A new study may help explain why men, like this patient in an Italian intensive care unit, are more likely than women to develop life-threatening COVID-19.
By Meredith WadmanSep. 24, 2020 , 2:00 PM
Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
From the first months of the COVID-19 pandemic, scientists baffled by the diseases ferocity have wondered whether the bodys vanguard virus fighter, a molecular messenger called type I interferon, is missing in action in some severe cases. Two papers published online in Science this week confirm that suspicion. They reveal that in a significant minority of patients with serious COVID-19, the interferon response has been crippled by genetic flaws or by rogue antibodies that attack interferon itself.
Together these two papers explain nearly 14% of severe COVID-19 cases. That is quite amazing, says Qiang Pan- Hammarstrm, an immunologist at the Karolinska Institute.
Tadatsugu Taniguchi, a pioneering interferon scientist and emeritus professor at the University of Tokyo, calls the discoveries remarkable. He says they highlight the critical role of type I interferons in SARS-CoV-2 infection and the development of potentially lethal COVID-19.
Co-author Isabelle Meyts, a pediatric immunologist at the University Hospitals Leuven, was struck by one papers finding that rogue antibodies underlie COVID-19 in 10% of gravely ill patients: There has never been any infectious disease explained at this level by a factor in the human body. And its not an isolated cohort of Europeans. Patients are from all over the world, all ethnicities. Another finding, that 94% of the patients with interferon-attacking antibodies were male, also helps explain why men face higher risk of severe disease.
The paired studies have immediate practical implications. Synthetic interferons, long used to treat other diseases, might help some at-risk patients, as might other therapies aimed at removing the damaging antibodies. A common kind of antibody test could be readily developed and return answers in hours. Those found to be at high risk of developing severe COVID- 19 could take precautions to avoid exposure or be prioritized for vaccination, says Elina Zuniga, an immunologist who studies interferons at the University of California, San Diego.
The findings also raise a red flag for plasma donations from recovered patients. Because it may be rich in antibodies to the virus, convalescent plasma is already given to some patients to fight the infection. But some donations could harbor the interferon-neutralizing antibodies. You should eliminate these patients from the pool of donors, Zuniga says. You definitely dont want to be transferring these autoantibodies into another person.
Type I interferons are made by every cell in the body and are vital leaders of the antiviral battle early in infection. They launch an immediate, intense local response when a virus invades a cell, triggering infected cells to produce proteins that attack the virus. They also summon immune cells to the site and alert uninfected neighboring cells to prepare their own defenses.
In one study, Jean-Laurent Casanova, an infectious disease geneticist at Rockefeller University, and his team examined blood samples from 987 gravely ill patients from around the world. In 10.2% of the patients, the researchers identified antibodies that attacked and neutralized the patients own type I interferon. A subgroup of affected patients had extremely low or undetectable blood levels of this interferon. Lab studies confirmed the antibodies knocked the interferon out of action and cells exposed to the patients plasma failed to fend off invasion by the new coronavirus.
At least 10% of critical COVID-19 is an autoimmune attack.
None of the 663 people in a control group with mild or asymptomatic SARS-CoV-2 infection had those damaging antibodies. The antibodies were also scarce in the general population, showing up in only 0.33% of more than 1200 healthy people tested. What this means is that at least 10% of critical COVID-19 is an autoimmune attack against the immune system itself, Casanova says.
The preponderance of male patients was a surprise, because women have higher rates of autoimmune disease. Our favorite hypothesis is that it is an X-linked recessive trait, Casanova says. Women with two X chromosomes are protected and men, with one, are not. Supporting that suspicion, one woman with a rare condition that silences one X chromosome was among the severely ill patients with autoantibodies.
If these striking results hold up, they might also help explain the increased vulnerability of older people to severe COVID-19: Half the gravely ill patients with autoantibodies were older than 65.
The second paper found genetic flaws in patients that led to the same end result: a grossly inadequate interferon response to SARS-CoV-2 infection. The team sequenced DNA from 659 critically ill COVID-19 patients and from 534 controls with mild or asymptomatic disease. They examined 13 genes, chosen because flaws in them impair the bodys production or use of type I interferon; mutations in the genes underlie life-threatening influenza or other viral illnesses. The researchers found that 3.5% of the critically ill patients harbored rare mutations in eight of those genes. In patients for whom blood samples were available, interferon levels were vanishingly small. No members of the control group carried any of the mutations. This is the first paper to pin down indisputably disease-causing mutations underlying severe COVID-19, Pan-Hammarstrm says.
But its probably the tip of the iceberg, says Paul Hertzog, an interferon expert at the Hudson Institute of Medical Research. Many other damaging mutations, interferon related and not, may influence the development of severe COVID-19, he says.
Zuniga notes that none of the patients who made antibodies against interferon or had the mutations had a history of life-threatening viral illnesses requiring hospitalization. This suggests that we are more reliant on type I interferons to protect ourselves against SARS-CoV-2 versus other viral infections, she says. That makes it important to try therapies aimed at boosting type I interferon responses.
Dozens of randomized clinical trials are now deploying interferons against SARS-CoV-2. One, led by Tom Wilkinson at the University of Southampton, reported promising findings in a small group of hospitalized COVID-19 patients. But synthetic interferons wont help patients who harbor mutations that prevent interferons from working, or those with antibodies that attack them.
Some researchers caution that the interferon-neutralizing antibodies could be a consequence, rather than a cause, of severe COVID-19. Its possible that they develop during the disease, says Miriam Merad, an immunologist at the Icahn School of Medicine at Mount Sinai. That would explain why the patients hadnt faced life-threatening viral infections before, she says.
But Casanova, who has made a career of discovering mutations that confer susceptibility to infectious diseases, says there is a strong case for causality. He points out that preexisting blood samples from a handful of patients showed they had the antibodies in their blood before contracting SARS-CoV-2. He argues that, in response to infection, its unlikely that the body could quickly generate the high levels of anti-interferon antibodies his team saw.
Yanick Crow, a clinical geneticist at the University of Edinburgh who studies interferon signaling, calls the antibody paper shocking, in part because men were so much more likely than women to carry the rogue antibodies. Tests screening for the antibodies can and should be rapidly developed, he says, and will quickly reveal whether the new findings hold up. Given tens of millions of cases worldwide, he says, 10% is such a high figure and the implications are very important.
*Correction, 25 September, 11 a.m.:A previous version of this story mistakenly reversed the words "cause" and "consequence" when introducing a quote from Miriam Merad. This has been corrected.
The NFL has its first COVID-19 team outbreak. At least nine members of the Tennessee Titans have produced confirmed positive test results in the past four days, a rash of coronavirus infections that could potentially have spread during Sunday's game against the Minnesota Vikings at U.S. Bank Stadium.
The Titans have closed their practice facility until at least Saturday, while the Vikings have closed theirs until they have further test results. Decisions on both teams' Week 4 games are pending.
Here's what we know at the moment, with appropriate context. We will continue to update as news develops.
Jump to:Timeline for return to facilitiesCould games get postponed?
Yes. On Saturday, Titans linebackers coach Shane Bowen returned a confirmed positive test. The Titans received the results before they departed Nashville for Minneapolis, and Bowen was held back from making the trip.
We don't know. What we do know is that the entire Titans traveling party was tested Saturday, as they would ordinarily be. The Titans had those results by Sunday morning. All were negative, meaning every coach, player and staff member was eligible for Sunday's game.
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The Titans stayed Saturday night at the JW Marriott, adjacent to the Mall of America in Bloomington, Minnesota, according to ESPN's Courtney Cronin. League protocol requires all members of the traveling party to have their own rooms and also prohibits them from "congregating, visiting or mingling with individuals outside of the Traveling Party once they have arrived in the game city."
On Sunday, they defeated the Vikings 31-30. The team flew home after the game ended.
Correct. The protocols call for daily testing on every day except game day. Neither the league nor the NFL Players Association (NFLPA) has explained explicitly why, but timing is likely a substantial part of the answer. Results for polymerase chain reaction (PCR) tests, performed on the morning of a game by nasal swab, probably wouldn't be returned in time for kickoff.
Point of care (POC) tests have quicker results -- PCR tests are usually returned overnight, whereas POC tests can be returned on the same day, and even before kickoff after a morning test -- but are not as accurate. At this time, POC tests are only used to help confirm initial positive tests, and the NFL doesn't yet trust them on their own. And the NFL likely didn't want to sideline a player or coach based only off a POC test.
All Tier 1 and Tier 2 employees from the Titans and Vikings, which includes players and coaches, were tested Monday morning. Of the eight Titans who returned confirmed positive tests, three were players and five were employees. They have not been identified. None were displaying symptoms, according to ESPN's Dan Graziano. No members of the Vikings returned positive tests.
Most officials travel home on the night of the game or the next morning. Per their protocol, they are tested twice per week -- once in their hometowns and once on the day before games. Referee Clete Blakeman's crew worked this game and will be tested daily this week. None of those officials will work a game in Week 4.
No. General guidance from public health officials suggests it can take up to five to seven days for an infection to register in a test. That's why the Titans' facility is closed through at least Saturday. The NFL/NFLPA protocol calls for increased monitoring for eight days for anyone who had close contact with someone who returned a confirmed positive test.
The protocols follow CDC guidelines: within 6 feet apart for at least 15 minutes of an infected individual. The league identified 48 close contacts to monitor, based on contact tracing of the eight confirmed positive individuals, according to Graziano. It's unclear if those are all members of the Titans, or if some are members of the Vikings.
That includes contact during a game as well as data recorded by mandatory proximity devices worn by all team employees before and after the game. Per the protocol, "Tier 1, Tier 2, Tier 2M and Tier 3 Individuals will also be required to wear Kinexon Proximity Recording tracking devices at all times while engaged in team activities (including in the Club facility, during practices, and during team travel)."
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Dianna Russini explains the possible origin of the Titans' coronavirus outbreak and why she doesn't anticipate Tennessee playing its Week 4 game against Pittsburgh.
If the Titans passed the infection to the Vikings, then yes. Games are the one point in the NFL week where social distancing is impossible, and the period when it's most likely that an infected person will breathe on others. That's part of the reason the NFL has insisted on coaches and other non-players wearing masks on the sideline.
The absence of game-day testing also heightens the risk. A POC test Sunday morning might have caught at least some of the positive results the Titans eventually recorded Monday.
They were. As of Tuesday morning, there were only four players on the NFL's COVID-19 list. Only seven players, and another 29 non-players, had returned positive results during the four testing periods from Aug. 12 through Sept. 19.
But as Zachary Binney, an epidemiologist at Oxford College of Emory University, said earlier this month: "An outbreak really can happen at any time." It's fair to wonder if this will prompt a shift to game-day testing.
We know the Titans won't return before Saturday at the earliest. The Vikings' return depends on whether they receive any confirmed positive results.
It's complicated. Here is a flow chart for symptomatic and asymptomatic positive tests.
At the moment, both are still scheduled to play Sunday. That could change in the coming hours and days, however. One possibility, according to ESPN's Adam Schefter, is to move the Titans' game Sunday in Nashville against the Pittsburgh Steelers from Sunday to Monday. The Titans' game could also easily be moved to Week 7, if the NFL moves the Steelers' Week 7 game against the Baltimore Ravens into Week 8, when both have byes. A potential rescheduling of the Vikings' game at the Houston Texans is less obvious.
The NFL formed an independent committee made up of unaffiliated former league officials to advise commissioner Roger Goodell on equity and fairness in these situations. One immediate question is whether it's fair for the Titans to play the Steelers on Sunday if they have been away from their team facility, and thus unable to practice, all week.
News Release
Tuesday, September 29, 2020
A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A report published today in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.
The experimental vaccine, mRNA-1273, was co-developed by researchers at NIAID and Moderna, Inc. of Cambridge, Massachusetts. The Phase 1 trial began on March 16, 2020, and was expanded to enroll older adults about one month later. Older adults are more vulnerable to complications of COVID-19 and are an important population for vaccination. Understanding how the vaccine affects older adults is a critical part of measuring its safety and efficacy.
The trial was conducted at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, Emory University in Atlanta, and NIAIDs Vaccine Research Center (VRC) clinic at the NIH Clinical Center in Bethesda, Maryland. Julie Ledgerwood, D.O., deputy director and chief medical officer at the VRC, oversaw the study at the NIH site. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for this trial. This trial is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through NIAID.
In its expansion to include older adults, the trial enrolled 40 healthy volunteers: 20 adults ages 56 to 70 years, and 20 adults ages 71 years and older. Ten volunteers in each age group received a lower dose of the vaccine (25 g), and 10 volunteers in each age group received a higher dose (100 g). After approximately one month, volunteers then received a second dose of the same vaccine at the same dosage. Throughout the study, volunteers attended clinic visits to track their responses to the vaccine and assess safety.
Overall, the researchers found that the investigational vaccine was well-tolerated in this older age group. Although some volunteers experienced some transient adverse effects, including fever and fatigue after vaccination, the researchers found that they also exhibited a good immune response to the vaccine: the blood of vaccinated volunteers contained robust binding and neutralizing antibodies against SARS-CoV-2. Importantly, the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups.
The study will continue to follow the older volunteers for approximately a year after second vaccination to monitor the long-term effects of the vaccine. According to the researchers, these Phase 1 trial results further support testing of the investigational vaccine in older adults in an ongoing large Phase 3 trial.
For more details on the trial, please see NIAIDsMarch 16 press release, NIAIDsMarch 27 statement, or visit ClinicalTrials.gov and search identifierNCT04283461.
Anderson et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. New England Journal of Medicine DOI: 10.1056/NEJMoa2028436 (2020).
Dr. John Beigel, associate director for Clinical Research in NIAIDs Division of Microbiology and Infectious Diseases, and Dr. Barney Graham, deputy director of NIAIDs Vaccine Research Center, are available for comment.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIHTurning Discovery Into Health
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The West VirginiaDepartment of Health and Human Resources (DHHR) reports as of 10:00a.m., September 28, 2020, there have been 552,844 totalconfirmatory laboratory results received for COVID-19,with 15,512 total cases and 337 deaths.
DHHR has confirmed the deaths of a 70-yearold male from Kanawha County, a 77-year old female from Taylor County, and a 92-yearold male from Berkeley County. Please join with me in sending our deepestcondolences to these families as they grieve the passing of their loved ones,said Bill J. Crouch, DHHR Cabinet Secretary.
CASES PERCOUNTY: Barbour(66), Berkeley (1002), Boone (220), Braxton (13), Brooke (113), Cabell (823),Calhoun (25), Clay (36), Doddridge (25), Fayette (622), Gilmer (45), Grant(161), Greenbrier (127), Hampshire (108), Hancock (149), Hardy (90), Harrison(369), Jackson (266), Jefferson (433), Kanawha (2,688), Lewis (38), Lincoln(169), Logan (620), Marion (274), Marshall (178), Mason (142), McDowell (84),Mercer (418), Mineral (175), Mingo (377), Monongalia (2,021), Monroe (149),Morgan (55), Nicholas (104), Ohio (373), Pendleton (53), Pleasants (17),Pocahontas (59), Preston (157), Putnam (566), Raleigh (521), Randolph (252),Ritchie (13), Roane (51), Summers (55), Taylor (127), Tucker (29), Tyler (16),Upshur (81), Wayne (398), Webster (8), Wetzel (55), Wirt (12), Wood (366),Wyoming (118).
Please note thatdelays may be experienced with the reporting of information from the localhealth department to DHHR. As case surveillance continues at the local healthdepartment level, it may reveal that those tested in a certain county may notbe a resident of that county, or even the state as an individual in questionmay have crossed the state border to be tested. Such is the case of Gilmer and Hancock counties in thisreport.
Please visit thedashboard located at www.coronavirus.wv.gov for more information.
Free COVID-19 testinglocations are available today in Boone, Cabell, Kanawha, Taylor, and Waynecounties and Tuesday in Fayette and Putnam counties:
Putnam County, September29, 9:00 AM 1:00 PM, Teays Valley Church of God, 185 Connection Point, ScottDepot, WV
Testing is available to everyone, including asymptomaticindividuals. For upcoming testing locations, please visit https://dhhr.wv.gov/COVID-19/pages/testing.aspx.
The surge of Covid-19 cases and deaths in America over the summer resulted from a toxic mix of factors: states reopening, lockdown fatigue, and a season typically filled with vacations and holidays like Memorial Day and the Fourth of July. People gathered and celebrated indoors at bars, restaurants, and friends and familys homes. Millions of people got sick, and tens of thousands died.
This fall, experts worry it will all happen again: States are rolling back restrictions, people are eager to get back to normal, and Thanksgiving and Christmas are coming up. America may be on the verge of repeating the same mistakes, which would risk yet another surge in the Covid-19 epidemic.
Coronavirus cases have already trended up since mid-September. On September 12, the US hit a recent low in its seven-day case average of around 35,000. As of September 26, it was back up to almost 45,000. The surge doesnt seem to be driven by any one particular state although some, like the Dakotas, are doing quite badly but rather upticks across much of the country all at once. (Increased testing capacity is likely detecting more cases, too.)
Part of the problem is America never really suppressed its Covid-19 cases to begin with. Think of a disease epidemic like a forest fire: Its going to be really difficult to contain the virus when there are still flames raging in parts of the forest and small embers practically everywhere. The country always risks a full blaze with each step toward reopening and with each failure to take precautions seriously.
Consider Florida. This month, the state reopened bars and, more recently, restaurants, despite the high risk of these indoor spaces. The last time Florida opened bars, in June, experts said the establishments were largely to blame for the states massive Covid-19 outbreak in the summer. As Florida reopens now, it has roughly two to three times the number of Covid-19 cases that it had in early June, and its test positivity rate suggests its still likely missing a lot of cases. The state is fanning its flames while its most recent fire is nowhere near extinguished.
This is, in effect, what much of the country is doing now as it rushes to reopens schools, particularly colleges and universities, and risky indoor spaces. Coupled with recent Labor Day celebrations, experts worry thats already leading to a new surge in Covid-19 cases.
President Donald Trump, for his part, has encouraged rapid reopenings. From his LIBERATE tweets in the spring to his recent demands that schools reopen, Trump has pushed forward with his efforts to return society to normal even as the coronavirus keeps spreading and killing people in the US.
The fall and winter threaten to make things much worse. Schools will continue to reopen. The cold in northern parts of America will push people back inside, where the virus has a much easier time spreading than the outdoors. Families and friends will come together for the holidays. A flu season could strain the health care system further.
States are once again starting to reopen more widely, as officials face pressure from businesses to reopen indoor dining before colder temperatures make outdoor activities less feasible. Experts worry that Americans as a whole will get even more fatigued with social distancing, now that the country is more than six months into its battle against Covid-19.
Its less excusable this time, Crystal Watson, senior scholar at the Johns Hopkins Center for Health Security, told me. We have an example of what happens when we reopen these types of businesses for indoor activities.
The good news is theres still time to act. Cities, states, and the country as a whole could take social distancing seriously again. They could require masks where they arent already mandated. They could close bars and restaurants, supporting these businesses with a bailout, to prioritize keeping K-12 schools open while reducing other risks. Colleges and universities could ease demands for in-person teaching or at least embrace aggressive testing-and-tracing measures to mitigate the risks of causing further Covid-19 outbreaks.
Without these steps, the fall and winter outbreaks could end up worse than the summer and potentially even the spring. That could mean not just more infections and deaths but yet another setback in Americas hopes of getting parts of life closer back to normal.
If you do things the right way, you can do them, Cedric Dark, an emergency medicine physician at the Baylor College of Medicine, told me. If you do them the wrong way, then youre going to get cases.
After the spring outbreaks hit the Northeast of the US, much of the country, led by conservative states like Arizona, Florida, and Texas, moved forward with aggressive reopenings. The problem, experts said, is many of these places never suppressed their Covid-19 outbreaks. As epidemiologist Pia MacDonald at RTI International told me at the time, many states never got to flat. Case counts continued to climb, and states continued to reopen anyway.
This created an environment that made it much easier for Covid-19 to spread. If theres already some community transmission going on, then its simply going to be more likely that one person will infect another. Add more spaces in which infections are very likely particularly close indoor spaces like bars and restaurants and that risk can be increased dramatically.
Today, the US seems to be heading in the same direction. While cases have fallen overall since late July, they plateaued at and recently started rising from a point that was still higher than the peak of Covid-19 cases in the spring (partly, but likely not entirely, attributable to more testing). Yet many states are moving forward with reopening once again.
So MacDonald is now repeating the same thing she told me this summer: We never got to low enough levels [of Covid-19] to start with in most places.
Of particular interest is indoor dining at restaurants and bars, which are reopening at varying levels across the country. Experts characterize these settings as perhaps the worst imaginable spaces for Covid-19 spread: People are close together for long periods of time; they cant wear masks as they eat or drink; the air cant dilute the virus like it can outdoors; and alcohol could lead people to drop their guards further. It was a recognition of all these risks that led many states to scale back and close indoor dining and bars during their summer outbreaks.
This time, though, theres another major variable: Schools are reopening. Some places have even reopened, or set plans to reopen, schools alongside bars or indoor dining making it hard to separate the effects of either and potentially compounding new outbreaks.
Already, there have been reports of outbreaks in K-12 settings, where students and teachers can potentially transmit the coronavirus to each other in the classroom. But theres still a lot we dont know about how younger kids, particularly in elementary schools, spread the virus.
Some experts raised graver concerns about colleges and universities. Students in these institutions arent just potentially spreading the coronavirus in their classrooms, although thats likely happening to some degree. Theyre also showing up at bars, clubs, and indoor restaurants, partying at dorms, and drinking a lot more than they should.
College kids are college kids, Carlos del Rio, executive associate dean of the Emory University School of Medicine, told me. Thats what I always tell every university president I talk to: You can make all the plans you want, but at the end of the day, its what happens outside your plans that matters.
The good news, for now, is that infections in colleges and universities will skew younger, and younger people are less likely to suffer major complications, including deaths, from Covid-19. That helps explain, along with general improvements in treatment, why daily Covid-19 deaths have still trended down since August (although theyre still at more than 700 a day in the US).
But young people can still get seriously ill and die from the coronavirus and if enough of them get infected, that could show up in higher death tolls eventually. Even if that doesnt happen, young people will likely interact with their teachers, parents, and grandparents at some point, potentially infecting them. That could produce yet another outcome that would look similar to the summer: The outbreaks started among young groups first but eventually spread to older populations who were more susceptible to illness and death.
After the summer surges, Brown University School of Public Health dean Ashish Jha told me, I was like, Okay, now weve all been through this every part of the country: the South, the West, the Midwest, the Northeast. Theres no denialism anymore that will work, because theres been this long denial while its been there but not here. Yet, he said, were starting to see this again.
He added, I, at this point, feel like I clearly no longer understand why our country cant learn its lessons and why we keep repeating the same mistakes.
For months, experts have worried that the fall and winter would lead to more outbreaks, citing, as one contributor, the reopening of schools. That seems to be happening now, as cases start to creep up nationwide, with reported outbreaks in K-12 schools, colleges, and universities around the US.
But things could still get worse.
People are bound to get more fatigued with social distancing and the pandemic more broadly as time drags on. As months pass since the last huge wave of Covid-19 in the US, people are more likely to convince themselves its safe out there. If that happens, more people could end up going out and putting themselves in dangerous settings, infecting each other along the way.
At the same time, colder temperatures, particularly in the northern parts of the US, will more likely push people indoors, where the virus is much more likely to spread thanks to poor ventilation. (One upside: This could have the opposite effect in southern parts of the country, where temperatures will get less unbearably hot, so the outdoors may actually get more tolerable.)
As Thanksgiving rolls around, followed by Christmas, Hanukkah, and New Years, families and friends will likely come together from around the country. That includes college and university students, who could come home from Covid-19 hot spots back in their dorms or classrooms.
If you put this all together, theres a real risk of a truly nationwide Covid-19 outbreak. As people come together from all over the country and return to home and school, they risk carrying the disease across local and state borders. That could result in a much more dispersed and perhaps larger coronavirus epidemic than the US has seen so far.
People will bring this back during Thanksgiving, during Christmas, during winter break, Dark said. This is a disease that has an incubation period of up to two weeks. So its not really safe to say, Okay, Im going to come home, and come back. By the time you develop symptoms, youve already exposed your parents.
On top of all that, another flu season this fall and winter could strain health care systems, hindering hospitals abilities to treat Covid-19 patients and potentially contributing to more deaths.
There are reasons to think it wont get so bad. Maybe since so many people have already gotten sick in the US, there will be enough community immunity, as long as theres enough social distancing and masking, to mitigate spread. Maybe people wont ease up on proper precautions after seeing 200,000 Covid-19 deaths in the US. Perhaps social distancing and masking for Covid-19 will hold off another flu season, as seemed to happen in the Southern Hemisphere.
But theres a risk. And the numbers are already heading in the wrong direction.
The next number in the fall is likely going to shoot way up, Michael Osterholm, director of the Center for Infectious Disease Research and Policy, told me. Likely well beyond 65,000, 70,000, the summers previous peak. I think this fall is going to be the biggest spike of all.
None of this set in stone. Experts told me again and again that the US still has time to act before it sees a repeat of the summer or worse.
None of the ideas to prevent all of this are shocking or new. Theyre all things people have heard before: More testing and contact tracing to isolate people who are infected, get their close contacts to quarantine, and deploy broader restrictions as necessary. More masking, including mandates in the 16 states that still dont have one. More careful, phased reopenings.
This is whats worked in other countries, from Germany to South Korea to New Zealand, to contain outbreaks. Its what studies support: As a review of the research published in The Lancet found, evidence shows that physical distancing of more than 1 m is highly effective and that face masks are associated with protection, even in non-health-care settings.
Its also whats worked in the US. After suffering huge outbreaks in the spring, states like New York and Massachusetts have suppressed the coronavirus with such policies. Cities, such as San Francisco, have avoided bad outbreaks entirely with similar efforts. Even single universities, like the University of Illinois Urbana-Champaign campus, have seen promising early results with aggressive testing and tracing. (The federal government would ideally be in charge of all of this, but Trump has by and large punted the pandemic down to the states to resolve.)
Theres no mystery about what causes new cases, Nahid Bhadelia, an infectious diseases physician and medical director of the Special Pathogens Unit at Boston University School of Medicine, told me. We have to make trade-off choices.
Much of the issue comes back to a careful reopening process. For this, some experts pointed to a budget model. The goal is to keep the spread of the coronavirus low enough that each new infection doesnt always lead to more infections, making it so over time the country slides to zero cases. In other words, the goal is to keep the effective reproduction number, or R0 or Rt in scientific parlance, below one. Within that limited budget of an R0 or Rt lower than one, states can try to fit some places to reopen but not everything.
Everything that reopens will add to the infection rate. Some places may have tiny, even negligible effects, such as parks. Some are bigger threats, like bars and indoor dining. And some may carry potentially high risk but still seem worth it to the community for their social benefits, like schools.
The goal, then, is to balance out a reopening doing it slowly, making it possible to see the effects of each extra step to make sure outbreaks dont get out of control. Ultimately, it may require not opening bars or indoor dining, perhaps ever, so schools and other more socially crucial places can open. At the same time, the government could offer shuttered businesses a bailout or other financial supports.
For us, as a society, to be able to send children to school, we have to make tough decisions and sacrifices in other areas, Jorge Salinas, an epidemiologist at the University of Iowa, told me. We cant have it all.
Other steps, too, could help build a bigger budget. More testing, tracing, and masking, for example, could reduce the infection rate in a community further, regardless of what else is going on.
By striking this balance, the country can not only avoid more infections and deaths but potentially an outbreak from getting so bad that it necessitates another lockdown. While experts all agreed that theres zero political appetite for a lockdown right now, a massive surge in the fall and winter could leave the US with no other option. Israel, for example, has shut down until early October at the earliest after suffering a massive increase in cases.
The reality is that the US will likely not go back to normal until it vanquishes the virus through a vaccine or similar treatment a process that could take months or years, even after a vaccine is proven safe and effective, as the country and world scale up distribution to actually reach sufficient levels of immunity within the population.
But maybe the US will continue muddling along, or worse. The country has already shown a much higher tolerance for Covid-19 cases and deaths than the rest of the developed world. Trump, for his part, seems content with that recently stating that the coronavirus affects virtually nobody and showing no interest in changing his hands-off approach.
If that holds, America could suffer tens of thousands more predictable, preventable deaths, on top of the 200,000 Covid-19 deaths its already seen.
MANSFIELD -- Tom Zellner told Richland County commissioners on Tuesday it feels like Ohio Gov. Mike Dewine has singled out the bar business in the battle against COVID-19.
"What's sad is we feel that we've been targeted," saidZellner, a partner in The Warehouse Tavern in downtown Mansfield."Why us? What did we do so wrong?"
Zellner, joined by other local bar/restaurant owners, presented a petition signed by 32 local owners, seeking an end to restrictions imposed by the governor at the end of July that ban alcohol sales after 10 p.m. and order bars closed at 11 p.m.
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"There is no science behind the State of Ohio's magic time of 10 p.m. that shows COVID-19 cases increase after that hour," Zellner said. "These current restrictions have been catastrophic to many businesses in our region and if they continue, we fear will lead to the closure of many more businesses in our county."
The local owners, most of whom have state-issued licenses allowing them to remain open until 2:30 a.m., indicated gross revenue losses ranging between 20 and 60 percent since DeWine imposed the restrictions through the state's Liquor Control Commission.
"These restrictions and time constraints are literally destroying our businesses," Zellner said, adding he and his partners chose to open a downtown bar in recent years during a time when local business was booming with momentum.
Bars and dine-in restaurants were among the "non-essential' businesses ordered closed by DeWine in March when the pandemic reached Ohio. They were later allowed to re-open in mid-May at limited capacity.
On July 30, in announcing the time restrictions, DeWine said alcohol consumption tended to lower patrons' inhibitions, leading to a lack of social distancing.
"The problem is, bars, by their nature, lend themselves to a revolving door of people in close contact, oftentimes indoors. Patrons either stay at one location, sometimes for hours or bar hop. Either way, they interact with many different people -- especially the younger crowd, DeWine said at the time.
Bar owners, however, said their employees are trained not to over-serve customers.
"We've been controlling those inhibitions as bar owners for years. I mean, have we not? So I don't understand why we can't do that in this current environment," said Ben Hoggard, general manager and executive chef at the Hudson & Essex in downtown Mansfield.
Bar owners said DeWine's rules have led to more dangerous habits such as people ordering multiple drinks just before 10 a.m. or leaving the bar at 10 p.m., purchasing alcohol, and engaging in large house parties with less monitoring than they would have had at the bar.
Commissioners Marilyn John, Darrell Banks and Tony Vero listened with sympathetic ears, agreeing with the local business owners, but saying DeWine has not been responsive to their questions and concerns since the pandemic began.
"These decisions are being made in one office in Columbus. They're not being made by anybody sitting at this table or anybody in this room," John said.
After the meeting, Commissioner Tony Vero sent an email to DeWine's administration, including the petition that asks for the restrictions to be lifted immediately or at least on Nov. 1 when the Liquor Commission is scheduled to review the order.
In his email, Vero called the governor's rule "capricious" and said DeWine has offered no accompanying science to support it.
Above is a chart showing the rate of positive Ohio COVID-19 tests since the pandemic began.
"These (bar owners) are struggling to survive under an order issued at the end of July where the slight bump (not curve) occurred in Ohio in late April 2020. They also question (as do all three Richland County commissioners) how such a prohibition can remain in place while 1/10 of 1% of Ohios population has an active COVID-19 diagnosis," Vero wrote in the email.
"To date, 0.139% of the state of Ohio has such a diagnosis, and that has remained fairly unchanged (actually a small decrease) since the state finally started publishing recovery figures several months ago," Vero wrote.
Bar owners and commissioners agreed DeWine is not being truthful when he says the state is "98 percent" re-opened.
"I think it's very disingenuous," Vero said during the meeting. "And it's a disservice to owners of these types of establishments who are losing revenue. (DeWine) owes to them to provide them something tangible and quantifiable as to why (the restrictions) exists. And I have yet to see it since the end of July."
Also on Tuesday, commissioners:
-- approved a $305,620 project, using federal CARES Act funds, to digitize and create microfilm of records for county Clerk of Courts Lin Frary's office, using Kofile, the same company doing a similar project for the county recorder's office. The project will include records from 1900 to 1996, which is when the office began to become computerized. It will allow residents and others to search records online, reducing the need to visit the courthouse to obtain public records.
-- approved a mitigation project that will allow Dayspring to move forward with plans on replacing the slate roof at the century-old facility while also seeking a state historical grant to fix the roof at the laundry building, the oldest building on the county home property.
Golden Corral pic courtesy Google maps
IDAHO FALLS Losing everything and starting over seems to be a recurring theme for Jacob and Senessa Tiffany of Idaho Falls.
They opened Kiwi Loco at 3198 South 25th East in March after a year-long remodel project. Everything was going great for several weeks until the COVID-19 pandemic began impacting eastern Idaho.
The Tiffanys did everything they could to stay afloat, but lack of customers and drastic price increases for supplies made it difficult to stay open.
We were paying $30 for a box of gloves. Then all this hit and we were paying $150, Senessa says. It turned into a nightmare.
The new business ultimately became a casualty of the outbreak and closed for the last time on Aug. 31 after five months of business.
We spoke to Senessa as they were opening in March. She told us about the wildfire that had destroyed their home in Paradise, California in November 2018. Idaho Falls became a place for them to start a new life together.
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Senessa was ecstatic the last time we spoke with her, but now theyre going to be starting from scratch all over again and our conversation this time around has a much different tone.
Its tragic what (the pandemic) has done to small businesses, Senessa says. A lot of people are suffering. How can you survive when prices are getting jacked up five times the original amount?
And its not just new restaurants with fledgling customer bases. More than a few longtime restaurants are seeing major declines as well due to COVID-19.
Golden Corral in Pocatello is one of those longtime restaurants. It closed its doors for the last time Sept. 13 after 19 years of business.
At the onset of the virus, owner-operator Pam Casey says they set up a kiosk that provided gloves for customers to wear while they dished up their food. Some people were OK with that, while others were not, Casey says, but once Idaho State University closed down, business was never the same.
On March 16, everything went away. We went from doing a pretty substantial volume to doing $10,000 a week. That doesnt cut it in an 8,500-square-foot restaurant with a heavy-duty bank payment, Pams husband, Jeff, says. After trying to stay open for a while, we decided just a few weeks ago we couldnt do it anymore.
The restaurant had many loyal customers, some of whom had been eating there since the beginning. Despite the long history of financial success, Jeff says the pandemic was a severe blow.
People dont like buffet restaurants when a virus is going around, and even with the precautions we took people still werent interested in coming in, he says.
The financial loss didnt just impact the Caseys. One of the most difficult aspects of the closure has been laying off employees, Jeff says, many of which have significantly contributed to the businesss success over the years.
The working relationship with his employees is what hes going to miss most of all.
Despite everything thats happened, Senessa Tiffany says it still could have been much worse. Theyve almost sold all the Kiwi Loco equipment and will likely break even.
She says the silver lining through all of this is the increased time with her kids and the support of the community. She has no plans to leave eastern Idaho and says shed rather go through a tragedy here than anywhere else.
We love it here. We have a great group of friends and a great community, Senessa says.
Senessa started doing eyelash extensions out of her home for friends and neighbors once her business closed. The response has been great, she says, and shes hoping to build up a bigger clientele. Her new goal is to go to esthetician school and be a one-stop-shop for skincare.
The situation isnt as tragic for the Caseys. They own a Golden Corral in Twin Falls, which will remain open. They also own some other businesses in the Boise area, including Caf Ol.
Chip Schwarze, President of the Idaho Falls Chamber of Commerce, says COVID-19 has fundamentally changed the way people do business. Many business owners have been forced to adapt and drastically change their business model to stay open.
While COVID-19 has negatively impacted some restaurants, Schwarze says its been a banner year for others.
I loved watching Pachangas here in downtown Idaho Falls, Schwarze says. When everybody was shut down, they were preparing packages where people could go home and cook their own Mexican (food). It fundamentally changed the way they did business because they adapted to a bad situation, and were seeing businesses do that across the board.
The impact of COVID-19 on the local economy will be long-lasting, he says, but in the long run, he believes the local economy will recover and eventually struggling businesses will thrive again.
I think our economy in eastern Idaho is going to continue with its rebound and were going to see it blossom over the next six to eight months and come back stronger and better than ever, Schwarze says.
Orgenesis has struck a deal to acquire Koligo Therapeutics. The takeover will give Orgenesis control of an autologous cell therapy treatment for respiratory disease caused by COVID-19.
Koligos business is built on technologies for developing autologous cell therapies, including a system for printing 3D cell and tissue constructs with a vascular network. In the case of the COVID-19 program KT-PC-301, Koligo is using its technologies to harvest fat from patients infected with the coronavirus and process the material into a cell therapy.
The COVID-19 therapy contains mesenchymal stem cells, vascular endothelial cells and immune cells that Koligo expects to migrate to the lung and other sites of inflammation when readministered back into the patient. By getting the cells to sites of inflammation, Koligo thinks it may be able to improve oxygenation, support antibody production and induce an anti-inflammatory effect. Those effects may help patients with acute respiratory distress syndrome caused by the pandemic coronavirus.
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Orgenesis is set to pay $15 million in stock to acquire KT-PC-301 and the rest of Koligos assets. After closing the takeover, Orgenesis will keep members of Koligos management including CEO Matthew Lehman and Chief Medical Officer Michael Hughes on to handle work related to the acquired assets. The start of a 75-subject phase 2 trial of KT-PC-301 is high on Koligos to-do list.
The deal will also give Orgenesis a commercially available treatment for chronic and recurrent acute pancreatitis and Koligos 3D-V bioprinting technology. The commercial product, Kyslecel, is made by resecting the pancreas from a patient, isolating pancreatic islet cells and infusing the minimally modified islets back into the patient.
Koligo has treated 40 patients with Kyslecel at six U.S. hospitals through a commercial pilot, generating revenues of around $2 million. Lehman expects the commercialization effort to benefit from the support of Orgenesis, which is connected to a network of hospitals and healthcare centers through its own point-of-care cell therapy platform.
Orgenesis sees its platform as complementary to the tools it is set to acquire from Koligo, leading CEO Vered Caplan to frame the takeover as a boost for his effort to implement new technologies to improve efficacy and lower the costs of cell and gene therapies. Caplan, in a statement to disclose the takeover, added that COVID-19 cell therapy KT-PC-301 may have applications in the treatment of other acute and chronic respiratory indications.
The number of COVID-19 cases linked to a coronavirus cluster at Brigham and Women's Hospital in Boston has increased.
The hospital announced Thursday that 19 patients and staff members had tested positive. As of Monday, there are a total of 42 cases connected to the outbreak.
"To date, 488 employees connected to the cluster have been tested with 30 testing positive," the hospital said in a statement. "All current inpatients are being tested for COVID-19, and this will be repeated every three days. This is in addition to the current hospital policy which requires testing for all patients upon admission and daily screening for symptoms. We have tested 581 patients across all inpatient areas, and 12 have tested positive. These 12 had been previously identified as connected to the cluster."
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Due to patient privacy concerns, the hospital said it was not able to provide any information on the conditions of the people who tested positive.
The hospital said it is working to make sure that others who may have been exposed are identified and tested. Any staff members who are symptomatic or have tested positive are being sent home immediately.
The cause of the cluster has not been determined. Brigham and Women's said it is investigating the source through contact tracing, testing and staff interviews.
"The Brigham is committed to creating and maintaining a safe care environment by testing all patients admitted to the hospital, requiring staff to attest to their health daily before working, requiring all staff, patients and visitors to wear hospital-issued masks while on campus, insisting on frequent hand hygiene, frequently cleaning the environment, and enforcing appropriate physical distancing," the hospital said.
Hospital officials believe the cluster was contained to two inpatient units and say it did not impact other parts of the hospital.
Admissions to the affected units were temporarily suspended and visitors were being restricted. The hospital said it is safe to visit other parts of the facility, but visitors are being restricted to certain areas.
Massachusetts Gov. Charlie Baker said Brigham and Women's reported the cluster to the state Department of Public Health immediately.
"We expect to work with them to chase down any additional cases that may have occurred," the governor said. "We'll do everything we can to support them to make sure the outbreak is contained."
