Several clinics across Iowa are still looking for vaccine trial volunteers.
Dr. Anthony Fauci says a coronavirus vaccine could be given to some of the most vulnerable individuals by the end of 2020.
In the meantime, thousands of people across the United States are participating in those closely-watched trials.
One of them, Ashley Vanorny, is a University of Iowa alum.
"As a former psychology student at the University of Iowa, I know what it's like to recruit patients," Vanorny told Local 5. "So because of that I've always decided that as many as I qualify for, I will do."
Vanorny is participating in the Pfizer study out of the University of Iowa, and says she got two doses at the beginning of the trial.
Researchers don't tell her if she got the real vaccine or a placebo.
But Vanorny thinks she might have received the real thing.
"I did have a different reaction. I had the injection at the beginning of the morning, and then by the end of that evening, I got chills and a mild moderate headache," Vanorny said. "But it was a risk I was willing to take, and I believe a good and necessary risk."
Throughout the trial, Vanorny logs her progress using a special app.
"It's really slick," Vanorny said. "It's just an app and then after that you are checking in once a week until your next appointment."
Vanorny is happy she's participating in something that could save millions of lives.
"For me, it's painless. And for me, I think it's important that as many people as possible that you participate in things like this if you're able," Vanorny said.
If you want to participate in coronavirus treatment trials or vaccine trials, several clinics across the state are looking for volunteers.
Pfizer revealed Tuesday that researchers have not yet conducted an analysis of the efficacy of the vaccine it is developing against Covid-19.
The announcement is both good news and bad news.
Umer Raffat, a senior managing director at the investment bank Evercore ISI, wrote in an analyst note that the fact that Pfizer hasnt conducted an interim analysis was a good thing because it means that, based on the details of the trial protocol, the vaccine had not failed to prevent more than 77% of Covid cases, the benchmark for success at this early juncture.
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But it also suggests that cases of Covid are being reported less frequently among participants in the Pfizer study than in the U.S. as a whole. That means that the study is progressing more slowly than Pfizer and its partner, BioNTech, originally expected. In August, Pfizer had thought that the first interim analysis could occur as early as September.
Pfizer and BioNTech are under a white-hot spotlight because their Covid-19 vaccine, by design, is likely to be the first to have any efficacy data. But that first analysis will come when there have been a total of only 32 cases of Covid-19 across the companys entire 42,000-volunteer study. It would be considered to be positive, Pfizer has said, if six or fewer of those 32 cases occurred in the group that received the vaccine, with the rest occurring in the group that received the placebo. The trial is expected to continue until 150 of the volunteers in the study have had Covid-19.
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Pfizer CEO Albert Bourla set the goal of having a Covid-19 vaccine ready by October this spring, in what appeared to be a bid both to combat the pandemic and to make a statement about the companys research prowess. Pfizer is in the midst of spinning off older, slower-growing parts of the company in a merger with Mylan, which will leave Bourla running a firm whose future will depend heavily on its research laboratories and the prospects of its experimental drugs.
The vaccine itself is expected to be a significant but not huge financial opportunity. Analysts at SVB Leerink estimate sales could peak at $3.5 billion in 2021, and then stabilize at $1.4 billion a year. In its third-quarter earnings, also announced Tuesday, Pfizer reported profits of $2.2 billion on sales of $12.1 billion.
But the October time frame has put Pfizer squarely in the political maelstrom of the U.S. election, as President Trump repeatedly predicted that a vaccine would be available before Election Day. It has been clear for months that other companies developing Covid-19 vaccines, including Moderna, AstraZeneca, and Johnson & Johnson, had no chance of hitting that mark.
On Oct. 6, the Food and Drug Administration released new guidance on safety data that would be required before it would consider clearing a vaccine through an emergency use authorization, or EUA, its fastest path to making a vaccine available. The agency told drug makers not to file for an EUA until at least half the patients in their studies have been followed for two months. In an Oct. 16 public letter, Bourla confirmed that this would prevent Pfizer from filing for an EUA until the third week of November.
At an advisory panel of outside experts the FDA held last week, the agency signaled that it was not certain it would grant an EUA for a vaccine until a sufficient amount of data had been accumulated to more fully understand the safety and efficacy of a vaccine prospect.
Against that backdrop, there is a huge amount of attention on Pfizers interim analyses, which were originally designed as a way to make a vaccine available as soon as possible. Such analyses are a standard part of clinical trials, and are conducted by an independent committee called a data and safety monitoring board, or DSMB.
However, its unusual that Pfizer will be getting reports from the DSMB on the efficacy of the study as it is still ongoing, and it is also unusual that those results will be announced as the study continues with patients and doctors remaining unaware of who has received the vaccine and who has received placebo. It might also have been possible, for instance, for Pfizer to have told the DSMB only to give it information if there is enough safety data to file for an EUA. That appears to be the approach, for instance, that is being taken by Johnson & Johnson with its Covid-19 vaccine. In many but not all circumstances, interim analyses are made public because a treatment or vaccine is so effective (or ineffective or unsafe) that it is no longer possible to continue a study.
Receiving these reports puts Pfizer in the position of having to disclose them for both financial and ethical reasons. Thats certainly true if the DSMB says the vaccine is effective or definitively not effective, but Pfizer may also feel the need to announce if the DSMB conducts an interim analysis and allows the study to continue.
Bourla said on a conference call Tuesday that he is cautiously optimistic that the study will have positive results, and that those could come in an interim analysis. You never know until you have a study result, he said. Lets all have the patience that is required for something so important for public health. He later said that he knows that the U.S election is raising the tension around the data readout. This is not going to be a Republican vaccine or a Democratic vaccine. This is going to be a vaccine for the citizens of the world. I hope that it is going to be effective.
Making educated guesses about what is happening in a clinical trial is normal practice for investors who follow pharmaceutical companies, but not for a general public that is hoping a vaccine will be able to help slow a pandemic. A warning, then, from past attempts from investors to read the tea leaves on clinical trials: They are frequently wrong.
For instance, on Monday, analysts at Morgan Stanley wrote that they suspected the first interim, which Pfizer said requires 77% vaccine efficacy, had happened in mid-October, and that Pfizer could be getting its second planned report on the data, which occurs after 62 cases of Covid-19 occur in the trial. That was smart speculation and, it turns out, incorrect.
In an unrelated update, Novavax, another closely watched vaccine maker, said the U.S. study of its Covid-19 vaccine would start in late November, after it was expected.
The portion of people in Britain with detectable antibodies to the coronavirus fell by roughly 27 percent over a period of three months this summer, researchers reported Monday, prompting fears that immunity to the virus is short-lived.
But several experts said these worries were overblown. It is normal for levels of antibodies to drop after the body clears an infection, but immune cells carry a memory of the virus and can churn out fresh antibodies when needed.
Some of these headlines are silly, said Scott Hensley, an immunologist at the University of Pennsylvania.
Declining antibody levels after the acute infection has resolved is the sign of a normal healthy immune response, Dr. Hensley said. It doesnt mean that those people no longer have antibodies. It doesnt mean that they dont have protection.
The research also raised some fears about the ability of vaccines to help populations reach herd immunity, the point at which enough people would be immune to the coronavirus to thwart its spread.
Its too early to know how long immunity to the new coronavirus lasts, and whether people can be reinfected many months to a year after a first bout with the virus. Still, experts said worries about vaccines, too, are unwarranted.
The vaccine doesnt have to mimic or mirror the natural infection, said Shane Crotty, a virologist at the La Jolla Institute for Immunology. Certainly I wouldnt be alarmist about these data.
The new results indicate the prevalence of coronavirus antibodies in the broader population but not in specific individuals. Several studies looking at antibody levels in individuals have shown that after some initial decline, the levels hold steady for at least four to seven months.
The British report is based on three rounds of antibody blood tests carried out in 350,000 randomly selected people from June 20 to Sept. 28. The participants tested themselves at home for antibodies using finger-prick assays that deliver a yes-or-no result, much like a pregnancy test.
Over the three-month period, the proportion of people with detectable antibodies in their blood dropped to 4.8 percent from 6 percent, the researchers reported. The smallest decline was among people ages 18 to 24 and the biggest in those over age 75.
Looking at the data a different way, about 73 percent of people who had antibodies early on still produced a positive result months later, noted Dr. Antonio Bertoletti, a virologist at Duke NUS Medical School in Singapore. Thats not such a dramatic decline.
Antibodies also represent only one arm of the immune response, albeit the one that can most easily be measured. There are at least three other branches of the immune system that can fend off illness, so antibody levels dont present the full picture.
Its not the whole immune response, said Dr. Paul Elliott, an epidemiologist at Imperial College London who heads the project.
When the body encounters a pathogen, it rapidly produces antibodies that recognize the invader. Once the acute infection resolves, the levels decline as they must for purely practical reasons.
Our lymphatic system, where immune cells are, only has a finite amount of space, Dr. Hensley said.
Depending on the test used, the small amount of antibodies still circulating in the blood may not be enough for a positive signal. The test used in the study has a sensitivity of 84.4 percent, well below that of lab-based tests that hover around 99 percent. That means it may miss anyone who has low antibody levels.
For example, people with mild to no symptoms may have produced fewer antibodies than those with severe illness. Most of the people with positive results were ill in March or April, at the peak of the outbreak in Britain, but about 30 percent did not recall having any Covid-19 symptoms. Even a small decrease in the amount of antibodies may drop their levels below the limit of detection.
Confused by the terms about coronavirus testing? Let us help:
Were saying the antibody response has declined below the threshold of detection, Dr. Elliott said. This is not a surprise to anyone who works in the field.
Data from monkeys suggests that even low levels of antibodies can prevent serious illness from the virus, if not a re-infection. Even if circulating antibody levels are undetectable, the body retains the memory of the pathogen. If it crosses paths with the virus again, balloon-like cells that live in the bone marrow can mass-produce antibodies within hours.
A very small number of people may not make any antibodies. But even those people may have immune cells called T cells that can identify and destroy the virus. The vast majority of people infected with the coronavirus develop lasting cellular responses, according to several recent studies.
T cells are unlikely to prevent infection, but they may at least prevent serious illness by blunting the attack, Dr. Crotty said. Given all that, he said, interpreting low antibody levels to mean that immunity disappears, or that coronavirus vaccines will not be effective is wrong.
For example, the human papillomavirus elicits a terrible immune response and lousy antibodies, he said. But the vaccine with a single immunization elicits fantastic antibodies that are 99 percent protective in people for 10-plus years, just a complete night-and-day difference.
Vaccines can also be designed to provoke much stronger responses than the natural infection, he added.
Though criticizing many of the interpretations of it, experts said the new studys results are an interesting glimpse into the prevalence of antibodies at a population level.
The same research team is also testing hundreds of thousands of people for presence of the virus. Together, Dr. Elliott said, the studies offer a really powerful tool for policymakers to gauge the size of a countrys epidemic.
Masked University of Michigan students walk around campus in Ann Arbor on Tuesday, October 20, 2020 after Washtenaw County Health Department issued a Stay in Place order for University of Michigan undergrad students due to the rising number of COVID-19 cases on campus.(Photo: Ryan Garza, Detroit Free Press)
As COVID-19 case numbers continue to go up and up and up in Michigan and nationally a debate is brewing about whether it's time to abandon effortsto contain the spread of the virusand insteadembrace a strategy of trying to reach herd immunity through infection.
With other diseases, such as smallpox, polio and measles, vaccines helped the U.S. reach herd immunity, which occurs when the vast majority of a population is immune to a disease, makingthe likelihood of its spread to vulnerable people less likely.
But because there is no coronavirus vaccine on the market yet, the only way to reach herd immunity would be to allow COVID-19 to spread unchecked through the population infecting most of the nation's 330 million people, and likely hospitalizing and killing millions along the way.
Most leading health officials including some from Michigan have called the idea unethical at bestand akin to mass murder at worst.
The death toll would be "enormous," said Dr. Anthony Fauci, the nation's leading infectious diseases doctor and director of the National Institute of Allergy and Infectious Diseases, if the U.S. tried to achieve herd immunity through infection.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says vulnerable populations would be at risk if a herd immunity strategy is tried.(Photo: AP)
"If you just let things rip and let the infection go ... that quite frankly is ridiculous," Fauci said inan Oct. 15interview on Good MorningAmerica. "There will be so many people in the communitythat you can't shelter, that you can't protect, who are going to get sick and get serious consequences. So this idea that we have the power to protect the vulnerable is total nonsense because history has shown that that's not the case.
"And if you talk to anybody who has any experience in epidemiology and infectious diseases, they will tell you that that isrisky, and you'll wind up with many more infections of vulnerable people, which will lead to hospitalizations and deaths."
Yet it's a strategy endorsed by a group of infectious diseases doctors and epidemiologistswho signed the Great Barrington Declaration earlier this month, calling for young, healthy people to resume life as usual whileurging older people with chronic conditions that put them at higher risk of complications or death from COVID-19 to stay home. The group calls it: Focused Protection.
President Donald Trump has said repeatedly that the nation ought to fully reopen, students shouldreturn to school and has been skeptical about the effectiveness of masks. He also said "herd mentality" may be the way forward during an ABC News town hallevent in September.
Trump also has saidthe U.S. is "rounding the corner" with the COVID-19 crisis and that the viruswill eventually disappear even without a vaccine, despite raging outbreaks in most states, including Michigan, which announced3,381 new cases in a combined Sunday/Monday count, and 29 new deaths bringing the statewide total to161,907 confirmed cases since March and 7,211 deaths.
Hospitalizations are rising, too.
The Michigan Department of Health and Human Servicesreported 1,479 adults were hospitalized statewide Monday withCOVID-19 or // suspected COVID-19 cases, as were 10 children. That's more than double the number of people who were hospitalized with coronavirus two weeks ago in Michigan, when the Michigan Health and Hospital Association reported that hospitalizations already were up 80% in the state.
The percentage of positive COVID-19 tests is climbing as well. The seven-day average percentage of positive tests in Michiganrose to 5.6% from Oct. 19-25, compared with 3.8% in the week from Oct. 5-11, according to state data.
Alex Azar, secretary of the U.S. Department of Health and Human Services, said"herd immunity is not the strategy of the U.S. government with regard to coronavirus"during an Oct. 2 hearing before the U.S. House Select Subcommittee on the Coronavirus Crisis.
U.S. Department of Health and Human Service Secretary Alex Azar speaks during a COVID-19 briefing at the Centers for Disease Control and Prevention headquarter campus in Atlanta, Wednesday, Oct. 21, 2020.(Photo: Alyssa Pointer, AP)
We may get herd slowing of transmission as we perhaps have seen inthe New York area and other concentrated areas. Our mission is to reduce fatalities, protect the vulnerable, keep coronavirus cases down to the lowest level possible, he said.
Dr. Anurag Malani, an infectious diseases specialist at St. Joseph Mercy Hospital in Ann Arbor, said theidea of pursuing herd immunity through infection is not "a viableor smart option."
"Estimates are probably 10% of the U.S. has had COVID," he said. "So that means, 90% has not, and that means that there's really a lot of vulnerable people that are out there."
And as many as 40% of Americans have pre-existing health conditions that put them at high risk for severe illness from COVID-19 or death, Malani said, noting that even when people survive the disease, many are reporting lingering long-term health problems.
"Herd immunity really shouldn't beachieved by exposing people to the virus," he said."We don't know the long-term ramifications."
Dr. Adnan Munkarah,Henry Ford Health System's executive vice president and chief clinical officer, also is opposed to the idea, calling it a "very concerning proposal."
"You can go for a herd immunity, but the question is at what expense and how many people are we going to letdie before we develop the herd immunity?" he asked.
"Are we willing to lose hundreds of thousands of people for that,to get that herd immunity?Aren't we better off protecting the population?We have many vaccines that are under trials. I am very optimistic that we'll have a couple of these that will show effectiveness, implement the vaccine, and let's get our immunityin a way that continues to protect our population health community, rather than lose a lot of people during that journey."
It's a position the World Health Organization also supports.
Tedros Adhanom Ghebreyesus, Director General of the World Health Organization warned against the idea that herd immunity might be a realistic strategy to stop the pandemic, dismissing such proposals as "unethical." At a press briefing on Monday, Oct. 12, 2020, WHO director-general Tedros Adhanom Ghebreyesus said health officials typically aim to achieve herd immunity _ where the entire population is protected from a virus when the majority are immune _ by vaccination. Tedros noted that to obtain herd immunity from measles, for example, about 95% of the population must be vaccinated.(Photo: Salvatore Di Nolfi, AP)
"Herd immunity is a concept used for vaccination, in which a population can be protected from a certain virus if a threshold of vaccination is reached," said WHO Director-GeneralDr. Tedros Adhanom Ghebreyesus in an Oct. 12 news briefing.
But attempting to create herd immunity by infecting large portions of the population "means allowing unnecessary infections, suffering and death." He called it "scientifically and ethically problematic."
Among the concerns is that the virus is so new, scientists don't know yet how long immunity lasts, and there have been a few documented cases of reinfection, and little is known about the long-term problems associated with COVID-19.
The best approach,Ghebreyesus said is to control transmission to save as many lives as possible.
"Its not a choice between letting the virus run free and shutting down our societies," he said. "This virus transmits mainly between close contacts and causes outbreaks that can be controlled by implementing targeted measures:... Find, isolate, test and care for cases, and trace and quarantine their contacts.
"This is what countries are proving works, every day."
Contact Kristen Jordan Shamus: kshamus@freepress.com. Follow her on Twitter @kristenshamus.
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Police stand guard outside of a rally with Vice President Pence on Oct. 13 in Waukesha, Wis. The state is experiencing a surge of COVID-19 cases, threatening to overwhelm rural hospitals. Scott Olson/Getty Images hide caption
Police stand guard outside of a rally with Vice President Pence on Oct. 13 in Waukesha, Wis. The state is experiencing a surge of COVID-19 cases, threatening to overwhelm rural hospitals.
It took Wisconsin more than seven months to reach 100,000 coronavirus cases. On Monday, just five weeks later, it reached 200,000.
Wisconsin is now experiencing a massive upsurge in cases that rivals the numbers seen in much bigger states. Hospital beds are at about 85% capacity statewide. The state just opened a field hospital near Milwaukee that can accommodate more than 500 patients.
"Early on in the pandemic, we put a lot of plans in place and then we were fortunate enough to be able to put those away for a while. We had COVID cases, but they weren't overwhelming. Things were going OK," says Dr. Jeffrey Pothof, an emergency room doctor in Madison. "And then everything changed. And now we are the next hot spot. And that's been so challenging for all of our staff who have been at this for so long now."
Pothof, who is also chief of quality for the University of Wisconsin-Madison's health system, tells NPR's Morning Edition that medical supplies are in OK shape. The biggest concern is staffing.
"It's one of the things that we as a health system just can't create by investing more money or more time. And, you know, we're running short of critical care nurses, critical care physicians for patients that need them because they have COVID-19 and they're in one of our ICUs," he says.
Hospitalizations have skyrocketed in the last month in Wisconsin, a state with a mix of rural and urban areas. Pothof says patients frequently come from rural hospitals that exceed their capacity to his hospital in Madison. It's those rural areas that are of particular concern as COVID-19 cases rise.
From the small city of Marshfield in central Wisconsin, nurse Theresa Weiler tells Morning Edition that "it's almost a rotating door here."
Weiler, who supervises the COVID-19 unit at Marshfield Medical Center, says they "either send somebody home or they leave and then we get somebody else in a bed right away."
In nearby Wausau, Dr. Ryan Andrews says coronavirus patients are very resource-intensive. Andrews is the chief medical officer for Aspirus, a rural health system that covers 35,000 square miles.
"Although we've planned and are working through our plan, there is a finite amount that we can support," he says. Many people already travel two to three hours to get to their facility. "And if we can't take care of them, if our capacity is reached, they're going to have to travel another one to two to three hours as well. And that's very hard on patients and also very hard on their families and communities."
Andrews says the system has not reached capacity yet, but has asked surgical partners to postpone elective surgeries.
Both Marshfield and Wausau are dealing with an additional challenge: staffers getting COVID-19 themselves.
"If we are putting ourselves at risk and we get sick, who covers for us?" says Weiler in Marshfield.
She emphasizes the advice of health officials for everyone: Wear a mask. Don't gather in groups. Social distance. Stay 6 feet apart. Wash your hands. If you're sick, stay home. "That little bit can kind of help us a long way."
Staff are tired, she says. "The exhausting part," says Weiler, is that "we don't know when it will end or when it will slow down."
Avery Keatley, Nina Kravinsky and Lilly Quiroz produced and Dalia Mortada edited the audio versions of this story.
Darrell M. WestContributor
Darrell M. West is Vice President and Director of Governance Studies at The Brookings Institution.
John R. AllenContributor
John R. Allen is President of The Brookings Institution.
The novel coronavirus has accelerated the use of many digital technologies. Forced in the spring to close their doors, most K-12 schools and universities shifted to online learning where teachers lead classes virtually and students submit their assignments electronically.
According to the World Economic Forum, it is estimated that 1.2 billion students around the world this year were out of the classroom due to the pandemic, while in the United States,over 55 millionK-12 students didnt receive in-person instruction.
The use of telemedicine and video conferencing also has become a principal platform for medical consultations as a result of the coronavirus. For example, aForrester analysisprojectedgeneral medical care visits to top 200 million this year, up sharply from their original expectation of 36 million visits for all of 2020. Virtual connections allow patients to get recommendations wherever they are and draw on a broad range of medical expertise.
E-commerce is taking off as consumersabandonsmall retail outlets and large department stores. Anindustry studyfound that total online spending inMay 2020reached$82.5 billion, up 77% from May of 2019 and those numbers almost surely will increase in coming months as people appreciate the convenience of online ordering and home delivery.
Yet the pandemic also has exposed dramatic inequities in technology access and utilization. Not everyone has the high-speed broadband required for online education, telemedicine and online shopping. The Federal Communications Commission has estimated it would take $40 billion to close the bulk of the broadband gap. But many people also lack laptops, notebooks, smartphones or electronic devices that allow them to stream videos and take advantage of new modes of service delivery.
It is not just that some are outside the online world, but that digital access is spread inequitably across various groups. According to anEducation Week survey, 64% of American teachers and administrators in schools with a large number of low-income students said their pupils faced technology limitations, compared to only 21% of students in schools with a small number of low-income students. The problem isnt simply broadband, but access to equipment and devices that allow pupils to make use of online resources.
There are substantial racial disparities as well. AMcKinsey analysis found that 40% of African-American students and 30% of Hispanic students in U.S. K-12 schools received no online instruction during COVID-induced school shutdowns, compared to 10% of whites. These gaps in access to online education and digital services widen the already substantial educational inequalities that exist, but push them to new heights. If continued for a lengthy period of time, such differentials expose our most disadvantaged students to large barriers to advancement and a future of income deprivation or economic stagnation. Even more tragic, there may be a tipping point beyond which the gap is no longer recoverable.
These types of inequities are intolerable injustices that create nearly insoluble gaps with serious social and economic consequences. The variations noted above increase income inequality, widen the opportunity gap between social groups and doom those left behind to low-paying jobs, temporary positions without health benefits or outright unemployment. Not having access to the digital superhighway limits opportunities for online education, telemedicine and e-commerce and makes it nearly impossible to apply for jobs, request government benefits or access needed health or educational materials.
What is required right now is investment in digital infrastructure and improvements in digital access that eliminate unfair disparities based on race, income and geography. For example, the Federal Communications Commission needs to expand its current Lifeline program designed to promote phone connectivity for poor people to the internet. Many providers combine phone and internet usage so there is no reason to provide subsidies for phone service without also including internet service. With the availability of Voice over Internet Protocols (VoIP), it is easy for underserved people to combine phone and internet connectivity.
This FCC also should expand its Schools and Libraries program called E-rate to include home schooling and remote learning. With so many educational institutions closed and providing instruction through online education, the commission should use the millions in unexpended program funds to close the homework gap created by the COVID-19 pandemic. That would help impoverished students access online resources and video conferencing facilities.
The Department of Agricultures Rural Utilities Service seeks to improve broadband service in rural areas but its funding currently cannot be used to improve low-speed broadband. At a time when many lack sufficient speed to access online educational resources, telemedicine or video streaming, that limitation makes little sense and needs to be altered so that rural-dwellers can upgrade their internet service.
In the education sphere, states and localities must ensure that racial and income-based disparities in access to online learning are not a permanent feature of the K-12 landscape. Addressing this issue is going to require much more than distributing free laptops to needy students, as is often advocated. Rather, it will involve making sure families can afford the broadband access that will enable pupils to use the laptops in productive ways, teachers are well-trained in distance learning and educational programs equip young people with the skills needed in the 21st century economy.
As we move into the future, broadband will be as vital to social and economic advancement as highways, bridges and dams were in earlier eras. Similar to the 20th century, improving access requires national planning and public and private sector investments. Indeed, digital access should be considered a human right in the same manner as access to universal healthcare. People cannot participate in the digital economy and online learning systems without high-speed broadband.
As noted in ourrecent AI book, the United States requires a national plan that funds digital infrastructure, reduces racial and geographic disparities, facilitates universal medical insurance and prepares workers for the digital economy. The list of national imperatives includes closing the digital divide, expanding anti-bias rules for the digital economy, building an inclusive economy through more equitable tax policies and training the next generation of workers.
New digital services or financial transactions taxes could help fund the programs that need to be undertaken to deal with these issues. One hundred years ago, as the United States underwent industrialization, national leaders adopted an income tax to pay for needed services, and as we move into a digital economy, there will need to be new types of taxes to pay for needed expenditures. We cannot allow current inequities in access to education and healthcare to deny opportunities to African-Americans, Hispanics, immigrants and poor people. Leaving those individuals behind as the digital economy grows is not a viable option if were ever as a nation to achieve our full potential by empowering all Americans.
Data is the key to many emerging technologies so it is crucial to have unbiased information to develop new services, evaluate digital innovation and deal with the ramifications of current products. Much of the current digital data is proprietary in nature and therefore limits the ability of researchers to improve innovation, close the digital divide and develop remedies that address equity problems. The federal government sits on a trove of data that should be made available for commercial and research purposes on an anonymized basis so that privacy is maintained. In the same way that census data enables research, economic development and program assessment, wider access to digital data likely would spur new products and services while also helping to address equity problems.
In a country that continues to beplagued by the coronavirus, it is vital to reduce the inequities that deny opportunity to large groups of Americans and make it impossible for them to share in thebenefits of the digital revolution. As we envision a post-COVID world, it is essential we build an inclusive economy that allows everyone toparticipate in and gain the benefits of the online world.
The fundamental shifts wrought by COVID are not going to slow even after a vaccine is developed and the effects of the coronavirus dissipate over time. Nearly all of the technological trends generated by COVID this year will remain a large part of our ongoing landscape. Due to advances in computer storage and processing power, 5G networks and the growing use of data analytics, technology innovation almost certainly will accelerate in coming years.
Having a substantial part of our fellow citizens outside the digital environment is a recipe for continued racial injustice, social conflict, economic deprivation and political division. It will ensure that cynicism, discontent and anger will remain a feature of the American social landscape for decades to come. The last four years have exposed the massive inequities in American society, made worse not only by the intentional political polarization of the American public, but also by a digital divide that is virtually certain to lock in many pernicious dimensions of inequality in America.
This is not a technology problem, its a leadership challenge. Leadership can solve this national crisis by demonstrating the will to wield technology in the best interests of all Americans. The next administration has it within its capacity to address these matters head on and eliminate this divide, or conversely, if it doesnt take appropriate action, condemn our most vulnerable citizens to four more years of neglect and inequity.
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Eli Lilly said Monday that it will end a U.S.-based clinical trial for its coronavirus antibody treatment because the data indicates the treatment is unlikely to help coronavirus patients recover from advanced stages of the disease, a move which comes two weeks after it paused the trial citing a potential safety concern.
A scientist working in a lab.
No additional patients will participate in the trial run by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
Eli Lilly said there is insufficient evidence the treatment improved clinical outcomes when added to other treatments for patients hospitalized with coronavirus.
Eli Lilly said it will continue other trials for its coronavirus antibody treatment, including a study for recently diagnosed patients with mild to moderate illness, a phase two trial for non-hospitalized people recently diagnosed with the virus and a phase three trial for the prevention of coronavirus in residents and staff at long-term care facilities.
Based on the data from the phase two trial, Eli Lilly said it is confident the therapy may prevent coronavirus progression for people in earlier stages of the disease.
President Trump has claimed an experimental antibody cocktail made by Regeneron that he was given was a cure and he has said positive things about Eli Lillys antibody therapy in recent videos. Trumps confidant, former New Jersey governor Chris Christie, said he was given Eli Lilys experimental antibody treatment when he was hospitalized for coronavirus this month. He had attended the September 26 event hosted at the White House to announce judge Amy Coney Barretts nomination to the Supreme Court. At least 14 people who attended have since tested positive.
Eli Lilly Covid-19 Antibody Treatment Trial Is Paused Due To 'Potential Safety Concern' (Forbes)
Report: Eli Lilly In Violation Of FDA Manufacturing Standards At Plant Preparing To Produce Covid Treatment (Forbes)
Full coverage and live updates on the Coronavirus
Four counties in the greater Bay Area moved into a less-restrictive coronavirus reopening tier Tuesday, allowing them to reopen more businesses and expand indoor operations for already-open businesses like restaurants and religious facilities.
Contra Costa, Marin, San Mateo and Santa Cruz counties all moved from Tier 2, the red tier, to Tier 3, the orange tier, in the state's four-tiered reopening system following decreases in their testing positivity rates and their rates of new cases.
In many cases, all four counties will be able to expand the maximum capacity of indoor businesses from 25 percent to 50 percent or 200 people, whichever is fewer.
Gyms, fitness centers and hotels will also be allowed to reopen indoor pools, while gyms themselves can increase their capacity from 10 percent to 25 percent of their maximum occupancy.
Moving into the orange tier also allows multiple sectors like offices, cardrooms, bowling alleys, climbing walls, wineries and bars, breweries and distilleries at which food is not served to resume operating inside with caps on capacity.
Last week, the state allowed counties in the orange tier to reopen outdoor theme parks and professional sporting venues to fans at limited capacities. However, indoor sports venues, such as the Santa Cruz Warriors' Kaiser Permanente Arena, are still not allowed to sell tickets.
State Health and Human Services Secretary Dr. Mark Ghaly said that while the four Bay Area counties and three others progressed to less-restrictive tiers on Tuesday, the state is still seeing warning signs of cases and hospitalizations rising.
"We do have a number of counties ... who we are concerned about moving back in the future," he said during Gov. Gavin Newsom's Tuesday update on the pandemic and wildfires burning across the state.
"We're working closely with their public health teams and other leaders in their counties to ensure that we are digging into the data, understanding it very well, so that we can take the appropriate steps ... to make sure transmission is reduced as far and as much as possible," Ghaly added.
San Mateo County Supervisor David Canepa argued the county's tier change could only be looked at as a positive, provided that county residents continue following public health guidance.
He also praised the county's resilience after San Mateo County was one of the Bay Area's first COVID-19 hot spots in March and April.
"This will allow many of our retail businesses to start operating at full capacity," Canepa said in a statement. "It means that there is no longer a substantial risk of catching (COVID-19) in this county. Now we must minimize the risk if we want to move to yellow and complete this historic comeback."
Marin County Public Health Officer Dr. Matt Willis said that while the county's tier change is a positive sign, maintaining that progress will be a key to saving lives as flu season continues and the holiday season arrives.
"We've all made sacrifices to get in front of this pandemic in Marin," Willis said. "This progress is a sign of what we can do. But it is way too early to let up."
All four counties will be required to stay in the orange tier for at least three weeks before they would be allowed to move into the state's least-restrictive tier, which includes resuming indoor operations for businesses like bars, arcades and ice- and roller-skating facilities.
Each county would also have to meet the least-restrictive yellow tier's case rate, test positivity rate and health equity metric thresholds for two consecutive weeks to be allowed into that tier.
To date, only San Francisco County has moved into the yellow tier among the 11 counties in the Bay Area and Monterey Bay peninsula.
A health worker injects a woman during clinical trials for a COVID-19 vaccine last month in Hollywood, Fla. Eva Marie Uzcategui/Bloomberg via Getty Images hide caption
A health worker injects a woman during clinical trials for a COVID-19 vaccine last month in Hollywood, Fla.
The Food and Drug Administration is preparing for the eventual rollout of one or more COVID-19 vaccines by identifying the concerns that some people have about taking such a vaccine.
At a meeting Thursday of experts advising the FDA on COVID-19 vaccines, the concerns of front-line workers and people of color were read aloud verbatim, highlighting the crucial project of communicating the safety and effectiveness of a vaccine in an environment of deep political distrust.
Those concerns were gathered at a series of listening sessions organized by the Reagan-Udall Foundation, a nonprofit that aims to advance the work of the FDA.
Susan Winckler, the foundation's CEO, noted that its study was rather narrow, with a focus on the role of the FDA in vaccine review and approval.
Nonetheless, participants in the sessions voiced a range of concerns:
The listening sessions focused on two groups. One was front-line workers in service, retail and health care settings. The second focused on people who are often underrepresented and are at increased risk for COVID-19: Black, Hispanic and Indigenous/Native American communities.
Eight such sessions have been conducted so far, and a few more are slated for the coming weeks. The foundation said its goal is to understand the perceptions that may lead Americans to feel hesitant about receiving a COVID-19 vaccine and to use that information to craft messaging that addresses those concerns.
Winckler noted that the participants' concerns often shared certain themes: concerns about the speed of the process, distrust of government and government agencies, distrust of the health care system, and concern that politics and economics will be prioritized over science.
People of color also voiced worries that the vaccine won't work for minority populations. Among their statements:
Participants also expressed fears based on past experiences. One person expressed a worry that "this is another Tuskegee experiment."
Vaccine hesitancy was a frequent topic at Thursday's FDA meeting recognition that the introduction of COVID-19 vaccines will be a nationwide communications effort as much as a scientific one.
The FDA meeting was one effort to demonstrate that the vaccine development process in the U.S. is safe and is being handled with great care and transparency.
Marion Gruber, director of the FDA's Office of Vaccines Research and Review, said that development of a vaccine is happening as quickly as it can but no faster.
"Vaccine development can be expedited," she said. "However, I want to stress that it cannot and must not be rushed."
(Photo by Alex Edelman-Pool/Getty Images)
Pool | Getty Images News | Getty Images
LONDON Hopes are rising that a Covid-19 vaccine could be approved by the end of the year, with drugmakers and research centers scrambling to help bring an end to the pandemic.
Dozens of candidate vaccines are in clinical evaluation, according to the World Health Organization, with some already conducting late-stage tests before seeking formal approval.
The outcome of the trials is being closely monitored around the world.
The U.S.'s leading expert on infectious disease believes it will only be a matter of weeks before the findings of a potential vaccine will be known.
"We will know whether a vaccine is safe and effective by the end of November, the beginning of December," White House coronavirus advisor Dr. Anthony Fauci said in a BBC interview on Sunday.
"The question is: Once you have a safe and effective vaccine, or more than one, how can you get it to the people who need it as quickly as possible?"
Fauci said a vaccine deemed safe and effective would be rolled out according to a set prioritization, with individuals such as health care workers and those in a higher risk category likely to receive the first doses. He said it would be "several months into 2021" before a vaccine becomes more widely available.
The development of a vaccine, Fauci warned, would not replace the need for public health measures to help protect people from the disease for some time.
To date, more than 43 million people have contracted the coronavirus worldwide, with 1.15 million related deaths, according to data compiled by Johns Hopkins University.
The race for a Covid vaccine has seen governments step in to try to help the process along by providing funds to allow companies to scale up manufacturing even before drugs have been approved.
Leo Varadkar, Ireland's deputy prime minister, has said he is hopeful an inoculation against the coronavirus could be approved before the end of the year.
"I'm increasingly optimistic, as is government, that we will see a vaccine approved in the next couple of months and that in the first half or first quarter of next year it'll be possible to start vaccinating those most at risk," Varadkar, who is a qualified doctor, told RTE radio on Sunday.
A Rehab Support worker checks on patient notes as the first patients are admitted to the NHS Seacole Centre at Headley Court, Surrey, a disused military hospital, which has been converted during the coronavirus pandemic.
Victoria Jones | PA Images via Getty Images
Not all public health experts share the same level of optimism about the development of a Covid vaccine before year-end, however.
The Mail on Sunday reported plans had been drawn up for frontline National Health Service staff to receive a coronavirus vaccine within weeks, citing an email sent by an NHS Trust chief to his staff.
In response to the report, U.K. Health Minister Matt Hancock said on Monday that it was not the government's expectation for NHS staff to receive access to a potential vaccine this year.
He did rule out the possibility of a Covid vaccine being delivered to hospital staff in 2020 but said the bulk of the rollout would likely take place in the first half of next year.
The U.K.'s chief scientific advisor, Patrick Vallance, has said he doesn't believe a Covid vaccine will be available for widespread use in the community until at least the spring.
He also told the National Security Strategy Committee in London last week that the coronavirus was likely to become as endemic as the annual flu.
This means the infection rate of the coronavirus, like other coronaviruses, will eventually stabilize at a constant level so that the virus becomes present in communities at all times.
Vallance said creating a vaccine from scratch took approximately 10 years on average. The fastest vaccine ever developed was for mumps, and it took more than four years.
Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration taken taken April 10, 2020.
Dado Ruvic | Reuters
Separately, Dr. David Heymann, who led the WHO's infectious disease unit during the SARS epidemic in 2002-2003, believes some governments may be over-reliant on the development of a vaccine at a time when effective communication, diagnostic testing and outbreak containment activities are all critically important tools.
"The difficulty right now is that in many countries, they are looking forward to a vaccine which may or may not come, which may or may not be effective in the short or long term, and they are looking at possible therapeutic (options) which could solve many of the problems," Heymann said during a webinar for think tank Chatham House last week.
"But, that's not a good way to proceed at present. We have to learn to live with the pandemic."
