President Trump on Monday moved to lift restrictions imposed on travelers to the U.S. from much of Europe and Brazil that were implemented last year to slow the spread of the novel coronavirus, though the action is expected to be stopped by the incoming Biden administration.
Trump issued an executive order terminating the travel restrictions on the United Kingdom, Ireland, Brazil and the countries in Europe that compose the Schengen Area effective Jan. 26. The order came two days before Trump leaves office. President-elect Joe Biden’s team immediately signaled they would move to reverse the order.
“With the pandemic worsening, and more contagious variants emerging around the world, this is not the time to be lifting restrictions on international travel,” tweeted incoming White House press secretary Jen Psaki.
“On the advice of our medical team, the Administration does not intend to lift these restrictions on 1/26. In fact, we plan to strengthen public health measures around international travel in order to further mitigate the spread of COVID-19,” Psaki continued.
The order states that Trump’s action came at the recommendation of outgoing Health and Human Services Secretary Alex Azar.The memo cites the new order from the Centers for Disease Control and Prevention (CDC) that requires passengers traveling by air to the U.S. to receive a negative COVID-19 test within three days before their flight departs, saying it will help prevent travelers from spreading the virus.
The Trump administration’s travel restrictions on China and Iran will remain in place, however, because, the order states, the countries “repeatedly have failed to cooperate with the United States public health authorities and to share timely, accurate information about the spread of the virus” and therefore cannot be trusted to implement the CDC’s order.
“Accordingly, the Secretary has advised me to remove the restrictions applicable to the Schengen Area, the United Kingdom, the Republic of Ireland, and the Federative Republic of Brazil, while leaving in place the restrictions applicable to the People’s Republic of China and the Islamic Republic of Iran,” Trump’s order states. “I agree with the Secretary that this action is the best way to continue protecting Americans from COVID-19 while enabling travel to resume safely.”
Though Trump signed the order on Monday, the action does not take effect until six days after he leaves office and Biden is inaugurated.
The order comes as coronavirus cases and deaths continue to hit worrisome, record-high levels on a daily basis. Nearly 400,000 people in the U.S. and more than 2 million people globally have died from COVID-19. While two vaccines have been approved for emergency use in the U.S., the Trump administration has fallen far short of early targets in distributing and administering the vaccine.
The order will be one of the final actions that Trump takes with respect to the pandemic, after being widely criticized for regularly minimizing the threat posed by the virus.
Trump announced in mid-March of last year that he would impose travel restrictions on individuals entering the United States from the 26 countries that compose the Schengen Area, weeks after the first case was reported in the U.S. The move initially attracted scrutiny because it did not include the U.K. or Ireland, and the Trump administration later moved to restrict travel from those countries as well.
Trump later placed travel restrictions on Brazil at the end of May.
The executive order lifting the travel restrictions was one of several released by the White House on Monday as the final hours of Trump’s presidency wind down. Trump is also expected to grant a final slew of pardons before he leaves office on Wednesday.
Yet despite the massive death toll and the changes to daily life caused by the pandemic, the individual deaths are largely invisible.
“Coronavirus victims who die in the hospitaloften spend their final days cut off from family and friends, their only human contact coming from medical personnel hidden behind layers of protective gear. Even those who die at home often decline in quarantine, keeping a lonely vigil over their body’s fight,” my colleagues write.
The numbers are expected to quickly rise. Rochelle Walensky, the incoming director of the Centers for Disease Control and Prevention, told “Face The Nation” on Sunday that she anticipated half a million deaths by mid-February.
“That doesn’t speak to the tens of thousands of people who are living with a yet- uncharacterized syndrome after they’ve recovered. We still yet haven’t yet seen the ramifications from holiday travel, holiday gathering in terms of high rates of hospitalizations,” Walensky added.
NEW: Does incoming @CDCgov dir. @RWalensky agree with current #COVID19 forecasts that the pandemic will get worse in the US in coming months?
By the time President-elect Joe Biden takes the oath of office on Wednesday, more than 400,000 Americans will have died of covid-19 — a dismal milestone in the deadly pandemic.
Yet the crucial task he faces— rapidly distributing coronavirus vaccines to the American public — is one that most experts one year ago didn’t think would even be an option by this point. Few expected multiple vaccines to be approved within a year — a record for vaccine development, by any measure. And although the rollout has been criticized, Israel and Great Britain are the only major nations the United States lags in vaccinations per capita and its daily rate of immunizations has more than doubled in the past two weeks.
“You have my word: We will manage the hell out of this operation,” Biden said in a speech on Friday, announcing his own vaccination plan.
Regardless of whether one views the vaccine effort up to this point as a failure or success, this much is true: Biden and his new administration will face an enormous task, not only in getting the vaccines distributed but also in ramping up testing, convincing Americans to follow public health recommendations and responding to the economic fallout from the pandemic.
Here are six key promises Biden is making about his pandemic response:
1. Administer 100 million doses of coronavirus vaccine during the first 100 days of his administration.
Biden previously cited this as a goal. He reiterated it Friday while rolling out a broader plan for coronavirus vaccinations
The plan would require a rate of 1 million immunizations per day — and the United States isn’t too far away from that goal right now. Nearly 800,000 Americans are getting shots every day on average. That’s a considerable improvement from two weeks ago, when the daily rate was closer to 350,000.
The 100-shot goal is “absolutely a doable thing,” Anthony S. Fauci, direct of the National Institute for Allergy and Infectious Disease, told NBC’s Chuck Todd yesterday.
“The feasibility of his goal is absolutely clear; there’s no doubt about it,” Fauci said. “That can be done.”
But top Biden advisers are also cautioning ramping up immunizations will be gradual and will require lots of coordination.
“The first days of that 100 days may be substantially slower than it will be towards the end,” Michael Osterholm, a member of Biden’s covid-19 task force, told Stat News.“It’s not going to occur quickly … you’re going to see the ramp-up occurring only when the resources really begin to flow.”
2. Set up mass vaccination clinics.
By the end of his first month in office, Biden has promised to open 100 federally managed clinics to administer shots. According to his vaccination plan, these sites would be set up by the Federal Emergency Management Agency. The federal government would reimburse states for sending National Guard members to help run them.
Biden says he also wants to deploy mobile units to rural and underserved areas, along with boosting the role already being played by pharmacies in distributing shots.
This approach would diverge significantly from how things are being done now, with the Trump administration leaving it up to hospitals, doctors, pharmacies and state public health departments to administer the shots. Some cities and states have set up large vaccination sites, but many haven’t.
“Overall, the president-elect’s plan lays out a more muscular federal role than the Trump administration’s approach, which has relied heavily on each state to administer vaccines once the federal government ships them out,” Anne Gearan, Amy Goldstein and Laurie McGinley report.
“Many of the elements — such as seeking to expand the number of vaccination sites and setting up mobile vaccination clinics — were foreshadowed in a radio interview Biden gave last week and in an economic and health ‘relief plan’ he issued Thursday, which contains a $20 billion request of Congress to pay for a stepped-up campaign of mass vaccination,” our colleagues add.
3. Allow federally qualified health centers to directly access vaccines.
These community health centers — which receive higher government reimbursements but are required to accept all patients regardless of their ability to pay — are a core part of the nation’s safety net for low-income Americans.
Biden’s plan proposes a new program “to ensure [federally qualified health centers] can directly access vaccine supply where needed,” although here, too, it’s unclear exactly how that might work.
Under the Trump administration’s plan, these centers have been asked to enroll with state health departments as vaccine providers. States were then supposed to communicate to the federal government how many doses were needed and where they should go.
How well this is actually working is “all over the map,” said Amy Simmons Farber of the National Association of Community Health Centers. She said supplies vary from county to county and many health centers have received their supplies with little notice, making it challenging to prioritize and plan.
Farber declined to comment on the Biden plan, saying she doesn’t have a lot of details about it. But she’s “very encouraged by the recognition of the important role health centers have played in fighting the pandemic and the need to adequately resource them.”
4. Use the Defense Production Act to ensure plenty of vaccine supplies.
Several times over the course of the pandemic, President Trump has invoked the Defense Production Act, which allows the president to require companies to prioritize contracts deemed essential for national security.
Ventilator tubes are attached to a covid-19 patient at Providence Holy Cross Medical Center in Los Angeles.
He has used the DPA to speed the production of coronavirus tests and ventilators, and to keep meatpacking plants open. But he hasn’t invoked the authority to compel faster production of the supplies needed for packaging and administering the vaccine.
Biden says he will invoke DPA to ensure a steady stream of these supplies, which include glass vials, stoppers, syringes, needles and the capacity for companies to rapidly fill vaccine vials and finish packaging them.
5. Sign executive actions to combat the virus.
Biden has promised a raft of executive actions in his first ten days as president, laid out over the weekend in a memo from incoming White House Chief of Staff Ron Klain. They’ll include a number of pandemic-related orders.
On Inauguration Day, Biden intends to issue a mask mandate on federal property and for interstate travel, while encouraging all Americans to wear masks for what he’s calling a “100 Day Masking Challenge.”
The following day, Thursday, he’ll sign executive orders aimed at helping schools and businesses reopen safely, expanding testing, protecting workers and establishing clearer public health standards. And on Friday, Biden will direct his Cabinet secretaries to take immediate action to deliver economic relief to families.
“President-elect Biden will take action — not just to reverse the gravest damages of the Trump administration — but also to start moving our country forward,” Klain wrote.
6. Launch a vaccine education campaign.
The memo says Biden will run a “federally-run, locally-focused public education campaign.”
“The campaign will work to elevate trusted local voices and outline the historic efforts to deliver a safe and effective vaccine as part of a national strategy for beating covid-19,” it says.
But the transition team hasn’t detailed how the education campaign might differ from one launched by the Trump administration last month.
The Department of Health and Human Services said it plans to spend $250 million on efforts to promote vaccine awareness. It kicked off the effort with a $150,000 buy on YouTube for ads that feature Fauci and Food and Drug Administration Commissioner Stephen Hahn.
The state has lost a greater share of its nursing home residents to COVID-19 than any other state this fall.
On October 9, an employee in the business office at Tieszen Memorial Home in Marion, South Dakota, tested positive for the coronavirus. She was sent home immediately, but three days later, a nursing aide and a housekeeper both tested positive.
Marion, a town of fewer than 1,000 residents, was experiencing a sharp uptick in cases — what scientists call community spread. It became more and more likely that the nursing home’s employees had become infected while, for example, grocery shopping.
On October 16, COVID-19 killed its first Tieszen resident. At that point, about thirteen of the home’s 55 residents had tested positive.
Nursing home administrator Laura Wilson called the days that followed the worst of her career.
“You almost feel like a battle zone,” she said. “We said, ‘You know, right now, we just need to survive.’”
South Dakota Republican Gov. Kristi Noem has taken a notably relaxed approach to the pandemic. This autumn, months deep into this pandemic, nursing homes there have seen a larger share of their residents die than any other state.
At Jenkin’s Living Center in Watertown, 24 residents have died from COVID-19 since the last week of October — about a fifth of the residents there — data submitted to the federal government show. Thirteen patients at Weskota Manor in Wessington Springs — more than a third of its patients — died from COVID-19 this autumn, most of them in one week. Walworth County Care Center in Selby, a 50-bed facility, saw COVID-19 kill 12 patients this autumn, an administrator said. Overall, more than 40 percent of South Dakota nursing homes have lost a tenth or more of their patients to the coronavirus, according to a Center for Public Integrity analysis of data from the federal Centers for Medicare and Medicaid Services.
Nationwide, more than 100,000 residents of long-term care facilities have died of COVID-19, making up 38% of the nation’s virus deaths, according to The Atlantic’s Covid Tracking Project, even though they represent less than 1 percent of the population.
The federal government has made protecting the elderly a priority, shipping millions of rapid tests to nursing homes across the country. Public health experts spent the first nine months of the pandemic perfecting strategies to keep the virus from spreading in close quarters. But, as researchers have learned, whether nursing home residents die from COVID-19 depends less on what happens inside than outside. Once COVID-19 permeates a town, there’s a limit to what nursing homes alone can do.
And that has made South Dakota an especially deadly place.
A LONG STRING OF DEATHS
During Tieszen’s outbreak, the nursing home was eerily quiet. On a normal day, “The Price is Right” might blare from a room, echoing down the hallways. But when the coronavirus hit, all the residents’ doors had to be closed to try to control the spread.
Before October, Tieszen had pandemic challenges but not mass tragedy. Wilson was forced to hunt for N95 masks on eBay, even though South Dakota is home to a 3M factory that makes them. She relied on her son, who works at Sam’s Club, to buy one pack of disinfecting wipes every day for the nursing home’s stockpile. Back when she was using lab-confirmed tests to screen her staff, she had trouble getting test results back within the time recommended by federal guidelines, as the Sioux Falls lab she had contracted with was swamped. And she says, like always, staffing was a problem: Tieszen told the federal government it was short on nurses and aides every week in October and November.
Wilson, who has worked at the nursing home for 42 years, said her staff did everything it could during the outbreak. Indeed, Tieszen, a small nonprofit that has earned five stars in the federal government’s nursing home quality rankings, passed three state inspections of its infection-control program between May and November, records show. It received roughly $70,000 in CARES Act incentive payments from the federal government in September based on good performance.
When the coronavirus hit, the nursing home dedicated two of its wings to COVID-19 patients, isolating them from other residents, until so many contracted the virus that they had to stay in their rooms. The entire nursing home, essentially, became a COVID ward. Wilson’s own 85-year-old father tested positive. Nurses worked overtime; Wilson put in 80-hour weeks and hired temporary help. Staff served residents’ meals on paper plates instead of dishes that might retain the virus. They conducted weekly audits of how often staff were washing their hands. They tested workers and residents at any sign of a sniffle, as well as regularly regardless of symptoms, using equipment shipped to the nursing home from the federal government. They followed up positive rapid test results with lab-confirmed PCR tests.
Despite all of these measures, the virus spread quickly.
The week after Tieszen’s first death on October 16, five more residents died, Wilson said. Among them was 89-year-old Maxine Ortman, a former teacher suffering from dementia whose husband would visit often, before the pandemic, from his home across the street.
The following week, seven more died.
In November, another seven died. They included 68-year-old Larry Johnson, a diabetic and former mechanic whose sense of humor and work ethic drew customers from all over northeastern South Dakota, his family wrote in his obituary.
And they included Randy Wieman, 64. He had Down syndrome, and died a week after testing positive for the virus, said his older sister, Carol Husby. He loved music, dancing and his many nieces and nephews. A normal December would find them celebrating Wieman’s birthday with chocolate cake.
“He would call me every morning to ask if I was up,” Husby said. “Randy was an amazing individual.”
In total, 20 residents died of the coronavirus — more than a third of those living at the Tieszen nursing home — in the space of five weeks.
OUT-OF-CONTROL SPREAD
Tamara Konetzka, a health researcher at the University of Chicago, has been studying the fate of nursing homes in the pandemic since the spring.
Her conclusion: “Nothing much has changed.”
Despite more testing and efforts to hone infection control practices, despite nine months of scientific study of the virus, nursing home residents are still at the mercy of their surrounding communities. “If they’re in virus hotspots, they’re going to be at risk,” Konetzka said. “The idea that we have found the secret to preventing nursing home cases and death is a little crazy.”
And this autumn, nearly all of South Dakota has been a hotspot. The state has ranked at or near the top of all 50 states in new coronavirus cases and deaths for months in reports issued to governors by the White House Coronavirus Task Force. During one week prior to Thanksgiving, South Dakota had 988 new coronavirus cases per 100,000 residents — more than double the national average. It had 19.6 deaths per 100,000 residents — the worst rate in the nation and more than six times the national average.
The state’s governor, Noem, is widely believed to have national political ambitions. She has proudly shunned strict measures to curb the virus. “Rather than following the pack and mandating harsh rules,” she wrote in The Wall Street Journal earlier this month, “we ask all South Dakotans to take personal responsibility for their health …. The state hasn’t issued lockdowns or mask mandates. We haven’t shut down businesses or closed churches.”
South Dakota Republican Gov. Kristi Noem has taken a relaxed approach to the pandemic, shunning strict measures to curb the virus. (AP Photo/James Nord, File)
Many South Dakotans have refused to wear masks or socially distance. In September, Wilson spoke at a meeting of local business owners in Marion and urged them to take mask-wearing seriously. She was met with blank stares.
“When I left that meeting I had basically resigned myself to the fact that I am living in a different world, and they don’t get it,” she said. “I’d be the only person in the grocery store with a mask on.”
Though limiting community spread is the best way to protect nursing homes, researchers said, some measures — especially having enough staff — can affect the severity of outbreaks. Here is where the federal government failed spectacularly, experts said. “What they needed — damn it — they needed money for more staffing,” said Larry Polivka, executive director of the aging-focused Claude Pepper Center at Florida State University. “And they needed all of the PPE. They needed massive testing capacity as quickly as possible in the spring — they didn’t get it.”
Wilson said the South Dakota Department of Health was helpful when she called or emailed with questions. The state continued to inspect nursing homes for infection control practices, and just 14 South Dakota nursing homes were cited by inspectors for inadequate infection control between March and October, according to federal data. The state has a program to recruit retired nurses and doctors to help work in healthcare settings. The federal government sent a “strike team” to South Dakota in October to help nursing homes tackle the coronavirus, a spokesman for CMS said in an email, and federal officials have offered training and guidance.
But it’s unclear what else, if anything, South Dakota did to help nursing homes weather the brutal autumn. For nine weeks in October and November, on average, nearly a quarter of all nursing homes in South Dakota told the federal government they were short on nursing staff, far more than the 16 percent that did so nationwide. On average, more than 40 percent of South Dakota nursing homes reported shortages of aides, more than double the nationwide figure. And 13 percent of South Dakota nursing homes during that time reported shortages of PPE — roughly the same as did nationwide.
Policymakers of all stripes, even those who embrace a controversial “herd immunity” strategy and wish the virus to run free through the population, stress the need to protect long-term-care residents. Noem has not explicitly endorsed a herd immunity approach but has emphasized that the coronavirus is less likely to harm young people. She has acknowledged that the elderly face greater risks from the coronavirus.
Yet the governor’s spokesperson did not answer questions from the Center for Public Integrity regarding nursing homes or respond to requests for comment. Noem’s health secretary did not respond to a request for an interview. The South Dakota Department of Health declined to answer multiple emails sent by Public Integrity over multiple weeks. The state’s long-term-care ombudsman refused through an agency spokesman to answer questions. When pressed, the spokesman said he did not know the reason but was given orders to decline the interview.
Even supposed advocates for nursing homes are reluctant to speak about the toll the coronavirus is taking on South Dakota’s elderly. Two trade associations representing nursing homes in the state declined interviews. One of them, the South Dakota Health Care Association, recommended that a reporter speak to the state department of health instead. Another lobbyist, who wished to remain anonymous to avoid angering the Noem administration, said people fear upsetting the governor’s office, known for its guarded approach to dealing with the media.
The state also waited until September to decide how to spend nearly $600 million in CARES Act funding approved by Congress in March. Noem finally set aside $115 million for nursing homes and other local health providers. But nursing homes had to apply for the funding during an 11-day period in October and meet strict qualifications. Tieszen applied but was not granted funds. Documents from the South Dakota Legislature dated Dec. 7 show that 115 health care organizations applied for the funding, and 47 were approved. But just $1.9 million had been handed out as of Dec. 18. The state is now proposing another grant program to distribute the money to health organizations based on bed numbers.
But for many nursing homes, the money comes too late to save lives. South Dakota may be past the worst of this COVID-19 surge. New coronavirus cases in the state are on the wane; vaccines are perhaps weeks away for nursing home residents at Tieszen and elsewhere.
All told, the state lost roughly one out of every 10 nursing home residents to COVID-19, according to federal data.
“I don’t understand why people didn’t take it seriously right from the beginning,” Husby said. “It just breaks my heart because it didn’t have to be this way.”
States were anticipating a windfall after federal officials said they would stop holding back second doses. But the approach had already changed, and no stockpile exists.
When Health and Human Services Secretary Alex Azar announced this week that the federal government would begin releasing coronavirus vaccine doses that had been held in reserve for second shots, no such reserve existed, according to state and federal officials briefed on distribution plans. The Trump administration had already begun shipping out what was available, starting at the end of December, taking second doses for the two-dose regimen directly off the manufacturing line.
Now, health officials across the country who had anticipated their extremely limited vaccine supply as much as doubling beginning next week are confronting the reality that their allocations will remain largely flat, dashing hopes of dramatically expanding access for millions of elderly people and those with high-risk medical conditions. Health officials in some cities and states were informed in recent days about the reality of the situation, while others were still in the dark Friday.
Because both of the vaccines authorized for emergency use in the United States are two-dose regimens, the Trump administration’s initial policy was to hold back second doses to protect against manufacturing disruptions. But that approach shifted in recent weeks, according to the officials, who spoke on the condition of anonymity because they were not authorized to discuss the matter.
Operation Warp Speed, which is overseeing vaccine distribution, stopped stockpiling second doses of the Pfizer-BioNTech vaccine at the end of last year, those officials were told. Shipping of the last reserve doses of Moderna’s supply, meanwhile, began over the weekend.
The shift, in both cases, had to do with increased confidence in the supply chain, so Operation Warp Speed leaders felt they could reliably anticipate the availability of doses for booster shots — required three weeks later in the case of the Pfizer-BioNTech product and four weeks later under Moderna’s protocol.
But it also meant there was no stockpile of second doses waiting to be shipped, as Trump administration officials suggested this week. Azar, at a briefing Tuesday, said, “Because we now have a consistent pace of production, we can now ship all of the doses that had been held in physical reserve.” He explained the decision as part of the “next phase” of the nation’s vaccination campaign.
Those in line for their second shots are still expected to get them on schedule because second doses are prioritized over first shots and states are still receiving regular vaccine shipments. But state and local officials say they are angry and bewildered by the shifting directions and changing explanations about supply. Their anxiety was deepened by projections that a highly contagious virus variant would spread rapidly throughout the United States and as daily covid-19 deaths averaged 3,320 this week.
The health director in Oregon, Patrick M. Allen, was so disturbed that he wrote Azar on Thursday demanding an explanation. In his letter, he recounted how Gustave F. Perna, the chief operating officer of Operation Warp Speed, had “informed us there is no reserve of doses, and we are already receiving the full allocation of vaccines.”
“If true, this is extremely disturbing, and puts our plans to expand eligibility at grave risk,” Allen wrote. “Those plans were made on the basis of reliance on your statement about ‘releasing the entire supply’ you have in reserve. If this information is accurate, we will be unable to begin vaccinating our vulnerable seniors on Jan. 23, as planned.”
HHS spokesman Michael Pratt confirmed in an email that the final reserve of second doses had recently been released to states but did not address Azar’s comments, saying only, “Operation Warp Speed has been monitoring manufacturing closely, and always intended to transition from holding second doses in reserve as manufacturing stabilizes and we gained confidence in the ability for a consistent flow of vaccines.”
But the explanations by the federal government were conflicting. The 13 million doses made available for states to order this week — for delivery next week — represented “millions more” than in previous weeks, Pratt said. He also said states have not requested the full amount they have been allocated.
Guidance circulated Friday among HHS officials acknowledged, however, that “the notion that there is a large bolus of second doses that will be released to jurisdictions is not accurate.” And state and municipal health officials said their allocations for next week had increased only marginally, if at all.
Chicago Public Health Commissioner Allison Arwady said her city’s share had gone from about 32,000 doses to 34,000 doses. “I have stopped paying a whole lot of attention to what is being said verbally at the federal level right now,” she said.
Nirav Shah, the director of Maine’s Center for Disease Control and Prevention, said he learned only Friday, by calling his state’s designated contact at Warp Speed, that the reserve no longer existed.
Maine still plans to broaden vaccination next week to those 70 and older. “Who is in line will not change,” Shah said. “The velocity of that line will change because this bolus of doses that we intuited was coming based on Azar’s comments is not coming.”
In an email that reached some state officials Friday morning, Christopher Sharpsten, an Operation Warp Speed director, called it a “false rumor” that “the federal government was holding back vaccine doses in warehouses to guarantee a second/booster dose.”
In fact, that information had come fromAzar, who said Tuesday that the “next phase” of the country’s vaccination campaign involved “releasing the entire supply we have for order by states, rather than holding second doses in physical reserve.”
Azar’s comments Tuesday followed a Jan. 8 announcement by President-elect Joe Biden’s transition team that his administration would move to release all available doses rather than holding half in reserve for booster shots. Biden’s advisers said the move would be a way to accelerate distribution of the vaccine, which is in short supply across the country.
Azar initially said the Biden plan was shortsighted and potentially unethical in putting people at risk of missing their booster shots. When he embraced the change four days later, however, he did not say that the original policy had already been phased out or that the stockpile had been exhausted. Trump administration officials and Biden’s team alike have sought to reassure the public that increasing the pace of immunizations would not endanger booster shots.
Azar also signaled to states that they would soon see expanded supply, urging them to begin vaccinating adults 65 and older and those under 64 with high-risk medical conditions. Officials in some states embraced that directive, while others said that suddenly putting hundreds of thousands of additional people at the front of the line would overwhelm their capacity.
In subsequent conversations with state and local authorities, federal officials sought to temper those instructions, said people who participated in the conversations. Perna, for instance, spoke directly to officials in at least two of the jurisdictions receiving vaccine supply, explaining that allocations would not increase and that they did not have to broaden eligibility as they had previously been told, according to a health official who was not authorized to discuss the matter.
The revised instructions led some state and local officials to hold off on changes. One state health official noted that the updated eligibility guidance announced Tuesday did not appear on the website of the CDC, even though it was stated as federal policy by Azar and by Robert R. Redfield, the CDC director, in their remarks. Under the original recommendations, adults 65 and older and front-line essential workers were to comprise the second priority group, known as Phase 1b, after medical workers and residents and staffers of long-term-care facilities.
There was additional confusion from another change Azar announced this week — making allocation of doses dependent on how quickly states administer them. He originally said that would not take effect for two weeks.
But Connecticut Gov. Ned Lamont (D) on Thursday tweeted that federal officials had notified him that the state would receive an additional 50,000 doses next week “as a reward for being among the fastest states” to get shots into arms. West Virginia, meanwhile, which is moving at the fastest clip, according to CDC data, did not get any additional doses, said Holli Nelson, a spokeswoman for the state’s National Guard.
In a sign that the incentive structure may not be long-lived, a senior Biden transition official, speaking on the condition of anonymity to address ongoing deliberations, said this week that the team did not look kindly on a system that “punishes states.”
Biden has said he wants to see 100 million shots administered within his first 100 days — an aim that will depend on quickly accelerating the pace of immunization. Together, Pfizer and Moderna have agreed to sell 200 million doses to the United States by the end of March, which is enough to fully vaccinate 100 million people.
🚨New CDC warning: The highly contagious variant B.1.1.7 originally detected in the U.K. could become the dominant strain in the U.S. by March.
Why it matters: The variant is estimated to be 30% to 50% more transmissible than other forms of the virus, threatening efforts to push the U.S. past its record high case count.
The variant is in 12 states, but has been diagnosed in only 76 of the 23 million U.S. cases reported to date, the AP reports.
It’s likely that the variant is more widespread than currently reported.
The big picture: Americans are exhausted and burned out, and COVID wariness is slipping.
So far, the variants do not appear to be resistant to the existing vaccines or cause more severe disease.
But the health care system is on the brink in places like Southern California.
Another spike in cases could lead us to a very dark place.
The bottom line:There’s no evidence that this variant is transmitted differently, so keep up the masks and social distancing.
Go deeper … The coronavirus variants: What you need to know.
I had been staring her in the eyes, as she had ordered, but when a doctor on my other side began jabbing me with a needle, I started to turn my head. “Don’t look at it,” the first doctor said. I obeyed.
This was in early August in New Orleans, where I had signed up to be a participant in the clinical trial for the Pfizer-BioNTech COVID-19 vaccine. It was a blind study, which meant I was not supposed to know whether I had gotten the placebo or the real vaccine. I asked the doctor if I would really been able to tell by looking at the syringe. “Probably not,” she answered, “but we want to be careful. This is very important to get right.”
I became a vaccine guinea pig because, in addition to wanting to be useful, I had a deep interest in the wondrous new roles now being played by RNA, the genetic material that is at the heart of new types of vaccines, cancer treatments and gene-editing tools. I was writing a book on the Berkeley biochemist Jennifer Doudna. She was a pioneer in determining the structure of RNA, which helped her and her doctoral adviser figure out how it could be the origin of all life on this planet. Then she and a colleague invented an RNA-guided gene-editing tool, which won them the 2020 Nobel Prize in Chemistry.
The tool is based on a system that bacteria use to fight viruses. Bacteria develop clustered repeated sequences in their DNA, known as CRISPRs, that can remember dangerous viruses and then deploy RNA-guided scissors to destroy them. In other words, it’s an immune system that can adapt itself to fight each new wave of viruses—just what we humans need. Now, with the recently approved Pfizer-BioNTech vaccine and a similar one from Moderna being slowly rolled out across the U.S. and Europe, RNA has been deployed to make a whole new type of vaccine that will, when it reaches enough people, change the course of the pandemic.
Drs. Ugur Sahin and Ozlem Tureci, Co-founders, BioNTech. In January 2020, before many in the Western world were paying attention to a new virus spreading in China, Dr. Ugur Sahin was convinced it would spur a pandemic. Sahin, who in 2008 co-founded the German biotech company BioNTech with his wife Dr. Ozlem Tureci, went to work on a vaccine and by March called his contact at Pfizer, a much larger pharmaceutical company with which BioNTech had previously worked on an influenza vaccine using mRNA. Less than a year later, the Pfizer-BioNTech COVID-19 vaccine became the first ever mRNA vaccine available for widespread use. Even so, Sahin, BioNTech’s CEO, and Tureci, its chief medical officer, maintain that BioNTech is not an mRNA company but rather an immunotherapy company. Much of the couple’s work—both at BioNTech and at their previous venture, Ganymed—has focused on treating cancer. But it is mRNA, and the COVID-19 vaccine made possible by the technology, that has pushed the famously hardworking couple into the limelight—and helped them become one of the richest pairs in Germany, though they reportedly still bicycle to work and live in a modest apartment near their office.
Up until last year, vaccines had not changed very much, at least in concept, for more than two centuries. Most have been modeled on the discovery made in 1796 by the English doctor Edward Jenner, who noticed that many milkmaids were immune to smallpox. They had all been infected by a form of pox that afflicts cows but is relatively harmless to humans, and Jenner surmised that the cowpox had given them immunity to smallpox. So he took some pus from a cowpox blister, rubbed it into scratches he made in the arm of his gardener’s 8-year-old son and then (this was in the days before bioethics panels) exposed the kid to smallpox. He didn’t become ill.
Before then, inoculations were done by giving patients a small dose of the actual smallpox virus, hoping that they would get a mild case and then be immune. Jenner’s great advance was to use a related but relatively harmless virus. Ever since, vaccinations have been based on the idea of exposing a patient to a safe facsimile of a dangerous virus or other germ. This is intended to kick the person’s adaptive immune system into gear. When it works, the body produces antibodies that will, sometimes for many years, fend off any infection if the real germ attacks.
One approach is to inject a safely weakened version of the virus. These can be good teachers, because they look very much like the real thing. The body responds by making antibodies for fighting them, and the immunity can last a lifetime. Albert Sabin used this approach for the oral polio vaccine in the 1950s, and that’s the way we now fend off measles, mumps, rubella and chicken pox.
At the same time Sabin was trying to develop a vaccine based on a weakened polio virus, Jonas Salk succeeded with a safer approach: using a killed or inactivated virus. This type of vaccine can still teach a person’s immune system how to fight off the live virus but is less likely to cause serious side effects. Two Chinese companies, Sinopharm and Sinovac, have used this approach to develop vaccines for COVID-19 that are now in limited use in China, the UAE and Indonesia.
Another traditional approach is to inject a subunit of the virus, such as one of the proteins that are on the virus’s coat. The immune system will then remember these, allowing the body to mount a quick and robust response when it encounters the actual virus. The vaccine against the hepatitis B virus, for example, works this way. Using only a fragment of the virus means that they are safer to inject into a patient and easier to produce, but they are often not as good at producing long-term immunity. The Maryland-based biotech Novavax is in late-stage clinical trials for a COVID-19 vaccine using this approach, and it is the basis for one of the two vaccines already being rolled out in Russia.
The plague year of 2020 will be remembered as the time when these traditional vaccines were supplanted by something fundamentally new:genetic vaccines, which deliver a gene or piece of genetic code into human cells. The genetic instructions then cause the cells to produce, on their own, safe components of the target virus in order to stimulate the patient’s immune system.
For SARS-CoV-2—the virus that causes COVID-19—the target component is its spike protein, which studs the outer envelope of the virus and enables it to infiltrate human cells. One method for doing this is by inserting the desired gene, using a technique known as recombinant DNA, into a harmless virus that can deliver the gene into human cells. To make a COVID vaccine, a gene that contains instructions for building part of a coronavirus spike protein is edited into the DNA of a weakened virus like an adenovirus, which can cause the common cold. The idea is that the re-engineered adenovirus will worm its way into human cells, where the new gene will cause the cells to make lots of these spike proteins. As a result, the person’s immune system will be primed to respond rapidly if the real coronavirus strikes.
This approach led to one of the earliest COVID vaccine candidates, developed at the aptly named Jenner Institute of the University of Oxford. Scientists there engineered the spike-protein gene into an adenovirus that causes the common cold in chimpanzees, but is relatively harmless in humans.
The lead researcher at Oxford is Sarah Gilbert. She worked on developing a vaccine for Middle East respiratory syndrome (MERS) using the same chimp adenovirus. That epidemic waned before her vaccine could be deployed, but it gave her a head start when COVID-19 struck. She already knew that the chimp adenovirus had successfully delivered into humans the gene for the spike protein of MERS. As soon as the Chinese published the genetic sequence of the new coronavirus in January 2020, she began engineering its spike-protein gene into the chimp virus, waking each day at 4 a.m.
Her 21-year-old triplets, all of whom were studying biochemistry, volunteered to be early testers, getting the vaccine and seeing if they developed the desired antibodies. (They did.) Trials in monkeys conducted at a Montana primate center in March also produced promising results.
Bill Gates, whose foundation provided much of the funding, pushed Oxford to team up with a major company that could test, manufacture and distribute the vaccine. So Oxford forged a partnership with AstraZeneca, the British-Swedish pharmaceutical company. Unfortunately, the clinical trials turned out to be sloppy, with the wrong doses given to some participants, which led to delays. Britain authorized it for emergency use at the end of December, and the U.S. is likely to do so in the next two months.
Johnson & Johnson is testing a similar vaccine that uses a human adenovirus, rather than a chimpanzee one, as the delivery mechanism to carry a gene that codes for making part of the spike protein. It’s a method that has shown promise in the past, but it could have the disadvantage that humans who have already been exposed to that adenovirus may have some immunity to it. Results from its clinical trial are expected later this month.
In addition, two other vaccines based on genetically engineered adenoviruses are now in limited distribution: one made by CanSino Biologics and being used on the military in China and another named Sputnik V from the Russian ministry of health.
There is another way to get genetic material into a human cell and cause it to produce the components of a dangerous virus, such as the spike proteins, that can stimulate the immune system. Instead of engineering the gene for the component into an adenovirus, you can simply inject the genetic code for the component into humans as DNA or RNA.
Let’s start with DNA vaccines. Researchers at Inovio Pharmaceuticals and a handful of other companies in 2020 created a little circle of DNA that coded for parts of the coronavirus spike protein. The idea was that if it could get inside the nucleus of a cell, the DNA could very efficiently churn out instructions for the production of the spike-protein parts, which serve to train the immune system to react to the real thing.
The big challenge facing a DNA vaccine is delivery.How can you get the little ring of DNA not only into a human cell but into the nucleus of the cell? Injecting a lot of the DNA vaccine into a patient’s arm will cause some of the DNA to get into cells, but it’s not very efficient.
Some of the developers of DNA vaccines, including Inovio, tried to facilitate the delivery into human cells through a method called electroporation, which delivers electrical shock pulses to the patient at the site of the injection. That opens pores in the cell membranes and allows the DNA to get in. The electric pulse guns have lots of tiny needles and are unnerving to behold. It’s not hard to see why this technique is unpopular, especially with those on the receiving end. So far, no easy and reliable delivery mechanism has been developed for getting DNA vaccines into the nucleus of human cells.
That leads us to the molecule that has proven victorious in the COVID vaccine race and deserves the title of TIME magazine’s Molecule of the Year: RNA. Its sibling DNA is more famous. But like many famous siblings, DNA doesn’t do much work. It mainly stays bunkered down in the nucleus of our cells, protecting the information it encodes. RNA, on the other hand, actually goes out and gets things done. The genes encoded by our DNA are transcribed into snippets of RNA that venture out from the nucleus of our cells into the protein-manufacturing region. There, this messenger RNA (mRNA) oversees the assembly of the specified protein. In other words, instead of just sitting at home curating information, it makes real products.
Scientists including Sydney Brenner at Cambridge and James Watson at Harvard first identified and isolated mRNA molecules in 1961. But it was hard to harness them to do our bidding, because the body’s immune system often destroyed the mRNA that researchers engineered and attempted to introduce into the body. Then in 2005, a pair of researchers at the University of Pennsylvania, Katalin Kariko and Drew Weissman, showed how to tweak a synthetic mRNA molecule so it could get into human cells without being attacked by the body’s immune system.
Stéphane Bancel, CEO, Moderna. Moderna’s COVID-19 vaccine was first tested in humans less than three months after news of the novel virus broke. But that lightning-fast development process belies the years of work that got Moderna to where it is today. The startup was founded in 2010 with the belief that mRNA technology, then still fairly new, could help treat any number of ailments. CEO Stéphane Bancel, pictured above, joined a year later. Moderna wasn’t originally focused on vaccines, but over time, its scientists began working toward vaccines against several infectious diseases as well as some forms of cancer. That experience came in handy when the COVID-19 pandemic arrived, leaving the world clamoring for a vaccine that could fight the deadly virus—and fast. Bancel’s company took the challenge in stride, using its mRNA platform to develop a vaccine around 95% effective at protecting against COVID-19 disease in less than a year.
When the COVID-19 pandemic hit a year ago, two innovative young pharmaceutical companies decided to try to harness this role played by messenger RNA: the German company BioNTech, which formed a partnership with the U.S. company Pfizer; and Moderna, based in Cambridge, Mass. Their mission was to engineer messenger RNA carrying the code letters to make part of the coronavirus spike protein—a string that begins CCUCGGCGGGCA … —and to deploy it in human cells.
BioNTech was founded in 2008 by the husband-and-wife team of Ugur Sahin and Ozlem Tureci, who met when they were training to be doctors in Germany in the early 1990s. Both were from Turkish immigrant families, and they shared a passion for medical research, so much so that they spent part of their wedding day working in the lab. They founded BioNTech with the goal of creating therapies that stimulate the immune system to fight cancerous cells. It also soon became a leader in devising medicines that use mRNA in vaccines against viruses.
In January 2020, Sahin read an article in the medical journal Lancet about a new coronavirus in China. After discussing it with his wife over breakfast, he sent an email to the other members of the BioNTech board saying that it was wrong to believe that this virus would come and go as easily as MERS and SARS. “This time it is different,” he told them.
BioNTech launched a crash project to devise a vaccine based on RNA sequences, which Sahin was able to write within days, that would cause human cells to make versions of the coronavirus’s spike protein. Once it looked promising, Sahin called Kathrin Jansen, the head of vaccine research and development at Pfizer. The two companies had been working together since 2018 to develop flu vaccines using mRNA technology, and he asked her whether Pfizer would want to enter a similar partnership for a COVID vaccine. “I was just about to call you and propose the same thing,” Jansen replied. The deal was signed in March.
By then, a similar mRNA vaccine was being developed by Moderna, a much smaller company with only 800 employees. Its chair and co-founder, Noubar Afeyan, a Beirut-born Armenian who immigrated to the U.S., had become fascinated by mRNA in 2010, when he heard a pitch from a group of Harvard and MIT researchers. Together they formed Moderna, which initially focused on using mRNA to try to develop personalized cancer treatments, but soon began experimenting with using the technique to make vaccines against viruses.
In January 2020, Afeyan took one of his daughters to a restaurant near his office in Cambridge to celebrate her birthday. In the middle of the meal, he got an urgent text message from the CEO of his company, Stéphane Bancel, in Switzerland. So he rushed outside in the freezing temperature, forgetting to grab his coat, to call him back.
Bancel said that he wanted to launch a project to use mRNA to attempt a vaccine against the new coronavirus. At that point, Moderna had more than 20 drugs in development but none had even reached the final stage of clinical trials. Nevertheless, Afeyan instantly authorized him to start work. “Don’t worry about the board,” he said. “Just get moving.” Lacking Pfizer’s resources, Moderna had to depend on funding from the U.S. government. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, was supportive. “Go for it,” he declared. “Whatever it costs, don’t worry about it.”
It took Bancel and his Moderna team only two days to create the RNA sequences that would produce the spike protein, and 41 days later, it shipped the first box of vials to the National Institutes of Health to begin early trials. Afeyan keeps a picture of that box on his cell phone.
An mRNA vaccine has certain advantages over a DNA vaccine, which has to use a re-engineered virus or other delivery mechanism to make it through the membrane that protects the nucleus of a cell. The RNA does not need to get into the nucleus. It simply needs to be delivered into the more-accessible outer region of cells, the cytoplasm, which is where proteins are constructed.
The Pfizer-BioNTech and Moderna vaccines do so by encapsulating the mRNA in tiny oily capsules, known as lipid nanoparticles.Moderna had been working for 10 years to improve its nanoparticles.This gave it one advantage over Pfizer-BioNTech: its particles were more stable and did not have to be stored at extremely low temperatures.
Katalin Kariko, Senior vice president, BioNTech. In 1995, after years of struggle, Hungarian-born Katalin Kariko was pushed off the path to full professorship at the University of Pennsylvania. Her work on mRNA, molecules she believed could fundamentally change the way humans treat disease, had stalled. Then, in 1997, she met and began working with immunologist Drew Weissman. In 2005, they published a study describing a modified form of artificial mRNA—a discovery, they argued, that opened the door to mRNA’s use in vaccines and other therapies. Eventually, Kariko and Weissman licensed their technology to the German company BioNTech, where Kariko, shown here in a portrait shot by a photographer working remotely, is now a senior vice president. Her patience paid off this year. The mRNA-based Pfizer-BioNTech coronavirus vaccine, which Kariko helped develop, has been shown to be 95% effective at preventing COVID-19.
By November, the results of the Pfizer-BioNTech and Moderna late-stage trials came back with resounding findings: both vaccines were more than 90% effective. A few weeks later, with COVID-19 once again surging throughout much of the world, they received emergency authorization from the U.S. Food and Drug Administration and became the vanguard of the biotech effort to beat back the pandemic.
The ability to code messenger RNA to do our bidding will transform medicine. As with the COVID vaccines, we can instruct mRNA to cause our cells to make antigens—molecules that stimulate our immune system—that could protect us against many viruses, bacteria, or other pathogens that cause infectious disease. In addition, mRNA could in the future be used, as BioNTech and Moderna are pioneering, to fight cancer. Harnessing a process called immunotherapy, the mRNA can be coded to produce molecules that will cause the body’s immune system to identify and kill cancer cells.
RNA can also be engineered, as Jennifer Doudna and others discovered, to target genes for editing. Using the CRISPR system adapted from bacteria, RNA can guide scissors-like enzymes to specific sequences of DNA in order to eliminate or edit a gene. This technique has already been used in trials to cure sickle cell anemia. Now it is also being used in the war against COVID. Doudna and others have created RNA-guided enzymes that can directly detect SARS-CoV-2 and eventually could be used to destroy it.
More controversially, CRISPR could be used to create “designer babies” with inheritable genetic changes. In 2018, a young Chinese doctor used CRISPR to engineer twin girls so they did not have the receptor for the virus that causes AIDS. There was an immediate outburst of awe and then shock. The doctor was denounced, and there were calls for an international moratorium on inheritable gene edits. But in the wake of the pandemic, RNA-guided genetic editing to make our species less receptive to viruses may someday begin to seem more acceptable.
Throughout human history, we have been subjected to wave after wave of viral and bacterial plagues. One of the earliest known was the Babylon flu epidemic around 1200 B.C. The plague of Athens in 429 B.C. killed close to 100,000 people, the Antonine plague in the 2nd century killed 5 million, the plague of Justinian in the 6th century killed 50 million, and the Black Death of the 14th century took almost 200 million lives, close to half of Europe’s population.
The COVID-19 pandemic that killed more than 1.8 million people in 2020 will not be the final plague. However, thanks to the new RNA technology, our defenses against most future plagues are likely to be immensely faster and more effective. As new viruses come along, or as the current coronavirus mutates, researchers can quickly recode a vaccine’s mRNA to target the new threats. “It was a bad day for viruses,” Moderna’s chair Afeyan says about the Sunday when he got the first word of his company’s clinical trial results. “There was a sudden shift in the evolutionary balance between what human technology can do and what viruses can do. We may never have a pandemic again.”
The invention of easily reprogrammable RNA vaccines was a lightning-fast triumph of human ingenuity, but it was based on decades of curiosity-driven research into one of the most fundamental aspects of life on planet earth: how genes are transcribed into RNA that tell cells what proteins to assemble. Likewise, CRISPR gene-editing technology came from understanding the way that bacteria use snippets of RNA to guide enzymes to destroy viruses. Great inventions come from understanding basic science. Nature is beautiful that way.
The highly contagious variant of the coronavirus first seen in the United Kingdom will become the dominant strain in the United States within about two months, its rapid spread heightening the urgency of getting people vaccinated, the Centers for Disease Control and Prevention predicted Friday in its most sobering warning yet about mutations in the virus.
In every scenario explored by the CDC, the U.K. strain, which British researchers estimate is roughly 50 percent more transmissible than the more common coronavirus strain, will account for a majority of cases in the United States by some point in March.
The CDC released modeling data to back up its forecast showing a rapid spike in infections linked to the U.K. strain. The agency said the emergence of these mutation-laden variants requires greater efforts to limit viral spread — immediately, even before the U.K. variant becomes commonplace.
So far, no variant is known to cause more severe illness, although more infections would inevitably mean a higher death toll overall, as the CDC made clear in an informational graphic released Friday: “MORE SPREAD — MORE CASES — MORE DEATHS,” it said.
The CDC report “speaks to the urgency of getting vaccines out. It’s now a race against the virus,” said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.
Scientists both in and out of government have stressed the need for the public to stick to proven methods of limiting viral spread, such as wearing a mask, social distancing, avoiding crowds and having good hand hygiene.
“We know what works and what to do,” CDC scientist Jay Butler said Friday.
The emergence of highly contagious variants has grabbed the full attention of scientists, who in recent weeks have warned that these mutations require closer surveillance. The CDC and its partners in private and academic laboratories are ramping up genomic sequencing efforts to gain better awareness of what is already circulating. Experts think there could be many variants containing mutations worth a closer look.
“This is a situation of concern. We are increasing our surveillance of emerging variants. This virus sometimes surprises us,” Butler said.
Mutations could limit the efficacy of vaccines or therapeutic drugs such as monoclonal antibodies. Scientists believe vaccines will probably remain effective because they produce a robust immune system response, but such reassurances have been paired with cautionary notes about how much remains unknown.
The coronavirus mutations are not unexpected, because all viruses mutate. There are now several “variants of concern” receiving close scrutiny, including ones identified first in South Africa and Brazil, and U.S. officials have said genomic surveillance is still ramping up here and that there may be other variants in circulation, not yet identified, that are enhancing transmission.
“We’re going forward with the assumption that these three variants that we know about now are not going to be the only variants that emerge that are of concern to us,” Greg Armstrong, head of the CDC’s strain surveillance program, said Friday.
The CDC model suggests that the level of pain and suffering in March, when the new variant is expected to be dominant, depends on actions taken today to try to drive down infection rates. Because the threshold for herd immunity depends in part on how infectious a virus is, the emergence of a more transmissible strain can prolong efforts to crush a pandemic.
The emergence in recent weeks of mutation-laden variants has alarmed the CDC and the scientific community because of accelerating infections in Britain, Denmark, Ireland and other countries where the variant named B.1.1.7 has been spreading.
“Increased SARS-CoV-2 transmission might threaten strained healthcare resources, require extended and more rigorous implementation of public health strategies, and increase the percentage of population immunity required for pandemic control,” the CDC wrote. “Taking measures to reduce transmission now can lessen the potential impact of B.1.1.7 and allow critical time to increase vaccination coverage.”
It is unclear if the winter surge in the United States is at a peak, but the numbers are staggering, with more than 200,000 new infections confirmed every day on average.
This is not the first warning from the CDC about variants of the virus, but it is the first to offer a plausible timeline for when and to what degree the mutations seen recently could complicate efforts to end the pandemic.
It shows that vaccination, performed rapidly, is critical to crushing the curve of viral infections. Without vaccines, under one CDC scenario, the country could be dealing with even greater levels of infections in May than in January.
But if public health agencies can ramp up to 1 million vaccinations a day, the CDC model forecasts that daily new infections will decline in the next few months — even with the extra boost from the highly contagious U.K. variant. It has been identified in 12 states, the CDC said Friday, and the agency has informed officials nationwide that they should assume the variant is present in their state.
The CDC and unaffiliated scientists have said they see no evidence that this particular variant is driving the winter surge in cases. So far, it has been involved in fewer than 0.5 percent of infections nationwide, testing data suggests.
Friday’s sobering CDC forecast is based on simple models and has limitations, the agency acknowledged.
The model looks at just the B.1.1.7 variant and does not consider the impact of other variants already discovered or not yet identified. The variants in South Africa and Brazil could prove to be even more problematic, though they have not been spotted so far in the United States. Researchers have noted the disastrous spike in cases in Manaus, Brazil, in recent weeks, despite the high percentage of the population believed to have been previously infected — a situation that raises suspicions, not confirmed by data, that some people who had recovered are becoming re-infected by the new strain.
The CDC model treats the country as a single unit even though the virus is spreading at different rates locally and regionally. No one knows, even at the national level, the current “R,” the reproduction number, of the common coronavirus variant. That’s the number of people an infected person will infect, on average.
The CDC model used plausible reproduction rates of 1.1 (faster spread right now) and 0.9 (slower). The CDC then used British data to project that the U.K. variant is 50 percent more transmissible than the common variant. The model assumes that between 10 and 30 percent of the population has been infected already and recovered and now has immunity.
“It would be foolish to say that this is never going to end, and we might as well stop trying,” the CDC’s Butler said Friday. “But there is reason to be concerned. We’re not out of the woods on this pandemic yet. We need to continue to press ahead.”
The annual J.P. Morgan Healthcare Conference is one of the best ways to diagnose the financial condition of the healthcare industry. Every January, every key stakeholder — providers, payers, pharmaceutical companies, tech companies, medical device and supply companies as well as bankers, venture capital and private equity firms — comes together in one exam room, even when it is virtual, for their annual check-up. But as we all know, this January is unlike any other as this past year has been unlike any other year.
You would have to go back to the banking crisis of 2008 to find a similar moment from an economic perspective. At the time, we were asking, “Are banks too big to fail?” The concern behind the question was that if they did fail, the economic chaos that would follow would lead to a collapse with the consumer ultimately picking up the tab. The rest is history.
Healthcare is “Too Vital to Fail”
2020 was historic in too many ways to count. But in a year when healthcare providers faced the worst financial crisis in the history of healthcare, the headline is that they are still standing. And what they proved is that in contrast to banks in 2008 that were seen by many as “too big to fail,” healthcare providers in 2020 proved that they were “too vital to fail.”
One of the many unique things about the COVID-19 pandemic is we are simultaneously experiencing a health crisis, where healthcare providers are the front line in the battle, and an economic crisis, felt in a big way in healthcare given the unique role hospitals play as the largest employer in most communities. Hospitals and health systems have done the vast majority of testing, treating, monitoring, counseling, educating and vaccinating all while searching for PPE and ventilators, and conducting clinical trials. And that’s just the beginning of the list.
Stop and think about that for a minute. What would we have done without them? Thinking through that question will give you some appreciation for the critical, challenging and central role that healthcare providers have had to play over the past year.
Simply stated, healthcare providers are the heart of healthcare, both clinically (essentially 100 percent of the care) and financially (over 50 percent of the $4 trillion annual spend on U.S. healthcare). Over the last year they stepped up and they stepped in at the moment where we needed them the most. This was despite the fact that, like most businesses, they were experiencing calamitous losses with no assurances of any assistance.
Healthcare is “Pandemic-Proof”
This was absolutely the worst-case scenario and the biggest test possible for our nation’s healthcare delivery system. Patient volume and therefore revenue dropped by over 50 percent when the panic of the pandemic was at its peak, driving over $60 billion in losses per month across hospitals and healthcare providers. At the same time, they were dramatically increasing their expenses with PPE, ventilators and additional staff. This was not heading in a good direction. While failure may not have been seen as an option, it was clearly a possibility.
The CARES Act clearly provided a temporary lifeline, providing funding for our nation’s hospitals to weather the storm. While there are more challenging times ahead, it is now clear that most are going to make it to the other side. The system of care in our country is often criticized, but when faced with perhaps the most challenging moment in the history of healthcare, our nation’s hospitals and health systems stepped up heroically and performed miraculously. The work of our healthcare providers on the front line and those who supported them was and is one thing that we all should be exceptionally proud of and thankful for.In 2020, they proved that not only is our nation’s healthcare system too vital to fail, but also that it is “pandemic proof.”
Listening to Front Line at the 2021 J.P. Morgan Healthcare Conference
There has never been a more important year to listen to the lessons from healthcare providers. They are and were the front line of our fight against COVID-19. If there was a class given about how to deal with a pandemic at an institutional level, this conference is where those lessons were being taught.
This year at the J.P. Morgan Healthcare Conference, CEOs, and CFOs from many of the most prestigious and most well-respected health systems in the world presented including AdventHealth, Advocate Aurora Health, Ascension, Baylor Scott & White Health, CommonSpirit Health, Henry Ford Health System, Intermountain Healthcare, Jefferson Health, Mass General Brigham, Northwell Health, OhioHealth, Prisma Health, ProMedica Health System, Providence, Spectrum Health and SSM Health.
I’ve been in healthcare for 30 years and this is my fifth year of writing up the summary of the non-profit provider track of the conference for Becker’s Healthcare to help share the wisdom of the crowd of provider organizations that share their stories. Clearly, this year was different and not because the presentations were virtual, but because they were inspirational.
What did we learn? The good news is that they have made many changes that have the potential to move healthcare in a much better direction and to get to a better place much faster. So, this year instead of providing you a nugget from each presentation, I am going to take a shot at summarizing what they collectively have in motion to stay vital after COVID.
10 Moves Healthcare Providers are Making to Stay Vital After-COVID
As a leader in healthcare, you will never have a bigger opportunity to drive change than right now. Smart leaders are framing this as essentially “before-COVID (BC)” and “after-COVID (AC)” and using this moment as their burning platform to drive change. Credit to the team at Providence for the acronym, but every CEO talked about this concept. As the saying goes, “never let a good crisis go to waste.” Well, we’ve certainly had a crisis, so here is a list of what the top health systems are doing to ensure that they don’t waste it and that they stay vital after-COVID:
1. Take Care of Your Team and They’ll Take Care of You: In a crisis, you can either come together as a team or fall apart. Clearly there has been a significant and stunning amount of pressure on healthcare providers. Many are fearing that mental health might be our nation’s next pandemic in the near future because they are seeing it right now with their own team. Perhaps one of their biggest lessons from this crisis has been the need to address the mental, physical and spiritual health of both team members as well as providers. They have put programs in place to help and have also built a tremendous amount of trust with their team by, in many cases, not laying off and/or furloughing employees. While they have made cuts in other areas such as benefits, this collective approach proved incredibly beneficial. And the last point here that relates to thinking differently about their team is that similar to other businesses, many health systems are making remote arrangements permanent for certain administrative roles and moving to a flexible approach regarding their team and their space in the future.
2. Focus on Health Equity, Not Just Health Care: This was perhaps the most notable and encouraging change from presentations in past years at J.P. Morgan. I have been going to the conference for over a decade, and I’ve never heard someone mention this term or outline their efforts on “health equity” — this year, nearly everyone did. In the past, they have outlined many wonderful programs on “social determinants of health,” but this year they have seen the disproportionate impact of COVID on low-income communities bringing the ongoing issue of racial disparities in access to care and outcomes to light. As the bedrock of employment in their community, this provides an opportunity to not just provide health care, but also health equity, taking an active role to help make progress on issues like hunger, homelessness, and housing. Many are making significant investments in a number of these and other areas.
3. Take the Lead in Public Health — the Message is the Medicine:One of the greatest failings of COVID, perhaps the greatest lesson learned, is the need for clear and consistent messaging from a public health perspective. That is a role that healthcare providers can and should play. In the pandemic, it represented the greatest opportunity to save lives as the essence of public health is communication — the message is the medicine. A number of health systems stepped into this opportunity to build trust and to build their brand, which are essentially one in the same. Some organizations have created a new role — a Chief Community Health Officer — which is a good way to capture the work that is in motion relative to social determinants of health as well as health equity. Many understand the opportunity here and will take the lead relative to vaccine distribution as clear messaging to build confidence is clearly needed.
4. Make the Home and Everywhere a Venue of Care:A number of presenters stated that “COVID didn’t change our strategy, it accelerated it.” For the most part, they were referring to virtual visits, which increased dramatically now representing around 10 percent of their visits vs. 1 percent before-COVID. One presenter said, “Digital has been tested and perfected during COVID,” but that is only considering the role we see digital playing in this moment. It is clear some organizations have a very narrow tactical lens while others are looking at the opportunity much more strategically. For many, they are looking at a “care anywhere and everywhere” strategy. From a full “hospital in the home” approach to remote monitoring devices, it is clear that your home will be seen as a venue of care and an access point moving forward. The pandemic of 2020 may have sparked a new era of “post-hospital healthcare” — stay tuned.
5. Bury Your Budget and Pivot to Planning:The budget process has been a source of incredible distrust, dissatisfaction and distraction for every health system for decades. The chaos and uncertainty of the pandemic forced every organization to bury their budget last year. With that said, many of the organizations that presented are now making a permanent shift away from a “budget-based culture” where the focus is on hitting a now irrelevant target set that was set six to nine months ago to a “performance-based culture” where the focus is on making progress every day, week, month and quarter. Given that the traditional annual operating budget process has been the core of how health systems have operated, this shift to a rolling forecast and a more dynamic planning process is likely the single most substantial and permanent change in how hospitals and health systems operate due to COVID. In other words, it is arguably a much bigger headline than what’s happened with virtual visits.
6. Get Your M&A Machine in Motion: It was clear from the presentations that activity around acquisitions is going to return, perhaps significantly. These organizations have strong balance sheets and while the strong have gotten stronger during COVID, the weak have in many cases gotten weaker. Many are going to be opportunistic to acquire hospitals, but at the same time they have concluded that they can’t just be a system of care delivery. They are also focused on acquiring and investing in other types of entities as well as forming more robust partnerships to create new revenue streams. Organizations that already had diversified revenue streams in place came through this pandemic the best. Most hospitals are overly reliant on the ED and surgical volume. Trying to drive that volume in a value-based world, with the end of site of service differentials and the inpatient only list, will be an even bigger challenge in the future as new niche players enter the market. As I wrote in the headline of my summary two years ago, “It’s the platform, stupid.” There are better ways to create a financial path forward that involve leveraging their assets — their platform — in new and creative ways.
7. Hey, You, Get into the Cloud:With apologies for wrapping a Rolling Stones song into a conference summary, one of the main things touted during presentations was “the cloud” and their ability to pull clinical, operational and financial dashboards together to monitor the impact of COVID on their organization and organize their actions. Focus over the last decade has been on the clinical (implementing EHRs), but it is now shifting to “digitizing operations” with a focus on finance and operations (planning, cost accounting, ERPs, etc.) as well as advanced analytics and data science capabilities to automate, gather insight, manage and predict. It is clear that the cloud has moved from a curiosity to a necessity for health systems, making this one of the biggest areas of investment for every health system over the next decade.
8. Make Price Transparency a Key Differentiator: One of the great lessons from Amazon (and others) is that you can make a lot of money when you make something easy to buy. While many health systems are skeptical of the value of the price transparency requirements, those that have a deep understanding of both their true cost of care and margins are using this as an opportunity to prove their value and accelerate their strategy to become consumer-centric. While there is certainly a level of risk, no business has ever been unsuccessful because they made their product easier to understand and access. Because healthcare is so opaque, there is an opening for healthcare providers to build trust, which is their main asset, and volume, which is their main source of revenue, by becoming stunningly easy to do business with. This may be tough sledding for some as this isn’t something healthcare providers are known for. To understand this, spend a few minutes on Tesla’s website vs. Ford’s. The concept of making something easy, or hard, to buy will become crystal clear as fast as a battery-driven car can go from zero to 60.
9. Make Care More Affordable:This represents the biggest challenge for hospitals and health systems as they ultimately need to be on the right side of this issue or the trust that they have will disappear and they will remain very vulnerable to outside players. All are investing in advanced cost accounting systems (time-driven costing, physician costing, supply, and drug costing) to truly understand their cost and use that as a basis to price more strategically in the market. Some are dropping prices for shoppable services and using loss leader strategies to build their brand. The incoming Secretary of Health and Human Services has a strong belief regarding the accountability of health systems to be consumer centric. The health systems that understand this are working to get ahead of this issue as it is likely one of their most significant threats (or opportunities) over the next decade. This means getting all care to the right site of care, evaluating every opportunity to improve, and getting serious about eliminating the need for expensive care through building healthy communities. If you’re worried about Wal-Mart or Amazon, this is your secret weapon to keep them on the sideline.
10. Scale = Survival: One of the big lessons here is that the strong got stronger, the weak got weaker. For the strong, many have been able to “snapback” in financial performance because they were resilient. They were able to designate COVID-only facilities, while keeping others running at a higher capacity. To be clear, while most health systems are going to get to the other side and are positioned better than ever, there are many others that will continue to struggle for years to come. According to our data at Strata, we see 25 percent operating at negative margins right now and another 50 percent just above breakeven. They key to survival moving forward, for those that don’t have a captive market, will be scale. If this pandemic proved one thing relative to the future of health systems it is this — scale equals survival.
When Will We Return to Normal?
Based on what the projections that these health systems shared, the “new normal” for health systems for the first half of 2021 will be roughly 95 percent of prior year inpatient volume with a 20 percent year-over-year drop in ED volume and a drop of 10-15 percent in observation visits. So, the pain will continue, but given the adjustments that were already made in 2020, it looks like they will be able to manage through COVID effectively. While there will be a pickup in the second half of 2021, the safe bet is that a “return to normal” pre-COVID volumes likely won’t occur until 2022. And there are some who believe that some of the volume should have never been there to begin with and we might see a permanent shift downward in ED volume as well as in some other areas.
With that said, I’ll steal a quote from Bert Zimmerli, the CFO of Intermountain Healthcare, who said, “Normal wasn’t ever nearly good enough in healthcare.”In that spirit, the goal should be to not return to normal, but rather to use this moment as an opportunity to take the positive changes driven by COVID — from technology to processes to areas of focus to a sense of responsibility — and make them permanent.
Thanking Our “Healthcare Heroes”
We’ll never see another 2020 again, hopefully. With that said, one of the silver linings of the year is everything we learned in healthcare. The most important lesson was this — in healthcare there are literally heroes everywhere. To each of them, I just want to say “thank you” for being there for us when we needed you the most. We should all be writing love letters to those on the front line who risked their lives to save others. Our nation’s healthcare system has taken a lot of criticism through the years from those on the outside, often with a blind eye to how things work in practice vs. in concept. But this year we all got to see first-hand what’s happening inside of healthcare — the heroic work of our healthcare providers and those who support them.
They faced the worst crisis in the history of healthcare. They responded heroically and were there for our families and friends.
They proved that healthcare is too vital to fail. They proved that healthcare is pandemic-proof.
HENRY KOTULA 