One of the most maddening things about the federal government’s response to the coronavirus pandemic was the complete 180 on masks. In the critical early weeks of the crisis, the US Surgeon General and the Centers for Disease Control and Prevention balked at telling the general public to wear face coverings, even as residents of other countries embraced them. It was only in April that the CDC reversed itself; although most cloth masks won’t do much to prevent you from catching the virus, studies have shown they dramatically reduce the risk of transmission to others. It’s hard to think about this and wonder what might have been—how many fewer cases, and how many fewer deaths, might there have been if there was a concerted national push to wear masks in early March?

In an appearance on Sunday on CBS’ “Face the Nation,” host Margaret Brennan read US Surgeon General Jerome Adams some of his old comments on masks. On March 8th, a maskless Adams told Brennan “masks do not work for the general public. On Twitter a week earlier, he said “Seriously people — STOP BUYING MASKS.”

“Do you regret saying that?” Brennan asked.

His response was…well, it was a response:

.@Surgenon_General on his past mask guidance that they don’t work for the "general public”@JeromeAdamsMD: "Once upon a time we prescribed cigarettes for asthmatics, and leeches and cocaine and heroine for people as medical treatments, when we learn better we do better" pic.twitter.com/GPe4rnW1tv

— Face The Nation (@FaceTheNation) July 12, 2020

“It’s important for people to understand that once upon a time we prescribed cigarettes for asthmatics, and leeches and cocaine and heroine for people as medical treatments,” Adams said. “When we learn better we do better.”

It’s not often you see a public health official compare something he said in March to doctors prescribing cigarettes for asthmatics, but it’s also not often you see anyone in the Trump administration acknowledge they made a mistake.

At least he’s wearing a mask now.

President Donald Trump spent a lot of the last week talking about re-opening public schools in the fall. As the Daily Beast reported, his campaign has done polling on the issue and found that it could be a winning electoral issue for him. The catch is that it’s only a winning electoral issue if people actually trust that you will be able to responsibly reopen schools. For that reason, Trump’s PR push is sort of self-defeating—if you were actually the person who was going to responsibly open public schools, you wouldn’t have just started thinking about it in July.

And, perhaps, you wouldn’t make the point person for all of this Education Secretary Betsy DeVos. On CNN’s State of the Union on Sunday, DeVos was asked by host Dana Bash to clarify what public-health experts were telling her about “the appropriate level of transmission for a school before it has to shut down.” It’s gets at the big question at the heart of all of this—what’s the plan? Everyone wants schools to reopen. It comes down to whether the conditions on the ground will allow it. Schools aren’t little epidemiology labs; they need guidance.

DeVos, though, acted as if she’d just strolled into home room and found out there was a test that day:

Disastrously embarrassing performance by DeVos this morning. pic.twitter.com/4ZGSpRwItK

— Jamie 😷’Grady ⚡ (@JamieOGrady) July 12, 2020

“Every school should have plans for that situation to be able to pivot and ensure that kids can continue learning, at a distance if they have to for a short period of time,” she said. What’s the plan? The plan is to have plans. It’s a plan plan.

Bash followed up: “Why do you not have guidance…just weeks before you want those schools to reopen,” she wondered, “and what happens if there’s an outbreak?”

“You know, there’s really good examples that have been utilized in the private sector and elsewhere, also with front line workers and hospitals, and all of that data and all of those examples can be referenced by school leaders,” DeVos said.

Again, Bash asked if DeVos—the Secretary of Education—for specifics. And Again, DeVos stopped short of offering any: “Schools should do what’s right on the ground at that time for their students and for their situation.”

What should they base those plans off of? Maybe some day we’ll find out.

The United States had a record-setting coronavirus week: On Friday, there were 68,000 new cases, the seventh record-high total in 11 days. Meanwhile, the first signs are appearing that the number of deaths is starting to rise. Despite the increasingly grim numbers, which in terms of hospital capacity and availability of necessary medical equipment and personal protective gear, are starting to resemble low points of the spring, some states are wavering on whether to issue new orders to stay home or pause reopenings in progress. Texas’ Republican governor Greg Abbott, who previously resisted local efforts to control the virus, announced that if the state’s numbers keep increasing, he would reinstitute an “economic lockdown.” Also on Friday, Atlanta’s Democratic mayor, Keisha Lance Bottoms, moved to rollback the city’s reopening—though Georgia’s GOP governor Brian Kemp put out a statement noting Lance Bottom’s orders weren’t mandatory.

In Florida, which has been particularly hard-hit, Disney World reopened on Saturday, despite the protests of many employees.

The number of new cases has been rising particularly quickly across the South and West, but President Donald Trump and his political allies have celebrated the fact that the number of reported deaths even in those regions continued to decline. Despite the president’s optimism, many medical experts warned that the number of deaths is typically a lagging indicator. Based on the most recent numbers, those warnings may be coming true as there were 827 deaths on Friday, according to a New York Times database of COVID-19 cases, a 13 percent increase over the last two weeks. 

BREAKING: 188 new deaths reported in Florida. Highest single day toll yet.@CNN

— John Berman (@JohnBerman) July 11, 2020

As recently as Tuesday, Trump was still bragging about how low the United States’ mortality rate was, but has been silent on the issue since: 

“COVID-19 (China Virus) Death Rate PLUNGES From Peak In U.S.” A Tenfold Decrease In Mortality. The Washington Times @WashTimes Valerie Richardson. We have the lowest Mortality Rate in the World. The Fake News should be reporting these most important of facts, but they don’t!

— Donald J. Trump (@realDonaldTrump) July 7, 2020

Despite Florida’s numbers, Disney World stuck to its plan to reopen on Saturday, admitting guests who had pre-registered, to two parks, with greatly reduced limits on number of guests at any one time. To celebrate, Disney released a peppy welcome video, featuring masked employees cleaning:

Cast members are ready to welcome guests back to Walt Disney World Resort.✨ pic.twitter.com/KHwFMTRqfF

— Disney Parks Jobs (@disneyparksjobs) July 11, 2020

But not all employees are pleased with the reopening—a petition created by employees asking management to not reopen has been signed by at least 20,000 people. A handful of other amusement parks also planned to reopen this weekend. 

Amid the record-breaking surge in coronavirus cases, and as parents around the country face the enormous decision of whether to send their children back to school this fall, President Trump on Wednesday threatened to pull federal funding from school districts and dismissed the Centers for Disease Control official guidance on how to safely reopen, because he claimed the requirements were too onerous and costly.

In Germany, Denmark, Norway, Sweden and many other countries, SCHOOLS ARE OPEN WITH NO PROBLEMS. The Dems think it would be bad for them politically if U.S. schools open before the November Election, but is important for the children & families. May cut off funding if not open!

— Donald J. Trump (@realDonaldTrump) July 8, 2020

I disagree with @CDCgov on their very tough & expensive guidelines for opening schools. While they want them open, they are asking schools to do very impractical things. I will be meeting with them!!!

— Donald J. Trump (@realDonaldTrump) July 8, 2020

The extraordinary tweets marked a new chapter in the president’s demands for schools to reopen—a critical component to reopening the economy—while, so far, staying quiet on additional federal funding for sufficient PPE equipment and social distancing measures school administrators have said are essential for safety. Instead, Trump has turned the issue of reopening schools into a political fight, claiming, without evidence, that Democrats prefer to keep schools closed because they believe it to be politically beneficial to them.

“They think it’s going to be good for them politically,” Trump said at a White House event on school reopenings Tuesday. “So they keep the schools closed.  No way.”

But for parents, many of whom are desperate for regular childcare and a return to some semblance of normalcy in the months ahead, Trump’s aggressive push to reopen schools while dismissing CDC guidelines will do little to reassure them that safety is a high priority for a president, who has repeatedly dismissed the threat of COVID-19 and the need for expanded testing by focusing on the economy. 

Furthermore, Trump’s threat to slash federal funding at this crucial juncture would undoubtedly exacerbate the disproportionate effects of the pandemic, with lower-income districts being more reliant on those funds than their wealthier counterparts. Several states are already suing Education Secretary Betsy DeVos over a rule they say unfairly directs relief funds away from public to private schools.

Ever in lockstep with the White House, Fox News this week has also urged schools to reopen, rationalizing the move with the poetic claim that “life is full of risks.”

“Kids should learn that early that life’s full of hurdles, you’ve got to find a way to overcome,” Fox anchor Brian Kilmeade said during a Fox & Friends segment on Wednesday before downplaying the coronavirus threat as “not Ebola.”

“Mostly kids 99.9 percent of kids will not be affected by it at all,” he continued, despite growing evidence that some children can become seriously ill from the virus and can transmit it to adult family members. “This is a risk that has to be taken.”

Brian Kilmeade says schools must re-open in the fall in part because "life is full of risks, kids should learn that early that life is full of hurdles, you've got to find a way to overcome." pic.twitter.com/zamv1HgMwj

— Bobby Lewis (@revrrlewis) July 8, 2020

As she sat on her couch in her house, alone, sick with COVID-19, an unwelcome series of thoughts crept into Erica Bial’s mind. If I die here, she wondered, who would ever notice? How long would the neighbor’s cat take to find me? Bial, a doctor living in Massachusetts, works at Lahey Hospitals northwest of Boston. She was two weeks into her self-imposed isolation with the disease, when it took a turn for the worse on her 45th birthday. “I had been—I thought—getting better,” she said.

Then came the seizure, the shortness of breath, and the feeling of being even more isolated as her symptoms became more serious. Bial, who doesn’t have children and had been furloughed from work, was severed from her usual supportive networks. Fear of infecting her colleagues prevented her from going to the hospital as a patient. “I probably have never gone that long without seeing someone,” she said. “It’s harder on the body than you think.”

After nearly seven weeks, she recovered. But during her illness, she couldn’t shake the question: “If I die alone, who ever will remember that this happened to me, or know why?” Where would she—and other physicians locked in the fight against the disease—be memorialized if they died? She saw no options, so in early April she created a Facebook page that she called COVID-19 Physicians’ Memorial. 

The premise was simple: Create a community of mourning by running a record of announcements about the deaths of US physicians from the coronavirus. A digital graveyard, group-sourced by members of the medical community and close readers of the obituary section. Bial launched the page, informing friends and colleagues. Soon, doctors, next of kin, spouses, patients, random people, reached out to her with requests to share the passing of these physicians. “Within two weeks, it had gone from word of mouth thing with some colleagues and friends to several thousand people,” she said.

The page now has expanded to include about 200 stories. The page testifies to the threat COVID-19 poses to everyone exposed. Herbert Henderson Jr., a medical examiner in Carroll County, South Carolina, was 56 when he died. “So young,” one commenter observed. Another physician who appears on the page, Priya Khanna, who worked at Clara Maass Medical Center in New Jersey, was only 43 when she died in April. Not long after, her father,  Satyender Khanna, a doctor at the same hospital also died from the virus. “What a blow to family and healthcare,” someone wrote. Another observed, “This hurts my heart. Looks so much like my family, could easily be us.” A third simply commented, “Heartache.”

Like the elder Dr. Khanna, many of the physicians memorialized were in their 70s and older. Jennifer Weiss, who is an orthopedic surgeon at Kaiser Permanente Los Angeles Medical Center, contributed two posts to the page: cardiologist Dr. Lawrence Glassberg and retired orthopedic surgeon Dr. Morton Farber. In the caption of Dr. Glassberg’s post, Dr. Weiss wrote, “My cousin was a gentle listener. He inspired me to be a better doctor.” As for Dr. Farber, Weiss recalled his “booming laugh and a comforting presence as a doctor and as a friend.” Both men practiced well into their 80s before they died. “They loved being doctors more than anything on the planet,” Dr. Weiss told me. “My cousin continued to go to work happily in his 80s, knowing he was risking himself.”

Like every other post on the COVID-19 Physicians Memorial, the stories of Dr. Glassberg and Dr. Farber inspired numerous messages of support from well wishers, and anecdotes from former colleagues and patients. “I actually recycled back to their families with these stories,” Weiss said. ‘They’d never have received [them] otherwise.”

Hannah Kotch, a radiologist in New Jersey, was at home in quarantine after COVID-19 exposure when she learned that one of her mentors from her residency at New York’s Mount Sinai Beth Israel Hospital, 62-year-old Dr. Mitch Horowitz, had died of COVID-19. “He died in a horrible and fast way,” she said. “It happened very quickly. He’d just gotten married.” Dr. Kotch had heard about Horowitz’s death through professional social circles. He’d been an excellent teacher and well-respected amongst colleagues, but given the remarkable number of deaths due to COVID-19, she was concerned that his passing was not noticed. “The television just isn’t covering individuals that often, so we rely on word of mouth,” she said. “For me, it was just sharing it with the people who might want to know. I do appreciate that there’s some place where there’s a record—how else are we going to remember this?”

COVID-19 Physicians Memorial is the only online memorial for physicians, but similar sites for other groups have proliferated across social media. For example, one Twitter account, US Healthcare Workers Lost to COVID-19, maintains a running thread of health care workers, from lab technicians and hospital orderlies to nurse practitioners and physicians, who’ve died from the virus. Claire Rezba, a physician in Virginia who runs the thread and also helps to administer Bial’s page, told me she’s seen memorial groups of all kinds appear. “There are even nation-specific immigrant pages,” she said, groups devoted to a specific diaspora in the US, such as Honoring Guyanese Lost to Coronavirus.

Social media has been a venue to grieve and honor loved ones who have died since the first days of Facebook in the early 2000’s. But today, social distancing has made the familiar rituals accompanying death impossible, even as mortality rates from the pandemic skyrocket. Facebook and Twitter have become even more important as places for mourners to gather. “There’s so much unknown and new about this experience,” said Erin Hope Thompson, a clinical psychologist and founder of The Loss Foundation, a UK-based organization that offers support to those who’ve lost love ones to cancer—and now COVID-19. Navigating grief, already an unfamiliar experience for many, becomes even more fraught without the reassurance of familiar rituals. “If you’re not able to do that in the same way, maybe there’s the need to do it in a different way” she said. “And these Facebook pages may be a good example of that.”

Facebook’s comment section is unlikely to provide the necessary support for those who must cope with catastrophic loss, and Thompson worries that over-reliance on it could deprive mourners of something integral to emotional processing along the way. “We’d encourage people to have lots of different kinds of outlets, speaking to somebody—professionally or non-professionally—writing, crying,” she said. “Would I be worried if somebody was just using social media? In the long run, Yes.” Then there are the all the other potential problems with the platform. “It’s a place where people can abuse anonymity,” she said. “There’s a possibility that somebody would be sharing vulnerability in a space that’s not always monitored.” 

For Dr. Bial, her work on the Physician’s Memorial became a blessing and a burden. Even after returning to work, she was spending considerable time poring over death in obituaries, or—as her role shifted from poster to administrator—policing the site for inappropriate, accusatory, political, overly-religious or, in one case, sexually explicit comments. As the page expanded, she met Claire in Maryland, who offered to help administer it and cross share posts from her own Twitter thread.

They became mutual sources of support in the grim tasks they set out for themselves. “There are some nights where I spent a couple hours at night looking for names—that’s not great for your mental health,” Claire told me. “It’s not something most people want talk about, but something I’ve been interested in. It’s nice to have [Erica] taking on the same thing.” 

Eventually the COVID-19 pandemic will end, but not before hundreds, perhaps thousands, of other physicians will have died. But when there is a vaccine, and schools and life return to normal, the digital meeting places that host conversations on death, like Claire’s and Bial’s, will remain—not only as a public record of the human costs of the disease, but also as a new form of acknowledging,  even celebrating, the lives of those who have died. With physical gatherings removed from the equation, there is nowhere else.

The latest jobs report is out—and with 4.8 million jobs added to the economy last month and unemployment falling to 11.1 percent, it’s far better than most economists had expected. It’s encouraging news, to be sure, but joblessness remains higher than at any point during the Great Recession. Furthermore, the report is a bit stale; the data, collected in mid-June, doesn’t reflect the recent decisions by governors across the country to halt reopening plans amid a surge in new coronavirus cases—moves that will very likely end the rehiring trend seen in the past two months.

In other words, any hope for a lasting, robust recovery is a distant one.

But desperate for a win—any win—President Trump on Thursday seized on the news to hold a last-minute press conference where he touted the report as “spectacular” and “historic.” 

“It’s coming back faster, bigger, and better than we ever thought possible,” he said. “These are not numbers made up by me. These are numbers.”

At one point, Trump appeared to acknowledge the country’s exploding numbers of new cases and deaths from COVID-19—the United States marks the fifth straight day of record-breaking case numbers—but dismissed them as mere “fires” that were under control. “It’s got a life,” the president said, referring to the virus. “We’re putting out that life because that’s a bad life we’re talking about.” It was the latest instance of dangerous magical thinking, fueled by an obsession with how he wants the crisis to look from the outside, replacing the consequences of the disorganized, confusing, and ineffectual response from his administration to a dire public health crisis.  

Naturally, Trump ended the press conference on Thursday without taking questions.

As coronavirus cases in Texas surge, Vice President Mike Pence spoke on Sunday at an indoor service at a Dallas megachurch. Gov. Greg Abbott, Housing Secretary Ben Carson, and Sen. John Cornyn, and joined the vice president at First Baptist Dallas for an event dubbed Celebrate Freedom Sunday.

Pastor Robert Jeffress, an ardent supporter of President Donald Trump, called the event “our annual patriotic service” in which his church celebrates “God’s unique blessings on our country.” As of Friday, 2,200 people were expected to worship inside the main sanctuary, with between 1,500 and 2,000 people in overflow rooms across the church’s six-block campus in downtown Dallas. Jeffress told a local news channel that the church would take worshipers’ temperatures and strongly encouraged masks and social distancing.

Have a good time this morning at First Baptist Dallas Church. The wonderful Pastor @robertjeffress will be joined by our GREAT @VP Mike Pence!

— Donald J. Trump (@realDonaldTrump) June 28, 2020

Jeffress, an evangelical preacher and Fox News regular, has acted as an informal faith advisor to Trump. He also has a long history of trumpeting racist and homophobic views. In a March sermon entitled, “Is the Coronavirus a Judgement from God?”, he cautioned 90,000 online viewers that while the coronavirus is not mentioned in the Book of Revelation, “All natural disasters can ultimately be traced to sin.”

Pence’s visit to Texas comes as the state is experiencing a post-reopening wave of the coronavirus. Two months ago, Gov. Abbott announced one of the nation’s earliest and quickest reopening plans. But the past two weeks saw record hospitalization rates, with local officials considering using convention centers and stadiums for overflow capacity. In total, there have been around 150,000 COVID-19 cases and 2,400 deaths in Texas.

On Friday, Abbott reversed course on his reopening plan, shutting bars back down, scaling back restaurant capacity to 50 percent, and prohibiting outdoor gatherings of more than 100 people unless local officials approved. “At this time, it is clear that the rise in cases is largely driven by certain types of activities, including Texans congregating in bars,” he said in a press release. “The actions in this executive order are essential to our mission to swiftly contain this virus and protect public health.”

Abbott’s order on Friday exempted churches and other houses of worship, where there is no occupancy limit.

President Trump campaign staffers who attended a recent rally in Tulsa, Oklahoma are being required to get tested for the coronavirus after eight people connected with the re-election bid tested positive, according to a memo obtained by ABC News on Friday.

The memo said explicitly that staffers “are required to obtain a negative COVID-19 test this weekend,” ominously leaving out the fate of staffers who test positive. The staffers who have already tested positive are still working while self-quarantining, according to a report.

Trump campaign staff were informed Friday night via email that all who were in Tulsa for last weekend's rally "are required to obtain a negative COVID-19 test this weekend," according to an email obtained by ABC. Reporting w/ @wsteaks & @Santucci

— Katherine Faulders (@KFaulders) June 27, 2020

Trump defiantly chose to proceed with the campaign rally despite surges in confirmed coronavirus cases across the country. As my colleague Jacob Rosenberg reported, Trump’s campaign didn’t even bother reaching out to local health officials to discuss the health implications of his rally. Oklahoma reported nearly 400 new cases in 24 hours, local news noted on June 26.

In addition to concerns over Trump rallies potentially being hotspots for spreading the virus, the rally had initially been scheduled for Juneteenth, the day celebrating the emancipation of enslaved Black people after the Civil War, in a city in which white mobs massacred a thriving community known as Black Wall Street in 1921. After public outcry, the Trump campaign decided to bump it back by one day. 

Talk about failing to read the room.

For well over three months, America has been without many of its great pastimes. Now that they’re coming back, coronavirus infections are soaring again.

Baseball, basketball, and football have all been suspended as sports teams and fans grapple with a coronavirus pandemic that shows no signs of letting up any time soon. But talk is shifting toward a return; the National Basketball Association just released its revamped schedule to finish the 2020 season in a bizarre bubble at Disney World in Orlando, Florida.

Most leagues are considering having teams come back without fans, but that’s proving to still be very dangerous for athletes. The NBA had players report back to their teams this week and required COVID tests, and 5 percent of its players have tested positive, according to Bloomberg. Coronavirus cases are also exploding all over the state of Florida. Nearly 10,000 people tested positive across the state on one recent day.

A whopping 37 players on Clemson University’s football team have tested positive, reported ESPN. And in the National Women’s Soccer League, the Orlando Pride, will sit out the rest of the season after several of its players tested positive for the virus.

The NBA, in particular, is at something of a crossroads. A majority of the league’s players are Black, and notable stars like Kyrie Irving have argued that they should use their platforms to advocate for racial justice rather than put themselves and their families in harm’s way. There are also financial considerations for players and teams. Aging athletes have to consider effectively missing a year of their playing career and the salary that comes along with it—especially as the league faces losing upwards of $1 billion as a result of the pandemic.

Coronavirus concerns have led some athletes to sit out even as their teams return to play. Los Angeles Lakers guard Avery Bradley declined to join his team’s NBA championship pursuit in Orlando because he’s worried about contracting the virus and passing it along to his son, who has a history of respiratory illness.

Sports would signal a return to normalcy, the argument goes. But these times are anything but normal. 

Nursing homes proved to be some of the earliest epicenters of America’s coronavirus epidemic. But a new report from the New York Times details just how central nursing and long-term care facilities have been in the crisis: more than 54,000 residents and workers at such facilities have died from the virus—amounting to 43 percent of the country’s total deaths—and more than 282,000 people at them have been infected across 12,000 facilities.

From the outset of the pandemic early in 2020, nursing homes near Seattle and New York City reported the first cases of staggering numbers of infections and deaths. Residents at these facilities are especially high risk, since many are over 60 years old and have underlying medical conditions that can be exacerbated by the virus.

The Times report also found that in at least 24 states, a majority of deaths were found to be linked to nursing homes. The Times based its findings on official data from states, counties and facilities themselves, and will update the data as more information from these sources becomes available. You can keep up with it here.

As coronavirus cases soar across the country, Vice President Mike Pence on Friday attempted to take a victory lap. 

“We slowed the spread, we flattened the curve, we saved lives,” Pence said during the first coronavirus briefing the White House has held in nearly two months. Pence also praised the “truly remarkable progress” in reopening the country.

But the gulf between that rosy characterization and the current reality facing the country could hardly be starker: More than half of the country is seeing the rapid spread of new cases, some to record highs, as well as increased rates of hospitalizations and deaths. In their most drastic moves since reopening yet, Republican governors in Texas and Florida on Friday abruptly halted additional reopening steps from moving forward as their infection rates shatter previous highs.

While Pence did note the alarming trend during the briefing, where he was joined by other members of the White House’s coronavirus task force, including Dr. Anthony Fauci and Dr. Deborah Birx, he insisted that the country was in a “much better place” than it was two months ago. He also repeated Trump’s misguided claim that expanded testing was solely to blame for the new surges—as if counting the cases caused them—even as health officials warn that removing social distancing measures has been the primary source fueling the current surge in cases. 

Birx effectively refuted that talking point on Friday with a graph that showed positive rates in Texas had declined in May even as testing increased. “It was in the last two and a half weeks that we saw this inflection of rising test positivity along with rising testing,” Birx said. 

But the chances of the President and his White House acolytes abandoning the claim, even as some administration aides refute it, remain slim as Trump appears to be undeterred in blaming testing for making him look bad.

Was Donald Trump joking when he confessed to commanding officials to “slow down” coronavirus testing? That’s what his aides have claimed again and again to explain Saturday’s rally-time confession. It was just in jest! A “light moment” offered just as the number of victims ticked over a grim threshold: 120,000 US deaths. But that spin campaign spun to a grinding halt on Tuesday, thwarted by the president himself.

“I don’t kid,” Trump told reporters on Tuesday when asked about his desire to scale back testing, which if true, would come as nearly half the country is seeing new cases from the virus spike. He then proceeded to argue that increased testing capabilities—a critical part of fighting the pandemic—makes the country “look bad.”

It was the latest signal by Trump that he views his administration’s response purely in terms of perception and optics after he told supporters at his rally in Tulsa, Oklahoma, on Saturday about ordering officials to slow down the country’s COVID-19 testing. The White House, along with Vice President Mike Pence, has since claimed that the remark was nothing more than a joke, but the president has now undermined those cascading defenses on multiple occasions, including on Twitter and in an exchange with a reporter on Monday:

There were plenty of reasons to doubt the White House’s defense that Trump was joking about slowing down testing but now we have one more.

Be sure to make it to the 45-second mark to see a man barely containing his burning desire to blurt out the truth. https://t.co/jUBer01lhq pic.twitter.com/SWtjLCHbqc

— Mother Jones (@MotherJones) June 23, 2020

If this feels familiar, that’s because it is. As I wrote yesterday, Trump has openly and repeatedly questioned the need to test long before the Tulsa rally. “I don’t need to have the numbers double because of one ship,” he said in March, making his preference to keep a coronavirus-hit cruise ship away in order to keep the country’s infection numbers down. 

“Any suggestion that testing has been curtailed is not rooted in fact,” White House Press Secretary Kayleigh McEnany said on Monday. “It was a comment that he made in jest.” 

For a look back at Trump’s first 100 days of deadly coronavirus denial to compare his recent statements, take a look at our detailed timeline, or watch our video below:

Cancer research, like so much else about this cursed year, has been derailed by the coronavirus pandemic. Clinical trials—which are crucial for discovering new treatments—have been shut down, postponed, and disrupted. Other trials have been modified to protect participants and researchers. But experts warn that even for trials that have been moving and will continue to move forward, researchers could miss potentially life-saving data without periodic in-person check ins at hospitals.

Since the pandemic began, the number of people enrolling in all kinds of clinical trials has dropped dramatically—74 percent by one estimate. In cancer research specifically, more than 200 cancer trials were suspended in March and April due to the pandemic, an analysis by health care data science firm IQVIA found. STAT also reports that the last two weeks of March saw a reduction in the number of enrollments in Phase 2 and 3 cancer trials by as much as 48 percent, though those numbers have since improved to around a 30 percent drop from pre-pandemic enrollments.

While the Food and Drug Administration issued recommendations in March for how to safely proceed with clinical trials during this public health crisis, the guidelines recognize that due to supply chain disruptions, some patients may not be able to access treatments, that it’s possible some trial subjects would become infected with COVID-19, and that “unavoidable protocol deviations” may arise. 

Biostatisticians Chaya Moskowitz and Katherine Panageas, both at Memorial Sloan Kettering Cancer Center in New York City, are now raising alarms about the bigger picture impact on clinical trials, arguing in an opinion piece published late last week in JAMA Oncology that changes and delays in procedures may threaten the reliability of researchers’ data and, in turn, the possibility of uncovering new therapies. 

I called up Moskowitz on Friday to get a breakdown of just how badly the coronavirus could damage cancer research:

Scientists may miss how tumors respond to treatments in the short term. 

In typical cancer trials, Moskowitz explains, patients who are taking a trial drug or therapy visit doctors’ offices at specific intervals—six weeks, eight weeks, 12 weeks, etc.—for imaging. Those images, typically from a CT scan or MRI, allow researchers to measure whether a patient’s tumors are growing, shrinking, or staying the same. “If patients cannot come in to get those images,” Moskowitz says, “you don’t know what’s happening to the tumor.”

This is important for early-stage, “single-arm,” studies, which often just include one group of patients that receives the therapy (as compared to randomized controlled trials, the “gold standard” of testing, wherein one group of patients receives a treatment, another group doesn’t, and researchers compare the two). In these “single-arm” studies, doctors look at patients’ tumors before, after, and during treatment. That means regular check-ins matter. For example, a drug may be effective in shrinking a tumor in the short term, but if the patient misses her visits, researchers may not see those results.

It’s true that the best-case scenario is a therapy that causes the tumor to shrink and to have it stay that way. “But it’s possible,” Moskowitz says, “that there are some really aggressive tumors where [short-term results] could be of interest.”

One key measurement—how long it takes for a tumor to start growing again—is difficult to capture without regular visits.

More importantly, as a patient undergoes a new treatment, cancer researchers are often looking to see how long it takes for the tumor to grow. “We realize that the tumor is likely to continue to grow at some point, but we want to push back that time as far as we possibly can,” Moskowitz says. Simply put, effective treatments slow tumor growth. So if part of the experiment is determining when the tumor starts growing again, regular, timely patient visits are critical.

“Suppose the tumor does grow at six weeks, but you aren’t coming in at six weeks to measure it,” Moskowitz explains. “Then you come in at 12 weeks, and now you measure it and you see—a ha—the tumor is growing. You’re going to record for that patient that the tumor grew at 12 weeks.” As a result, the drug may appear to be much more effective than it really was.

Researchers may fail to capture “adverse events.”

Another loss that comes from missing in-person visits, Moskowitz argues, is that researchers could lose out on tracking “adverse events.” Patients checking in with scientists over the phone or by video chat are probably able to self-report things like nausea and pain. “But there are some things,” she says, “that require monitoring of what’s going on inside their bodies, like liver function, things that require blood work to be done—if they’re not coming in for in-person visits, that information is not being collected.” 

One way to make sure research during the pandemic is reliable is to record everything. 

“If patients didn’t get the drugs, that needs to be recorded. If patients are missing visits, it needs to be recorded,” Moskowitz says. Then, in analysis, researchers should disclose the limitations in their data, and potentially examine their findings during the pandemic separately from the data collected before and after it. 

After all, Moskowitz points out, clinical trials are really the only way scientists have to evaluate whether a drug works or not. And participants are contributing their own time—and bodies—to get answers. “We have an ethical and moral obligation to be using people’s research data in a way that allows us to draw meaningful conclusions.”

President Donald Trump sent his aides scrambling this weekend after his trip to Tulsa, Oklahoma, where he revealed during his first campaign rally since the lockdown that he had recently ordered health officials to “slow down” coronavirus testing. 

Trump’s logic for scaling back a crucial tool for fighting the pandemic was that testing—rather than relaxed social distancing measures as health officials have warned—was to blame for the steady rise in new coronavirus cases. The remarks sparked alarm, and the White House went into overdrive to deny their seriousness.

There are plenty of reasons to doubt the White House’s “tongue in cheek” defense but now, we have one more. Be sure to make it across to the 45-second mark to see a man barely containing his burning desire to blurt out the truth.

A reporter just asked President Trump if he in fact ordered health officials to “slow down” coronavirus testing.

His answer was not great. https://t.co/jUBer0iW8Y pic.twitter.com/9j3AqfvW5s

— Mother Jones (@MotherJones) June 22, 2020

Coronavirus cases continue to soar across the country, with more than half of US states recording new spikes this week. But as the numbers tick upward and communities emerge from lockdown, President Trump and his allies are resorting to the same denialist tactics they employed when the crisis first began, once again downplaying the threat of the virus that has now claimed 120,000 American lives.

The latest came when Trump, while speaking at a campaign rally in Tulsa, Oklahoma, on Saturday, blamed the expansion of testing for the steady increase in cases—an assertion public health officials have labeled misguided.

“So I said to my people, ‘Slow the testing down, please,’” Trump told supporters, in what appeared to be a shocking admission that the president preferred to limit a critical tool for fighting the pandemic. While the White House was quick to claim that the remarks were a joke, as my colleague Jacob Rosenberg noted, it wasn’t the first time Trump has questioned the role of COVID-19 testing. Here he was in March, telling reporters that he wanted passengers aboard a coronavirus-hit cruise ship to stay away to keep the numbers of cases down.

“I like the numbers being where they are. I don’t need to have the numbers double because of one ship” — Trump explains that he doesn’t want to let people off the Grand Princess cruise ship because he doesn’t want the number of coronavirus cases in the country to go up pic.twitter.com/ELhZDjiZW9

— Aaron Rupar (@atrupar) March 6, 2020

In a more recent example, Trump told the Wall Street Journal that testing is “overrated” and that “in many ways, it makes us look bad.”

But Trump’s record of airing dangerous statements about COVID-19 testing isn’t the only reason to doubt that his remarks on Saturday were merely “tongue-in-cheek.” In fact, the effort to attribute the rise in cases to increased testing appears to be the administration’s official new line. From the New York Times last week:

“I would just encourage you all, as we talk about these things, to make sure and continue to explain to your citizens the magnitude of increase in testing,” Mr. Pence said on a call with governors, audio of which was obtained by the New York Times. “And that in most of the cases where we are seeing some marginal rise in number, that’s more a result of the extraordinary work you’re doing.”

He added: “But also encourage people with the news that we are safely reopening the country. That, as we speak today, because people are going back to hospitals and elective surgery and getting ordinary care, hospitalization rates may be going up. But according to our most current information, hospitalizations for coronavirus are going down across the country.”

That statement is untrue: hospitalizations, particularly where states are experiencing the biggest surges, are rising. Health officials say that is further evidence that relaxed social distancing measures—not the rise in testing capabilities—are to blame. In his remarks to governors, it was clear that Pence, like his boss, seemed to prioritize optics over science.

During a separate press conference on police reform, Trump last Wednesday falsely claimed that the virus would disappear even in the absence of a vaccine. In the same breath, Trump pointed to a non-existent AIDS vaccine as proof.

For a look back at Trump’s first 100 days of deadly coronavirus denial to compare his recent statements, take a look at our detailed timeline, or watch our video below:

This story was published in partnership with ProPublica, a nonprofit newsroom that investigates abuses of power. Sign up for ProPublica’s Big Story newsletter to receive stories like this one in your inbox as soon as they are published.

Since May, the Trump administration has paid a fledgling Texas company $7.3 million for test tubes needed in tracking the spread of the coronavirus nationwide. But, instead of the standard vials, Fillakit LLC has supplied plastic tubes made for bottling soda, which state health officials say are unusable.

The state officials say that these “preforms,” which are designed to be expanded with heat and pressure into 2-liter soda bottles, don’t fit the racks used in laboratory analysis of test samples. Even if the bottles were the right size, experts say, the company’s process likely contaminated the tubes and could yield false test results. Fillakit employees, some not wearing masks, gathered the miniature soda bottles with snow shovels and dumped them into plastic bins before squirting saline into them, all in the open air, according to former employees and ProPublica’s observation of the company’s operations.

“It wasn’t even clean, let alone sterile,” said Teresa Green, a retired science teacher who worked at Fillakit’s makeshift warehouse outside of Houston for two weeks before leaving out of frustration.

The Federal Emergency Management Agency signed its first deal with Fillakit on May 7, just six days after the company was formed by an ex-telemarketer repeatedly accused of fraudulent practices over the past two decades. Fillakit has supplied a total of more than 3 million tubes, which FEMA then approved and sent to all 50 states. If the company fulfills its contractual obligation to provide 4 million tubes, it will receive a total of $10.16 million.

Officials in New York, New Jersey, Texas and New Mexico confirmed they can’t use the Fillakit tubes. Three other states told ProPublica that they received Fillakit supplies and have not distributed them to testing sites. FEMA has asked health officials in several states to find an alternative use for the unfinished soda bottles.

“We are still trying to identify an alternative use,” said Janelle Fleming, a spokeswoman for the New Jersey Department of Health.

Fillakit owner Paul Wexler acknowledged that the tubes are normally used for soda bottles but otherwise declined to comment.

The Fillakit deal shows the perils of the Trump administration’s frantic hiring of first-time federal contractors with little scrutiny during the pandemic. The federal government has awarded more than $2 billion to first-time contractors for work related to the coronavirus, a ProPublica analysis of purchasing data shows. Many of those companies, like Fillakit, had no experience with medical supplies.

The U.S. has lagged behind many European countries in its rate of testing people for the coronavirus, partly because of supply shortages or inadequacies. Epidemiologists say testing is vital to tracking the virus and slowing transmission. In at least one state, the shipment of unusable Fillakit tubes contributed to delays in rolling out widespread testing.

“They’re the most unusable tubes I’ve ever seen,” said a top public health scientist in that state, who asked to remain anonymous to protect his job. “They’re going to sit in a warehouse and no one can use them. We won’t be able to do our full plan.”

In a written response to questions, FEMA said it inspects testing products “to ensure packaging is intact to maintain sterility; that the packing slip matches the requested product ordered, and that the vials are not leaking.” It said that “product validation” that medical supplies are effective “is reinforced at the state laboratories.”

The agency did not answer questions about the size and lack of sterilization of Fillakit’s tubes or about why it sought an alternative use for them.

Fillakit is one of more than 300 new federal contractors providing supplies related to COVID-19. A ProPublica analysis last month found about 13% of total federal government spending on pandemic-related contracts went to first-time vendors. FEMA said last month that it only pays for products once they have been delivered, minimizing the risk of wasting taxpayer dollars.

“FEMA does not enter into contracts unless it has reason to believe they will be successfully executed,” it said.

Preforms, the small tubes also known in the plastics industry as “baby soda bottles” or “blanks,” have a following among elementary school science teachers and amateur scientists, but they don’t meet rigorous laboratory standards. They’re much cheaper than glass vials and can be sealed off with a soda bottle cap. When inflated with high-pressure air, the soft plastic expands to the size of a 2-liter soda bottle.

The preforms arrive at Fillakit’s warehouse in a huge shipping container. The tubes are then shoveled into smaller bins. Workers add the saline solution and screw on caps. The tubes are then loosely piled in bags and sent to FEMA, which forwards them to the states. Typically, test tubes are individually packaged to guard against contamination.

Washington state, an epicenter of the first outbreak of the virus, got more than 76,000 Fillakit vials from FEMA. None can be used.

“They were packaged unusually,” said Frank Ameduri, a spokesman for the state Health Department. “Not in a way we’re used to seeing, and they were not labeled. Some of them have been sent to our lab for quality control. None of the vials will be used until we’ve identified what’s in them and that they are safe for use.”

About 140,000 Fillakit tubes are also shelved in Texas, where officials were slow to roll out testing. The number of confirmed cases in Texas has increased by more than one-third in the past two weeks, according to data gathered by The COVID Tracking Project.

“There were issues with the labeling, and they use saline rather than viral transport medium, so we have not used them for our testing efforts,” said Chris Van Deusen, a spokesman for the Texas health department.

The U.S. Food and Drug Administration has only validated one solution, known as viral transport medium, as reliable in preserving the coronavirus RNA from decay or destruction by substances in the container. However, because that medium is in short supply, the FDA has also granted an emergency authorization for other products it believes can keep the virus intact for up to three days.

Fillakit has been squirting one of the alternatives into its tubes, phosphate buffered saline, which the FDA says should be placed into “a sterile glass or plastic vial.”

A spokeswoman for the Maryland-based Association of Public Health Laboratories, a membership organization that writes best practices and helps connect public health labs with government agencies, said it has heard rumblings about Fillakit’s tubes but “nothing deadly.”

“The bigger issue is the size of the tubes,” said the spokeswoman, Michelle Forman. “They are an unusual shape so they don’t fit racks, and we are getting lots of pushback about how difficult it is to work with them from our clinical partners.”

Richard Loeb, a contract law expert at the University of Baltimore, said FEMA has the power to claw back money paid to contractors, remove them from the government’s list of approved vendors or refer them to the agency’s inspector general.

“It’s outrageous enough that they [FEMA] ordered something to test for COVID-19, and they got something that can’t be used to test for COVID-19,” Loeb said. “I still am a little bit troubled as to why FEMA accepted them. … They may have stupidly accepted something that was nonconforming.”

Wexler, Fillakit’s owner, has a background in law and real estate, not medical supplies. In 2012, the Federal Trade Commission accused Wexler and his telemarketing firm of illegal robocalling, making unauthorized charges to consumers’ bank accounts and falsely claiming to be a nonprofit organization. Wexler’s firm allegedly misrepresented itself as a credit counseling service for several years, charging customers for work it did not do, according to court records.

Wexler, who denied the charges, settled the case a year later. The settlement banned him from offering debt relief services—but not from being a federal contractor—and imposed a $2.7 million judgment.

Fillakit and another Wexler company, Cleargate Labs, operate out of the same warehouse in The Woodlands, a sprawling Houston suburb.

Cleargate describes itself as a “network of primary clinical laboratories” on its website. Last year, the company cold-called an elderly Iowa woman, told her that it was marketing a DNA screening for cancer genes and offered to send her testing supplies in exchange for her Medicare number, the Tampa Bay Times reported. Suspecting a scam, the woman reported the company to local law enforcement. Cleargate did not bill her and was not charged with a crime.

Three former Fillakit employees said that its process was unsterile. Workers shoveled up the tubes from unsanitary surfaces. The liquid that they added to each tube to preserve samples for lab analysis was kept in trays exposed to the air, which was whipped around by large fans.

Standards were compromised in the rush to meet productivity goals, Green said. “At the beginning, they were being picky, saying, ‘You have to make sure it’s at least 2 milliliters.’ And sometimes there were tubes that didn’t have any [solution] in there,” she said.

Wexler would come in and “cuss and scream at everybody in this warehouse about how nobody’s paying attention to what they’re doing,” she said.

Wexler and Stephen Wachtler, a manager at Cleargate and Fillakit, “were telling us, ‘Yeah, we gotta have four bins by lunch,’” Green said. “‘We gotta have 10 bins before you leave at 5 o’clock. Work faster, work faster.’”

Green said that few employees at the company had backgrounds in science or medicine. In May, during Fillakit’s first week of operations, the company did not provide workers with face masks, she said, raising concerns that fluid from their noses and mouths could land inside the tubes. Later, supervisors did hand out masks but did not require employees to wear them.

On June 10, a ProPublica reporter observed workers, some not wearing masks, standing over snow shovels and bins of tiny soda bottles.

Wexler and workers loaded a shipment of tubes into an Enterprise rental truck, which lacked the refrigeration that the Centers for Disease Control and Prevention say is needed to safely transport legitimate testing supplies.

Wexler denied a request to tour the warehouse. Asked about the lack of sterile conditions and the use of soda preforms, Wexler screamed, “What’s your problem, man?”

Michelle Hardy, a retired nurse who worked at Fillakit through June 10, said her concerns about contamination were dismissed by Wachtler. He did not respond to requests for comment.

“I kind of said to Stephen, ‘Is this supposed to be, like, clean technique, or sterile technique or what?’” Hardy said. “He’s like: ‘No, it’s fine. It’s fine what you’re doing because they’re just testing for COVID, and so if there’s any other bacteria or viruses in there then it’s not going to show up.’”

That’s not true, according to Vjollca Konjufca, an associate professor of microbiology at Southern Illinois University. If Fillakit employees were infected, they might have contaminated the tubes with their own virus, potentially causing false test results, she said.

Konjufca was part of a team at her university that manufactured the viral transport solution validated by the FDA. She said they followed strict protocols to ensure tests aren’t contaminated.

“We filter-sterilize, and then we add antibiotics,” Konjufca said. “The whole work is handled under a biosafety hood … so it does not allow any sort of air from the room, particulates or whatever, to get into your vials.”

There are many ways to mess up medical testing, so careful manufacturing is vital. Some substances in saliva or the plastic vials can damage virus RNA and alter test results, Konjufca said.

“You cannot just makeshift use soda bottles to make tubes,” she said. “You have enzymes in there and you have contaminants that can mess up the results.”

Riffing about the coronavirus during a rally in Tulsa, Oklahoma, to reboot his reelection campaign, President Trump said he asked for less testing to track the coronavirus pandemic for fear the increase in positives might make him look bad. The White House quickly clarified that Trump was joking, though it’s the sort of thing the president has said in the past. (Remember this?)

“When you do testing to that extent, you’re going to find more people, you’re going to find more cases,” Trump said. “So I said to my people, ‘Slow the testing down, please.'”

"Here's the bad part: When you do testing to that extent, you're gonna find more people, you're gonna find more cases. So I said to my people, 'slow the testing down please!'" — Trump pic.twitter.com/m5MOV9je70

— Aaron Rupar (@atrupar) June 21, 2020

A little later:

White House official says Trump was clearly joking. "He's never advised staff to slow testing. We are extremely proud of the 25 million tests we are conducting at a rapid pace." https://t.co/TLlZxtyvXo

— Michael C. Bender (@MichaelCBender) June 21, 2020

Our weak testing capability hamstrung the initial response to the coronavirus, and the country is still paying the price for it. As of Saturday, nearly 122,000 Americans have died in the pandemic. Joke’s on them, I guess.

President Donald Trump’s rally tonight could be, health officials warned, a “super spreader” event—risking a rise in hospitalizations in the community. In light of that potential spread, local health officials in Tulsa have cautioned against the gathering. Still, Trump decided to go ahead with it.

In theory, if someone did test positive for COVID-19 after attending the rally, there would be a need to conduct contact tracing to mitigate the spread. I was curious if the Trump campaign had reached out to local officials to put a plan in place in the event someone does get the virus. You could imagine the campaign potentially helping Tulsa’s 60 public health officials trace to stop the spread of the virus after a mass event, that, after all, they didn’t want in the first place. Resources like the campaign’s databases of tickets could be helpful, for example.

But, nope, the Trump campaign has not talked to city officials about combating any outbreak.

“The Tulsa Health Department has not been contacted by any representatives from the Trump campaign,” the city’s health department told me in a statement.

This is even more worrying considering that, this morning, it was revealed six Trump staffers doing logistics for the rally tested positive for COVID-19.  When it was revealed, Trump just got mad that it went public.

Six people working on logistics for President Trump’s Tulsa rally have tested positive for COVID-19, according to NBC News. Twenty-thousand people, none of whom will be required to wear masks, are expected at the rally, which will be held inside.  

JUST IN – 6 members of the Trump campaign advance staff in Tulsa doing logistics for Trump's rally tested positive for COVID, per @carolelee @kwelkernbc @albamonica @kellyo

— Josh Lederman (@JoshNBCNews) June 20, 2020

“Quarantine procedures were immediately implemented,” said a Trump spokesperson, adding: “No COVID-positive staffers or anyone in immediate contact will be at today’s rally or near attendees and elected officials.”

The top health official in Tulsa warned against President Donald Trump’s first rally since the coronavirus pandemic, saying it could cause havoc, including a surge in hospitalizations. Even the president, the official warned, was at risk.

“A large indoor rally with 19-20,000 people is a huge risk factor today in Tulsa, Oklahoma,” he said, as we reported earlier. “I’m concerned about our ability to protect anyone who attends a large, indoor event, and I’m also concerned about our ability to ensure the president stays safe as well.”

Health officials have worried that this could be a “super spreader” event. But as we’ve documented in timeline form, the president’s self-regard always comes first, even at the expense of other people’s lives.

This story was published in partnership with ProPublica, a nonprofit newsroom that investigates abuses of power. Sign up for ProPublica’s Big Story newsletter to receive stories like this one in your inbox as soon as they are published.

Pharmaceutical companies are racing to develop a coronavirus vaccine, with the most ambitious timelines ever attempted in history. When announcing Operation Warp Speed, the government’s effort to develop a vaccine, President Donald Trump said in May, “We’re looking to get it by the end of the year if we can, maybe before.”

Vaccine development under normal circumstances typically takes about 10 to 15 years. Now, developers are compressing the traditional timeline with both technological innovation and by putting vast amounts of money at risk.

But one stage, the phase 3 clinical trial, which is the key to proving a vaccine’s safety and efficacy, is frustratingly hard to predict in terms of its timeline. It’s dependent on the rate of infection in the locations where the study is being conducted, because the goal is to compare how many people get sick in the vaccine arm of the trial versus the placebo arm. If public health measures, like social distancing, are working very well, and there are low rates of transmission, that’s good for the general public, but it could take a long time for enough trial participants to get sick and for the study to come to a conclusion.

One potential shortcut to approval, if phase 3 trials are taking too long, is for the U.S. Food and Drug Administration to authorize the use of a vaccine based on what’s known as an “immune correlate.” This was suggested by Dr. Philip Dormitzer, Pfizer’s vice president and chief scientific officer for viral vaccines, and Dr. Tal Zaks, chief medical officer of Moderna Therapeutics. (Paul Sagan, chairman of ProPublica‘s board, is also one of Moderna’s board members. ProPublica’s board members have no say in what reporters write about, nor do they know about articles before they are published.)

The idea here would be to show that vaccinated participants have levels of neutralizing antibodies in their blood that are at least as high as patients naturally infected by the virus, and to greenlight the use of a vaccine based on its anticipated benefit, perhaps limited initially to some high-risk populations. Neutralizing antibodies are a type of antibody that can directly block a virus from infecting cells, but as of now, it’s still unclear if there’s a level of neutralizing antibodies that can guarantee immunity.

“We believe that by September there will be proof in animals that neutralizing antibodies can prevent disease, and that there will be proof that the vaccine, when given to people, can generate levels of neutralizing antibodies that are similar or higher than levels of antibodies in people who have been infected naturally, so some people will say that there is a reasonable likelihood that this should work, while people are continuing to die every day without a vaccine,” Zaks said.

He added, “For any drug approval, there’s always a balance between benefit and risk, so there’s a rational question to be asked: In September or October, if I’ve demonstrated enough potential benefit, and I’ve made half a million doses, should the government start to vaccinate people who are exceptionally at risk, based on expected benefit, or should they wait for proven benefit?”

Some fear that this winter, as the annual flu season returns, there could be a “double threat” with both viruses circulating simultaneously, adding to the urgent need for a coronavirus vaccine.

Pfizer’s Dormitzer said his company will be simultaneously running a full phase 3 trial while gathering data on antibody levels in vaccinated participants. “We want public health measures to reduce infection levels, but we also want a vaccine. That can create a dilemma if there aren’t enough cases,” he said. “We need a plan B, just in case.”

Both Dormitzer and Zaks noted that ultimately, the decision is not for pharmaceutical companies to make but is up to the FDA. “It’s our job to come up with the data and the arguments, and they say yes or no,” Dormitzer said.

Other experts cautioned against approving a vaccine based on a proxy.

“There are still a lot of coronavirus cases in the United States. Given the current attack rate”—the pace at which people are getting infected—“you should be able to do a good study,” said Dr. Luciana Borio, former FDA acting chief scientist and current vice president at In-Q-Tel, a nonprofit strategic investment firm. “There’s still significant uncertainty about what level of antibody response will be required to prevent disease.”

There is precedent for the FDA approving products based on a biomarker that is supposed to correlate with real-world benefit before trials are completed to prove benefit on symptoms or outcome of the disease. The agency has typically made these calls in cases where the need is acutely high, such as when patients have no other treatments available. Vaccines have been approved based on immune correlates in the past, when the rate of natural infection is low, such as meningococcal vaccine.

Sometimes, the FDA’s decisions have been controversial, such as in 2016, when the agency approved a drug for a rare form of muscular dystrophy based on data from a trial with just 12 boys. The study showed that the drug helped some patients make dystrophin, a protein that is critical to muscle function. But the trial didn’t have a placebo arm and the company didn’t prove that its drug helped the patients walk or breathe better. The drug, Exondys 51, is still on the market, and the company is years behind schedule on a requirement to confirm the drug’s benefit in muscle function.

The history of drug development is also full of surprising disappointments, which often come in the final-stage trials. For example, an experimental drug that lowered bad cholesterol in hundreds of patients in mid-stage phase 2 trials didn’t end up proving its ability to prevent heart attacks or strokes in thousands of participants in the big phase 3 study.

Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, noted that many approved vaccines on the market today don’t have a known immune correlate. “The immune response may or may not be predictive,” he said. “The proof is in the pudding. The pudding is the big phase 3 trial.”

The FDA is in a difficult position of having to weigh risk and benefit, when the stakes are high on both sides, explained Dr. Tim Persons, chief scientist at the U.S. Government Accountability Office.

“It’s one thing to say, ‘I want to be fast,’ but on the other hand, if you’re fast and you’re wrong or you miss some things, imagine how that fuels concerns about having any type of vaccine at all,” he said.

On the other hand, “CDC has reported that 8 in 10 deaths from the coronavirus are seniors, which is a terrible thing, so perhaps we’re willing to take more risk and not wait a decade for a vaccine.”

Evaluating vaccine efficacy may include looking at evidence of immune responses, which would entail a “rigorous scientific process” to determine which biomarkers could predict protection, the FDA said in an emailed statement.

“Provided the incidence of COVID-19 remains high enough to conduct randomized, controlled clinical trials that directly evaluate protection against disease, such studies are likely to be the most efficient way to demonstrate the effectiveness of COVID-19 vaccines,” the agency said.

No matter what happens, Moderna is committed to completing its phase 3 trial, Zaks said, even if the FDA allows its vaccine on the market based on antibody data before the trial is complete. That way, there will eventually be data from a placebo-controlled, randomized trial.

After phase 3 trials begin this summer, everyone in the vaccine world will be watching the infection rates at the trial sites, anxiously hoping that the trials will be able to come to a definitive conclusion.

“Certainly, one hopes that the phase 3 trials will be large enough that they will be able to measure actual clinical protection,” said Dr. Walter Orenstein, associate director of Emory University’s vaccine center. “On the other hand, if you have 1,000 people dying a day in the U.S., you might be willing to take a chance. It’s a last resort.”