Category: Corona Virus Vaccine

A global effort wants to make sure incoming scientists don't bring the coronavirus to Antarctica with them.

At this very moment a vast world exists that's free of the coronavirus, where people can mingle without masks and watch the pandemic unfold from thousands of miles away.

That world is Antarctica, the only continent without COVID-19. Now, as nearly 1,000 scientists and others who wintered over on the ice are seeing the sun for the first time in weeks or months, a global effort wants to make sure incoming colleagues don't bring the virus with them.

From the U.K.'s Rothera Research Station off the Antarctic peninsula that curls toward the tip of South America, field guide Rob Taylor described what it's like in "our safe little bubble."

In pre-coronavirus days, long-term isolation, self-reliance and psychological strain were the norm for Antarctic teams while the rest of the world saw their life as fascinatingly extreme.

"In general, the freedoms afforded to us are more extensive than those in the U.K. at the height of lockdown," said Taylor, who arrived in October and has missed the pandemic entirely. "We can ski, socialize normally, run, use the gym, all within reason."

Like teams across Antarctica, including at the South Pole, Taylor and his 26 colleagues must be proficient in all sorts of tasks in a remote, communal environment with little room for error. They take turns cooking, make weather observations and "do a lot of sewing," he said.

Good internet connections mean they've watched closely as the pandemic circled the rest of the planet. Until this year, conversations with incoming colleagues focused on preparing the newcomers. Now the advice goes both ways.

"I'm sure there's a lot they can tell us that will help us adapt to the new way of things," Taylor said. "We haven't had any practice at social distancing yet!"

At New Zealand's Scott Base, rounds of mini-golf and a filmmaking competition with other Antarctic bases have been highlights of the Southern Hemisphere's winter, which ended for the Scott team when they spotted the sun last Friday. It had been away since April.

"I think there's a little bit of dissociation," Rory O'Connor, a doctor and the team's winter leader, said of watching the pandemic from afar. "You acknowledge it cerebrally, but I don't think we have fully factored in the emotional turmoil it must be causing."

His family in the U.K. still wouldn't trade places with him. "They can't understand why I came down here," he joked. "Months of darkness. Stuck inside with a small group of people. Where's the joy in that?"

O'Connor said they will be able to test for the virus once colleagues start arriving as soon as Monday, weeks late because a huge storm dumped 20-feet (6-meter) snowdrifts. Any virus case will spark a "red response level," he said, with activities stripped down to providing heating, water, power and food.

While COVID-19 has rattled some diplomatic ties, the 30 countries that make up the Council of Managers of National Antarctic Programs teamed up early to keep the virus out. Officials cited unique teamwork among the United States, China, Russia and others.

As a frightened world was locking down in March, the Antarctic programs agreed the pandemic could become a major disaster. With the world's strongest winds and coldest temperatures, the continent roughly the size of the United States and Mexico is already dangerous for workers at 40 year-round bases.

"A highly infectious novel virus with significant mortality and morbidity in the extreme and austere environment of Antarctica with limited sophistication of medical care and public health responses is High Risk with potential catastrophic consequences," according to a COMNAP document seen by The Associated Press.

Since Antarctica can only be reached through a few air gateways or via ship, "the attempt to prevent the virus from reaching the continent should be undertaken IMMEDIATELY," it said.

No more contact with tourists, COMNAP warned. "No cruise ships should be disembarking." And for Antarctic teams located near each other, "mutual visits and social events between stations/facilities should be ceased."

Antarctic workers have long been trained in hand-washing and "sneeze etiquette," but COMNAP slipped in that reminder, adding, "Don't touch your face."

In those hurried weeks of final flights, the U.S. "thankfully" augmented medical and other supplies for winter and beyond, said Stephanie Short, head of logistics for the U.S. Antarctic program.

"We re-planned an entire research season in a matter of weeks, facing the highest level of uncertainty I've seen in my 25-year government career," she said.

Antarctic bases soon slipped into months of isolation known as winter. Now, with the glimmer of spring, the next big test has begun.

Everyone is sending fewer people to the ice for the summer, COMNAP executive secretary Michelle Finnemore said.

In the gateway city of Christchurch, New Zealand, Operation Deep Freeze is preparing to airlift some 120 people to the largest U.S. station, McMurdo. To limit contact between Antarctic workers and flight crew, the plane contains a separate toilet mounted on a pallet.

The Americans' bubble began before leaving the U.S. in early August and continues until they reach the ice. They've been isolated in hotel rooms well beyond New Zealand's 14-day quarantine. Bad weather has delayed their departure for weeks. It's now planned for Monday.

"We're trying to do a really good job keeping up their spirits," said Anthony German, the U.S. Antarctic program's chief liaison there.

The U.S. is sending a third of its usual summer staff. Research will be affected, though investment in robotics and instrumentation that can transmit data from the field will help greatly, said Alexandra Isern, head of Antarctic sciences for the U.S. program with the National Science Foundation.

The COVID-19 disruptions are causing some sadness, she said. "In some cases, we're going to have to have contingents digging instruments out of the snow to make sure we can still find it."

Like other countries, New Zealand will prioritize long-term data sets, some begun in the 1950s, which measure climate, ozone levels, seismic activity and more, said Sarah Williamson, chief executive of Antarctica New Zealand. It's sending 100 people to the ice instead of 350, she said.

Some programs are deferring Antarctic operations to next year or even 2022, said Nish Devanunthan, South Africa's director of Antarctic support.

"I think the biggest concern for every country is to be the one that is fingered for bringing the virus," he said. "Everyone is safeguarding against that."

Precautions extend to the gateway cities Cape Town, Christchurch, Hobart in Australia, Punta Arenas in Chile and Ushuaia in Argentina. Each has quarantine and testing protocols for workers boarding planes or ships heading south.

Antarctica always has its challenges, Devanunthan said, but when it comes to COVID-19 and the international community as a whole, "I would say this is on the top of the list."

A few weeks ago at McMurdo Station, workers carried out a drill to simulate what the rest of the world knows too well: mask-wearing and social distancing. "It will be difficult not to run up and hug friends" once they arrive, station manager Erin Heard said.

He and the others will start wearing masks two days before the newcomers fly in, he said, "to help us get muscle memory." For the masks, the team plundered McMurdo's craft room, stocked with fabric, and found designs online.

As colleagues arrive, Heard will leave Antarctica. He once might have planned to thaw out on a beach. Now he's weighing the new normal.

"Do I ask a friend to pick me up? I don't know if I'm comfortable doing that," he said as he imagined stepping off the plane. "It will be super weird, to be honest, to be coming from what feels like another planet."

Perry reported from Wellington, New Zealand.

Follow AP's pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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Antarctica is still free of COVID-19, hopes are it'll stay that way - NewsWest9.com

Many very sick COVID-19 patients, like some in this Brazilian intensive care unit, have obesity.

By Meredith WadmanSep. 8, 2020 , 6:00 PM

Science's COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

This spring, after days of flulike symptoms and fever, a man arrived at the emergency room at the University of Vermont Medical Center. He was youngin his late 30sand adored his wife and small children. And he had been healthy, logging endless hours running his own small business, except for one thing: He had severe obesity. Now, he had tested positive for COVID-19 and was increasingly short of breath.

He was admitted directly to the intensive care unit (ICU) and was on a ventilator within hours. Two weeks later, he died.

He was a young, healthy, hardworking guy, recalls MaryEllen Antkowiak, a pulmonary critical care physician who is medical director of the hospitals ICU. His major risk factor for getting this sick was obesity.

Since the pandemic began, dozens of studies have reported that many of the sickest COVID-19 patients have been people with obesity. In recent weeks, that link has come into sharper focus as large new population studies have cemented the association and demonstrated that even people who are merely overweight are at higher risk. For example, in the first metaanalysis of its kind, published on 26 August inObesity Reviews, an international team of researchers pooled data from scores of peer-reviewed papers capturing 399,000 patients. They found that people with obesity who contracted SARS-CoV-2 were 113% more likely than people of healthy weight to land in the hospital, 74% more likely to be admitted to an ICU, and 48% more likely to die.

A constellation of physiological and social factors drives those grim numbers. The biology of obesity includes impaired immunity, chronic inflammation, and blood thats prone to clot, all of which can worsen COVID-19. And because obesity is so stigmatized, people with obesity may avoid medical care.

We didnt understand early on what a major risk factor obesity was. Its not until more recently that weve realized the devastating impact of obesity, particularly in younger people, says Anne Dixon, a physician-scientist who studies obesity and lung disease at the University of Vermont. That may be one reason for the devastating impact of COVID-19 in the United States, where 40% of adults are obese.

People with obesity are more likely than normal-weight people to have other diseases that are independent risk factors for severe COVID-19, including heart disease, lung disease, and diabetes. They are also prone to metabolic syndrome, in which blood sugar levels, fat levels, or both are unhealthy and blood pressure may be high. A recent study from Tulane University of 287 hospitalized COVID-19 patients found that metabolic syndrome itself substantially increased the risks of ICU admission, ventilation, and death.

But on its own, BMI [body mass index] remains a strong independent risk factor for severe COVID-19, according to several studies that adjusted for age, sex, social class, diabetes, and heart conditions, says Naveed Sattar, an expert in cardiometabolic disease at the University of Glasgow. And it seems to be a linear line, straight up.

The impact extends to the 32% of people in the United States who are overweight. The largest descriptive study yet of hospitalized U.S. COVID-19 patients, posted as a preprint last month by Genentech researchers, found that 77% of nearly 17,000 patients hospitalized with COVID-19 were overweight (29%) or obese (48%). (The Centers for Disease Control and Prevention defines overweight as having a BMI of 25 to 29.9 kilograms per square meter, and obesity as a BMI of 30 or greater.)

Another study captured the rate of COVID-19 hospitalizations among more than 334,000 people in England. Published last month in theProceedings of the National Academy of Sciences, it found that although the rate peaked in people with a BMI of 35 or greater, it began to rise as soon as someone tipped into the overweight category. Many people dont realize they creep into that overweight category, says first author Mark Hamer, an exercise physiologist at University College London.

Among 334,000 people in England this spring, the chances of being hospitalized with COVID-19 increased steadily with their body mass index (BMI).

Hamer et al., PNAS, 10.1073/pnas.2011086117

The physical pathologies that render people with obesity vulnerable to severe COVID-19 begin with mechanics: Fat in the abdomen pushes up on the diaphragm, causing that large muscle, which lies below the chest cavity, to impinge on the lungs and restrict airflow. This reduced lung volume leads to collapse of airways in the lower lobes of the lungs, where more blood arrives for oxygenation than in the upper lobes. If you are already starting [with] this mismatch, you are going to get worse faster from COVID-19, Dixon says.

Other issues compound these mechanical problems. For starters, the blood of people with obesity has an increased tendency to clotan especially grave risk during an infection that, when severe, independently peppers the small vessels of the lungs with clots. In healthy people, the endothelial cells that line the blood vessels are normally saying to the surrounding blood: Dont clot, says Beverley Hunt, a physician-scientist whos an expert in blood clotting at Guys and St. Thomas hospitals in London. But we think that signaling is being changed by COVID, Hunt says, because the virus injures endothelial cells, which respond to the insult by activating the coagulation system.

Add obesity to the mix, and the clotting risk shoots up. In COVID-19 patients with obesity, Hunt says, Youve got such sticky blood, oh mythe stickiest blood I have ever seen in all my years of practice.

Immunity also weakens in people with obesity, in part because fat cells infiltrate the organs where immune cells are produced and stored, such as the spleen, bone marrow, and thymus, says Catherine Andersen, a nutritional scientist at Fairfield University. We are losing immune tissue in exchange for adipose tissue, making the immune system less effective in either protecting the body from pathogens or responding to a vaccine, she says.

The problem is not only fewer immune cells, but less effective ones, adds Melinda Beck, a co-author of theObesity Reviewsmetaanalysis who studies obesity and immunity at the University of North Carolina, Chapel Hill. Becks studies of how obese mice respond to the influenza virus demonstrated that key immune cells called T cells dont function as well in the obese state, she says. They make fewer molecules that help destroy virus-infected cells, and the corps of memory T-cells left behind after an infection, which is key to neutralizing future attacks by the same virus, is smaller than in healthy weight mice.

Becks work suggests the same thing happens in people: She found that people with obesity vaccinated against flu had twice the risk of catching it as vaccinated, healthy weight people. That means trials of vaccines for SARS-CoV-2 need to include people with obesity, she says, because coronavirus vaccines may be less effective in those people.

Beyond an impaired response to infections, people with obesity also suffer from chronic, low-grade inflammation. Fat cells secrete several inflammation-triggering chemical messengers called cytokines, and more come from immune cells called macrophages that sweep in to clean up dead and dying fat cells. Those effects may compound the runaway cytokine activity that characterizes severe COVID-19. You end up causing a lot of tissue damage, recruiting too many immune cells, destroying healthy bystander cells, says Ilhem Messaoudi, an immunologist who studies host responses to viral infection at the University of California, Irvine. Of the added risk from obesity, she adds: I would say a lot of it is immune-mediated.

The severity of COVID-19 in people with obesity helps explain the pandemics disproportionate toll in some groups. In American Indians and Alaska Natives, for example, poverty, lack of access to healthy food, lack of health insurance, and poor exercise opportunities combine to render rates of obesity remarkably high, says Spero Manson, a Pembina Chippewa who is a medical anthropologist at the University of Colorados School of Public Health. And obesity is connected to all these other [illnesses], such as diabetes and cardiovascular disease, rendering us susceptible to severe COVID-19, Manson says.

In addition, a large body of literature shows that people with obesity may delay seeking medical care due to fear of being stigmatized, increasing their likelihood of severe disease or death. Patients that experience weight stigma are less likely to seek care and less likely to seek follow up because they dont feel welcome in the health care environment, says Fatima Cody Stanford, an obesity medicine physician-scientist at Harvard Medical School and Massachusetts General Hospital.

COVID-19specific research on this question is urgently needed, she adds. We dont know how many people are dying in the community that are never making it in, Stanford says. Maybe that was [due] to their weight or to their race, the two most prevalent forms of stigma in the U.S.

For people with obesity, the extra risk adds a psychological burden, says Patty Nece, vice chair of the Obesity Action Coalition. My anxiety is just totally ramped up, she says, adding that because of stress eating shes recently regained 30 of the 100 pounds she lost before the pandemic. You have the general anxiety of this pandemic and then you layer on top of it: You in particular, you could get really sick.

Data on how to treat COVID-19 patients with obesity are scant. Published evidence supports giving such patients higher doses of anticoagulants, says Scott Kahan, an obesity medicine physician who directs the National Center for Weight and Wellness. But very little is known about whether and how to adjust other treatments such as remdesivir and dexamethasone, partly because patients with obesity are often excluded from clinical trials, he says. He urges that COVID-19 treatment trials include people with high BMIs wherever possible.

People with obesity should take extra care to avoid getting sick, Messaoudi says. If you are a person with obesity, be extra, extra cautious, she says. Wear your mask. Wash your hands. Avoid large gatherings.

In addition, exercising and, separately, losing even a little weight can improve the metabolic health of a person with obesity, and, in doing so, reduce their chances of developing severe COVID-19 if they become infected, says Stephen ORahilly, a physician-scientist who directs the MRC Metabolic Diseases Unit at the University of Cambridge. If youre 300 pounds, even losing a modest amount is likely to have a disproportionate benefit on how well you do with coronavirus infection. You dont have to become a slim Jim to benefit.

Read more here:

Why COVID-19 is more deadly in people with obesityeven if they're young - Science Magazine

The race to develop a safe and effective COVID-19 vaccine is well under way, setting the stage to bring to market the fastest vaccine in history.

There are dozens of coronavirus vaccines in development, primarily in the preclinical phase when they are tested on animals. In the U.S., there are seven vaccine candidates that have moved into clinical trials with human participants, including three that have moved into the crucial Phase 3 development phase.

The first and second phases of clinical studies are primarily conducted to test for safety, while the third and final stage is used to determine whether vaccines are efficacious and can prevent infection among participants. At that point, the vaccine makers will decide when to pursue an emergency-use authorization from the Food and Drug Administration and/or a full approval. The majority of the vaccines in development have received funding from the U.S. government, either to help support clinical development or pay for manufacturing and distribution of the vaccines as part of the Trump administrations Operation Warp Speed program.

MarketWatch will update this tally as the vaccines move through development.

AstraZeneca AZN, -1.95% AZN, +0.13%, in partnership with the University of Oxford

Year-to-date stock performance: Up 7.8%.

Name: AZD1222.

Type: Vector-based.

Phase 1/2: Data from the Phase 1/2 trial, which is being conducted in the U.K., was published July 20 in the Lancet. It reported neutralizing antibody responses in 91% of 35 patients when using one test and 100% of 35 patients when using a different test.

Phase 3: This trial, which will be held in the U.S., is expected to enroll up to 30,000 participants. (Late-stage studies are also being conducted in Brazil, South Africa and the U.K.) Data are expected by the end of the year. However, trials were halted in early September over concerns about a serious adverse event.

Clinical development and manufacturing funding from the U.S. government: up to $1.2 billion.

U.S. dose promise: 300 million doses.

Dosing: 2 doses.

BioNTech BNTX, +4.16% and Pfizer Inc. PFE, +0.69%

Year-to-date stock performances: BioNTech, up 75%; Pfizer, down 8.3%.

Name: BNT162b2.

Type: mRNA.

Phase 1: The companies published preliminary data on July 1 for BNT162b1 as a preprint. They said then that 24 participants in the study who received two doses of the lower-dose vaccine developed neutralizing antibodies. A second preprint was published on Aug. 28 for BNT162b2 that found this candidate produced similar levels of antibodies but participants reported fewer reactions.

Phase 2/3: This trial is expected to focus on BNT162b2. It is expected to enroll up to 30,000 participants in Argentina, Brazil and the U.S.

Manufacturing funding from the U.S. government: $1.95 billion.

U.S. dose promise: 100 million doses, with option to buy up to 500 million more doses.

Dosing: 2 doses.

Moderna Inc. MRNA, +4.71%

Year-to-date stock performance: Up 187.8%.

Name: mRNA-1273.

Type: mRNA.

Phase 1: Preliminary data were released May 18; more detailed data published July 14 in the New England Journal of Medicine. Modernas vaccine candidate elicited neutralizing antibodies in all 45 participants in this trial, which was conducted in the U.S. in partnership with the National Institute of Allergy and Infectious Diseases.

Phase 2a: This study closed enrollment of 600 participants on July 8. This trial is also focused on the U.S.

Phase 3: This study is expected to complete enrollment of up to 30,000 people some time in September.

R&D funding from BARDA: $955 million.

Supply funding from the U.S. government: Up to $1.525 billion.

U.S. dose promise: 100 million, with option to acquire up 400 million additional doses.

Dosing: 2 doses.

Inovio Pharmaceuticals Inc. INO, +6.92%

Year-to-date stock performance: Up 191.2%.

Name: INO-4800.

Type: DNA.

Phase 1: The company released some preliminary data on June; it has not yet shared the full data but has submitted the results for publication in a peer-reviewed medical journal. The trial is being conducted in the U.S.

Phase 2/3: Inovio said on Sept. 8 that it plans to launch this phase of the study in September, if it is given the go-ahead by the FDA.

U.S. government funding: It received $71 million from the Department of Defense to make and buy the devices that will be used to dispense the companys vaccine if it is authorized or approved.

Johnson & Johnson JNJ, +1.65%

Year-to-date stock performance: Up 1.2%.

Name: Ad26. COV2. S.

Type: Vector-based.

Phase 1/2a: The study began in the second half of July, with a goal of enrolling 1,045 adults in Belgium and the U.S.

Phase 3: It plans to launch this trial in September.

R&D funding from BARDA: $456 million

U.S. government funding for manufacturing and delivery:More than $1 billion (from BARDA and the Department of Defense).

U.S. dose promise: 100 million doses, with option to buy up to 200 million additional doses.

Novavax Inc. NVAX, +6.48%

Year-to-date stock performance: Up 2,167.6%.

Name: NVX-CoV2373.

Type: Protein subunit.

Phase 1: Preliminary data from a trial conducted in Australia were published Sept. 2 in the New England Journal of Medicine.

Phase 1/2: The second phase of the Phase 1/2trial started in August and will be conducted in Australia and the U.S.

Phase 3: TBD.

Clinical development and manufacturing funding from the U.S. government:$1.6 billion.

U.S. dose promise: 100 million doses.

Sanofi SNY, +2.48% SAN, -0.29% , in combination with GlaxoSmithKlines GSK, +2.00% GSK, -0.83% adjuvant technology

Year-to-date stock performance: Up 0.6%.

Name: TBD.

Type: Protein-based.

Phase 1/2 study: The trial was initiated Sept. 3, with a goal of enrolling 440 adults in the U.S. Results are expected in December.

Phase 3: This study is expected to launch by the end of 2020.

Clinical development and manufacturing funding from the U.S. government: Up to $2.1 billion.

U.S. dose promise: Up to 100 million doses, with option to buy up to 500 million doses.

Sources: Company websites, federal data, the World Health Organization, RBC Capital Markets.

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There are seven coronavirus vaccine candidates being tested in the U.S. heres where they stand - MarketWatch

A reminder: We are holding a DealBook Debrief call on Thursday as part of The Timess special project for the 50th anniversary of the seminal Milton Friedman essay that changed the course of capitalism. Joining us are special guests Leo Strine Jr., the former Delaware chief justice, and Joey Zwillinger, the C.E.O. of the shoe company Allbirds. R.S.V.P. here for the call tomorrow at 11 a.m. Eastern.

Want this delivered to your inbox each day? Sign up here.

The conventional wisdom is that a coronavirus vaccine will be widely available by next summer, if not earlier. But AstraZenecas move to halt testing of its treatment calls that into question and puts into doubt how quickly the global economy can recover from the pandemic.

AstraZeneca is investigating a serious suspected adverse reaction in a volunteer in a late-stage U.K. trial. It isnt clear whether the illness is linked to the companys vaccine, or for how long the drug maker will keep its trial on hold. The AstraZeneca vaccine, which is being developed with Oxford University, is reportedly under consideration by the Trump administration for fast-track approval.

To be clear, this isnt necessarily a bad thing. Medical experts say the point of late-stage clinical trials is to uncover potential side effects by giving thousands of people a treatment under controlled conditions. The perspective we need to keep in mind, said Dr. Faheem Younus, the chief of infectious diseases at the University of Maryland Upper Chesapeake Health, is this one potential case of a serious side effect versus the tens of thousands of Covid-19 patients currently hospitalized in the U.S.

AstraZeneca was one of nine pharmaceutical companies to sign a public pledge not to submit their coronavirus vaccines for authorization until the treatments have been cleared in clinical trials.

Still, the move raises several issues about life without a vaccine:

Coronavirus infections appear to be leveling off in the U.S., but at a persistently high level, and experts fear a flare-up in the fall. That could lead to more government-imposed social restrictions, something that countries like Britain are reintroducing amid a resurgence in cases.

Treatments for coronavirus infections, such as remdesivir and antibody drugs, will assume more importance. But theyre also subject to the same questions of safety, efficacy and availability as vaccine candidates.

Widespread coronavirus testing at airports, schools, workplaces, restaurants and more will become even more critical to restoring the publics confidence. But the capacity to manufacture and use virus tests, particularly in the U.S., is limited. How quickly can that be ramped up?

What path will the economic comeback take if a vaccine doesnt come for a long time? Inequality created by a K-shaped recovery, in which circumstances for wealthy people who can afford to isolate are improving and those for everyone else are not, could worsen.

____________________________

Todays DealBook Briefing was written by Andrew Ross Sorkin in Connecticut, Lauren Hirsch in New York, and Michael J. de la Merced and Jason Karaian in London.

____________________________

The $16.2 billion deal between LVMH and Tiffany, agreed in November but recently delayed by the pandemic, looks even less certain today. LVMH said it could not complete the deal, and Tiffany has filed a lawsuit to force LVMH to go ahead with it.

There has been concern for months that LVMH would seek to renegotiate the deal, in light of the stress the pandemic has put on the jewelry business. LVMH said in a statement that it wouldnt do the deal as it stands, citing a request from the French government to delay the acquisition beyond Jan. 6 because of the threat of U.S. tariffs on French goods.

Tiffany claims that LVMH is in breach of its contract. It rejects the idea that LVMH can avoid the deal by claiming that Tiffany has undergone a material adverse effect that would have breached its merger obligations. Its lawsuit, filed in Delaware, also says that LVMH cannot avoid completing the deal because it is in some way inconsistent with its patriotic duties as a French corporation.

DealBook hears that Tiffany decided to sue LVMH over frustration that 10 months after the deal, it had not yet filed for deal approval in the European Union.

Markets tumbled again, with tech leading the way down. Another sharp sell-off in tech stocks yesterday led to the Nasdaqs falling over 4 percent reaching correction territory and the S&P 500 slipping nearly 3 percent. Tesla shed a quarter of its value, in part because it wasnt included in the S&P 500 index (more on that below). Futures are currently looking up, though, suggesting an end to the three-day slide.

Senate Republicans plan to vote on their skinny coronavirus aid bill. The move is meant to put pressure on Democrats to compromise on economic stimulus measures. House Democrats have rejected the $500 billion proposal as pathetic, and even some Senate Republicans are likely to oppose it.

JPMorgan Chase said customers and workers had misused federal relief money. The bank said it had found instances of customers misusing Paycheck Protection Program loans, unemployment benefits and other government programs. JPMorgan said it was cooperating with law enforcement.

New York real estate faces its biggest challenge since the financial crisis. Under 10 percent of New Yorks office workers had returned as of last month, and just 54 percent of companies plan to return by July, The Times reports. Businesses have increasingly put off decisions to sign new leases, and some are holding out for steeper discounts than are now on offer.

The first day of school in the U.S. didnt go smoothly. Website crashes and cyberattacks bedeviled many students logging on remotely. A lot of districts are just wildly unprepared for online learning, one expert told The Times. College students attending in-person classes arent faring much better: Tens of thousands have been infected with the coronavirus, and universities are resorting to lockdowns.

Steven Davidoff Solomon, a.k.a. the Deal Professor, is a professor at the U.C. Berkeley School of Law and the faculty co-director at the Berkeley Center for Law, Business and the Economy. Here, he and Panos N. Patatoukas, a professor at Berkeleys Haas School of Business, run the numbers on Tesla and try to make sense of its volatile valuation.

Its been a torrid time for Tesla, which has lost a third of its value over the past week or so. Yesterday alone it erased 21 percent in value, leading another down day for technology stocks. It follows an amazing bull run for tech stocks in general and Tesla in particular.

Is the correction warranted?

Lets look at it through the eyes of Tesla investors. What did they need to believe about its path ahead to have been willing to value Tesla at almost $500 billion in market capitalization at its recent peak?

We can apply traditional valuation techniques to see what would need to happen for this valuation to be justified. In theory, a companys fundamental value is the capital in place plus the expected added value. Value added, the theory goes, should be based on investors expectations about growth and profitability. Using this basic framework, we recasted the Tesla story in terms of fundamental projections over a 10-year horizon.

There are two key aspects: sales growth and profit margins.

If Tesla is going to justify a half-trillion market capitalization, it needs to increase its sales from $24.6 billion in 2019 to approximately $140 billion by 2030. This would require an annualized growth rate of 19 percent, and end up with the company becoming as big as G.M. and Ford are today.

At the same time, Tesla also needs to expand its net profit margin, the money earned for shareholders per dollar of sales. By our calculations, its net margin will need to increase from minus 3.5 percent in 2019 to over 21.5 percent by 2030. That means that by 2030 Teslas margin would converge to what Apples is today. Toyota is among the most profitable big automakers, and its margin in its latest fiscal year was around 7 percent.

Over all, if you were willing to buy Teslas shares at their recent peak, then you should also be willing to believe that over the next decade Tesla will achieve the scale of Ford or G.M. with the margins of Apple. This implies that Tesla would become more than a car company: It would have to become a renewable technology company in which cars are only a small part of its business. Elon Musks moves into solar panels and batteries suggests that he understands this.

Eventually, expectations reflect reality and fundamental valuation drivers come into play. That said, expectations may take a long time to correct themselves if investors arent very focused on fundamentals. Its possible that Tesla and other hot tech stocks will justify their recent highs, but a lot needs to go right in the long term. Perhaps investors are starting to realize this, and revising their expectations.

One of the best-known advisers to companies on ethics and compliance, LRN, will announce today that it is buying a rival to expand internationally. It comes as the New York-based firm capitalizes on companies growing interest in overhauling their corporate cultures at a time of social justice movements.

LRN plans to acquire Interactive Services, a Dublin-based provider of compliance and online learning programs. Interactive Services clients include Biogen, BNP Paribas, Citigroup, FedEx and Hershey. The combined company will count about 40 percent of the Fortune 500 as clients. The terms of the deal were not disclosed.

The deals roots lie in a 2018 investment by Leeds Equity Partners, a capital infusion intended to help LRN increase its share in an estimated $3 billion market for ethics and compliance training.

The sorts of services that LRN provides are in high demand. We are being asked to help companies create powerful codes of conduct that help their people genuinely live company values, said Dov Seidman, LRNs founder and chairman. At DealBooks 2018 summit, Mr. Seidman was named a Groundbreaker for his role in changing the business world. You will be much more effective if you earn the moral authority to lead rather than rely on the formal authority that goes with your title, he said at the time.

Eric Ries is launching the Long-Term Stock Exchange today, nine years after his book The Lean Startup laid the foundations of the concept and made him a mini-celebrity in Silicon Valley.

The big idea: LTSEs pitch is that it makes it easier for companies to manage for you guessed it the long-term instead of obsessing about quarterly targets. The risks of short-term thinking have been called out by the likes of Jamie Dimon and Warren Buffett, and the embrace of stakeholder capitalism has questioned the wisdom of serving shareholders alone.

The exchange says its more than just marketing. Companies that list on the San Francisco-based exchange are required to report on and maintain a series of principles that focus on long-term value creation. This should appeal to institutions like pension funds that tend to take a longer-term view of returns, Mr. Ries said. He dismissed concerns that even companies with the best intentions could find themselves vulnerable to activist investors or takeover threats, forcing them to make short-term, defensive moves. The bullying tactics only work if youre actually afraid, Mr. Ries said.

It doesnt have any companies signed up yet. Today is the starting gun in which LTSE can begin the solicitation process, beginning with companies that have yet to go public. Asana has explored the prospect of listing on LTSE, people familiar with the matter said, as has Airbnb, The Times has reported. I think this is such a seismic change that to get even one company to do it is unbelievable, Mr. Ries said.

One of the companies that lists on LTSE may be the LTSE itself. The company would not consider exploring a sale, but would consider going public on its own exchange, of course.

Deals

Berkshire Hathaway will invest $570 million in the I.P.O. of Snowflake, the cloud database company, in a rare bet by Warren Buffett on enterprise tech. (FT)

G.M. agreed to take an 11 percent stake in the electric truck maker Nikola, valuing the start-up at nearly $19 billion. (NYT)

The merger of the digital ad companies Outbrain and Taboola has fallen apart nearly a year after the deal was announced. (CNBC)

Sard Verbinnen, the public relations firm, agreed to buy Oakhill Communications of Britain to bolster its U.K. practice. (Sard Verbinnen)

Politics and policy

In an unusual move, the Justice Department is seeking to replace President Trumps private counsel in a defamation suit. (NYT)

Britains top government lawyer quit yesterday amid plans to override the countrys Brexit treaty with the E.U. (NYT)

Tech

Uber plans to spend $800 million by 2025 to help drivers switch to electric vehicles, as part of a pledge to make all rides emissions-free by 2040. (Bloomberg)

Apple countersued Epic Games over their App Store dispute, accusing the Fortnite developer of plotting to violate payments rules. (The Verge)

Best of the rest

The reality TV hit Keeping Up With the Kardashians is calling it quits after 20 seasons. (LA Times)

If you received a package of mystery seeds from China in the mail, would you plant them? These Americans did. (Vice)

Is Zoom on the road to genericide? (Quartz)

Correction: In yesterdays newsletter, we should have said that Deval Patrick is a former executive at Bain Capital, not a current one. He resigned last November to pursue a presidential bid; the return to politics is why some think hes in the mix for a top post in a Biden administration.

Wed love your feedback. Please email thoughts and suggestions to dealbook@nytimes.com.

Read more:

What if There Isnt a Covid-19 Vaccine for Years? - The New York Times

Illinois health officials Wednesday announced 1,337 new known cases of COVID-19 and 30 additional fatalities, bringing the total number of known infections in Illinois to 253,690 and the statewide death toll to 8,214 since the start of the pandemic.

Meanwhile, the Chicago Public Schools on began the school year Tuesday with remote learning. Most educators were teaching from their homes, although some streamed lessons from their school classrooms.

Many suburban school districts have already resumed classes, with teachers giving lessons remotely from their school classrooms. Some private schools, including the Archdiocese of Chicagos students, already went back to school in person.

Also Tuesday, the city of Chicago added Kentucky to its mandatory quarantine order and removed California and Puerto Rico, officials announced.

Heres whats happening Wednesday with COVID-19 in the Chicago area and Illinois:

9:05 p.m.: No COVID-19 relief package before the election? Top GOP senators make pessimistic predictions.

Top Republican senators made pessimistic predictions Wednesday about securing a bipartisan coronavirus relief package before theNovember election, signaling instead they will just try to pass legislation that would avoid a federal shutdown as lawmakers head home to campaign.

Senate Majority Leader Mitch McConnell, R-Ky., said he was optimistic that Republicans would deliver strong support for the GOPs $500 billion slimmed-downCOVID-19rescue package in a test vote Thursday. But he declined to say whether his majority would be fully on board. Democrats have indicated they will shelve the Republican measure as insufficient, leaving lawmakers at an impasse.

Theres no indication yet that bipartisan talks that crumbled last month will restart. Lawmakers closely tracking recent efforts to strike a deal that could pass before the November election said they saw little reason for hope.

Unless something really broke through, its not going to happen, said Sen. Richard Shelby, R-Ala., chairman of the Senate Appropriations Committee.

The stalemate is politically risky for all sides heading into the fall election that will decide not only the presidency, but alsocontrol of Congress.

7:45 p.m.: Half of Chicago households report serious financial problems during the COVID-19 pandemic, NPR-Harvard poll finds

Half of Chicago households, many of them Black and Latino families, reported facing serious financial problems caused by the coronavirus pandemic, according to a poll of more than 3,400 respondents in four major U.S. cities published Wednesday.

The poll was conducted from July 1 through Aug. 3 in New York City, Los Angeles, Houston and Chicago by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

During the pandemic, many Chicago residents have struggled to pay bills, rent and utilities, as well as afford medical care and child care. Many have also depleted their savings, according to the study.

The poll found 69% of Black households, 63% of Latino households and 59% of households making less than $100,000 annually in Chicago reported serious financial problems.

6:30 p.m. (update): COVID-19 vaccine by Nov. 3? Halted study explains just how unlikely that is.

The suspension of a huge COVID-19 vaccine study over an illness in a single participant shows there will be no compromises on safety in the race to develop the shot, the chief of the National Institutes of Health told Congress on Wednesday.

AstraZeneca has put on hold studies of its vaccine candidate in the U.S. and other countries while it investigates whether a British volunteers illness is a side effect or a coincidence.

This ought to be reassuring, NIH Director Dr. Francis Collins said before a Senate committee. When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.

Read more here. Associated Press

4:30 p.m.: Lightfoot says she doesnt expect mass crowds of trick or treating this Halloween

On what should have been an epic year for Halloween lovers, with the annual celebration of costumes and candy falling on a Saturday, it seems the coronavirus will be playing the final trick on those seeking treats in Chicago.

Mayor Lori Lightfoot said the citys looking at how to best celebrate the holiday and doesnt expect it to look like years past. Lightfoot said the city is working on plans to recognize and celebrate Halloween, but in a way thats consistent with the public health guidance.

I dont expect to see mass crowds of trick or treating like we have in years past, she said. Its not safe for the children. Its not safe for the adults.

The announcement isnt a surprise in a city thats discouraged large social gatherings while urging people to be careful about who they come into contact with, though its unclear how the city would enforce trick or treat bans.

3:45 p.m.: CPS clerks must continue to work in person for now, but unfair labor complaint prompted by COVID-19 will be heard

Chicago Public Schools employees who say the risks of COVID-19 make their buildings unsafe must continue to show up for in-person work for now.

Illinois education labor board denied a request from the Chicago Teachers Union for emergency relief for clerks and other school employees whove been asked to work in person but say CPS has not bargained with them in good faith over working conditions.

Despite the outcome of Wednesdays hearing, the board has agreed to advance the case.

1:43 p.m.: United, pilots union reach tentative deal to avoid furloughs

United Airlines and the union representing its pilots have reached an agreement that would spare almost 3,000 pilots from furloughs next month.

1:41 p.m.: Positive COVID-19 test at Hinsdale Central High School

Hinsdale High School District 86 has launched its contract tracing procedure as someone at Hinsdale Central High School has had a positive COVID-19 test.

District officials notified families Wednesday morning about the positive test, but did not say when the person was tested or when the individual was in the school.

Students have been doing remote learning since the start of school last month, so students are not attending classes in person at Hinsdale Central or Hinsdale South high schools.

Students could be at the school campus participating in one of the fall sports, which include girls and boys cross country, girls tennis and girls swimming and diving.

1:04 p.m.: Impact of COVID-19 seen on enrollment numbers at Illinois universities

The number of freshmen and international students are down at many Illinois universities as the impact on the coronavirus on fall enrollment begins to come into view.

At the University of Illinois, the number of undergraduate students enrolled is down about 350 from last years high. The freshman class is also down about 1.8%, and the number of students who chose to defer enrollment was nearly five times higher than in a typical year, officials said.

For more on fall enrollment at UIUC and other Illinois colleges, read more here. Elyssa Cherney

12:24 p.m.: I wanted to always play it down: President Trump admits to downplaying the threat of coronavirus in new Bob Woodward book

President Donald Trump acknowledged to journalist Bob Woodward that he had knowingly played down the coronavirus earlier this year even though he was aware it was deadly and vastly more serious than the seasonal flu.

This is deadly stuff, Trump told Woodward on Feb. 7 in one of a series of interviews he conducted with the president for his upcoming book, Rage.

The Washington Post and CNN were given advance copies of the book and published details Wednesday.

You just breathe the air and thats how its passed, Trump said. And so thats a very tricky one. Thats a very delicate one. Its also more deadly than even your strenuous flu.

That was a vastly different story than what Trump was telling the public.

I wanted to always play it down, Trump told Woodward on March 19. I still like playing it down, because I dont want to create a panic.

12:05 p.m.: 1,337 new known COVID-19 cases, 30 additional deaths reported

Illinois health officials Wednesday announced 1,337 new known cases of COVID-19 and 30 additional fatalities, bringing the total number of known infections in Illinois to 253,690 and the statewide death toll to 8,214 since the start of the pandemic.

11:22 a.m.: NIH: Halted vaccine study shows there will be no compromises on safety

AstraZenecas suspension of final testing of its potential COVID-19 vaccine while it investigates a volunteers illness shows there will be no compromises on safety in developing the shots, the chief of the National Institutes of Health told Congress on Wednesday.

This ought to be reassuring, NIH Director Dr. Francis Collins said before a Senate committee. When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.

Late Tuesday, AstraZeneca announced its final-stage studies are on temporary hold while the company looks into whether a test subjects illness is a side effect of the shot or a coincidence. The company gave no details on the illness, but Collins said it involved a spinal problem.

10:22 a.m.: Tamale Guy restaurant reopens today in Chicago as owner remains in ICU

Tamale Guy Chicago reopens today in the Ukrainian Village neighborhood. The namesake restaurant of Claudio Velez was closed for nearly two weeks after he tested positive for COVID-19, just two weeks after a grand opening with 10 block long lines, two hour waits and selling out of thousands of tamales. Prior to the coronavirus mandated closures, Velez was best known for his red cooler full of warm tamales, sold bar to bar on the North Side of the city.

Velez remains hospitalized on a ventilator in ICU with his condition improving. His business partners, longtime chef and friend Pierre Vega and his wife Kristin Vega, will continue operations. All staff tested negative for the coronavirus. They also have cleaned and disinfected the takeout-only restaurant according to CDC guidelines, said Velezs son, Osmar Abad.

A GoFundMe for Velezs medical expenses has raised more than $56,000 to date. Last week Abad said the family planned to close the campaign, but its still open. We will leave the funds there until my dad is able to wake up and make his own decisions, said Abad.

9:24 a.m.: Dr. Anthony Fauci sticks with 2021 prediction for coronavirus vaccine

Dr. Anthony Fauci said hes sticking with his projection that a safe and effective coronavirus vaccine may be ready in early 2021. He said its possible it could be sooner, but unlikely.

The White House adviser on the coronavirus told "CBS This Morning the more likely scenario is that we will know by the end of this calendar year and hopefully well be able to start vaccinations in earnest as we begin early 2021.

Fauci said its routine for late-stage vaccine studies to be put on hold because of side effects. A study by AstraZeneca of a potential coronavirus vaccine was recently paused for safety reasons after an illness from a shot in a recipient in Britain.

7:15 a.m.: JPMorgan Chase says some customers and employees misused PPP, other stimulus programs

JPMorgan Chase said Tuesday that a number of its employees and customers may have abused the Paycheck Protection Program and other coronavirus stimulus programs.

The New York-based bank said it is working with law enforcement in some cases, although in a memo sent to employees it did not state how many employees may have unethically misused the programs, or what exactly they did. The bank declined to comment beyond the memo.

Unfortunately, weve also seen conduct that does not live up to our business and ethical principles and may even be illegal, the memo said.

7 a.m.: Pritzker to attend Springfield memorial service for those who died from COVID-19

After census event in Normal in the morning, Gov. J.B. Pritzker was scheduled to attend a memorial service in Springfield Wednesday evening for people who have died from the coronavirus, according to his office.

Pritzker was scheduled to attend a memorial service at the First Presbyterian Church in Springfield to honor those who have lost their lives to coronavirus and their families, according to his press office. Further details werent immediately released.

6:45 a.m.: Parents, students at Wheaton rally call for in-person learning and the early return of high school sports

Could Illinois be next on the list for an early return of high school sports?

That was an idea behind a large gathering Tuesday night in Wheaton.

Wheaton businessmen Dave Ruggles and Eric Brown helped form a We Stand for the Students rally at Memorial Park. More than 1,000 people showed up for two purposes bringing back fall sports in its regular form as well as in-person learning to schools.

On Sept. 3, Michigan government officials lifted an order restricting organized sports. The Michigan High School Athletic Association then reinstated football and other fall sports.

The next day, the Louisiana High School Athletic Association announced football will resume in that state on Oct. 8. Colorado is considering doing the same for football and other fall sports.

Stay up to date with the latest information on coronavirus with our breaking news alerts.

Here are five stories from Tuesday related to COVID-19.

Continue reading here:

COVID-19 in Illinois updates: Heres whats happening Wednesday - Chicago Tribune

Nine pharmaceutical companies issued a joint pledge on Tuesday that they would stand with science and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy.

The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on large, high quality clinical trials and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved, the companies said.

President Trump has repeatedly claimed in recent weeks that a vaccine could be available before Election Day Nov. 3 heightening fears that his administration is politicizing the race to develop a vaccine and potentially undermining public trust in any vaccine approved.

Well have the vaccine soon, maybe before a special date, the president said on Monday. You know what date Im talking about.

The move was welcomed by some researchers who said that the statement could increase public confidence in a coronavirus vaccine at a time when skepticism was running high. Theres absolutely a desperate need for this vaccine, said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University in Morgantown. I love the fact that the nine big vaccine manufacturers today said they would not do anything premature I think theres enormous pressure to do something premature.

Three of the companies that signed the pledge are testing their candidate vaccines in late-stage clinical trials in the United States: Pfizer, Moderna and AstraZeneca.

Pfizer has said repeatedly over the past week that it could apply to the F.D.A. for emergency approval as early as October. On Tuesday, its chief executive, Dr. Albert Bourla, predicted in an interview on the Today show on NBC that the company would have an answer about whether its vaccine worked by the end of October, but acknowledged that did not mean its vaccine would be available to the public by then.

Moderna and AstraZeneca have been less specific, saying only they hope to have a vaccine by the end of the year. Last week, Modernas chief executive said the company was slightly slowing its enrollment in order to include more people from groups that had been most affected by Covid-19.

Pfizer and Moderna are each close to fully enrolling the 30,000 participants in each of their trials, with some analysts predicting they will be finished within the next two weeks. AstraZeneca is further behind in its U.S. trials, having begun enrollment on Aug. 31.

Federal officials have been pushing back against Mr. Trumps enthusiastic predictions. Late last week, Moncef Slaoui, the top scientist on Operation Warp Speed, the federal effort to quickly bring a vaccine to market, warned in an interview with National Public Radio that the chance of successful vaccine results by October was very, very low.

And on Tuesday, Dr. Anthony S. Fauci, the nations top infectious disease expert, said he believed that researchers would know whether the Moderna and Pfizer vaccines were effective by November or December.

In a statement on Tuesday, Dr. Slaoui said the goal of Operation Warp Speed was to ensure that no technical, logistic or financial hurdles hinder vaccine development or deployment without curtailing the critical steps required by sound science and regulatory standards. He added that the pledge reiterates the position of Operation Warp Speed, that this project is driven by science and that any vaccine must meet the gold standard of the Food and Drug Administration.

Drug companies have had to carefully navigate the political landscape. A successful vaccine could help restore the industrys battered image and offer an end to the pandemic. But rushing a vaccine to market that winds up causing serious side effects or simply does not work could do catastrophic damage to their reputations.

In the nine companies statement on Tuesday, they did not mention Mr. Trump, saying only that they have a united commitment to uphold the integrity of the scientific process.

The other six companies that signed the pledge were BioNTech, which is developing the vaccine in partnership with Pfizer, GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi.

Read more:

Coronavirus Vaccine: 9 Drug Companies Pledge to Stand With Science - The New York Times

"When everything looks bleak, we know that someone somewhere is full of hope and strength and wants to take action," says one ad, showing a series of Black people. "Walking the walk and rolling their sleeves to go to normal sooner."

"Volunteer to find the Covid-19 vaccine. Help end the uncertainty," the voice-over says.

Another ad shows a couple cooing in Spanish at a video of their newborn grandson.

The couple's daughter looks into the camera.

"I wonder when they're going to get to see him," she says in Spanish.

The vaccine trials -- there are three underway in the United States -- need more minorities to sign up. Dr. Larry Corey, who runs the group that put out the ads, said he knows the ads won't instantly increase enrollment, but he hopes they help.

"Not everybody is thinking about how they could play a role in ending the pandemic," said Corey, who is leading the Covid-19 Prevention Network. "The point of any advertising is to reveal options, to reveal choices."

The ads were developed by the Covid-19 Prevention Network, which is based at the Fred Hutchinson Cancer Research Center in Seattle, and two advertising agencies, Socialisssima and Sam Bonds Creative. The ads are scheduled to start airing Tuesday on major television networks as well as the BET network, the Oprah Winfrey Network, TV One, Telemundo, and Univision.

Why clinical trials are seeking minority volunteers

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has urged that about 37% of the volunteers in coronavirus vaccine clinical trials be Latino, and 27% be Black.

Enrollments so far have fallen far short of that.

Researchers have two reasons for wanting to improve these numbers.

Vaccines and medicines can work differently in different racial and ethnic groups, so diversity in clinical trials is important.

Also, in order for the vaccine clinical trials to succeed, scientists have to recruit people who have a high likelihood of encountering the virus. Otherwise, the researchers will have to wait a longer time to know if the vaccine works or not.

Ads are not enough

Pastor Ricky Temple, who leads a large Black church in Savannah, Georgia, said he found the ads "touching."

"I think these are great. The pointing to the arm was a graceful invitation to participate that was inviting and personal," he said of the ads, which include Black and Latino bus drivers, teachers, nurses, students, parents, and grandparents.

Inspired by Dawn Baker, a Savannah television news anchor who in July became the first person to enroll in a Phase 3 coronavirus clinical trial in the US, Temple asked leaders in his church how they felt about encouraging members of the congregation to join the trials.

The answer was a resounding "no."

"It was a response based in fear centered in a lack of trust, and it's on my left, it's on my right, it's everywhere I turn," Temple said.

The Black community has historically been hesitant to join clinical trials because of past abuses in medical trials and ongoing injustices in the healthcare system. Black study subjects were horrifically mistreated in the Tuskegee syphilis trials from 1932 until 1972, and Black people still face injustices and disparities in today's medical system.

Temple said President Trump adds to that mistrust when he says a vaccine could be ready by Election Day, which experts say would be too quick and scientifically unsound.

Temple said the ads won't change all of this, but they're "a good start" towards building trust in medical research within the Black community.

"You chip away, you chip away, you chip away, and one day people won't remember all the bad things that happened. Tuskegee will be way in the back somewhere and we'll think those people are no longer with us and now there's a new crew," he said.

See the original post here:

New ads encourage minorities to roll up their sleeves and participate in coronavirus vaccine trials - CNN

Researchers across the world are racing to produce a safe and effective coronavirus vaccine. Currently, 37 vaccines are being tested in clinical trials on humans, and at least 91 vaccines are in the preclinical phase. Russia was the first country to approve a vaccine, but it did so without a Phase 3 trial; now scientists are working to conduct additional trials after receiving international disapproval.

The White House has made optimistic assertions that a vaccine could be ready before the Nov. 3 election, but many scientists, regulators and public health experts are concerned that the rush to distribute a vaccine before it has been fully tested for safety and efficacy is potentially dangerous.

As of Tuesday, Sept. 8, more than 27.4 million people had been infected with the coronavirus worldwide and more than 890,000 had died. Clearly there is a need for speed to put a halt to the spread of the coronavirus and to save lives. And there is a need for safety to create a vaccine that is both effective and not harmful. How should we balance those two important needs?

In the Sept. 4 article Pharma Companies Plan Joint Pledge on Vaccine Safety, Katie Thomas, Noah Weiland and Sharon LaFraniere write about a group of drug companies that said they would not release any vaccines that do not follow rigorous efficacy and safety standards:

Scientists have been rushing at record speed to develop a vaccine that could end the pandemic, which has taken nearly 190,000 lives and infected more than six million people in the United States. Three companies Moderna, Pfizer and AstraZeneca are testing their candidates in late-stage clinical trials.

Pfizers chief executive said this week that the company could see results as early as October, but the others have said only that they plan to release a vaccine by the end of the year.

Public health experts have applauded the companies rapid development of a vaccine, and early results have been promising. But in recent weeks, they have grown worried as Mr. Trump and his allies have begun talking about a vaccine that could be ready before the election on Nov. 3.

Even as companies are competing to be the first to bring a coronavirus vaccine to market, they must navigate perilous political terrain. If they are among the first to bring a successful vaccine to market, they could earn major profits and help rehabilitate the image of an industry battered by rising drug prices.

But if a vaccine turns out to have dangerous side effects for some people, the fallout could be catastrophic, damaging their corporate reputations, putting their broader portfolio of products at risk and broadly undermining trust in vaccines, one of the great public health advances in human history.

In tweets and public comments, Mr. Trump has explicitly tied his re-election fortunes to a vaccine, an idea detailed last week at the Republican National Convention, where promotional videos featured the administrations efforts to fund and develop one in its crash program called Operation Warp Speed.

What goes into making a vaccine and having it approved for public use? In What We Know About the C.D.C.s Covid-19 Vaccine Plans, Carl Zimmer and Katie Thomas detail the stages of vaccine approval:

Once vaccines are designed, they go through four stages of testing. In the preclinical stage, researchers test them on animals. For Covid-19, these animals include hamsters and genetically modified mice, both of which can experience some of the same symptoms as humans.

If these tests yield promising results, then the vaccines go into three phases of clinical trials in people.

In Phase 1, doctors give the vaccine to a small number of volunteers. They keep an eye on them to make sure they dont have any immediate negative reactions. Its not uncommon for people to feel achiness in their muscles or even a mild fever, but these mild symptoms typically dont last long.

In Phase 2 trials, scientists give the vaccine to hundreds of people split into groups, like children and older adults, to determine whether the vaccine acts differently in them. In both Phases 1 and 2, researchers analyze the blood of volunteers to see if their immune systems are learning to fight the virus with antibodies and immune cells that can kill infected cells.

Finally, in Phase 3 trials, scientists give the vaccine to tens of thousands of people and a placebo to tens of thousands of others.

Mr. Zimmer and Ms. Thomas go on to explain the importance of a Phase 3 trial:

In such a trial, volunteers are randomly assigned to receive either the vaccine or the placebo. They dont know which one they are given, nor do their doctors. By blinding the trial, researchers ensure that no bias creeps into the study.

A Phase 3 trial collects data about the symptoms volunteers experience after their injection, and whether they become infected with the coronavirus. After unblinding the data, researchers compare the rates of infection and adverse side effects between people who receive the vaccine and those who receive the placebo.

If significantly more people get Covid-19 on the placebo than the vaccine, that is evidence that the vaccine is effective. The F.D.A. has indicated that vaccine makers should aim for 50 percent protection in order to be considered effective.

If significantly more people who receive the vaccine suffer serious side effects, that may indicate that the vaccine isnt safe or may be safe only for certain groups, like people under the age of 65.

Students, read the rest of the first article, then tell us:

How concerned do you feel about your own health and well-being from the coronavirus? What about that of your family, friends and community? What would an effective and safe vaccine mean to you? What would it mean for the country? The world?

Consider the benefits of expediting the vaccine creation and approval process. Consider the risks. Do you think the benefits outweigh the risks? Why or why not?

Are you concerned that politics and the United States election might affect the vaccine approval process? Are you worried that the Trump administration might be pressuring manufacturers to rush vaccine development for political purposes? Or, do you think any White House pressure is appropriate given the severity of the pandemic and its effects on our health and society?

Are you encouraged by the prospect of a vaccine that could become widely available sometime soon? Or are you worried about it? Do you think drug companies and the Centers for Disease Control and Prevention are doing enough to make sure it is safe and effective? If not, what more could they do?

About Student Opinion

Find all our Student Opinion questions in this column. Have an idea for a Student Opinion question? Tell us about it. Learn more about how to use our free daily writing prompts for remote learning.

Students 13 and older in the United States and the United Kingdom, and 16 and older elsewhere, are invited to comment. All comments are moderated by the Learning Network staff, but please keep in mind that once your comment is accepted, it will be made public.

Here is the original post:

How Should We Balance Safety and Urgency in Developing a Covid-19 Vaccine? - The New York Times

Half a million U.S. children have been diagnosed with COVID-19, according to the American Academy of Pediatrics and the Children's Hospital Association.The groups said 70,630 new child cases were reported from Aug. 20 through Sept. 3. This is a 16% increase in child cases over two weeks, bringing up the total to at least 513,415 cases, the groups said in their weekly report on pediatric coronavirus cases."These numbers are a chilling reminder of why we need to take this virus seriously," American Academy of Pediatrics President Dr. Sally Goza said in a news release. "While much remains unknown about COVID-19, we do know that the spread among children reflects what is happening in the broader communities," she added."A disproportionate number of cases are reported in Black and Hispanic children and in places where there is high poverty. We must work harder to address societal inequities that contribute to these disparities."Children represent nearly 10% of all reported cases in the U.S., according to the report. The child cases are likely underreported because the tally relies on state data that is inconsistently collected."This rapid rise in positive cases occurred over the summer, and as the weather cools, we know people will spend more time indoors," Dr. Sean O'Leary, the vice chair of the AAP Committee on Infectious Diseases, said in a news release."Now we are heading into flu season. We must take this seriously and implement the public health measures we know can help," O'Leary added."That includes wearing masks, avoiding large crowds, and maintaining social distance. In addition, it will be really important for everyone to get an influenza vaccine this year. These measures will help protect everyone, including children."The AAP recommends that any child 6 months or older get a flu shot in line with recommendations from the Centers for Disease Control and Prevention.Pediatricians say it's more important than ever to make sure kids get either the flu shot or the protective nasal spray before the end of October.That's because having two respiratory disease circulating at the same time flu and coronavirus will be confusing to doctors, parents and caregivers. Plus, hospitals and clinics could become overwhelmed with the double burden.The two viruses cause similar symptoms but a study published Tuesday in JAMA Network Open found that children hospitalized with COVID-19 were more likely to have fever, aches, diarrhea and vomiting than were children with influenza.Children with COVID-19 also tended to be older and have at least one underlying health condition.COVID-19 and seasonal flu in children lead to similar rates of hospitalization, intensive care admission, and need for a ventilator to help breathing, the study found. The CDC says 188 children died from flu over the 2019-2020 season.

Half a million U.S. children have been diagnosed with COVID-19, according to the American Academy of Pediatrics and the Children's Hospital Association.

The groups said 70,630 new child cases were reported from Aug. 20 through Sept. 3. This is a 16% increase in child cases over two weeks, bringing up the total to at least 513,415 cases, the groups said in their weekly report on pediatric coronavirus cases.

"These numbers are a chilling reminder of why we need to take this virus seriously," American Academy of Pediatrics President Dr. Sally Goza said in a news release. "While much remains unknown about COVID-19, we do know that the spread among children reflects what is happening in the broader communities," she added.

"A disproportionate number of cases are reported in Black and Hispanic children and in places where there is high poverty. We must work harder to address societal inequities that contribute to these disparities."

Children represent nearly 10% of all reported cases in the U.S., according to the report. The child cases are likely underreported because the tally relies on state data that is inconsistently collected.

"This rapid rise in positive cases occurred over the summer, and as the weather cools, we know people will spend more time indoors," Dr. Sean O'Leary, the vice chair of the AAP Committee on Infectious Diseases, said in a news release.

"Now we are heading into flu season. We must take this seriously and implement the public health measures we know can help," O'Leary added.

"That includes wearing masks, avoiding large crowds, and maintaining social distance. In addition, it will be really important for everyone to get an influenza vaccine this year. These measures will help protect everyone, including children."

The AAP recommends that any child 6 months or older get a flu shot in line with recommendations from the Centers for Disease Control and Prevention.

Pediatricians say it's more important than ever to make sure kids get either the flu shot or the protective nasal spray before the end of October.

That's because having two respiratory disease circulating at the same time flu and coronavirus will be confusing to doctors, parents and caregivers. Plus, hospitals and clinics could become overwhelmed with the double burden.

The two viruses cause similar symptoms but a study published Tuesday in JAMA Network Open found that children hospitalized with COVID-19 were more likely to have fever, aches, diarrhea and vomiting than were children with influenza.

Children with COVID-19 also tended to be older and have at least one underlying health condition.

COVID-19 and seasonal flu in children lead to similar rates of hospitalization, intensive care admission, and need for a ventilator to help breathing, the study found. The CDC says 188 children died from flu over the 2019-2020 season.

More here:

Half a million US children have been diagnosed with COVID-19 - KMBC Kansas City

Trump fixates on the promise of a coronavirus vaccine real or not as key to reelection bid  The Philadelphia Inquirer

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Trump fixates on the promise of a coronavirus vaccine real or not as key to reelection bid - The Philadelphia Inquirer