Samantha Montano of Massachusetts Maritime Academy, who studies disasters. “Famines and complex humanitarian crises are closer approximations.” Health experts are burning out. Long-haulers are struggling to find treatments or support. But many Americans are turning away from the pandemic. “People have stopped watching news about it as much, or talking to friends about it,” Redbird says. “I think we’re all exhausted.” Optimistically, this might mean that people are becoming less anxious and more resilient. More worryingly, it could also mean they are becoming inured to tragedy.

The most accurate model to date predicts that the U.S. will head into November with 220,000 confirmed deaths. More than 1,000 health-care workers have died. One in every 1,125 Black Americans has died, along with similarly disproportionate numbers of Indigenous people, Pacific Islanders, and Latinos. And yet, a recent poll found that 57 percent of Republican voters and 33 percent of independents think the number of deaths is acceptable. “In order for us to mobilize around a social problem, we all have to agree that it’s a problem,” Lori Peek says. “It’s shocking that we haven’t, because you really would have thought that with a pandemic it would be easy.” This is the final and perhaps most costly intuitive error …

9. The Habituation of Horror

The U.S. might stop treating the pandemic as the emergency that it is. Daily tragedy might become ambient noise. The desire for normality might render the unthinkable normal. Like poverty and racism, school shootings and police brutality, mass incarceration and sexual harassment, widespread extinctions and changing climate, COVID-19 might become yet another unacceptable thing that America comes to accept.

 

 

 

 

Fauci Says It Will Be ‘Well Into 2021’ Before U.S. Returns To Normal From Coronavirus

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Credibility, Economic Crisis, Economic Recovery, Economic Stimulus, Election, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, False Hope, False Narrative, Food and Drug Administration (FDA), Honesty, Infection Control, Infection Control Plan, Infectious Virus, Integrity, Leadership Decentralized, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Transparency, Trust, Truth, Vaccine • Leave a comment

https://www.forbes.com/sites/sarahhansen/2020/09/11/fauci-says-it-will-be-well-into-2021-before-us-returns-to-normal-from-coronavirus/#4eb5a0862f7c

Dr Anthony Fauci disagrees with Trump over the coronavirus says US has not turned the final corner | Daily Mail Online

TOPLINE

Dr. Anthony Fauci, the country’s top infectious disease official, told MSNBC on Friday that because of the timeline for manufacturing and distributing a coronavirus vaccine, it will be well into next year before American life returns to normal.

 

KEY FACTS

President Trump suggested this week that a vaccine will be ready in time for November’s election, but Fauci has said such an accelerated timeline is not realistic. 

Fauci said Friday it’s possible that a vaccine could be available by the end of this year or early 2021.

Manufacturing the vaccine in large quantities and distributing it to the majority of the population will take significantly longer, however, meaning that returning to “normal” life—including indoor and enclosed activities like movie theaters—won’t happen until the middle or end of next year. 

Fauci on Friday also refuted Trump’s comments Thursday that the U.S. is “rounding the corner” on coronavirus, characterizing the current data on the virus, which shows about 40,000 new cases and 1,000 deaths a day, as “disturbing.”

During a discussion with doctors from Harvard Medical School on Thursday, Fauci said the U.S. needs to prepare to “hunker down” this fall and winter and warned against looking only at the “rosy side of things,” CNBC reported. 

 

CRUCIAL QUOTE

“If you’re talking about getting back to a degree of normality, which resembles where we were prior to COVID, it’s gonna be well into 2021,” Fauci said. “Maybe even towards the end of 2021.”

 

KEY BACKGROUND

According to a New York Times tracker, there are 38 coronavirus vaccine candidates being tested on humans in clinical trials. This week, pharma giant AstraZeneca announced it had paused a late-stage vaccine trial after a participant developed what is suspected to be an adverse reaction to the drug. The heads of nine pharma companies have also pledged that they would not submit their coronavirus vaccine candidates to regulators until they are shown to be safe and effective in large critical trials. 

 

 

 

 

The Pandemic’s Most Treacherous Phase

Posted on by • Posted in 2020 Election Issues, Coronavirus, Economic Crisis, Economic Recovery, Economic Stimulus, Federal Reserve, Herd Immunity, Infection Control, Infection Control Plan, Infectious Virus, Job, Job Loss, Job Market, Job Search, Job Security, Leadership Decentralized, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Superspreader, Superspreader Event, Superspreader Facilities, Superspreading Events, Vaccine • Leave a comment

https://www.project-syndicate.org/commentary/us-pandemic-crisis-will-worsen-in-october-by-barry-eichengreen-2020-09?utm_source=Project+Syndicate+Newsletter&utm_campaign=d57658f7c7-sunday_newsletter_13_09_2020&utm_medium=email&utm_term=0_73bad5b7d8-d57658f7c7-105592221&mc_cid=d57658f7c7&mc_eid=5f214075f8

The most dangerous phase of the COVID-19 crisis in the US may actually be now, not last spring. If the economy falters a second time, whether because of inadequate fiscal stimulus or flu season and a second COVID-19 wave, it will not receive the additional monetary and fiscal support that protected it in the spring.

April marked the most dramatic and, some would say, dangerous phase of the COVID-19 crisis in the United States. Deaths were spiking, bodies were piling up in refrigerated trucks outside hospitals in New York City, and ventilators and personal protective equipment were in desperately short supply. The economy was falling off the proverbial cliff, with unemployment soaring to 14.7%.

Since then, supplies of medical and protective equipment have improved. Doctors are figuring out when to put patients on ventilators and when to take them off. We have recognized the importance of protecting vulnerable populations, including the elderly. The infected are now younger on average, further reducing fatalities. With help from the Coronavirus Aid, Relief, and Economic Security (CARES) Act, economic activity has stabilized, albeit at lower levels.

Or so we are being told.

In fact, the more dangerous phase of the crisis in the US may actually be now, not last spring. While death rates among the infected are declining with improved treatment and a more favorable age profile, fatalities are still running at roughly a thousand per day. This matches levels at the beginning of April, reflecting the fact that the number of new infections is half again as high.

Mortality, in any case, is only one aspect of the virus’s toll. Many surviving COVID-19 patients continue to suffer chronic  and impaired mental function. If 40,000 cases a day is the new normal, then the implications for morbidity – and for human health and economic welfare – are truly dire.

And, like it or not, there is every indication that many Americans, or at least their current leaders, are willing to accept 40,000 new cases and 1,000 deaths a day. They have grown inured to the numbers. They are impatient with lockdowns. They have politicized masks.

This is also a more perilous phase for the economy. In March and April, policymakers pulled out all the stops to staunch the economic bleeding. But there will be less policy support now if the economy again goes south. Although the Federal Reserve can always devise another asset-purchase program, it has already lowered interest rates to zero and hoovered up many of the relevant assets. This is why Fed officials have been pressing the Congress and the White House to act.

Unfortunately, Congress seems incapable of replicating the bipartisanship that enabled passage of the CARES Act at the end of March. The $600 weekly supplement to unemployment benefits has been allowed to expire. Divisive rhetoric from President Donald Trump and other Republican leaders about “Democrat-led” cities implies that help for state and local governments is not in the cards.

Consequently, if the economy falters a second time, whether because of inadequate fiscal stimulus or flu season and a second COVID-19 wave, it will not receive the additional monetary and fiscal support that protected it in the spring.

The silver bullet on which everyone is counting, of course, is a vaccine. This, in fact, is the gravest danger of all.

There is a high likelihood that a vaccine will be rolled out in late October, at Trump’s behest, whether or not Phase 3 clinical trials confirm its safety and effectiveness. This specter conjures memories of President Gerald Ford’s rushed swine flu vaccine, also prompted by a looming presidential election, which resulted in cases of Guillain-Barré syndrome and multiple deaths. This episode, together with a fraudulent scientific paper linking vaccination to autism, did much to help foster the modern anti-vax movement.5

The danger, then, is not merely side effects from a flawed vaccine, but also widespread public resistance even to a vaccine that passes its Phase 3 clinical trial and has the support of the scientific community. This is especially worrisome insofar as skepticism about the merits of vaccination tends to rise anyway in the aftermath of a pandemic that the public-health authorities, supposedly competent in such matters, failed to avert.

Studies have shown that living through a pandemic negatively affects confidence that vaccines are safe and disinclines the affected to vaccinate their children. This is specifically the case for individuals who are in their “impressionable years” (ages 18-25) at the time of exposure, because it is at this age that attitudes about public policy, including health policy, are durably formed. This heightened skepticism about vaccination, observed in a variety of times and places, persists for the balance of the individual’s lifetime.

The difference now is that Trump and his appointees, by making reckless and unreliable claims, risk aggravating the problem. Thus, if steps are not taken to reassure the public of the independence and integrity of the scientific process, we will be left only with the alternative of “herd immunity,” which, given COVID-19’s many known and suspected comorbidities, is no alternative at all.

All this serves as a warning that the most hazardous phase of the crisis in the US will most likely start next month. And that is before taking into account that October is also the beginning of flu season.

 

 

Nearly half of Americans hesitant to get a COVID vaccine

Posted on by • Posted in Clinical Research, Coronavirus, Food and Drug Administration (FDA), Pandemic, Physician, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Scientists, Transparency, Trust, Truth, Vaccine • Leave a comment

https://mailchi.mp/365734463200/the-weekly-gist-september-11-2020?e=d1e747d2d8

The race for a COVID-19 vaccine is well underway, with dozens of vaccine candidates being tested worldwide. Because vaccines typically take a decade to get to market, the pace of Operation Warp Speed—which aims to deliver a COVID vaccine by January 2021—has raised concerns that the government will sacrifice vaccine safety and efficacy for speed.

Shown in the graphic above, a survey conducted by Jarrard Phillips Cate & Hancock and Public Opinion Strategies found nearly half of American adults are on the fence about getting a COVID-19 vaccine, with over 20 percent saying they are unlikely to get one at all.

This hesitancy is greater among both female and Black respondents—with the latter doubly concerning given that Blacks have been disproportionately impacted by the disease. The top reasons given for skepticism include concerns about side effects (47 percent) and the risk of becoming infected by the vaccine (22 percent).

A related survey from STAT and the Harris Poll found that 78 percent of Americans worry the vaccination approval process is being driven more by politics than science.

Whom do consumers trust for information? Their doctors. Physicians must be prepared to answer questions about how they have evaluated a vaccine, why they believe it to be safe and effective, and whether they have chosen to take it themselves.

As providers prepare to deliver millions of vaccine doses once one is approved and available, leveraging the trust inherent in physician-patient relationships will be essential, especially among vaccine-hesitant populations.

 

 

 

 

Major coronavirus vaccine trial is paused to investigate unexplained illness

Posted on by • Posted in 2020 Election Issues, Clinical Research, Coronavirus, Election, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Food and Drug Administration (FDA), National Institute of Health (NIH), Pharmaceutical Industry, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Scientists, Vaccine • Leave a comment

https://www.washingtonpost.com/health/2020/09/09/astrazeneca-covid-vaccine-safety-trial/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR2gomNZclHdUubRHKRqa3u5a6b06VEM2-wwNYFHitq9pK8_5ya8XflTFI0

The halt shows that safety protections are working, experts say

A major coronavirus vaccine trial is on hold as an independent committee investigates whether a case of spinal inflammation in a single British participant is linked to the vaccine — a step that several experts said is a sign of the protections in place to ensure the safety of products ultimately used in millions of healthy people.

The hold on human testing of the vaccine candidate being developed by the pharmaceutical company AstraZeneca and the University of Oxford was confirmed by the company in a statement Tuesday evening, calling it a “routine action.”

“The announcement yesterday about the AstraZeneca vaccine is a concrete example of how even a single case of an unexpected illness is sufficient to require a clinical hold for the trial in multiple counties,” said Francis Collins, director of the National Institutes of Health, at a Senate hearing.

The announcement comes as scientists and a growing numbers of Americans express concern about the politicization of the vaccine approval process during a presidential election campaign. President Trump has made approval of a coronavirus vaccine a cornerstone of his campaign and repeatedly said it could be greenlighted before the Nov. 3 election.

But Collins and other scientists pointed to AstraZeneca’s decision as evidence that scientists, rather than politicians, are running the process. The experts said that it was hard to estimate how long the investigation would take, but that the pause was a good sign and not unexpected in trials of this size and scale, where many thousands of people are closely followed.

Collins testified that while minimal information is available about the adverse event, he has heard it described as transverse myelitis, rare inflammation of the spinal cord that has been associated with vaccinations, but has also been documented in a few cases of covid-19 and can occur in immune system disorders such as multiple sclerosis.

A study in the journal Lupus reported that between 1970 and 2009, there were 37 cases of transverse myelitis associated with various vaccines.

“The event is being investigated by an independent committee, and it is too early to conclude the specific diagnosis,” said AstraZeneca spokesman Brendan McEvoy.

Serious adverse events are closely monitored in clinical trials to determine whether they are likely to be linked to the drug or vaccine being administered. In trials with many thousands of people, sicknesses are likely to occur, and they may have no connection to the drug or vaccine being tested.

Collins also said he was not worried that the delay or even possible elimination of the AstraZeneca vaccine candidate would limit the eventual availability of vaccines to Americans.

“The reason we’re investing not in one, but in six different vaccines is because of the expectation that they won’t all work,” he told members of the Senate Health, Education, Labor and Pensions Committee.

“To have a clinical hold as has been placed on AstraZeneca as of yesterday because of a single serious adverse effect is not at all unprecedented,” Collins said.

He said that if after a thorough investigation, the adverse reaction is traced back to the vaccine candidate, then all the doses of that vaccine being manufactured would be thrown away. The United States has committed up to $1.2 billion to AstraZeneca to support development of the vaccine and to purchase 300 million doses.

A hold on a trial is not common, but is also not cause for alarm — it is a sign the system in place to protect participants is working, said Susan Ellenberg, a biostatistician at the University of Pennsylvania who has served on the independent data safety monitoring boards that investigate such incidents.

“The process is when something unusual develops, they might want to put a hold on things — and given the incredible attention that’s being given to these vaccines, and the recognition of how fast we’re trying to go, I think people are bending over backwards to show safety is really the top priority,” Ellenberg said.

This is the second pause for the trial. An information sheet for study participants from July noted that the trial had been put on hold after a participant developed neurological symptoms, but those were determined to be caused by an “unrelated neurological illness.”

“I think the company is being prudent to stop and look and to determine whether this severe adverse event, whatever it is, was a coincidence that followed vaccination, or was caused by the vaccine,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “The vaccine is designed to prevent covid-19, not everything else” that adults might develop.

The pause came a day after the leaders of nine drug companies signed a highly unusual pledge that they would be guided by science and prioritize safety in their effort to develop a coronavirus vaccine, amid worries that political pressure could lead to an unsafe or ineffective vaccine to be used in millions of healthy people.

“This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” Pascal Soriot, the AstraZeneca chief executive, said in a statement. “We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

“Even if it turns out this is causally related to the vaccine, that doesn’t automatically mean this is something you might not carry on,” said Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health. “The benefit versus risk needs to be evaluated with the likelihood of each of these things and is clearly context dependent. If there was no covid in the world, you’d not want to take a vaccine.”

But Collins underscored at the hearing that the safety review and pause was just another reason that the United States was spreading its bets so widely, investing in six different vaccines. The United Kingdom has also made purchasing agreements for six vaccines in the final stages of human testing.

At a news conference at 10 Downing Street on Wednesday, United Kingdom chief scientific adviser Patrick Vallance said it was not unusual for a large Phase 3 trial test of effectiveness and safety of vaccines to be paused.

This is precisely why a Phase 3 trial is undertaken, he said.

“A pause is obviously not good,” Vallance said. “But it is sensible to look closely to see what is going on.”