Anthony Fauci, the United States' top infectious diseases official, said Wednesday the government wouldn't make any future COVID-19 vaccine obligatory for the general public -- though local jurisdictions could make it mandatory for some groups, like children.
"You don't want to mandate and try and force anyone to take a vaccine. We've never done that," said Fauci, a member of the White House coronavirus task force, during a video talk organized by George Washington University.
"You can mandate for certain groups of people like health workers, but for the general population you can't" he added, citing the example of the National Institutes of Health, where health workers can't treat patients without a flu shot.
Australia's Prime Minister Scott Morrison hours earlier announced that coronavirus vaccines, once approved, would be mandatory for everyone in his country, barring medical exemptions.
But the United States' decentralized system of government, and anti-vaccine sentiments that have been building for decades, had in any case made a program of mandatory immunization unlikely.
"It would be unenforceable and not appropriate," said Fauci.
This however doesn't prevent states from making a vaccine mandatory for children to attend school, as is already the case for certain diseases such as measles, though some are exempt for medical or religious reasons.
At any rate, the administration of President Donald Trump has pre-ordered hundreds of millions of vaccine doses from six companies, and these will be distributed for free.
ico/dax/ia/jm
MADISON (WKOW) -- As the world continues to battle COVID-19, the status and eventual use of a vaccine are subjects of constant debate. In order to address questions and confusion, UWHealthofficials are going over how vaccines are tested and why they work.
For a vaccine to be approved and recommended to the public by medical professionals, it needs to pass numerous tests. Even with the urgency surrounding COVIID-19 vaccines, those protocols are still being followed to ensure any eventual vaccine is safe and effective.
Many care treatments, including vaccines, go through clinical trials. Clinical trials take place in three phases.
Several COVID-19 vaccines are now or will soon be in phase 3.
Vaccines are about preventing the disease, not treating it. A vaccine activates your immune system to produce antibodies, exactly like it would if you were exposed to the disease, but without getting you sick. Once you are vaccinated, you develop immunity to the disease without having to get the disease first.
Scott Duke Kominers is the MBA Class of 1960 Associate Professor of Business Administration at Harvard Business School, and a faculty affiliate of the Harvard Department of Economics. Previously, he was a junior fellow at the Harvard Society of Fellows and the inaugural research scholar at the Becker Friedman Institute for Research in Economics at the University of Chicago.
Alex Tabarrok is the Bartley J. Madden Chair in Economics at the Mercatus Center at George Mason University.
Gotta bleed the crabs now.
Photographer: Timothy Fadek/Corbis Historical/Getty Images
Photographer: Timothy Fadek/Corbis Historical/Getty Images
Weve already seen the costs of supply-chain failures during the Covid-19 pandemic: Delays in the production of simple nasal swabs slowed testing by months even as the pandemic exploded in the U.S. The world is now eagerly awaiting a vaccine, and will need billions of doses as quickly as possible. If the vaccine supply chain fails, the economic and human cost of Covid-19 will be prolonged.
The multilinked vaccine production chain will take months to set up, which means starting now. Some parts are already seeing investment glass manufacturers, for example, are ramping up production of vials. But the supply of less obvious inputs needed earlier in the chain is uncertain.
Vaccine supply chains contain some unusual links, including horseshoe crab blood, shark liver oil and an enzyme thats one of the worlds most expensive products. Other links rely on novel manufacturing processes that have not yet been implemented at scale. Each link in the chain needs to be stress-tested and strengthened. For the potential weak spots, alternative manufacturing processes need to be considered and prepared.
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Vaccines manufacturing requires a long series of biological processes, and avoiding contamination is crucial. Endotoxins, which are dangerous molecules shed by bacteria, are one source of contamination. To detect them, each batch of vaccine, along with its vials and stoppers, is tested with a substance called Limulus amebocyte lysate. The only known natural source of LAL is horseshoe crab blood which means that the supply varies year to year, and we have to be careful not to deplete the crab population. Luckily, a synthetic version of LAL has recently been developed and approved by the U.S. Food and Drug Administration and the European health ministry. But companies need time to validate and prepare production to be ready for a Covid-19 vaccine.
Shark livers are another surprising link in the supply chain for some vaccines. The shark liver oil squalene, which is mostly used in cosmetics and sunscreens, is part of a vaccine adjuvant a factor that accompanies a vaccine and amplifies its effects by giving an extra stimulus to the immune system. We should be able to repurpose squalene from the cosmetic market to aid in vaccine production, but it might be even better to use synthetic squalene. That can be produced under highly controlled conditions, but again, we need to prepare the production processes now. We dont want vaccine delivery to fail because we dont have enough shark liver oil.
Traditional vaccines work by exposing the bodys immune system to a virus that has been weakened or killed; then, when the vaccinated immune system meets the dangerous version of the virus, its been trained to fight back. Recently, entirely new types of vaccines have been developed that use DNA and mRNA. These vaccines copy pieces of the viruss genetic material and then program the bodys own cells to produce the immune-training antigens. This approach is faster and more standardized than traditional vaccines, and it has the potential to be especially safe because it doesn't involve exposing subjects to the virus.
DNA and mRNA vaccine technologies have shown promising results, and two of the leading vaccine contenders, from Pfizer Inc. and Moderna Inc., use mRNA technology. But mRNA has never been used to produce a commercial vaccine for humans, let alone at scale. And scaling these technologies may not be easy. In particular, mRNA degrades rapidly. To prevent this, it must be capped by a very rare substance called vaccinia capping enzyme.
Just over 10 pounds of this VCE is enough to produce a hundred million doses of an mRNA vaccine but the current manufacturing processes for VCE require so much bioreactor capacity that making 10 pounds would cost about $1.4 billion. More important, global bioreactor capacity cannot support production at that level while also producing other vaccines and cancer-fighting drugs.
If we work hard now, we may be able to find more efficient means of producing VCE. Expanding bioreactor production and repurposing bioreactors from existing large-scale industrial applications will also help to lessen the pressure on the supply chains for multiple types of vaccines.
Even delivering vaccines can be complicated. Vaccines made with mRNA technology must be stored at very cold temperatures, which may be especially difficult in developing countries. DNA vaccines dont need cold storage, but they require new methods of delivery such as gene guns that shoot gold bullets. We need to be developing and testing different delivery methods now.
We don't yet know which vaccine candidates will be successful. It could be the traditional vaccines, or the newer DNA and mRNA approaches, or possibly something else. We may want more than one vaccine for use in different populations the elderly, for example, might respond better to one version than another. Meanwhile, some vaccines will be more suitable for use in developing countries than others.
Because we don't know which candidates will work and because building production capacity takes time we have to shore up the supply chain for all of these different types of vaccines at once. The world economy is losing on the order of $500 billion a month due to Covid-19, so even if building out supply chains costs billions, it's a wise investment.
Of course, we might think that private companies would have incentives to coordinate supply chains themselves and to some extent, they are doing so. But many have pledged to keep their vaccine prices close to costs, both out of altruism and because they may fear public backlash (or legal action) if they're perceived as price gouging in the middle of a pandemic. And if companies dont stand to profit much from Covid-19 vaccines, then they dont have much incentive to invest in increasing capacity. In short: If prices cant rise, then the only way to encourage companies to invest more in production is to reduce their costs and that means we need public investment.
Investments in supply-chain improvements such as refining the VCE manufacturing process have aspects of a public good because they will benefit many pharmaceutical businesses at once. Public investment in those kinds of R&D is justified in normal times and even more so in todays extraordinary moment.
Supply chains failed as the pandemic began, and we can't let that happen again with vaccines. Nobody should die because poor preparation keeps us from being able to deploy lifesaving technology quickly. We have to be ready to produce billions of doses as soon as a vaccine is approved and that means we need to invest now.
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
To contact the authors of this story:Scott Duke Kominers at skominers1@bloomberg.netAlex Tabarrok at Tabarrok@gmu.edu
To contact the editor responsible for this story:Stacey Shick at sshick@bloomberg.net
Before it's here, it's on the Bloomberg Terminal.
Scott Duke Kominers is the MBA Class of 1960 Associate Professor of Business Administration at Harvard Business School, and a faculty affiliate of the Harvard Department of Economics. Previously, he was a junior fellow at the Harvard Society of Fellows and the inaugural research scholar at the Becker Friedman Institute for Research in Economics at the University of Chicago.
Alex Tabarrok is the Bartley J. Madden Chair in Economics at the Mercatus Center at George Mason University.
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The COVID-19 vaccine is on track to become the fastest-developed vaccine in history, but that doesnt mean critical steps are being skipped, Ruth Karron argues.
Ruth Karron, who leads the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, is one of the top vaccine experts in the world, serving on vaccine committees for the US Centers for Disease Control and Prevention, the World Health Organization, and the US Food and Drug Administration.
Here, she explains where things stand in the development of a COVID-19 vaccine and how that process will unfold in the months ahead:
President Donald Trump has made it abundantly clear that he thinks a Covid-19 vaccine would improve his electoral prospects, saying that a vaccine could be ready as soon as November 3 Election Day.
The Food and Drug Administration approving a vaccine by then would certainly be a monumental October surprise, one that could help speed the pandemics end and may give Trump a much-needed boost.
But as fast as vaccine development is proceeding, such a deadline is likely out of the question, according to researchers. Large-scale clinical trials for vaccines have only just started, and it will likely take months before they yield any useful information.
And although theres currently no evidence that the White House is meddling in vaccine research, some scientists still worry that the presidents public pronouncements about a vaccine especially ones so nakedly tied to his political prospects could undermine the fragile public confidence needed to deploy it successfully. If there is a perception that a Covid-19 vaccine was rushed, it could make people hesitant to get vaccinated.
[Trump has] created enough perception of political interference that there may not be deep trust in a vaccine, even if its a good product, said Nicole Lurie, who led emergency preparedness at the Department of Health and Human Services (HHS) under President Barack Obama. There is incredible public skepticism of the FDA because of whats happened with prior emergency use authorizations, and because the president appears to continue to try to mess with the system.
In March, after the president repeatedly promoted the anti-malaria drug hydroxychloroquine as a treatment for Covid-19, the FDA issued an emergency use authorization for the medicine, despite scant evidence of its effectiveness. In June, the FDA revoked this authorization.
However, according to researchers, its unlikely the FDA would do something similar for a vaccine, given the vastly higher stakes. Even getting to the point of considering emergency use for a vaccine would require vastly more information than we have now, and gathering that data requires several critical and time-consuming steps. A Covid-19 vaccine may yet be ready in record time, but its chances of that happening before the November election are miniscule.
Prior to the coronavirus, the fastest a vaccine had ever been developed was four years (for the mumps). Most vaccines have taken a decade or longer.
But with the global Covid-19 pandemic, scientists and governments have poured an unprecedented amount of money and know-how into the vaccine effort. Thats led to rapid progress.
It took researchers just over two months between the time the viruss genome was sequenced to when Phase I human vaccine trials began. There are now 10 vaccine candidates in Phase III clinical trials, the final step before a vaccine gets the green light for widespread use.
Thats why some scientists are optimistic that a vaccine could gain approval by the end of the year or early 2021.
But Phase III trials are slow and tedious. Theres little that can be done to speed them up, and theyve only just begun. Although the Russian government recently said it has a Covid-19 vaccine ready to go, other researchers have warned that the vaccine, known as Sputnik V, didnt go through this critical step and was tested in only 76 people. And even if it is a viable vaccine, it would still need to gain FDA approval before it could be used in the US, which demands more data.
Jonathan Zenilman, a professor at the Johns Hopkins University School of Medicine who has overseen clinical trials for vaccines, explained that Covid-19 Phase III trials are large, aiming to enroll 30,000 participants each. For example, Moderna, a company developing an mRNA Covid-19 vaccine, is one of the teams thats furthest along. It was the first in the US to start enrolling participants for its Phase III trial, across 89 sites.
Phase III requires recruiting participants from more diverse backgrounds compared with those in earlier testing stages in order to better represent the population at large, including people with some preexisting health conditions. (Participants are screened to ensure that they dont have conditions like immune system disorders that could cause complications with a vaccine.)
These participants also have to consent to being tracked by scientists for the duration of the trial, which is typically two years. Theyre then randomly split into groups that receive either the actual vaccine or a placebo. In a double-blind trial, neither the recipients nor the people administering the vaccine know at the outset who received the actual vaccine. That ensures participants wont change their behavior in a way that could interfere with the trial (a person who knows they have a Covid-19 vaccine could end up taking more risks, for example).
Finding tens of thousands of people who meet all of these requirements for a Phase III trial is tedious. Simply enrolling enough people is a process that can take months.
Although some Covid-19 vaccine Phase III trials began in July, none have completed the enrollment process. Moderna said it expects to finish enrolling participants in September.
After getting consent from volunteers and enrolling them in the trial, you have to give them the vaccine. Many Covid-19 vaccine candidates require two doses spaced up to four weeks apart, so just getting someone the full vaccine dose can take around a month. For most of the vaccine candidates in Phase III trials, that would take them well into, if not past, October.
Then you have to wait for people to get Covid, and you cant do anything with the data until you have a certain number of Covid cases, Zenilman said. To get a statistically meaningful result, researchers typically wait until they see around 150 infections in their group. At that point, they can break the blind and see who got the vaccine and who got the placebo and compare the numbers to see whether its working.
Right now, many places in the US are still maintaining pandemic control measures such as social distancing and mask-wearing. Such tactics help control the spread of the virus, but for a vaccine trial, they also limit how quickly research teams can get the data necessary to draw conclusions of whether the vaccine is working. Thats why researchers are aiming to test their vaccines in rising Covid-19 hot spots.
Of course, there is no guarantee that any vaccine will clear clinical trials. And the first vaccine to gain approval would not be available for widespread use right away. Health officials have to contend with the logistics of manufacturing, distributing, and administering the millions of doses needed to control the Covid-19 pandemic, which could take years.
Its also likely that no single vaccine will be suited for everyone. Several vaccines will be needed to protect different demographics, including older people, those with weaker immune systems, or those with certain preexisting health conditions. So even after the first Covid-19 vaccine gets approved, some people will still have to wait for other clinical trials to conclude.
FDA regulators are adamant that a vaccine will not be approved until it is demonstrated to be safe and effective. According to FDA guidelines, a vaccine needs to provide protection against the coronavirus for at least 50 percent of the people who get it. The safety benchmarks are higher for vaccines than for other drugs because vaccines are given to vastly more people, which magnifies infrequent problems. And since vaccines are given to healthy people rather than those who are already sick, there is a lower tolerance for side effects.
But at the same time, the HHS launched the $10 billion Operation Warp Speed in June with the explicit aim of delivering 300 million doses of a Covid-19 vaccine by January 2021.
In an August 7 editorial in JAMA, FDA Commissioner Stephen Hahn acknowledged the tension between the need for speed and the need to hew closely to established rules.
Hahn and his coauthors Anand Shah and Peter Marks wrote that the emphasis on speed has provoked public anxiety about the safety and effectiveness of vaccines developed on expedited timelines. Among the concerns are that the regulatory standards for approval will be lowered under political pressure for a vaccine.
However, Hahn and his coauthors also wrote that there is a line separating the governments efforts to focus resources and funding to scale vaccine development from FDAs review processes. In other words, the FDA says it will not compromise its standards for approving a vaccine, despite pressure for faster results.
But what about the emergency use authorization (EUA) process? Could the FDA create a limited exception for a vaccine like it did with hydroxychloroquine?
Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA (the body that governs vaccine approval), said the agency could do that, in theory. But as with the agencys standard process, the rubric is stricter for a vaccine than for a drug, and regulators would still need to see data demonstrating that a vaccine meets the minimum benchmark of preventing infection in 50 percent of people who have been vaccinated.
I think as we think about EUA here, the calculus for a vaccine is going to be different than the calculus for therapeutic, Marks told reporters at the National Press Foundation on August 12. I think we ... optimally would like to see the data thats from a trial thats reached its efficacy endpoint.
That would come near the end of a Phase III trial, which, again, is unlikely to yield results for months. So there may not be enough evidence to warrant vaccine approval before the November election, even on an emergency basis.
And if there were political meddling to push out a vaccine before its ready, in spite of all these constraints, there would be strong opposition among the career scientists at the FDA. I think you would see a revolt at the agency, Zenilman said.
A vaccine cant end the Covid-19 pandemic on its own. It has to be given to enough people to achieve herd immunity, at which point a large enough percentage of a population is protected against the virus so that it cant easily spread.
Even in the most ideal scenario with a highly effective vaccine, getting to herd immunity would require immunizing millions of people. And already, many in the United States are saying they wouldnt get vaccinated. A Gallup poll conducted July 20 to August 7 found that one-third of Americans said they would not get an approved Covid-19 vaccine if it were ready immediately. A CNN poll conducted August 12-15 found that 56 percent of Americans said they would get a vaccine, a decline from 66 percent in May.
Whether due to general hesitancy around vaccines or swirling conspiracy theories, public health researchers are concerned that if enough people dont elect to get immunized, the Covid-19 pandemic will persist.
Thats why even the appearance that political considerations influenced vaccine approval could be dangerous.
The perception of political pressure and the perception of things being hurried really risks trust, said Jesse Goodman, a former chief scientist at the FDA whos now a professor of medicine at Georgetown University. Its not just trust in this Covid vaccine, but trust in the whole public health response to Covid and trust in vaccines in general.
Restoring that trust will take time. It will require transparency about the progress and results of clinical trials, as well as how decisions are made in federal agencies. It will also demand clear and coherent messaging.
But even that might not be enough.
Personally, I think it will take a new president and new leadership at the top of the FDA before were going to be at a point where the public can start to have more trust, said Lurie.
Which means that even with the urgency of thousands of people dying, taking the time to get a vaccine right is critical from the vaccine itself to how its tested, documented, communicated, and administered. Rushing will likely only cost us more time.
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You can work from home without feeling so isolated. Here are some great ways to stay connected with your team. USA TODAY
Florida, one of the hardest hit states from the coronavirus, just registered its 10,000th death due to COVID-19.
It came after the state recorded 174 new deaths Wednesday, giving it a total that's fifth highest among states around the country. It has recorded more than 584,000 cases of COVID-19 so far.
The virus, meanwhile, continues to play havoc with colleges' attempts to reopen classes.
A day after officials at University of North Carolina at Chapel Hill decided to pivot to online classes afterat least four clusters of outbreaks in student living spaces, North Carolina State University reported its firstcluster of positive cases in off-campus housing.Also Tuesday, the University of Notre Dame said it was movingto online classes for two weeks in hopes that infections won't surge.
And sports fans who thought they could get a break from the coronavirus fallout can't catch a break: new NFL rules will keep mascots and cheerleaders -- as well as sideline reporters -- off the field.
Some significant developments:
Today's numbers:The U.S. has 5.4million confirmed infections and more than 171,000 deaths. Worldwide, there have been more than 781,000deaths and 22.1 million cases, according toJohn Hopkins University data.
What we're reading:Wearing a mask inpublic restrooms should be mandatory during thepandemic, researchers say, because there'sincreasing evidence that flushingtoilets and now urinals can release inhalable coronavirus particles into the air.
This file will be updated throughout the day. For updates in your inbox,subscribe to the Daily Briefing.
Tourists visiting The Strip could befueling the pandemic,according to a ProPublica investigation. An analysis of smartphone data during four days,a Friday to Monday in mid-July,revealed how most of theU.S.is connected to Las Vegas a likely hot spot of COVID-19 spread.
During that time frame, about 26,000 devices were identified on The Strip, according to data mined by the companiesX-ModeandTectonix. Some of those smartphones thentraveled to every state on the mainland except Maine.
Heres a look at where those devices ended up during thosesame four days, according to Propublica:
The cellphone analysis highlights a reason the virus keeps spreading and shows how travel to Las Vegas could be fueling the pandemic, according to health officials.
Ed Komenda, Reno Gazette Journal
Just 48 hours after saying a COVID-19 outbreak on campuswouldn't affect plans to play football this fall, the University of North Carolina has suspended all athletic activities through at least Thursday afternoon. In addition, all recreational facilities on the Chapel Hill campus willbe closed to students, coaches and staff.
"After consulting with our health experts and University leadership, we are taking this action to protect our students, coaches and staff,''UNC athletics director Bubba Cunningham said. "We want to make sure we continue to do everything we can to ensure that that our teams, campus and community remain healthy.''
The school welcomed students back to campus for in-person classes last week, butafter at least four clusters of COVID-19 outbreaks,university officials reversed course and moved all classes online.
Steve Gardner
Georgia Gov. Brian Kemp defended his administrations handling of the coronavirus pandemic in fiery remarks Wednesday after a report from the White House coronavirus task force said Georgia led the nation last week in new cases per capita.
The White House report, dated Aug. 16, recommends several steps to curb the virus that Kemp has declined to take, including closing bars and issuing mask mandates in counties with 50 or more active cases.
Kemp was among the first governors to ease earlier restrictions this spring, and while infections declined for weeks afterwards, they began to rise in June and peaked in late July.
First reported by the Atlanta Journal-Constitution, the report says Georgias small gains are fragile and statewide progress will require continued, expanded, and stronger mitigation efforts, including in all open schools.
Kemp insisted Wednesday that other markers hes watching paint a different picture.
Associated Press
Puerto Ricos governor announced Wednesday that she will place the U.S. territory on a 24-hour lockdown every Sunday as part of stricter measures to fight a spike in coronavirus cases.
Gyms, theaters and bars will remain closed and only restaurants with outdoor areas will be allowed to seat people, but at 25% capacity. Gov. Wanda Vzquez said violators will be shut down for a month.
In addition, beaches will remain open only to those doing exercise such as runners and surfers, and businesses, malls and banks will be allowed to operate at only 25% capacity.
The new measures go into effect Saturday and will remain in place until Sept. 11. Face masks remain mandatory.
We have to adjust to living in a new reality, Vzquez said, blaming the jump in cases on careless people.
Associated Press
Cheerleaders and mascots will not be allowed to be on the field during NFL games this season.
The league-wide policy was part of new protocols unveiled Wednesday in conjunction with the NFL Players Association, a person familiar with the decision told USA TODAY Sports' Jarrett Bell. The person spoke on condition of anonymity because they were not authorized to speak publicly on the matter.
Previously, some of these decisions were being left to individual teams.
Sideline reporters and pregame panelists also will not be allowed on the field level, per the agreement.
Michael Middlehurst-Schwartz
A new study casts doubt on whether a virus can be transmitted by breast milk.
The study found only one of 64 samples of breast milk from 18 women in the U.S. who had become infected with the virustested positive. Further tests found that the virus couldn't replicate, making it unable to potentially infect a breast-fed infant.
The study by was conducted jointly by researchers at the University of California campuses in San Diego and Los Angeles and the results were published Wednesday in the online edition of the medical journal JAMA.
We hope our results and future studies will give women the reassurance needed for them to breastfeed. Human milk provides invaluable benefits to mom and baby, said Dr. Grace Aldrovandi, co-principal investigator of the study and chief of the Division of Infectious Diseases at UCLA Mattel Childrens Hospital.
Chinese government officials were involved in a coverup about the coronavirus, but not at the national level, says a U.S. intelligence report obtained by the New York Times.
Officials in the Wuhan and Hubei provinces in central China, where the virus first appeared, attempted to keep China's central leadership in Beijing from knowing key information about the early outbreak, concludes the report compiled by several U.S. intelligence agencies, including the CIA. Local officials feared reprisal from the central government.
The report, prepared in June with a mix of classified and unclassified data, backs the overall view that Communist Party officials hid important information from the World Heath Organization even as they sought to get details on the outbreak themselves from recalcitrant local officials.
President Donald Trump has repeatedly accused China of a coverup, alleging the virus could have been stopped much faster if it had been more forthcoming.
Deaths in Florida from the coronavirus surpassed 10,000, while teachers and state officials argued in court over whether in-person schools should reopen this month.
Florida reported 174 deaths on Wednesday, bringing the total confirmed deaths to at least 10,067 the fifth-highest death toll in the nation. The state reported an additional 4,115 confirmed coronavirus cases, bringing the total to 584,047. The positivity rate for coronavirus testing in Florida has averaged about 11.4% during the past week.
There were 5,351 patients being treated for the disease in Florida hospitals on Wednesday, down from peaks above 9,500 patients in late July.
Meanwhile, Floridas largest teachers union is seeking an injunction from a judge in Tallahassee to stop schools from reopening by this Friday.
Associated Press
Dreamed of actually snagging tickets to screenings at a major film festival? Because of the coronavirus pandemic, you make be able to see the films from your living room.
The festivals are where critics and insiders get early peeks at movies either slated for theaters or those hoping to receive the kind of breakout attention that will get them there. Because of the virus, the festivals have gone virtual streamed to living rooms.
The New York Film Festival is kicking off Sept. 25 with an opening night featuring Steve McQueens Lovers Rock, and will premiere two other of the Black filmmakers works, Mangrove and Red, White and Blue, part of the same anthology. Also on tap: Chloe Zhaos anticipated Nomadland with Frances McDormand, Sam Pollards documentary MLK/FBI, and the documentary Time, about a woman trying to get her husband released from his 60-year prison sentence.
Jeff Friday, founder of the American Black Film Festival, which runs through Aug. 30, has already seen the positives of making the move to virtual. Usually, 10,000 film fans show up for his annual June event in Miami; this year, he's predicting 200,000 people interested in streaming more than 90 films celebrating Black cinema, as well as panel discussions featuring Oscar-winning filmmaker Barry Jenkins, Candyman director Nia DaCosta, Mary J. Blige, Lena Waithe and Gabrielle Union.
Brian Truitt
Bars that cater to members of the LGBTQ community are not just bars: they serve as community hubs and safe spaces for lesbian, gay, bisexual, transgender and queer folks.So when they had to shut down due to the coronavirus pandemic in mid-March, those spaces were lost. Fighting back, some have launched crowdfunding campaigns to stay afloat until they are full back in business.
The owner of Harlem's Alibi Lounge, one of the only Black-owned LGBTQ bars in New York City, unveiled a campaign in May that has raised more than $166,000 and counting.
Julius Bar part of the National Register of Historic Places, the oldest gay bar in New York City and one of the oldest continually operating bars in the city overall has raised more than $97,000 via a GoFundMe campaign since early July.Its Greenwich Village neighbor, the Stonewall Inn, has raised more than $320,000 on the platform.
When, all of a sudden, a pandemic like COVID-19 tells you that you have to isolate, that you have to stay home and if you go to a bar, you go to a restaurant, you could be at a high risk to be exposed to the virus, it makes people not even think twice," said Alibi Lounge owner Alexi Minko. "They decide, Well, in that case I am not going to a bar, Im not going to a restaurant until I know that its safer.
Alex Biese, Asbury Park Press
Many furloughed workers were not being immediately called to report back to duty, a new study finds.In an analysis of its small business clients, payroll service Gusto found that only 37% of workers who were initially furloughed in March and 47% of those who were furloughed in April had returned to their jobs by July. Furthermore, among those furloughed in March who were able to go back to work, nearly 25% had their wages reduced.
Furloughed workers are counted as unemployed when determining the jobless rate, which means the fate of those still in limbo could drive unemployment up or down in the coming months.
Since April, the jobless rate has slowly declined, but if a large number of furloughed workers are able to return to their employers, we could see those numbers drop even more. That would spell good news for an economy that's stuck in a recession. On the other hand, a large chunk of furloughed workers could be permanently laid off in the coming months, too.
Maurie Backman, The Motley Fool
Pharmacists in all 50 states are now allowed to give childhood vaccinations under a new directive aimed at preventing future outbreaks of measles and other preventable diseases.
Alex Azar, the head of the U.S. Department of Health and Human Services, took the step using emergency powers he has during the coronavirus epidemic, which was declared a public health emergency.The directive announced Wednesday will temporarily preempt restrictions in 22 states starting this fall.
The move is designed to help prevent vaccination rates from falling during the pandemic, Azar said.
Separately, Massachusetts officials announced Wednesday that they will require flu vaccinations for all students, from child care to college. The vaccinations are required by Dec.31. Home-schooled students and those who are studying entirely remotely are exempted.
Associated Press
The New York Police Department announced its created a task force specifically to deal with a rise in hate crimes against Asian Americans during the coronavirus pandemic.
There have been 21 reported anti-Asian hate crimes leading to 17 arrests since March around the time the pandemic intensified in the United States, whichChief of Detectives Rodney Harrison told reporters is higher than normal Tuesday.
"Thisincrease was cultivated due to the anti-Asian rhetoric about the virus that was publicized and individuals began to attack Asian New Yorkers either verbal attack or physical assault," Harrison said. "We saw a spike in every borough throughout the city."
N'dea Yancey-Bragg
A patron who spent hours inside a bar during the Sturgis motorcycle rally in South Dakota, which ended last Sunday, has tested positive for COVID-19, health officials confirmed.
The person spent nearly six hours atOne-Eyed Jacks Saloon on Aug. 11. State officials are encouraging anyone at the bar to monitor themselves for any symptoms of the coronavirus.
The 2020 Rally drew more than 460,000 vehicles during the 10-day event, according to a count South Dakota transportation officials released Tuesday. The event was scaled down, but face coverings were not required during the event.
Michael Klinski, Sioux Falls Argus Leader
Pope Francis on Wednesday cautioned against prioritizing future coronavirus vaccines based on wealth. Deviating fromhis plannedweekly public address, he said that "we must come out better" from the COVID-19 pandemic.
How sad it would be if for the COVID-19 vaccine priority is given to the richest," he said. The pandemic has laid bare the difficult situation of the poor and the great inequality that reigns in the world."
The pontiff added that the vaccine should be "universal and for all," rather than "the property of this nation or another," not naming any countries in particular.
At least two dozen Maine residents tested positive for COVID-19 after a wedding reception in rural Maine the states first outbreak linked to a social gathering.
About 65 people attended theindoor event at the Big Moose Inn in Millinocket, said Maine CDC spokesman Robert Long. About 18 people in attendance and around 10others who came into contact with attendees all tested positive, according to WABI-TV in Bangor, Maine.
The owner of the Big Moose Inn could face a $10,000 fine if the state's executive orders limiting group gatherings to 50 were violated, officials said.
R-0 may be the most important scientific term youve never heard of when it comes to stopping the coronavirus pandemic. USA TODAY
During the pandemic, people are talking a lot about children missing classes, graduations and proms. What has received far less attention, child development experts say, is the impact the pandemic is having on the youngest children: babies, toddlers, preschoolers, kindergartners.
Birth to age five is a critical time for child development, research shows, and new data from the Rapid Assessment of Pandemic Impact on Development Early Childhood Household Survey Project (RAPID-EC Project) shows caregiver distress is cascading down to young children in ways science shows can be toxic in the short- and long-term.
The project has been conducting weekly surveys since April and has found caregivers of young children are experiencing distress, material hardship and loss of emotional supports. Since the project's data is sequential, it also is able to show a chain reaction. When a family is stressed about meeting basic needs, the next week they report more emotional distress, and the week after report increases in their child's emotional distress.
"if you can't buy food or you can't pay your rent, that you are experiencing the kind of stress that is going to be toxic to your children,"said RAPID project director Phil Fisher.
Alia E. Dastagir
Nearly 80 teachers in Utah's Salt Lake County have resigned or retired as in-person classes are set to resume at schools this year, the Salt Late Tribune reported.
The Tribune tallied 79 teachers who left their posts due to concerns about COVID-19. At least 16 of the resignations came in the last week, the newspaper reported.
Salt Lake County has the highest number of virus cases in the state, and teachers leaving the classroom told the newspaper that they'd rather resign or retire now than return in the fall, risking their own health or the health of their students.
Were just being told to jump in like nothing is wrong, Jan Roberts, a teacher of32 years who just retired, told the Tribune. Its not OK.
Health officials have identified a COVID-19 cluster at another North Carolina university.
A statement from North Carolina State University confirmed on Tuesday that Wake County health officials identified of COVID-19 cases at off-campus housing east of the Raleigh, North Carolina, campus.
The school said several people who have tested positive as part of this cluster have been identified, including some who are N.C. State students. Contact tracing has been initiated with direct communication to anyone known to have been in close contact with a person who has tested positive for COVID-19, according to the school.
The school said reports indicated a party or some type of gathering was hosted at the location on or around Aug. 6. The notice said it was not known how many people were at the gathering, but encouraged anyone who attended to visit their personal healthcare provider or Student Health Services.
Switching from in-person to online schooling has been hard on many families and on their budgets.
About one-quarter of parents say theyve gone into debt to pay for their kids at-home school expenses, and many blame the cost of their kids breakfasts and lunches when they switched to learning remotely from home.
A survey from Credit Karma examines how this school year could affect household finances. More than half of parents say they expect to spend slightly to significantly more on school supplies, the survey of more than 1,000 parents found.
The reasons for the debt are higher grocery prices and the sudden switch to at-home schooling in March.
Secured additional funding for Covid-19 testing and back-up drug discovery
LEIDEN, Netherlands, Aug. 20, 2020 /PRNewswire/ -- Hercules Pharmaceuticals, a Dutch biopharmaceutical company focusing on developing small molecule inhibitors of the Aryl Hydrocarbon Receptor (AhR) for treatment of cancer and viral infections, today announced the publication of promising preclinical in-vivo trial results, showing efficacy of its Aryl Hydrocarbon Receptor (AhR) inhibitor HP163 against Zika virus infection and potentially against Corona-virus infection. On top of this, the company secured new funding to test the efficacy of the compound against Covid-19 and to generate back-up AhR inhibitors.
A recent publication in Nature Neurosciencereported that Hercules' AhR inhibitor HP163 reduces viral replication in animals infected with Zika-virus and reduced microencephaly. In-vitro studies also showed efficacy of AhR inhibitors against Dengue, a related virus.
In addition, a pre-publication of an article onResearch Squareconcludes that AhR inhibition may also be effective against Covid-19 and other corona virus infections via a similar mechanism.
It was found that virus infection triggers AHR activation, limiting the production of type I interferons (IFN-I), involved in antiviral immunity. Moreover, AHR activation suppressed intrinsic anti-viral immunity driven by the promyelocytic leukemia (PML) protein, resulting in increased viral replication. AHR inhibition with Hercules' HP163 blocked Zika virus replication and ameliorated newborn microcephaly in a murine model.
Successful development of AhR inhibitors could lead to oral treatment of patients with early stages of virus infection.
New funding by Pharma Connect Capital
Hercules will further investigate the potential of its AhR-inhibitors for treatment of Covid-19 infections and will generate additional novel AhR inhibitors for both anti-viral and cancer treatment. To fund this program, Hercules has received an investment from Groningen based Pharma Connect Capital and a grant from SNN (Samenwerkingsverband Noord Nederland). As part of the investment, Hercules will relocate to Groningen.
Bart Wuurman, CEO of Hercules Pharmaceuticals, comments:
"We are excited by the novel finding that the Aryl Hydrocarbon Receptor acts as a host factor for viral infections to allow viral replication. A remedy is urgently needed to treat zika and dengue infection, but mentioned studies also suggest that AhR inhibitors might be an effective oral treatment of patients with Covid-19, the virus which is holding our daily life hostage at this moment."
About Zika and Dengue
Zika virus is spread by mosquitoes and is related to dengue, yellow fever, Japanese encephalitis, and West Nile viruses. Zika can spread from a pregnant woman to her baby. This can result in microcephaly, severe brain malformations, and other birth defects.
Dengue fever is also a mosquito-borne tropical disease caused by the dengue virus. Symptoms may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic skin rash. In some cases, the disease develops into severe dengue, also known as dengue hemorrhagic fever, or into dengue shock syndrome. About 390million people are infected each year and approximately 40,000 die.
About Hercules Pharmaceuticals
Hercules Pharmaceuticals is a Dutch private biopharmaceutical company, focusing on developing small molecule inhibitors of the Aryl Hydrocarbon Receptor (AhR) for treatment of cancer and viral infections. AhR-inhibitors are known for enhancing anti-cancer immunity in the tumor microenvironment, and several AhR inhibitors are in clinical development for treatment of solid tumors. Founder and Chief Scientific Officer of Hercules, Professor David Sherr is a key opinion leader in immunology related to the Aryl Hydrocarbon Receptor, based in Boston.
About Pharma Connect Capital
Pharma Connect Capital B.V. (www.pharmaconnectcapital.com) is an investment fund that finances early stage drug development. The fund is an initiative of Investerings Fonds Groningen, University Medical Center Groningen and the Noordelijke Ontwikkelings Maatschappij (NOM) and was launched in October 2017.
Contact:For more informationBart Wuurman, CEO bart.wuurman@hercules-pharma.nlGalileiweg 8, 3222BD Leiden, The NetherlandsMob: +31-64-66-23-735www.hercules-pharma.nl
LifeSpring Life Sciences Communication, Amsterdam, the NetherlandsLeon MelensT: +31-6-538-16-427E: lmelens@lifespring.nl
View original content:http://www.prnewswire.com/news-releases/hercules-ahr-inhibitor-hp163-blocks-viral-replication-in-zika-infection-and-potentially-in-covid-19-301115210.html
SOURCE Hercules Pharmaceuticals
Last week, Russia became the first country in the world to license a coronavirus vaccine when President Vladimir Putin announced its approval. But the vaccine has not yet passed the advanced trials normally required to prove it works before being licensed, a major breach of scientific protocol.
MADISON, Wis. (AP) With more positive coronavirus cases in Wisconsin linked to parties and other gatherings, state health officials on Wednesday released a new tool that people can use to measure risk levels of different activities.
Positive COVID-19 cases tied to mass gatherings grew from 7% of cases in May to 21% in June and 20% in July, the state Department of Health Services said. Overall, nearly 67,500 people have tested positive in Wisconsin with 1,060 deaths.
That death count is the 28th highest in the country overall and the 37th highest per capita at 18 deaths per 100,000 people. Over the past two weeks, the rolling average number of daily new cases has decreased by 209, a decrease of 25%. There were 174 new cases per 100,000 people in Wisconsin over the past two weeks, which ranks 24th in the country for new cases per capita.
The tool unveiled Wednesday allows people to answer a series of questions to determine the risk of certain behaviors, like who will be gathering, where will people be getting together and how widespread is COVID-19 in the area.
The state health department also released guidelines for school districts to follow in preventing, investigation and controlling COVID-19 outbreaks. The guidelines include instructions for school staff in identifying cases and close contacts among students as well as best practices for isolation and quarantine of infected students and staff.
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The coronavirus crept into Heartland Health Care Center, a nursing home in Moline, Ill., on the last day of July, when a member of the nursing staff tested positive.
It was an ominous sign: The virus can spread through a nursing home in a flash. Older people who are often sick and frail and need regular hands-on attention are uniquely susceptible. Staff members who care for residents are at high risk of infection and of unintentionally spreading the virus.
Although nursing home residents make up just 1.2 percent of the United States population, they account for about 40 percent of Covid-19 deaths.
But this time, the nursing home was not defenseless. Heartland was the first facility to participate in a large clinical trial of drug that might protect residents from the infection in nursing homes and assisted living facilities.
Drug companies and the federal government often avoid testing drugs in older people, even if they are the ones who need treatment most. The elderly may have a range of complicating conditions that make difficult to tell if the drug is working, and nursing home and extended care facilities are governed by a raft of complex regulations regarding privacy and access.
Experts say the new research, sponsored by Eli Lilly and the National Institutes of Health, is among the first large clinical trials to involve nursing home residents. And the scientists are delighted.
These patients are so underserved, said Dr. Rebecca Boxer, medical director of clinical trials at the Kaiser Permanentes Institute for Health Research in Colorado. They do not get access to innovative new drugs and trials.
The experimental drug is a monoclonal antibody, an artificially synthesized version of coronavirus antibodies produced by the body. In this case, the antibody was cloned from those found in the blood of a Seattle man, one of the first patients to survive Covid-19, the illness caused by the coronavirus.
Monoclonal antibodies are one of the great hopes in the war on the coronavirus. They already serve as the basis for effective treatments for arthritis, cancer, lupus even Ebola. They are difficult to manufacture, however, and expensive.
Despite the obstacles, two companies, Regeneron and Eli Lilly, have forged ahead with clinical trials. The trial in nursing homes is pivotal to Eli Lillys effort to determine whether its version can stop the coronavirus.
Some people ask, If we have a vaccine, why do this? said Dr. Myron Cohen, a University of North Carolina researcher who proposed the trial. But a vaccine will take a month to produce antibodies, and some populations need a more emergent intervention.
But it is not easy to do a trial in nursing homes. Because the residents cannot be expected to travel to a clinic for an infusion and subsequent testing and monitoring, the clinical trial must to come to them.
Eli Lillys researchers are watching facilities in which a single case of Covid-19 appears after having no active cases for at least 14 days. Once the case is reported, a sort of medical SWAT team scrambles to the facility as quickly as possible.
A nursing supervisor at Heartland called Eli Lilly as soon as the home learned of the employees positive test. The team wasted no time getting to the facility.
The next day, medical personnel pulled up in two vehicles. One was a moving truck carrying infusion chairs, poles for intravenous infusions, bedside tables, and privacy screens. The other was an R.V. with an interior retrofitted as a mobile lab with infusion materials, a centrifuge, freezers and computers to transmit data.
The team quickly turned Heartlands large dining room which was not being used, because the pandemic had put a stop to communal dining into an infusion center. The day after the medical team arrived, the first residents and staff who agreed to participate received infusions.
Participants are randomly assigned to receive one of two infusions: a placebo, or the monoclonal antibody, designed to latch onto the virus and to block it from entering and infecting cells. At Heartland, 25 of the 80 residents who were approached eventually agreed to join the trial.
The drug should remain in participants bodies for at least a month, and possibly as long as three months, the researchers say. Participants and doctors do not know who is getting the antibody and who is not.
Its a little daunting from the patients standpoint, said Dr. Mark Gloth, chief medical officer at ProMedica Senior Care/HCR ManorCare, a nationwide chain of 222 nursing homes and long-term care facilities, including Heartland.
We have been restricting visitors for months. Some family members say, I cant even get in there and hold my loved ones hand. I want to be sure its OK with them.
Lee Rouland, 45, was in the nursing home recovering from a serious pressure sore when he was asked if he wanted to join the study. He readily agreed.
A paraplegic since falling from a fire escape when he was 22, Mr. Rouland was unable to leave his room because he cannot sit in his wheelchair. So the investigators came to him. The infusion took an hour.
For the next two hours, the team monitored Mr. Roulands vital signs: heart rate, blood pressure, blood oxygen levels. Because he cannot easily travel to a lab for subsequent tests, investigators plan to visit to his home once he leaves Heartland.
Hes worried, of course. If he got the drug, it might cause adverse reactions. But somebody has to go first, Mr. Rouland said.
The study is being undertaken at nursing homes and extended care facilities across the United States and will enroll 2,400 residents and staff. Eli Lilly hopes to enlist 500 facilities so far, about 125 have agreed to join the study and the company anticipates enrolling 40 to 80 participants at each site.
Updated August 17, 2020
There are obvious advantages to testing the drug in nursing homes. Residents are all in one place, making it easy to do contact tracing. And the rocket pace of a nursing home outbreak makes it easier to see if the coronavirus can be halted with this drug.
Monoclonal antibodies are difficult to make. The drug, if it works, is expected to be expensive an infusion of a monoclonal antibody can cost thousands of dollars. Eli Lilly has not announced what it will charge for the drug if it is approved for marketing.
There is no guarantee of success, and previous attempts to do studies in nursing homes have fallen short. Nursing home residents can be difficult participants: Many have dementia, or have difficulty seeing and hearing. Yet they or, in some cases, someone designated to make decisions for them, must provide informed consent.
Informed consent is very scripted and can be incredibly challenging, especially with an infused experimental drug, Dr. Boxer said. Potential participants have to read and understand a form that explains the risks and the adverse side effects that can occur.
Then, she said, participants usually have to repeat back in their own words what they are being asked to do. The people soliciting informed consent most often are not nursing home staff, since they have to be credentialed by an ethics board that approved the study.
Yet they need to understand the limitations of working with the very old and disabled, Dr. Boxer said.
Often, residents will want someone else to sign the consent form for them, but states have varying regulations governing who may be authorized. Some residents with dementia might agree one day but forget the next that they agreed to take part, and then reverse their decision.
Nursing homes are very protective of patient privacy. But research regulations allow investigators, in some circumstances, to review patients medical records to identify patients who might be eligible for a study.
There just isnt a culture in nursing homes that is attuned to doing research and clinical trials, said Dr. Mathew Wynia, director of the Center for Bioethics and Humanities at the University of Colorado.
When Dr. Cohen, who is working with the National Institute of Allergy and Infectious Diseases to run clinical trials of antibodies, thought of the nursing home trial, he began calling chief executives of nursing home chains.
At the end of the calls, I was really shaken up, he said. They explained the unbelievable suffering of clients and families.
Residents who were infected were dying alone, no visitors allowed, he learned. Staff members were falling ill. Nursing home executives were eager to participate in the study.
In Citrus Heights, Calif., a staff member at a nursing home tested positive earlier this month. The moving van and R.V. appeared the next day, and Katy Tenner, 37, a staff dietitian, was among those who volunteered for the study.
The infusion and monitoring took so long she had to get the treatment on her day off. Every day for the next 56 days, she has to have her vital signs checked. Every week she has to have a coronavirus test.
But she is excited about the study. So often, she said, she drives home from work, listening to news on the radio and bawling my eyes out, hearing about my fellow health care workers dying from this virus.
This could be a weapon to fight it and maybe outsmart it, she said.
