A key FDA vaccine committee declined to vote on a Covid-19 vaccine

Food and Drug Administration officials on a key committee said Thursday they were not planning to make a decision about granting emergency approval for a Covid-19 vaccine just yet. This all but ends the chances of a vaccine getting the green light in the US before the November 3 presidential election, and likely over the next month.

The Vaccines and Related Biological Products Advisory Committee was convened to go over the early results of Covid-19 vaccine clinical trials, the benchmarks to approve a vaccine candidate, and how to maintain safety throughout the process. However, no decisions are on the agenda.

“Of note, the committee is not asked today to vote on any issues discussed,” said Marion Gruber, director of the Office of Vaccines Research and Review at the FDA during the meeting.

President Trump has made it clear that a Covid-19 vaccine would improve his electoral prospects, and he has been leaning on regulators like the FDA to approve a vaccine on this timeline. That’s raised concerns that the agency would yield to political pressure and grant approval to a vaccine before it’s ready.

Trump also put out a video earlier this month saying that a vaccine would be cleared for use soon after the election. “We’re going to have a great vaccine very, very shortly,” Trump said. “I think we should have it before the election, but frankly the politics gets involved and that’s okay, they want to play their games, it’s going to be right after the election.”

But while vaccine development is proceeding in record time, researchers and other experts have said many times such a deadline is unlikely. Even the Trump administration’s own health officials at the Centers for Disease Control and Prevention have already said November is nearly impossible.

There are now 11 vaccines in phase 3 trials, including candidates from companies like Moderna, AstraZeneca, and Pfizer. However, some of these companies have only just completed enrollment in large-scale clinical trials, at which point they will have to administer the vaccine and observe infection patterns, which could take months.

And although there’s currently no evidence that the White House is directly meddling in vaccine research, some scientists worry that the president’s public pronouncements about a vaccine — especially ones so nakedly tied to his political prospects — are a form of interference that could undermine the fragile public confidence needed to deploy it successfully.

Trump has “created enough perception of political interference that there may not be deep trust in a vaccine, even if it’s a good product,” said Nicole Lurie, who led emergency preparedness at the Department of Health and Human Services (HHS) under President Barack Obama. “There is incredible public skepticism of the [FDA] because of what’s happened with prior emergency use authorizations, and because the president appears to continue to try to mess with the system.”

However, according to researchers, it’s unlikely the FDA would compromise a vaccine, given the vastly higher stakes for public health. Even getting to the point of considering emergency use for a vaccine would require much more information than it has now, and gathering that data requires several critical and time-consuming steps.

Why getting a vaccine approved by November is nearly impossible

Prior to the coronavirus, the fastest a vaccine had ever been developed was four years (for mumps). Most vaccines have taken a decade or longer.

But with the Covid-19 pandemic, scientists and governments have poured a staggering amount of money and know-how into the vaccine effort. That’s led to rapid progress.

It took researchers just over two months between the time the virus’s genome was sequenced and when phase 1 human vaccine trials began. There are now 11 vaccine candidates in phase 3 clinical trials, the final step before a vaccine gets the green light for widespread use.

That’s why some scientists are optimistic that a vaccine could gain approval by the end of the year or early 2021.

But phase 3 trials are slow and tedious. There’s little that can be done to speed them up, and they’ve only just begun. Although the Russian government recently said it has a Covid-19 vaccine ready to go, other researchers have warned that the vaccine, known as Sputnik V, didn’t go through this critical step and was tested in only 76 people. And even if it is a viable vaccine, it would still need to gain FDA approval before it could be used in the US, which demands more data.

Jonathan Zenilman, a professor at the Johns Hopkins University School of Medicine who has overseen clinical trials for vaccines, explained that Covid-19 phase 3 trials are large, aiming to enroll 30,000 participants each. For example, Moderna, a company developing an mRNA Covid-19 vaccine, is one of the teams that’s furthest along. It was the first in the US to start enrolling participants across 89 sites for its phase 3 trial.

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Phase 3 requires recruiting participants from more diverse backgrounds compared with those in earlier testing stages in order to better represent the population at large, including people with some preexisting health conditions. (Participants are screened to ensure they don’t have conditions like immune system disorders that could cause complications with a vaccine.)

These participants also have to consent to being tracked by scientists for the duration of the trial, which is typically two years. They’re randomly split into groups that receive either the vaccine or a placebo. In a double-blind trial, neither the recipients nor the people administering the vaccine know at the outset who received the vaccine. That ensures participants won’t change their behavior in a way that could interfere with the trial (a person who knows they have a Covid-19 vaccine could end up taking more risks, for example).

Finding tens of thousands of people who meet all these requirements for a phase 3 trial is tedious. Simply enrolling enough people is a process that can take months.

Although some Covid-19 vaccine phase 3 trials began in July, few have completed the enrollment process. Moderna said it is close to wrapping up enrollment.

After getting consent from volunteers and enrolling them in the trial, you have to give them the vaccine. Many Covid-19 vaccine candidates require two doses spaced up to four weeks apart, so just getting someone the full vaccine dose can take around a month. For most of the vaccine candidates in phase 3 trials, that would take them well into, if not past, October.

“Then you have to wait for people to get Covid, and you can’t do anything with the data until you have a certain number of Covid cases,” Zenilman said. To get a statistically meaningful result, researchers typically wait until they see around 150 infections in their group. At that point, they can “break the blind” and see who got the vaccine and who got the placebo — and compare the numbers to see whether it’s working.

Right now, many places in the US are still maintaining pandemic control measures such as social distancing and mask-wearing. Such tactics help control the spread of the virus, but for a vaccine trial, they also limit how quickly research teams can get the data necessary to draw conclusions about whether the vaccine is working. That’s why researchers are aiming to test their vaccines in rising Covid-19 hot spots.

There is also no guarantee that any vaccine will clear clinical trials. And the first vaccine to gain approval would not be available for widespread use right away. Health officials have to contend with the logistics of manufacturing, distributing, and administering the millions of doses needed to control the Covid-19 pandemic, which could take years.

Moderna CEO Stéphane Bancel said on September 30 that his company’s vaccine, which is one of the candidates furthest ahead in clinical trials, would not be ready for widespread distribution until next spring. He told the Financial Times that the company wouldn’t even consider applying for an emergency use authorization until November 25.

It’s also likely that no single vaccine will be suited to everyone. Several vaccines will be needed to protect different demographics, including older people, those with weaker immune systems, or those with certain preexisting health conditions. So even after the first Covid-19 vaccine gets approved, some people will still have to wait for other clinical trials to conclude.

Officials say they will not budge on vaccine safety and efficacy rules

FDA regulators are adamant that a vaccine will not be approved until it is demonstrated to be safe and effective. According to FDA guidelines, a vaccine needs to provide protection against the coronavirus for at least 50 percent of the people who get it. The safety benchmarks are higher for vaccines than for other drugs because vaccines are given to vastly more people, which magnifies infrequent problems. And since vaccines are given to healthy people rather than those who are already sick, there is a lower tolerance for side effects.

But at the same time, HHS launched the $10 billion Operation Warp Speed in June with the explicit aim of delivering 300 million doses of a Covid-19 vaccine by January 2021.

In an August 7 editorial in JAMA, FDA Commissioner Stephen Hahn acknowledged the tension between the need for speed and the need to hew closely to established rules.

Hahn and his co-authors, Anand Shah and Peter Marks, wrote that “the emphasis on speed has provoked public anxiety about the safety and effectiveness of vaccines developed on expedited timelines. Among the concerns are that the regulatory standards for approval will be lowered under political pressure for a vaccine.”

However, Hahn and his co-authors also wrote that “there is a line separating the government’s efforts to focus resources and funding to scale vaccine development from FDA’s review processes.” In other words, the FDA says it will not compromise its standards for approving a vaccine, despite pressure for faster results.

But what about the emergency use authorization (EUA) process? Could the FDA create a limited exception for a vaccine like it did with hydroxychloroquine?

Marks, the director of the Center for Biologics Evaluation and Research at the FDA (the body that governs vaccine approval), said the agency could do that, in theory. But as with the agency’s standard process, the rubric is stricter for a vaccine than for a drug, and regulators would still need to see data demonstrating that a vaccine meets the minimum benchmark of preventing infection in 50 percent of people who have been vaccinated.

“I think as we think about EUA here, the calculus for a vaccine is going to be different than the calculus for therapeutic,” Marks told reporters at the National Press Foundation on August 12. “I think we … optimally would like to see the data that’s from a trial that’s reached its efficacy endpoint.”

That would come near the end of a phase 3 trial, which, again, is unlikely to yield results for months. So there may not be enough evidence to warrant vaccine approval before the November election, even on an emergency basis.

And if there were political meddling to push out a vaccine before it’s ready, in spite of all these constraints, there would be strong opposition among the career scientists at the FDA. “I think you would see a revolt at the agency,” Zenilman said.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a recent interview with Today, Explained host Sean Rameswaram that he is also confident the process will be transparent.

“The FDA has pledged publicly multiple times that they will not approve a vaccine unless they’ve established that nonpolitical scientists agree that it’s safe and effective … And if it turns out somebody tries to force it out, I tell you, I will be one of the first ones that will object to that,” Fauci said.

Trust is critical for deploying a Covid-19 vaccine. But trust is fragile.

A vaccine can’t end the Covid-19 pandemic on its own. It has to be given to enough people to achieve herd immunity, at which point a large enough percentage of a population is protected against the virus so that it can’t easily spread.

Even in the most ideal scenario with a highly effective vaccine, getting to herd immunity would require immunizing millions of people. And already, many in the United States are saying they wouldn’t get vaccinated. A Gallup poll conducted July 20 to August 7 found that one-third of Americans said they would not get an approved Covid-19 vaccine if it were ready immediately. A CNN poll conducted August 12-15 found that 56 percent of Americans said they would get a vaccine, a decline from 66 percent in May.

Whether due to general hesitancy around vaccines or swirling conspiracy theories, public health researchers are concerned that if enough people don’t elect to get immunized, the Covid-19 pandemic will persist.

That’s why even the appearance that political considerations influenced vaccine approval could be dangerous.

Vaccine makers have pushed back against the pressure to speed up development even further as well because if the public perceives a vaccine was rushed, it could make people hesitant to use their product.

“The perception of political pressure and the perception of things being hurried really risks trust,” said Jesse Goodman, a former chief scientist at the FDA who’s now a professor of medicine at Georgetown University. “It’s not just trust in this Covid vaccine, but trust in the whole public health response to Covid and trust in vaccines in general.”

In March, after the president repeatedly promoted the anti-malaria drug hydroxychloroquine as a treatment for Covid-19, the FDA issued an emergency use authorization for the medicine, despite scant evidence of its effectiveness. In June, the FDA revoked this authorization.

Restoring that trust will take time. It will require transparency about the progress and results of clinical trials, as well as how decisions are made in federal agencies. It will also demand clear and coherent messaging.

But even that might not be enough.

“Personally, I think it will take a new president and new leadership at the top of the FDA before we’re going to be at a point where the public can start to have more trust,” said Lurie.

Which means that even with the urgency of thousands of people dying, taking the time to get a vaccine right is critical — from the vaccine itself to how it’s tested, documented, communicated, and administered. Rushing will likely only cost us more time.

Trump failed on the opioid crisis — and Democrats are letting him get away with it

The Republican National Convention on Tuesday spent more time on the opioid epidemic than the entirety of the Democratic National Convention.

In a touching speech, Ryan Holets, a police officer in New Mexico, told a story about how he adopted a child from a person struggling with homelessness and drug addiction. “Today, our beautiful daughter, Hope, is a thriving 2-year-old,” Holets said. “Crystal [the biological mother] is approaching three years of recovery. She is a dear friend and a constant inspiration to me and others.”

Since this was a political convention, Holets used the speech to support President Donald Trump’s reelection, boasting about Trump approving $3 billion a year in new funding to help combat opioid misuse and launching efforts to reduce opioid painkiller prescriptions.

“And it’s having an impact,” Holets claimed. “Drug overdose deaths decreased in 2018 for the first time in 30 years. Many of the states hardest hit by the opioid crisis are seeing the largest drop in deaths. We’re seeing that doctors are writing fewer prescriptions for opioid pain drugs. These are significant improvements that have a meaningful impact.”

The reality, however, is not so great. While drug overdose deaths did dip from a record high from 2017 to 2018, preliminary federal data shows overdose deaths increased in 2019, and local and state data suggests that 2020 will be even worse due to problems caused by the Covid-19 pandemic and the continued spread of fentanyl, a dangerous synthetic opioid, in illegal drug markets.

In fact, experts broadly agree that Trump and the federal government simply haven’t done anywhere near enough to address the opioid crisis. Referring to the 2018 drop in overdose deaths, Stanford drug policy expert Keith Humphreys recently told me, “I’m not sure that’s because of anything we did.”

Instead, the same structural problems that led to the opioid crisis and allowed it to fester remain: America still doesn’t support addiction treatment anywhere near enough, the treatment facilities that do exist are often detached from evidence and even fraudulent, harm reduction services like needle exchanges remain underused, and there’s still far too much opioid prescribing. For years, experts have called for a significant investment — including health care reform and tens of billions of dollars — to fix these problems, but nothing from the federal government, including under Trump, has approached the scale warranted.

So overdose deaths increased again in 2019 and are set to increase further in 2020.

But you wouldn’t know Trump’s failure from the Democratic National Convention. Based on the transcripts for all four nights of the DNC, Democrats didn’t mention “addiction,” “opioid,” or “overdoses” a single time at their convention.

It’s not because they don’t have a plan. Former Vice President Joe Biden, the Democratic nominee, has a very good plan — one that would make a serious investment into treatment and harm reduction as well as crack down on opioid prescriptions.

It’s also not because the issue isn’t politically salient. Several swing states, including Ohio and Pennsylvania, are among the most affected by the drug overdose crisis. An analysis by historian Kathleen Frydl found that the Ohio and Pennsylvania counties that flipped from Barack Obama to Donald Trump in the 2016 presidential election were hit particularly hard by opioid overdose deaths.

Yet Democrats seem ready to let Trump own the issue, even as many experts and activists say Trump has failed on it.

Trump’s approach to the opioid crisis has failed

Based on the preliminary federal data, drug overdoses spiked in 2019 to more than 72,000. That was higher than the previous record high for a single year, of less than 72,000 in 2017, meaning, if the early data is right, that all of the gains from 2018’s decline were erased and then some.

At the same time, there are several signs that things will be even worse in 2020. Fentanyl, which has increasingly supplanted heroin in illegal drug markets, appears to be spreading to the West of the US — a huge point of concern because fentanyl, as a more potent opioid than heroin, is more likely to cause overdoses. Overdoses involving stimulants, like cocaine and meth, are also going up.

All of this, experts say, is a result of federal inaction. It’s not that Trump and Congress have done literally nothing, but what they’ve done has been far too little: The single-digit billions they’ve put toward the issue fall short of the tens of billions experts say is needed, and their regulatory tweaks to improve access to treatment amount to too little, too late. The addiction treatment system remains not just underfunded but under-regulated, allowing fraud and abuse to take root in many facilities and a failure to follow any evidence-based practices in others.

Leana Wen, a health policy expert at George Washington University, summarized much of the expert consensus when she described the federal moves so far as “tinkering around the edges.”

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On these fronts, Trump hasn’t suggested going much bigger — and has at times proposed significant cuts to agencies involved in fighting the opioid epidemic.

So the crisis continues and, in most years, keeps getting worse, contributing to a decline in life expectancy in recent years.

The other actions Trump has proposed wouldn’t do much about the issue, either. He’s said his wall at the US-Mexico border would help keep drugs out, but the evidence suggests it wouldn’t. He’s called for tougher prison sentences and the death penalty for high-level drug dealers, but that’s discredited by a body of research finding that tougher criminal penalties don’t slow the flow of drugs into the US.

In fact, Trump has put out multiple proposals that would make the overdose crisis worse. For one, he’s repeatedly called for repealing the Affordable Care Act (“Obamacare”) and advocated for cutting Medicaid. The ACA alone expanded access to health care, including addiction treatment, to hundreds of thousands of people with addictions. A recent study in JAMA Network Open linked Obamacare’s Medicaid expansion to a 6 percent reduction in opioid overdose deaths.

Trump did declare a national emergency over the opioid crisis. But that led to almost nothing, as the Government Accountability Office concluded in a report. (The emergency declaration lapsed for nine days in January, as Dan Diamond reported for Politico, and no one seemed to notice.)

These failures were in some ways a prelude to the Covid-19 pandemic. The opioid crisis is an issue Trump should have taken seriously — it’s important to the country, but particularly his base of white voters without a college education, whom the crisis has hit especially hard. Yet Trump simply hasn’t taken the issue seriously or made it a major priority throughout his administration. As with Covid-19, the political incentives are there, but the president’s magical thinking and refusal to do the tough work of policymaking and governing has left a void of federal inaction on a serious public health issue.

Democrats aren’t talking about the opioid epidemic. They should.

Meanwhile, Democrats aren’t bringing attention to Trump’s failures. At their convention last week, they didn’t mention the opioid crisis at all.

Biden does have a plan. It would put $125 billion over 10 years — the largest commitment of any 2020 campaign — to scale up addiction treatment and other prevention and recovery programs, paid for with higher taxes on pharmaceutical companies’ profits. It would take steps to stop the overprescription of opioid painkillers while encouraging better care for chronic pain, and it would try to slow the flow of illicit drugs from China and Mexico. It would also move to “reform the criminal justice system so that no one is incarcerated for drug use alone.”

It’s a plan that could help a lot of people. It could help from a purely cynical political perspective: Ohio and Pennsylvania, two swing states, are among the hardest hit by the crisis in recent years.

It’s also a plan that could actually happen. While Democrats have spent a lot of the campaign talking about sweeping health care reform, a Green New Deal, and massive economic investments, these are proposals that are, frankly, not very likely to become law even if Biden wins the White House, especially if Republicans keep control of the Senate.

The opioid crisis is different. Several Republican senators, including Rob Portman (OH) and Shelley Moore Capito (WV), have shown a lot of interest in getting work done on the crisis. It’s telling that one of the few major pieces of legislation Trump has done was related to the opioid epidemic, even if experts agree it was too little, too late.

Simply put, starting from a place in which some Republicans and all Democrats are willing to work on an issue is certainly much better than a place in which no Republicans and not even all Democrats are willing to do something significant.

The issue could become even more relevant in the next few years. As Covid-19 (hopefully) fades, the overdose crisis will, unfortunately, stick around — and, based on the data, may even get worse as fentanyl spreads and stimulants make a comeback. With the right leadership, that could push the federal government to more action.

There are good reasons to be skeptical about whether Biden could get the full $125 billion he’s proposing to fight the opioid crisis. One thing I’ve heard consistently from sources in Congress is Republicans in particular are skeptical of spending too much money on addressing the overdose crisis. That will continue into a Democratic administration, likely even more so as Republicans become resistant to giving a Democratic president a victory.

But that’s all the more reason for Democrats to highlight the issue. There are substantial differences here between the parties, on top of Biden versus Trump, that could make a big difference in people’s lives.

Democrats so far aren’t doing that. So Trump gets to own the issue, despite his poor performance.

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Hurricane Laura hits Gulf Coast as an “extremely dangerous” storm

The National Hurricane Center warned that Hurricane Laura will cause “life-threatening storm surge” reaching up to 40 miles inland and rising up to 20 feet as the storm made landfall in Texas and Louisiana.

Laura reached the Gulf Coast after midnight on Thursday morning at an “extremely dangerous” Category 4 strength, with winds reaching 140 mph. After landfall, it weakened to a still dangerous Category 2 storm.

During a Wednesday news conference, Louisiana Gov. John Bel Edwards said Laura’s storm surge would reach levels not seen since 1957’s Hurricane Audrey.

“The storm surge flooding is starting now in Louisiana,” Edwards said. “It’s well ahead of the storm. It will just get worse over the next day or so.”

Texas Gov. Greg Abbott implored residents to evacuate. “The conditions of this storm are unsurvivable, and I urge Southeast Texans to take advantage of these final few hours to evacuate, secure their property, and take all precautions to keep themselves and their loved ones safe,” he said at a Wednesday press conference.

Laura is expected to cause flash floods and a life-threatening storm surge in areas from High Island, Texas, to the mouth of the Mississippi River, inundating places that rarely see such high water levels.

About 20 million people reside in the path of the storm and more than 500,000 have been ordered to evacuate, a task complicated by the Covid-19 pandemic.

“The combination of a dangerous storm surge and the tide will cause normally dry areas near the coast to be flooded by rising waters moving inland from the shoreline,” the NHC reported in its latest hurricane bulletin. Storm surge, where high winds push water inland several feet above high tide, is often the deadliest consequence of hurricanes.

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Laura may also spawn tornadoes and drench the Gulf Coast with up to 10 inches of rainfall. Initially, Laura was projected to make landfall alongside Hurricane Marco, but Marco weakened to tropical storm strength and quickly fizzled out as it made landfall on Tuesday.

Laura, on the other hand, underwent rapid intensification, a hallmark of several recent major hurricanes. Rapid intensification is defined as a gain of 35 mph or more in wind speed over 24 hours. In Laura’s case, the storm went from below hurricane strength with 65 mph winds early Tuesday to Category 4 strength on Wednesday, then weakened somewhat to a Category 2 storm after hitting land, with winds still dangerously high. Further weakening is expected on Thursday.

The storm’s US landfall comes amid an unusually active hurricane season, one that the National Oceanic and Atmospheric Administration predicted back in May.

For Gulf Coast residents, Laura is stirring eerie echoes of past storms. Hurricane Harvey in 2017 swept over Texas at Category 4 strength and inundated Houston with a gargantuan amount of rain that left the city soaked for weeks.

Laura is also making landfall in the US around the 15th anniversary of Hurricane Katrina, a Category 5 storm that resulted in 1,200 deaths as it struck New Orleans. Both Harvey and Katrina are tied as the costliest storms on record. Laura is now the strongest August hurricane in the Gulf of Mexico since Katrina, Colorado State University meteorologist Phil Klotzbach told USA Today. The storm is believed to have killed at least 23 people in Haiti and the Dominican Republic.

The destruction recent storms caused was fueled by coastal development in vulnerable areas as well as climate change amplifying sea-level rise, and the damaging elements of extreme weather like heavy rainfall.

It’s likely Laura will also come with a high price tag. “I do expect this to be a multi-billion dollar disaster,” said meteorologist Jeff Masters on a conference call with reporters on Tuesday.

Forecasts show that Laura’s current course takes the storm far inland to states like Arkansas before hooking east on Friday.

How to follow Hurricane Laura:

  • The National Hurricane Center has a page updating every few hours with the latest watches and warnings for Laura. Check it out.
  • Follow the National Hurricane Center on Twitter; it will provide updates with all the latest forecasts, hazards, and warnings.
  • Follow the Capital Weather Gang’s Twitter account. These folks tend to live-tweet storm updates.
  • Here’s a Twitter list of weather experts via meteorologist and journalist Eric Holthaus. These experts will give you up-to-the-second forecasts and warnings.

New goal: 25,000

In the spring, we launched a program asking readers for financial contributions to help keep Vox free for everyone, and last week, we set a goal of reaching 20,000 contributors. Well, you helped us blow past that. Today, we are extending that goal to 25,000. Millions turn to Vox each month to understand an increasingly chaotic world — from what is happening with the USPS to the coronavirus crisis to what is, quite possibly, the most consequential presidential election of our lifetimes. Even when the economy and the news advertising market recovers, your support will be a critical part of sustaining our resource-intensive work — and helping everyone make sense of an increasingly chaotic world. Contribute today from as little as $3.

What makes California’s current major wildfires so unusual

Wildfires continue burning in California, with unhealthy air from smoke still cloaking some parts of the state. Combined with the Covid-19 pandemic, the fires are compounding risks that have been brewing for years.

Fire officials have grouped some of the smaller fires in an area into complexes to coordinate their response. The largest of these is the SCU Lightning Complex. It had burned more than 365,000 acres as of Wednesday across parts of the southern San Francisco Bay Area, including Santa Clara and Alameda counties. The SCU Lightning Complex was 25 percent contained as of Wednesday morning.

To the north, the LNU Lighting Complex near Napa has burned more than 357,000 acres and destroyed or damaged 937 structures. Thousands were forced to evacuate. The fire was 33 percent contained as of Wednesday morning, and officials anticipate the flames could spread further.

At least 650 wildfires have raged across the Golden State, burning more than 1.25 million acres, since August 15, leaving at least seven people dead, according to Cal Fire.

Many of the blazes were ignited by a massive dry lightning storm last week concentrated in the San Francisco Bay Area.

“We had close to 11,000 strikes in a matter of three days,” said Brice Bennett, a spokesperson for the California Department of Forestry and Fire Protection (Cal Fire). “With an already-warm weather pattern and very, very dry conditions here in California, with those lightning strikes coming through, over 367 new fires were started.”

Smoke, soot, and ash from the fires also shrouded Northern California in the dirtiest air in the world at several points last week.

Wildfires are nothing new for Californians, who have grown wearily accustomed to the destruction, smoke, and evacuations in recent years. But this summer’s blazes stand out for their scale, timing, locations, and intensity, even among recent record-breaking fire seasons. And as David Wallace-Wells writes for New York’s Intelligencer, “What is most remarkable about the fires of 2020 is that these complexes are burning without the aid of dramatic wind, which is typically, even more than the tinder of dry scrub and forest, what really fuels California fire.”

The wildfires are just one of several disasters affecting California right now. The state has been in a two-decade megadrought, and was scorched by a record-breaking heat wave in early August, with several days in a row of temperatures reaching triple digits in some places, even at night. Temperatures in Death Valley topped 130 degrees Fahrenheit. That heat led to rolling blackouts as utilities struggled to meet cooling demand.

All the while, the Covid-19 pandemic is still a threat, making the already difficult task of controlling wildfires even harder.

Here are the factors that have fueled the recent fires and are now complicating the efforts to control them.

Extreme heat, strange storms, and climate change set the stage for California’s fires

The lightning storm around the San Francisco Bay Area that sparked many of the current California fires was a rare event.

“The last time we had something like this was over a decade ago, actually,” said Bennett. The fact that lightning started these fires is also noteworthy. The vast majority of wildfires in California are ignited from human sources — power lines, arson, neglected campfires, and so on.

But the fires wouldn’t have been so bad were it not also for the extreme heat that’s been baking the state for weeks.

“This is a big, big, prolonged heat wave characterized not only by hot daytime temperatures but also record-warm overnight temperatures and an unusual amount of humidity,” said Daniel Swain, a climate scientist at the University of California Los Angeles and a researcher at the National Center for Atmospheric Research. “It turns out increased humidity plays a role in why there are so many fires right now.”

A decaying tropical storm earlier this month in the eastern Pacific Ocean sent a plume of moisture over California. Amid the scorching heat, the moisture formed clouds that generated immense amounts of wind, thunder, and lightning but very little rain. “The humidity was high enough to produce these thunderstorms, but not high enough to produce significant flooding rainfall that would mitigate fire risk,” Swain said.

Much of California’s vegetation was also parched and primed to burn, and concerns that this would be an exceptionally bad fire year started to emerge in February as the state emerged from one of its driest winters on record. This was then followed by an abnormally hot spring. “There were a number of unusually significant early-season heat waves this spring both in Northern and in Southern California,” Swain said.

And California is now experiencing the impacts of climate change, which is manifesting in fires. The weather in California is becoming more volatile. Temperatures are also rising, which is causing the state’s forests, grasslands, and chaparral to dry out even more. The state already has millions of dead trees stemming from years of drought and pests like pine beetles. More heat could stress these ecosystems even further.

“It’s not just how hot are the heat waves; it’s how hot is it the rest of the time,” Swain said. “What really matters is the sustained warming and drying over seasons and years.”

Some of California’s current fires are in areas that don’t regularly burn

It’s important to remember that fires are a normal part of the ecology in California, from the coniferous forests in the Sierra Nevada to the chaparral shrubland in the south. Periodic blazes clear out decaying vegetation, restore nutrients to the soil, and help plants germinate.

Humans, however, continue to make California’s wildfires worse at every step. By suppressing naturally occurring fires, fuel has accumulated in forests and shrublands, increasing the danger when fires do ignite. People are also building closer to areas that are prone to burn. That increases the likelihood of starting fires and raises the blazes’ damage toll. People have also introduced invasive plant species like eucalyptus trees, which have spread throughout California and readily ignite. And burning fossil fuels emits greenhouse gases that are warming the planet, increasing the amount of vegetation that can burn.

Even with this backdrop, some of the fires in California stand out because they are raging in places that don’t burn very often.

“I think what’s key to understand is that different parts of California have very different normal fire seasons,” said Crystal Kolden, an assistant professor of fire science at the University of California Merced. “And that’s in part because California is such a big state. It has really variable topography and different vegetation or ecosystems across the state.”

Because the coastal forests are under the influence of marine weather systems, they are much cooler and retain more moisture than the pine forests of the Sierra Nevada and other inland areas. The coastal forests do burn periodically and are home to many species that have adapted to fire, but they rarely ignite during the summer.

That some portions of them have burned is remarkable, a product of high atmospheric pressure over the area that allowed heat to accumulate and overwhelm the cooling effect from the ocean. “Those coastal areas are incredibly dry, incredibly hot relative to normal, and that arid and hot condition had this potential to have really explosive fires,” Kolden said.

Covid-19 is adding a wallop to California’s fires

The Covid-19 pandemic has rattled every part of society, and firefighting efforts are not immune. “It definitely has affected our response, primarily in our inmate fire crews,” Bennett said.

California often relies on prison labor to bolster its firefighting efforts, with almost 200 inmate fire crews. Inmates are paid between $2 and $5 a day, plus $1 per hour when fighting a fire. But with severe Covid-19 prison outbreaks in the state, some inmates were released to relieve overcrowding. Others were hampered by infections, and many remain under quarantine. The number of available inmate fire crews has been nearly halved.

Anticipating a severe fire season, state officials did line up an additional 800 seasonal firefighters, but they have to take additional precautions. Fire crews are essentially staying in small bubbles, where they live and work with just each other, to help limit coronavirus transmission.

At base camps where fire crews rest and refuel, officials have designated more space for workers to maintain social distance.

The state is also facing a budget crunch, with the economic slowdown because of the pandemic. That’s led some fire prevention maintenance measures — like clearing dry grass away from roads and buildings — to languish.

As for the Californians fleeing the fires, Covid-19 has made it harder to coordinate evacuations and shelters. The declining air quality from the wildfires is also a threat to people with Covid-19, since exposure to air pollution can damage airways and make people more susceptible to respiratory infection. Extreme heat also worsens the public health impact of Covid-19 as people spend more time in enclosed spaces together to avoid the heat.

And the current round of blazes may take weeks to extinguish, raising the concern that stiff autumn winds — the Santa Ana winds in the south and the Diablo winds in the north — may spread the flames again.

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Hurricane Laura: The danger of storm surge, explained

Hurricane Laura made landfall at 1 am ET Thursday in Cameron, Louisiana, as a fierce Category 4 hurricane with 150 mph winds. It has since downgraded to a Category 1 hurricane, with wind speeds of 75 mph, and is moving north.

But perhaps the most dangerous part of the storm may be the storm surge that still threatens coastal areas.

Storm surge, or coastal flooding, tends to be the deadliest aspect of hurricanes. It results from the storm’s winds pushing water onshore several feet above the normal tide, and it can trap people in their homes, wash away houses, and make rescue missions harrowing and slow. Rising sea levels linked to climate change have also increased the risk of storm surge and property damage in coastal cities and regions.

The National Hurricane Center (NHC) said Thursday morning a storm surge warning was still in effect from Sabine Pass, Texas to Port Fourchon, Louisiana; this kind of warning means a danger of life-threatening flooding. People located in these zones should follow evacuation and other instructions from local officials.

But so far, the highest storm surge reported seems is 9 feet, according to meteorologist Chris Gloninger:

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But other meteorologists say it’s too soon to assess the total storm surge from Hurricane Laura. The water pushed on land by the winds could also still reach up to 40 miles inland “and flood waters will not fully recede for several days after the storm,” according to the NHC.

The larger the area with tropical storm-force winds, the more potential for those winds to push water onshore, and the greater the impact of storm surge, Colorado State University atmospheric scientist Chris Slocum says. Portions of Louisiana, Mississippi, and Arkansas could also see up to 6 to 12 inches of rain with isolated totals of 18 inches from Laura, which will add to the floodwaters.

The storm surge “is a life-threatening situation,” the NHC warns in its latest forecast. “Persons located within these areas should take all necessary actions to protect life and property from rising water and the potential for other dangerous conditions.”

How to follow Hurricane Laura:

  • The National Hurricane Center has a page updating every few hours with the latest watches and warnings for Laura. Check it out.
  • Follow the National Hurricane Center on Twitter; it will provide updates with all the latest forecasts, hazards, and warnings.
  • Follow the Capital Weather Gang’s Twitter account. These folks tend to live-tweet storm updates.
  • Here’s a Twitter list of weather experts via meteorologist and journalist Eric Holthaus. These experts will give you up-to-the-second forecasts and warnings.

New goal: 25,000

In the spring, we launched a program asking readers for financial contributions to help keep Vox free for everyone, and last week, we set a goal of reaching 20,000 contributors. Well, you helped us blow past that. Today, we are extending that goal to 25,000. Millions turn to Vox each month to understand an increasingly chaotic world — from what is happening with the USPS to the coronavirus crisis to what is, quite possibly, the most consequential presidential election of our lifetimes. Even when the economy and the news advertising market recovers, your support will be a critical part of sustaining our resource-intensive work — and helping everyone make sense of an increasingly chaotic world. Contribute today from as little as $3.

Hurricane Laura was already a deadly storm before it reached the US

Before Hurricane Laura made landfall in the United States, it had already proved to be a deadly storm in three Caribbean countries, bringing torrential downpours, flooding, power outages, and other damage that killed over 20 people and has made life dangerous for millions more.

As a tropical storm, Laura pummeled the Dominican Republic last weekend with heavy rains and winds, impacting the capital Santo Domingo and the rest of the nation’s 11 million people. According to the country’s United Nations office, a total of nine people died due to the conditions that also damaged around 2,000 homes and left about 700,000 without power and around 1.5 million people without access to water.

The Miami Herald reported that a 7-year-old, Darwin Frias, and his 44-year-old mother, Clarissa, were killed in Santo Domingo after their house collapsed.

Videos circulating online showed roads and city streets, including those of Santo Domingo, completely flooded due to rainfall and swollen rivers. But Dominican authorities have said the damage is much more widespread, with downed trees and power lines along with broken roads that make it hard to provide essential services to the millions of affected people.

New Dominican President Luis Abinader has toured the country to reassure citizens the nation will get back on its feet. “It will take us several years,” Abinader told one woman who lost her home last weekend. “We will relocate you to somewhere safe and help you with everything. The government is here for you.”

The situation is also severe in Haiti, located west of the Dominican Republic on the island of Hispaniola. Haitian authorities report 21 people were killed after the storm hit the country on Sunday with about eight inches of rain and 50-miles-per hour winds.

While the Haitian government is still assessing the extent of the damage, the capital Port-au-Prince saw raging floods, and hundreds of thousands across the country remain without power. That’s a problem on its own, but it’s exacerbated by officials’ need to communicate with people in areas near flooded rivers and dams.

One important dam that produces electricity and irrigates crops, Peligre, was overflowing so much that authorities had to release much of its water. That put the crops in nearby valleys at risk, but the government had difficulty getting in touch with those in harm’s way without power.

“All the radio stations that are here who can call the people of the Artibonite, tell them, ‘Attention!’ Secure their belongings because there is going to be a lot of water in the Artibonite Valley,” Public Works Minister Nader Joaseus said on Sunday.

The storm weakened by the time it made it to Cuba on Monday. The island nation did see heavy rains that contributed to flooding in parts of the country and high winds that knocked out power lines, but no deaths were recorded by the government. And despite concerns that it wouldn’t hold, the seawall in the capital Havana wasn’t breached.

Cuba still has some reeling communities, though. Tens of thousands were forced to evacuate, finding shelter in government facilities or in the homes of relatives. River flooding in the mountainous southeastern region of Granma cut off certain towns from one another, and fires instigated by the storm heavily damaged a school and farm in Santiago de Cuba. Many coastal towns are still digging out of streets full of debris and mud.

But considering the damage to the Dominican Republic and Haiti, Cuba avoided the worst of the storm. Altogether, though, some experts believe the toll the storm took on these three Caribbean nations means the US should step up efforts to support the region.

Laura “reminds us that vulnerable communities are hit the hardest,” said Rebecca Bill Chavez, who served as a top Pentagon official for the Western Hemisphere from 2013 to 2017.

The Caribbean’s experience may have some lessons for the US

As Hurricane Laura now batters Texas and Louisiana, local and federal officials can draw some takeaways from what just happened to America’s southern neighbors.

Broadly speaking, Chavez says storms like Laura — potentially powered by the effects of climate change — should make clear that major weather events can destabilize countries in the region. “It is an existential threat to our Caribbean neighbors,” she said. That could lead to further complications, such as a refugee crisis, governance failures, economic strain, and much more.

Beyond the negative impact that would have on the people in those countries, it could also pose problems for the US, especially since it has extensive economic and security partnerships with Caribbean nations. Providing post-storm disaster relief and resilience assistance ahead of the next storm could minimize the risk of those problems.

More concretely, the Dominican Republic, Haiti, and Cuba are all dealing with coronavirus outbreaks of their own. As the storm approached, officials thought deeply about how to minimize the risk of further outbreaks. For example, Jose Antonio Torres Iribar, the head of the provincial defense council in Havana, Cuba, limited the amount of people who could live in shelters to wait out the storm.

“If under normal circumstances, these shelters could house 500 people, now this number must be reduced for the evacuation process not to become a problem in the context of the pandemic,” he said on Sunday.

In Haiti, however, many had nowhere to go but a shelter. “I’m particularly concerned about Haiti where the devastating floods means more demand for shelters,” Chavez said.

It seems that officials in Louisiana had similar concerns. Normally, impacted citizens would be placed in mega shelters. But worries about increased transmission led the state to reserve over a thousand hotel rooms instead.

“This is very, very different,” Gov. John Bel Edwards said on Wednesday. “We’re going to take advantage of all the space available at hotels and motels that we can contract.”

It’s unclear if Edwards’s team got the idea from precautions taken in the Caribbean, but it’s clear nations in that region led the way on how to safely protect people during Laura and the pandemic.

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Trump asked for fewer Covid-19 tests. Now the CDC is recommending less testing.

A couple of months ago, President Donald Trump said he told federal officials to “slow the testing down, please.”

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Now the Trump administration is taking a step that would, in effect, slow down testing.

On Monday, the Centers for Disease Control and Prevention (CDC) updated its testing guidelines to no longer recommend people get tested even when they’ve come into close contact with someone who’s infected.

The previous guidelines stated, “Testing is recommended for all close contacts of persons with SARS-CoV-2 infection. Because of the potential for asymptomatic and pre-symptomatic transmission, it is important that contacts of individuals with SARS-CoV-2 infection be quickly identified and tested.”

The updated guidelines claim, “If you have been in close contact (within 6 feet) of a person with a COVID-19 infection for at least 15 minutes but do not have symptoms: You do not necessarily need a test unless you are a vulnerable individual or your health care provider or State or local public health officials recommend you take one.”

CDC Director Robert Redfield said in a statement that “testing may be considered for all close contacts of confirmed or probable Covid-19 patients.” But that still doesn’t explicitly recommend testing for close contacts of people with Covid, as many experts say is needed.

When I asked the CDC about the changes earlier this week, they referred the question to the Department of Health and Human Services — which struck me as unusual, since it suggested the CDC wasn’t overseeing the guidelines. An HHS official told me that the recommendations were “revised to reflect current evidence and the best public health interventions.”

HHS didn’t provide or explain that evidence when pressed further, or explain why someone who’s been exposed to a person with Covid-19 shouldn’t always try to get tested. Experts widely agree that more testing is crucial to stopping the coronavirus pandemic, with some already calling the guidelines change misguided and dangerous.

The change appears to have come from the White House’s coronavirus task force. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told Sanjay Gupta at CNN he was under anesthesia for surgery when the task force met to finalize the changes.

He added, “I am concerned about the interpretation of these recommendations and worried it will give people the incorrect assumption that asymptomatic spread is not of great concern. In fact, it is.”

Testing is crucial to stopping outbreaks. But Trump has called for less of it.

We don’t know how involved Trump was in the guideline change, if he was at all. But we do know Trump has repeatedly complained about the US testing too much. He’s argued that “testing is a double-edged sword,” adding that “when you do testing to that extent, you’re going to find more people — you’re going to find more cases.” The implication is that testing makes the US look bad, since it will have more confirmed coronavirus cases.

Experts counter that this is absurd: Whether testing confirms Covid-19 cases or not, those cases are there, leading to more infections, sickness, and deaths.

And it’s important to catch those cases. Paired with contact tracing, testing lets officials track the scale of an outbreak, isolate those who are sick, quarantine their contacts, and deploy community-wide efforts as necessary to contain the disease. It’s been successfully deployed in Germany, New Zealand, and South Korea, among other countries, to control Covid-19 outbreaks.

Successful testing includes asymptomatic and presymptomatic people. People who don’t show any or serious symptoms can still spread the disease, and there’s no way to verify whether they’re potentially infectious without a coronavirus test.

But the US has struggled to build its testing capacity to match the full scope of its outbreak. To gauge this, experts rely on the percentage of tests that come back positive. If a place tests enough, it should have a low positive rate because it should be testing lots and lots of people, including those who don’t have serious symptoms. High positive rates indicate that only people with obvious symptoms are getting tested, which suggests a need to ramp up testing to match the scope of an outbreak.

While the US has increased its testing capacity in the past few months, America’s positive rate for the past week was more than 6 percent — above the recommended 5 percent, and higher than the rates of Germany (less than 1 percent), New Zealand (less than 0.1 percent), and South Korea (about 2 percent). In some states, the positive rate is still above 15 percent or even 20 percent.

Given America’s ongoing testing problems, some experts have suggested that the US should be smarter about how it rations tests, which could include deprioritizing those who don’t have symptoms. But HHS said that’s not what’s going on here, telling the New York Times, “Testing capacity has massively expanded, and we are not utilizing the full capacity that we have developed. We revised the guidance to reflect current evidence and the best public health interventions.”

Brett Giroir, the administration’s testing czar, denied Trump’s involvement and said politics weren’t involved in the CDC’s new guidance. “We’re trying to get appropriate testing, not less testing,” he told reporters.

So we don’t really know exactly why the CDC changed its guidelines. But it conveniently accomplishes what Trump has asked for: potentially fewer people getting tested for Covid-19.

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Rapid $1 Covid-19 tests exist. Why can’t we get them?

To get the US pandemic under control, a growing number of health and medical experts are making a clarion call for an additional testing approach to Covid-19.

What we need, they argue, are at-home rapid tests that look for antigens, proteins the live virus makes. These kits would allow anyone to test themselves for the coronavirus any time (and anywhere) for between $1 and $5, and get results in about 15 minutes. No doctors, labs, expensive machines, or special chemicals required.

“I see these [antigen] tests as a solution that’s literally sitting in front of us,” says Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health, who has led an effort to get these rapid tests authorized by the Food and Drug Administration. “We could be getting massive outbreaks down to nothing. … It’s a no-brainer to me.”

Back in April, Deborah Birx, the White House coronavirus response coordinator, actually called for just this sort of solution in an interview on Meet the Press. “We have to have a breakthrough innovation in testing,” she said. “We have to be able to detect antigen.”

Several small companies have been developing these simple tests, and the conglomerate 3M is working with MIT on another one. (The new BinaxNOW test from Abbott, authorized August 26, is different — it requires a health professional to administer it, and the patient must have symptoms to get a prescription.)

And some of these at-home tests are ready to go. But they have been sitting on the shelf, unused, for months. Why?

The holdup is that rapid, over-the-counter antigen tests are not nearly as sensitive to the coronavirus as the molecular PCR (polymerase chain reaction) tests currently used for most Covid-19 testing. In fact, by PCR standards, some at-home antigen tests might catch only half or a third of people who test positive on a PCR test.

But that’s because they’re looking for different things in different ways. A PCR test, designed to diagnose an individual with infection, can catch very low levels of viral material before or after a person spreads the virus. An over-the-counter antigen test, meanwhile, relies on high levels of the virus to be able to detect it. These high levels, though, also happen to coincide with when a person is most likely to transmit the virus to others.

“The antigen test is maximally sensitive at the same time that you are maximally infectious,” says David Paltiel, a professor of public health and health policy at the Yale School of Public Health. “The antigen test is picking up the infections I want. Because I don’t care about infections, I care about infectiousness.”

Since at-home antigen tests would be fast and cheap, they could allow people to test themselves regularly. Currently, PCR testing is relatively expensive (about $100) and often experiences processing delays that hamstring efforts to stop transmission.

PCR tests’ sensitivity, however, is the current benchmark by which the FDA judges new tests for emergency authorization.

This pre-pandemic framework, Mina and others argue, is a problem as we look for the most effective tools to fight the coronavirus right now. So they are calling for a new way to evaluate these tests, one based in public health terms rather than individual diagnostic ones — in other words, widely accessible tests that are well tuned to find those who are most likely to spread the virus.

Let’s take a look at how and why this potential solution has gotten sidelined in the pandemic battle — and what might be done to get these tests off companies’ shelves and out to the public.

A test to find infectiousness, not infection

To understand the stalemate around antigen tests, it’s helpful to first understand what they are, how they differ from classic PCR tests, and the trajectory of coronavirus infections.

First: An antigen test looks for a particular protein from a live virus. (Not to be confused with an antibody test, which finds immune cells your body has made after mounting a defense against the virus.) These tests need a lot of viral material to generate a positive result.

Second: A PCR test looks for the virus’s genetic material — its RNA — making copies of itself until it reaches a detectable level. As a result, it has a fairly low (although not perfect) false-negative rate, or the proportion of time it would tell someone who has the virus that they don’t.

Finally: One of this new coronavirus’s superpowers is its ability to spread from people before they start to experience symptoms. In fact, people tend to carry the most live virus the day or so before they begin feeling sick, and the amount tends to quickly trail off in the several days after symptom onset.

So proponents of at-home antigen testing say that PCR tests, while useful in determining whether an individual is infected with Covid-19, are actually a poor tool in finding people who are most likely to spread the virus. That’s because PCR tests are so sensitive, they are excellent at picking up traces of the virus even after someone has beat it back and is no longer infectious.

Thomas Tsai, a health policy expert at the Harvard T.H. Chan School of Public health, compares the two types of testing this way: PCR tests are reactive tests, usually used for people who either have symptoms, a close contact with the virus, or other reason to think they are likely to have caught it. Rapid, widespread antigen tests are proactive tests, designed to find cases before they spread the virus more widely.

And as the Center for Evidence-Based Medicine noted earlier this month, “while an infectious stage may last a week or so because inactivated RNA degrades slowly over time, it may still be detected many weeks after infectiousness has dissipated.”

To look a little bit deeper at how this works, an August 7 preprint report which hasn’t been peer reviewed proposes that people with 10,000 copies of the virus detected in their airways are unlikely to spread the virus to someone else, even with sustained contact (according to their models, it would happen about 0.002 percent of the time). Once that viral load climbs to 10 million copies (which happens quickly, potentially in about a day), they have about a 40 percent chance of transmitting it to a close contact — and about 80 percent chance at 100 million viral copies (it’s worth noting that when they first reach this level they still might not have any symptoms).

By the time someone has had Covid-19 symptoms for several days (which might currently be about the time they receive results from a PCR test), however, the amount of virus in their system has likely waned to the point of actually being less transmissible. As the authors of the study note, “transmission after the first week of infection is quite rare.”

At that point, says Mina, it’s more likely that “they just have residual [virus] RNA hanging about.” So although many of these people would get a positive PCR test — and a negative at-home antigen test — they are much less likely to transmit the virus than someone who feels fine now but will develop symptoms in a day or two.

“The PCR is being fooled all the time,” Paltiel says. “The PCR is just picking up strands of viral junk.” If your goal is to slow an outbreak, he notes, this sort of data is not actually that useful. “Outbreak control is all about figuring out who’s actually spreading this stuff.”

This could also help explain why so many people continue to get positive PCR test results weeks after getting over most of their symptoms. One small JAMA study, for example, found that one in six former Covid-19 patients with no symptoms tested positive for the virus via PCR test four to 24 days after being discharged from the hospital. As an author of a commentary about that paper noted about these long-tail positive test results, “the clinical significance and infectivity are minimal. These PCR tests likely are responding to noninfective RNA fragments and do not represent detection of viable virus.”

Antigen tests, however, need a much higher level of the virus to register a positive result because they don’t rely on multiplying their target.

This, experts argue, make them well matched for finding people with Covid-19 at precisely their most infectious points rather than potentially long after symptoms have arrived and infectiousness has faded, as is more likely now with the long delays in PCR results and contact tracing. As Paltiel describes it, the concept is pretty simple: “The more viruses around your airway, the more likely you are to be a risk to others.”

According to an analysis from the June preprint (on which Mina was a co-author), this crucial time period is precisely where the antigen test is most sensitive: detecting viral load at around 10,000 copies, which is just before someone’s infectiousness skyrockets. PCR tests, on the other hand, can pick up about 1,000 copies of the virus, which gives them about a day’s head start at finding the virus. Although with a lag of more than a day in returning results, that benefit is lost.

To put it in other terms, these tests could be “superspreading detectors,” Mina says, locating many of those who would otherwise go on to unknowingly infect many other people before they know they have the virus.

“Their whole goal is to capture the 90 percent of people who might be transmitting the virus,” Mina says. So if they were to be evaluated in this population — those with high levels of the virus — he says, the sensitivity for these tests would soar from 30 or 50 percent (as measured against PCR) up to 95 percent. (They also have very low false-positive rates, in which they would tell someone they had the virus when they actually didn’t.)

Another selling point to antigen tests, proponents argue, is that they would give people their results much faster than PCR tests. Since delays of more than a day or so in getting PCR results back make containment and tracing much less effective, being able to have results back in 15 minutes or so would be a vast improvement.

Because these tests would be fast and affordable, people could also test frequently, which could help overcome worry about the tests being less sensitive than PCR — especially in the very small window early in an infection when a PCR test might catch the virus but an antigen test wouldn’t.

And such frequent testing would be far superior to the still relatively rare PCR testing that we’re currently doing, Paltiel says. “Of all the variables that we control, the frequency of screening is the most important,” he says. Even if the antigen-based test only caught half of all cases (regardless of infectiousness level), he says, if it’s “between a test that is missing 50 percent [but rapid and easy] and a test that is getting everyone that is so expensive or so cumbersome or has such a long turnaround time that it takes a week, I’ll take what’s behind door No. 1.”

In the June preprint study, the researchers found the sensitivity of a test made little difference in the rate at which it could bring viral transmission down. For example, running either of these tests, PCR or at-home antigen testing, on a population weekly could lower the spread of the virus by about 60 percent, they posit.

So, Mina suggests, we shouldn’t just be asking what level of sensitivity a test has, but rather, what it’s sensitive to. PCR tests are great at finding traces of the coronavirus but, he says, “it’s going to have a 0 percent sensitivity to detect elephants.” And if what we want is to start finding elephants — or people who are most infectious — we should look for new testing options, he argues.

The FDA’s job is to help keep us safe, but it might lack a pandemic public health protocol

One of the FDA’s essential responsibilities is to make sure dangerous medications, ineffective vaccines, or misleading diagnostic tests don’t make it to US consumers. So it applies rigorous standards to make sure new products are reliable before they are allowed on the market.

And the FDA has applied this same rubric when it has evaluated new tests for the coronavirus this year.

“Tests are still being considered first and foremost as diagnostic tools,” Mina says. This is evident in how the FDA has required antigen tests to perform at PCR-levels in detecting traces of the virus in people’s systems, he notes. For example, a new test might need to detect the virus in 80 or 90 percent of emergency room patients who’ve received a positive PCR test.

So when you compare the numbers and see a test that catches half or a third of the positive cases a PCR test does, it makes sense for the FDA to worry about a huge number of Covid-19-positive people thinking they are negative.

And Mina says he gets that. “If I’m a doctor, which I am, and I have a patient in front of me, I would want the absolute best and most sensitive molecular test to make sure I don’t miss something,” he says.

But he is also an epidemiologist. “For public health, it’s totally different. It requires a really different type of thinking.” One that targets minimizing spread of the virus among people.

“Unfortunately, the FDA just doesn’t have that,” he says. “They don’t even have a lens with which to think about it.”

And so, he says, they’re still evaluating at-home antigen tests as individual medical diagnostic tools rather than “as a virus control tool at the population level.”

The FDA has already authorized four antigen-based tests, including ones from Quidel (in May), BD Veritor (in July), LuminaDX (in August), and the new one from Abbott. To meet the FDA’s current sensitivity standards, however, the first three of these use proprietary machines to read results. (Some of these machines are now being allocated by the Centers for Medicare & Medicaid Services to nursing homes around the country.)

But an over-the-counter antigen test, the sort that Mina and others are advocating for, simply can’t be authorized under the current standards.

This gets at the essential tension between the FDA’s individual-based medical diagnostic framework and the broader public health needs of the pandemic. And, says Tsai, “We really need to shift gears.”

Concerns remain about at-home antigen testing

Beyond the sensitivity question, the FDA and others also have hesitations about these sorts of tests being done outside of the health care setting.

Current Covid-19 tests require a health care professional to order them and provide the results, allowing for them to give patients medical advice. If people are taking these tests on their own at home or before entering a business, a nurse won’t be on hand, for example, to advise them to isolate if necessary or take other steps to prevent spread.

“Due to the lack of healthcare professional supervision, FDA believes it is important for over-the-counter non-lab diagnostic tests to have a low rate of false negative results,” Emma Spaulding, a spokesperson for the FDA wrote to Vox in an email. “For example, an individual with a false negative result from an OTC diagnostic test may be less likely to quarantine despite symptoms, putting others in the community at risk,”

This is one reason they are recommending such tests catch 90 percent of the PCR-positive cases, she says. They would lower this to 80 percent if the tests required a prescription and were done under the supervision of a health care worker (such as via telemedicine).

Others worry about individual compliance. Rebecca Lee Smith, an epidemiologist at the University of Illinois, notes that this sort of testing would probably be most readily adopted by people who are already putting in the most effort to avoid catching and spreading Covid-19, such as those regularly wearing masks and practicing physical distancing.

“But the people who aren’t concerned about the virus may not choose to do at-home testing — they’re also the people who are not taking the precautions. So the same people we would absolutely want to be checking for the virus, then, would be the people less likely to do it at home.”

She also has concerns about at-home tests being used to clear people for work, school, or other activities. If someone needed to produce a negative test result, they could theoretically get someone else to take the test for them but still gain entry to, say, their college classes for the day. That was a point of discussion at her university, where they eventually opted for supervised (rather than collected-at-home) saliva-based PCR testing. “We decided that it was more important that we know, for sure, that the person who checked in for testing is the person giving the sample,” she says.

Administering these tests out in the community as a way to enter a workplace or a restaurant, for example, could also help alleviate this issue — as well as the concern about those with higher chances of contracting the virus not taking the test.

The newly approved Abbott test, BinaxNOW, is a step toward more accessible antigen testing. It doesn’t require a machine to read the results — and still, according to data presented to the FDA, has a 97 percent specificity level compared with PCR tests. It is also $5 for one test, and the company says they will be able to ship 50 million of them a month this fall.

The downside is it is only available with a prescription, and it needs to be given by a health care professional or other trained individual (such as a pharmacist or workplace health specialist). The test requires a nasal swab and a small amount of specialized chemicals known as reagents. And it is only to be used for people who developed Covid-19 symptoms within the past week, making it inapplicable for broader population-wide screening.

With an over-the-counter test, we might also lose a lot of important public health disease surveillance data. If people are testing positive at home — or even in a public setting — and not following up with a health care worker or public health department, their case might not get counted or their contacts traced. “You would need to have a link back to public health,” Smith says. They would also want to get information on the test that was performed so they could properly interpret the results.

This is where our existing PCR testing capacity could run backup. Smith explains that a positive antigen test result could be a trigger to get a PCR test to confirm the infection. It could also possibly reduce the number of PCR tests that are run, potentially speeding up delivery of those results as well.

“In a perfect world,” Smith says, “we would have this cheap, at-home test that anybody could take, as frequently as they want, that would give them a quick result. If there is a reason — if they have symptoms, if they’ve been exposed, or the at-home test comes back positive — then they report for PCR.”

Tsai agrees PCR tests would still be important. “It’s really thinking about how we use the pros and cons of all the different tests in a more comprehensive strategy,” he says. “Let’s put these pieces together.”

How could at-home antigen tests get authorized?

With over-the-counter antigen tests at a regulatory stalemate in the FDA’s current authorization system, experts are spitballing alternative routes to getting these tests to the public.

First and foremost, says Mina, government involvement in authorizing new tests is essential to make sure that those that do reach the market work in the way they are supposed to.

One route for this, he proposes, is a new standard by which the FDA could authorize tests, setting a different benchmark for test sensitivity at levels of the virus that are most likely to be transmissible rather than at very low detectable levels. In other words, he notes, the FDA could adjust their language from looking at sensitivity to the virus broadly to “sensitivity during peak infection.”

The FDA could also reframe the way it characterizes these tests, he says. Instead of being evaluated as an individual diagnostic test, he says, “it would essentially be indicated as a transmission-detecting test … [or] a public health diagnostic test, where the real reason of doing that diagnostic test is one of public health.”

Another option would be to designate these tests as surveillance tools rather than diagnostic tests. Under that category, they fall outside the FDA’s purview and would more likely be overseen by the CDC and local health departments.

This plan has a big hitch, though. Surveillance test results are aggregated and are not shared back with the individual taking the test. Diagnostic tests, on the other hand, are those which have results given back to the individual so that they might take a specific action. The latter is, of course, the goal here (to let people know, for example, if they need to start self-isolating).

“It’s this awful catch-22 that could easily be changed if there was a will,” Mina says. “There just doesn’t seem to be much of a will.” Or a regulatory framework for thinking about things differently — even in the midst of a pandemic, he says.

The FDA has recently conceded that they would consider authorizing a less sensitive test if it were part of a high-frequency testing plan, with each person being tested multiple times (which they call “serial testing”), Spaulding says.

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This, to Mina and others, seems like a step in the right direction, and he is hoping the FDA will provide more detailed guidance on what this would look like in practice.

But the FDA also notes that it would require an application for this sort of serial testing to “include the capacity to manufacture a sufficient supply of tests with which to conduct multiple tests per person,” Spaulding says.

Mina suggests that this is an arbitrary ask. For other authorized tests, like those using PCR or machine-based antigen detection, the agency has not required makers to show manufacturing capacity — or even the supply chain to turn results around in a certain amount of time (which is a key aspect to slowing transmission of Covid-19). “They’re perfectly fine approving tests that might take a year to return results, but that’s a 100 percent useless test,” Mina says.

Mina also worries that as some of these companies with at-home antigen tests wait for the government to greenlight them, they will decide to make them more complex to meet the current (PCR-based) requirements for diagnostic viral detection.

He calls this going from the sort of “instant coffee model” of testing (where anyone can take a test, cheaply, pretty much anywhere) to the “Nespresso model” (where you need access to a specialized machine to get a result).

And slowdowns in rolling out these machine-based antigen tests are already happening. Both BD and Quidel, two companies making rapid antigen tests, are now facing supply chain issues as they try to fulfill orders for their machines and tests, the Wall Street Journal reported.

Tsai notes that public health officials in Florida have been advised to use the Quidel antigen tests only for symptomatic, older adults. Which, he says, makes sense in targeting those most at-risk for complications from the virus, but “in some ways also defeats the purpose of the frequent testing strategy.”

Mina has been challenging those who are still on the fence about rapid, at-home antigen testing to say whether, in hindsight, it would have been good to have five months ago.

“Almost all of them say, ‘yes, that would have been great.’ Compared to what has happened, of course it would have been great.” Now, he says, “we’re in an almost worse spot today, we’re hitting up against September and October, when coronaviruses can start spreading like crazy. We have to cut our losses and say, ‘okay, we didn’t do it five months ago, but we can do it today.’”

Like the old tree-planting aphorism: The best time to plant a tree may have been 20 years ago, but the second-best time is now. “We could potentially save ourselves from ourselves in the fall. But I don’t know if it’s going to happen, frankly,” he says.

Part of that reason, he notes, has to do with our general national mindset. “I think Americans, including policymakers, are having a hard time coming to terms with the idea that there’s actually something bad happening to us.”

Just adding this new type of testing on its own, however, won’t be enough to get us out of the pandemic. “We can’t test our way out of it,” Smith says. “We also need masks, we need distancing.”

But, she says, many presymptomatic and asymptomatic cases are not being detected with our current testing strategy. “And those people are able to spread the infection further without knowing it. If we can’t identify these cases, we are never going to get out of this.”

Katherine Harmon Courage is a freelance science journalist and author of Cultured and Octopus! Find her on Twitter at @KHCourage.

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Tropical Storm Laura’s flooding and other impacts on the ground: What we know

Tropical Storm Laura, which has been downgraded from a hurricane, made landfall early Thursday morning in Cameron, Louisiana — just 35 miles east of the Texas-Louisiana border — as a Category 4 storm with 150 mph winds.

Already, pictures and videos of the storm from Lake Charles, Louisiana, a town about 50 miles north of Cameron, show torn-off roofs, downed power lines, blown-out windows, and dozens of trees ripped from the ground.

Louisiana Gov. John Bel Edwards said he’d received a report Thursday morning of the first American fatality from Laura, a 14-year-old girl from Vernon Parish who died when a tree fell on her home. Edwards later said a total of four people in his state have died — all as a result of fallen trees. Laura was also responsible for at least 23 deaths in Haiti and the Dominican Republic earlier this week.

There has been no official word of other injuries or deaths in the US since the storm made landfall. What we know is that about 20 million people reside in the path of the storm and 500,000 have been ordered to evacuate, a task complicated by the Covid-19 pandemic.

And so far, more than 740,000 homes and businesses are without power in Texas and Louisiana.

Louisiana and Texas residents were warned the storm surge could be “unsurvivable”

As a Category 4 hurricane, Laura reportedly became the strongest storm on record to make landfall along the western Louisiana and northern Texas coast. Although the storm has weakened since moving inland, prompting its downgrade from hurricane status, it is still sustaining winds of 52 mph.

Hurricane-force winds can cause normally dry areas near the coast to be flooded by rising waters. The National Hurricane Center (NHC) predicted that this phenomenon, referred to as “storm surge,” could result in up to 20 feet of flooding in places within 40 miles of shoreline where Laura made landfall, rendering some areas “unsurvivable” and resulting in “catastrophic damage.” However, it appears as if a slight change in wind direction may have spared the worst-hit areas from the feared 20-foot surge.

The NHC said Thursday the worst of the initial storm surge hit communities directly east of Cameron, which are experiencing surge of around 9 feet.

Some meteorologists, however, warn against jumping to premature conclusions about the extent of storm surge from Hurricane Laura, considering the limited number of data points currently available.

Heavy rain is also predicted to be widespread across the west-central Gulf Coast, with 5 to 10 inches falling over a broad area, and up to 18 inches locally. And this rain is expected to result in flash flooding throughout the region.

After making landfall Thursday morning, Laura tracked north across Louisiana throughout the day, and its center is expected to move into Arkansas overnight. The storm will then move through the Tennessee Valley and the mid-Atlantic from Friday into Saturday. As of now, the NHC predicts the storm will continue to give off heavy rain and sustain winds between 30 and 40 mph.

One of the most powerful storms in US history

Meteorologists categorize hurricanes based on the intensity of storms’ maximum sustained winds:

  • Category 1: 74-95 mph (a storm with winds below 74 mph is classified as a “tropical storm,” and below 38 mph is a “tropical depression”)
  • Category 2: 96-110 mph
  • Category 3: 111-129 mph
  • Category 4: 130-156 mph
  • Category 5: 157 mph or higher

Laura’s 150 mph winds at landfall made it a Category 4 hurricane and one of the most powerful in US history — as powerful as Hurricane Charley in 2004 and slightly less powerful than Hurricane Michael in 2018, but far more powerful than Hurricane Katrina (which clocked in at 125 mph at landfall) in 2005.

These categorizations are important in terms of assessing potential damage to life and property. From 1900 to 2005, US hurricanes that clocked in at category 3, 4, and 5 at landfall have been responsible for 85 percent of total hurricane damage, despite making up around a quarter of total hurricanes. That’s because relatively small changes in wind speeds can lead to exponentially more damage. For instance, hurricanes like Laura that make landfall at around 150 mph cause, on average, 256 times more damage than hurricanes less than half their speed, at 75 mph, would.

But wind speed alone doesn’t determine how deadly a hurricane will be. As my colleagues Brian Resnick and Eliza Barclay explain, storm surge, the coastal flooding that occurs when a storm’s winds push water onshore several feet above the normal tide, is particularly dangerous. Severe storm surge — like that expected with Laura — can trap people in their homes, wash away houses, and make rescue missions harrowing and slow.

So far, we don’t know what the damage from Tropical Storm Laura will be, but we do have reference points. Hurricane Rita, which hit the same area as Laura in 2005, produced up to 15 feet of storm surge, had Category 3 winds of 115 mph, and resulted in 97 to 125 deaths and $18.5 billion in damage. By comparison, Laura made landfall with Category 4 winds of 150 mph and is predicted to produce up to 20 feet of storm surge.

A record season for hurricanes

Laura is the 12th of as many as 25 named storms that the National Oceanic and Atmospheric Administration (NOAA) has predicted would form this hurricane season (which lasts from June 1 to November 30); seven to 11 of those storms, including Laura, were expected to become hurricanes. If NOAA’s predictions are correct, this will be a record-breaking season for hurricanes.

“This is one of the most active seasonal forecasts that NOAA has produced in its 22-year history of hurricane outlooks. NOAA will continue to provide the best possible science and service to communities across the Nation for the remainder of hurricane season to ensure public readiness and safety,” said Commerce Secretary Wilbur Ross, who oversees the agency. “We encourage all Americans to do their part by getting prepared, remaining vigilant, and being ready to take action when necessary.”

There are a few explanations for this record-breaking season, but chief among them are the above-average sea surface temperatures in the tropical Atlantic Ocean and Caribbean Sea, particularly in the region between West Africa and the Leeward Islands, which tends to be a prime development region for hurricanes.

These warmer-than-average waters are, in part, the result of climate change. A new study published earlier this year in the Proceedings of the National Academy of Sciences by a group of NOAA and University of Wisconsin Madison researchers found that from 1979 to 2017, the odds that a given tropical cyclone would become a Category 3, 4 or 5 hurricane increased about 8 percent per decade as the planet has warmed.

This finding builds on lots of previous research — like multiple academic studies demonstrating that Hurricane Harvey’s record-blasting rains were likely amplified by climate change.

“We’ve just increased our confidence of our understanding of the link between hurricane intensity and climate change,” James Kossin, the lead author of the new study, told the Washington Post. “We have high confidence that there is a human fingerprint on these changes.”

In other words, Laura might be the most recent of the major hurricanes to reach US shores, but it certainly won’t be the last.

How to follow Tropical Storm Laura:

  • The National Hurricane Center provides updates every few hours, with projections and important warnings. Take a look here.
  • The National Hurricane Center’s Twitter account has similar updates, as well as the latest on forecast changes and public safety concerns.
  • Meteorologist and journalist Eric Holthaus has compiled a Twitter list of weather experts that’s a valuable repository of forecasts, data, and useful information on hurricanes in general.

Correction, August 26: An earlier version of this story misstated the relative strength of Hurricanes Michael and Charley.

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How Trump let Covid-19 win

As America, and even his own administration, woke up to the threat of Covid-19, President Donald Trump still didn’t seem to get it. Within weeks of suggesting that people social distance in mid-March, the president went on national TV to argue that the US could reopen by Easter Sunday in April. “You’ll have packed churches all over our country,” Trump said in March. “I think it’ll be a beautiful time.”

The US wasn’t able to fully and safely reopen in April. It isn’t able to fully and safely reopen in September.

The virus rages on, affecting every aspect of American life, from the economy to education to entertainment. More than 200,000 Americans are confirmed dead. Many schools are closing down again after botched attempts to reopen — with outbreaks in universities and K-12 settings. America now has one of the worst ongoing epidemics in the world, with the second most daily new Covid-19 deaths among developed nations, surpassed only by Spain.

America does not have the most Covid-19 deaths per capita of any rich country, but it’s doing worse than most. The US reports about seven times the Covid-19 deaths as the median developed country, ranking in the bottom 20 percent for coronavirus deaths among wealthy nations. Tens of thousands of lives have been needlessly lost as a result: If America had the same death rate as, for example, Canada, about 120,000 more Americans would likely be alive today.

The Easter episode, experts said, exemplified the magical thinking that has animated Trump’s response to the Covid-19 pandemic before and after the novel coronavirus reached the US. It’s a problem that’s continued through September — with Trump and those under him flat-out denying the existence of a resurgence in Covid-19, falsely claiming rising cases were a result of more tests. With every day, week, and month that the Trump administration has tried to spin a positive story, it’s also resisted stronger action, allowing the epidemic to drag on.

A pandemic was always likely to be a challenge for the US, given the country’s large size, fragmented federalist system, and libertarian streak. The public health system was already underfunded and underprepared for a major disease outbreak before Trump.

Yet many other developed countries dealt with these kinds of problems too. Public health systems are notoriously underfunded worldwide. Australia, Canada, and Germany, among others, also have federalist systems of government, individualistic societies, or both — and they’ve all fared much better.

Instead, experts said, it’s Trump’s leadership, or lack thereof, that really sets the US apart. Before Covid-19, Trump and his administration undermined preparedness — eliminating a White House office set up by the previous administration to combat pandemics, making cuts across other key parts of the federal government, and proposing further cuts.

Once the coronavirus arrived, Trump downplayed the threat, suggesting that it would soon disappear “like a miracle.” The Centers for Disease Control and Prevention (CDC) took weeks to fix botched tests, and the administration actively abdicated control of issues to local, state, and private actors.

“There was a failure to realize what an efficiently spreading respiratory virus for which we have no vaccine and no antiviral meant,” Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told me. “From the very beginning, that minimization … set a tone that reverberated from the highest levels of government to what the average person believes about the virus.”

Several developed countries — including Belgium, France, Italy, and Spain — were caught off-guard by the pandemic and were hit hard early, suffering massive early outbreaks with enormous death tolls. But most developed countries took these crises seriously: adopting lengthy and strict lockdowns, widespread testing and contact tracing, masking mandates, and consistent public messaging about the virus. (Though parts of Europe are now seeing second waves, seemingly because they prematurely relaxed social distancing measures.)

America did not take the steps necessary, even after an outbreak spiraled out of control in New York. So the US suffered a wave of huge cases over the summer that other developed nations generally avoided, leading to new and continued surges in both cases and deaths. And while other developed countries have seen spikes in cases as fall neared, America also has seen cases start to rise once again.

“If George W. Bush had been president, if John McCain had been president, if Mitt Romney had been president, this would have looked very different,” Ashish Jha, dean of the Brown University School of Public Health, told me, emphasizing the failure to act after Covid-19 hit the US hard was a phenomenon driven by Trump.

Experts worry that things will again get worse: Colder weather is coming, forcing people back into risky indoor environments. So are holiday celebrations, when families and friends will gather from across the country. Another flu season looms. And Trump, experts lamented, is still not ready to do much, if anything, about it.

The White House disputes the criticisms. Spokesperson Sarah Matthews claimed Trump “has led an historic, whole-of-America coronavirus response” that followed experts’ advice, boosted testing rates, delivered equipment to health care workers, and remains focused on expediting a vaccine.

She added, “This strong leadership will continue.”

The US wasn’t prepared for a pandemic — and Trump made it worse

During the 2014 Ebola outbreak, President Barack Obama’s administration realized that the US wasn’t prepared for a pandemic. Jeremy Konyndyk, who served in the Obama administration’s Ebola response, said he “came away from that experience just completely horrified at how unready we would be for something more dangerous than Ebola,” which has a high fatality rate but did not spread easily in the US and other developed nations.

The Obama administration responded by setting up the White House National Security Council’s Directorate for Global Health Security and Biodefense, which was meant to coordinate the many agencies, from the CDC to the Department of Health and Human Services to the Pentagon, involved in contagion response.

But when John Bolton became Trump’s national security adviser in 2018, he moved to disband the office. In April 2018, Bolton fired Tom Bossert, then the homeland security adviser, who, the Washington Post reported, “had called for a comprehensive biodefense strategy against pandemics and biological attacks.” Then in May, Bolton let go the head of pandemic response, Rear Adm. Timothy Ziemer, and dismantled his global health security team. Bolton claimed that the cuts were needed to streamline the National Security Council, and the team was never replaced.

In the months before the coronavirus arrived, the Trump administration also cut a public health position meant to detect outbreaks in China and another program, called Predict, that tracked emerging pathogens around the globe, including coronaviruses. And Trump has repeatedly called for further cuts to the CDC and National Institutes of Health, both on the front lines of the federal response to disease outbreaks; the administration stood by the proposed cuts after the pandemic began, though Congress has largely rejected the proposals.

The Trump administration pushed for the cuts despite multiple, clear warnings that the US was not prepared for a pandemic. A 2019 ranking of countries’ disaster preparedness from the Johns Hopkins Center for Health Security and Nuclear Threat Initiative had the US at the top of the list, but still warned that “no country is fully prepared for epidemics or pandemics.”

A federal simulation prior to the Covid-19 pandemic also predicted problems the US eventually faced, from a collapse in coordination and communication to shortages in personal protective equipment for health care workers.

Bill Gates, who’s dedicated much of his Microsoft fortune to fighting infectious diseases, warned in 2017, “The impact of a huge epidemic, like a flu epidemic, would be phenomenal because all the supply chains would break down. There’d be a lot of panic. Many of our systems would be overloaded.”

Gates told the Washington Post in 2018 he had raised his concerns in meetings with Trump. But the president, it’s now clear, didn’t listen.

There are limitations to better preparedness, too. “If you take what assets the United States had and you use them poorly the way we did, it doesn’t matter what the report says,” Adalja said, referring to the 2019 ranking. “If you don’t have the leadership to execute, then it makes no difference.”

As Covid-19 spread, Trump downplayed the threat

On February 25, Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters that Americans should prepare for community spread of the coronavirus, social distancing, and the possibility that “disruption to everyday life might be severe.”

Six months later, Messonnier’s comments seem prescient. But soon after the briefing, she was pushed out of the spotlight — though she’s still on the job, her press appearances have been limited — reportedly because her negative outlook angered Trump. (Messonnier didn’t respond to a request for comment.)

The CDC as a whole has been pushed to the sidelines with her. The agency is supposed to play a leading role in America’s fight against pandemics, but it’s invisible in press briefings led by Trump, Vice President Mike Pence, advisers, and health officials like Anthony Fauci and Deborah Birx who are not part of the organization. CDC Director Robert Redfield acknowledged as much: “You may see [the CDC] as invisible on the nightly news, but it’s sure not invisible in terms of operationalizing this response.”

University of Michigan medical historian Howard Markel put it in blunter terms, telling me the US has “benched one of the greatest fighting forces against infectious diseases ever created.”

Meanwhile, the president downplayed the virus. The day after Messonnier’s warning, Trump said that “you have 15 people [with the coronavirus], and the 15 within a couple of days is going to be down to close to zero.” This type of magical thinking appears to have driven Trump’s response to Covid-19 from the start, from his conviction that cases would disappear to his proclamation that the country would reopen by Easter.

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This was deliberate. As Trump later acknowledged in recorded interviews with journalist Bob Woodward, he knew that the coronavirus was “deadly stuff,” airborne, more dangerous than the flu, and could afflict both the young and old. Yet he deliberately downplayed the threat: “I wanted to always play it down,” he told Woodward on March 19. “I still like playing it down, because I don’t want to create a panic.”

Trump has long said he believes in the power of positive thinking. “I’ve been given a lot of credit for positive thinking,” he told Axios reporter Jonathan Swan during a wide-ranging discussion about Covid-19 in July. “But I also think about downside, because only a fool doesn’t.” Pressed further, he added, “I think you have to have a positive outlook. Otherwise, you have nothing.”

The concern, experts said, is the signal this messaging sends. It tells the staffers under Trump that this issue isn’t a priority, and things are fine as they are. And it suggests to the public that the virus is under control, so they don’t have to make annoying, uncomfortable changes to their lives, from physical distancing to wearing masks.

It creates the perfect conditions for a slow and inadequate response.

The CDC botched the initial test kits it sent out, and it took weeks to fix the errors. The Food and Drug Administration (FDA) also took weeks to approve other tests from private labs. As supply problems came up with testing kits, swabs, reagents, machines, and more, the Trump administration resisted taking significant action — claiming it’s up to local, state, and private actors to solve the problems and that the federal government is merely a “supplier of last resort.”

South Korea, which has been widely praised for its response to coronavirus, tested more than 66,000 people within a week of the first community transmission within its borders. By comparison, the US took roughly three weeks to complete that many tests — in a country with more than six times the population.

Asked about testing problems in March, Trump responded, “I don’t take responsibility at all.” In June, Trump claimed that “testing is a double-edged sword,” adding that “when you do testing to that extent, you’re going to find more people — you’re going to find more cases. So I said to my people, ‘Slow the testing down, please.’”

The testing shortfall was a problem few thought possible in the wealthiest, most powerful nation on earth. “We all kind of knew if a biological event hit during this administration, it wasn’t going to be good,” Saskia Popescu, an infectious disease epidemiologist, told me. “But I don’t think anyone ever anticipated it could be this bad.”

Trump also consistently undermined the advice of experts, including those in his administration. When the CDC released reopening guidelines, Trump effectively told states to ignore the guidance and reopen prematurely — to “LIBERATE” their economies. When the CDC recommended masks for public use, Trump described masking as a personal choice, refused to wear one in public for months, and even suggested that people wear masks to spite him. While federal agencies and researchers work diligently to find effective treatments for Covid-19, Trump has promoted unproven and even dangerous approaches, at one point advocating for injecting bleach. Trump’s allies have even held up CDC studies that could contradict the president’s overly optimistic outlook.

The most aggressive steps Trump took to halt the virus — travel restrictions on China and Europe imposed in February and March, respectively — were likely too limited and too late. And to the extent these measures bought time, it wasn’t properly used.

The federal government is the only entity that can solve many of the problems the country is facing. If testing supply shortfalls in Maine are slowing down testing in Arizona or Florida, the federal government has the resources and the legal jurisdiction to quickly act. Local or state offices looking for advice on how to react to a national crisis will typically turn to the federal government for guidance.

But the inaction, contradictions, and counterproductive messaging created a vacuum in federal leadership.

In the months after Trump’s prediction that coronavirus cases would go down to zero, confirmed cases in the US grew to more than 160,000. As of September 22, they stand at more than 6.8 million.

Months into the pandemic, Trump has continued to flail

After the initial wave of coronavirus cases began to subside in April, the White House stopped its daily press briefings on the topic. By June, Trump’s tweets and public appearances focused on Black Lives Matter protests and the 2020 election — part of what Politico reporter Dan Diamond described, based on discussions with administration officials, as an “apparent eagerness to change the subject.”

Then another wave of coronavirus infections hit beginning in June, peaking with more than 70,000 daily new cases, a new high, and more than 1,000 daily deaths.

America’s response to the initial rise of infections was slow and inadequate. But other developed countries also struggled with the sudden arrival of a disease brand new to humans. The second surge, experts said, was when the scope of Trump’s failure became more apparent.

By pushing states to open prematurely, failing to set up national infrastructure for testing and tracing, and downplaying masks, Trump put many states under enormous pressure to reopen before the virus was under control nationwide. Many quickly did — and over time suffered the consequences.

Rather than create a new strategy, Trump and his administration returned to magical thinking. Pence, head of the White House’s coronavirus task force, wrote an op-ed titled “There Isn’t a Coronavirus ‘Second Wave’” in mid-June, as cases started to increase again. Internally, some of Trump’s experts seemed to believe this; Birx, once a widely respected infectious disease expert, reportedly told the president and White House staff that the US was likely following the path of Italy: Cases hit a huge high but would steadily decline.

Trump trotted out optimistic, but misleading, claims and statistics. He told Axios reporter Jonathan Swan in July that the US was doing well because it had few deaths relative to the number of cases. When Swan, clearly baffled, clarified he was asking about deaths as a proportion of population — a standard metric for an epidemic’s deadliness — Trump said, “You can’t do that.” He gave no further explanation.

Seemingly believing its coronavirus mission accomplished, the Trump administration, the New York Times reported, moved to relinquish responsibility for the pandemic and leave the response to the states — in what the Times called “perhaps one of the greatest failures of presidential leadership in generations.”

“The biggest problem in the US response is there is not a US response,” Konyndyk, now a senior policy fellow at the Center for Global Development, told me. “There is a New York response. There’s a Florida response. There’s a Montana response. There’s a California response. There’s a Michigan response. There’s a Georgia response. But there is not a US response.”

When the coronavirus first hit the US, the country struggled with testing enough people, contact tracing, getting the public to follow recommendations such as physical distancing and masking, delivering enough equipment for health care workers, and hospital capacity. In the second wave, these problems have by and large repeated themselves.

Consider testing: It has significantly improved, but some parts of the country have reported weeks-long delays in getting test results, and the percentage of tests coming back positive has risen above the recommended 5 percent in most states — a sign of insufficient testing. The system once again appeared to collapse under the weight of too much demand, while the federal government failed to solve continuing problems with supply chains. Months after Congress approved billions of dollars in spending to deal with testing problems, the Trump administration has not spent much of it.

Some of Trump’s people seemed to listen to his calls to slow down testing: On August 24, the CDC updated its guidelines to suggest people exposed to others with Covid-19 don’t necessarily have to get tested — a move for effectively less testing that experts described as “dangerous” and “irresponsible.” Only after weeks of criticism did the CDC back down and, on September 18, once again call for testing people without symptoms.

Mask-wearing also remains polarized. While surveys show that the vast majority of Americans have worn masks in the past week, there’s a strong partisan divide. According to Gallup’s surveys, 99 percent of Democrats say they’ve gone out with a mask in the previous week, compared to 80 percent of Republicans. Leveraging surveys on mask use, the New York Times estimated that the percentage of people using masks in public can fall to as low as 20, 10, or the single digits — even in some communities that have been hit hard. Anti-mask protests have popped up around the country.

Testing and mask-wearing are two of the strongest weapons against Covid-19. Testing, paired with contact tracing, lets officials track the scale of an outbreak, isolate those who are sick, quarantine their contacts, and deploy community-wide efforts as necessary to contain the disease — as successfully demonstrated in Germany, New Zealand, and South Korea, among others. There’s also growing scientific evidence supporting widespread and even mandated mask use, with experts citing it as crucial to the success of nations like Japan and Slovakia in containing the virus.

It’s not that other developed nations did everything perfectly. New Zealand has contained Covid-19 without widespread masking, and Japan has done so without widespread testing. But both took at least one aggressive action the US hasn’t. “While there’s variation across many countries, the thing that distinguishes the countries doing well is they took something seriously,” Kirsten Bibbins-Domingo, an epidemiologist at the University of California San Francisco, told me.

One explanation for the shortfalls in the US response is Trump’s obsession with getting America, particularly the economy, back to normal in the short term, seemingly before Election Day this November. It’s why he’s called on governors to “LIBERATE” states. It’s why he’s repeatedly said that “the Cure can’t be worse than the problem itself.” It’s one reason, perhaps, he resisted embracing even very minor lifestyle changes such as wearing a mask.

The reality is that life will only get closer to normal once the virus is suppressed. That’s what’s working for other countries that are more earnestly reopening, from Taiwan to Germany. It’s what a preliminary study on the 1918 flu found, as US cities that emerged economically stronger back then took more aggressive action that hindered economies in the short term but better kept infections and deaths down overall.

“Dead people don’t shop,” Jade Pagkas-Bather, an infectious diseases expert and doctor at the University of Chicago, told me. “They can’t stimulate economies.”

The window to avert further catastrophe may be closing

As cases and deaths climbed over the summer, and as the November election neared, Trump at times appeared to spring back into action — bringing back coronavirus press conferences and briefly changing his tone on masks (before going back to mocking them).

But Trump still seems resistant to focusing too much on the issue. He’s tried to change the subject to former Vice President Joe Biden’s supposed plans to destroy the “Suburban Lifestyle Dream.” He’s continued to downplay the crisis, saying on July 28, as daily Covid-19 deaths once again topped 1,000, “It is what it is.” His Republican convention continued to diminish the risks of Covid-19 and exaggerate Trump’s successes in fighting the virus. At a campaign rally in Ohio on September 21, Trump claimed the virus “affects virtually nobody.”

So while combating Covid-19 aligns with Trump’s political incentives (it remains Americans’ top priority), he and his administration continue to flounder. And White House officials stand by their response so far, continually pushing blame to local and state governments.

“There’s no national plan to combat the worst pandemic that we’ve seen in a century,” Jen Kates, director of global health and HIV policy at the Kaiser Family Foundation, told me.

The summer surge of Covid-19 has calmed now, although cases across the US flattened out at a much higher level than they were in the spring, likely a result of cities, counties, states, and the public taking action as the federal government didn’t. Still, cases have started to pick back up again.

Experts now worry that the country could be setting itself up for another wave of Covid-19. Schools reopening across the country could create new vectors of transmission. The winter will force many Americans indoors to avoid the cold, while being outdoors in the open air can hinder the spread of the disease. Families and friends will come together from across the country to celebrate the holidays, creating new possibilities for superspreading events. And in the background, another flu season looms — which could limit health care capacity further just as Covid-19 cases spike.

“The virus spreads when a large number of people gather indoors,” Jha said. “That’s going to happen more in December than it did in July — and July was a pretty awful month.”

There are reasons to believe it might not get so bad. Since so many people in the US have gotten sick, that could offer some element of population immunity in some places as long as people continue social distancing and masking. After seeing two large waves of the coronavirus across the country, the public could act cautiously and slow the disease, even if local, state, and federal governments don’t. Social distancing due to Covid-19 could keep the spread of the flu down too (which seemed to happen in the Southern Hemisphere).

But the federal government could do much more to push the nation in the right direction. Experts have urged the federal government to provide clear, consistent guidance and deploy stronger policies, encouraging people to take Covid-19 as a serious threat — now, not later.

“I’m really concerned that the window might be closing,” Kates said.

Without that federal action, the US could remain stuck in a cycle of ups and downs with Covid-19, forcing the public to double down on social distancing and other measures with each new wave. As cases and deaths continue to climb, America will become even more of an outlier as much of the developed world inches back to normal. And the “beautiful time” Trump imagined for Easter will remain out of reach.