AUSTIN, Texas The experimental vaccine against SARS-CoV-2 that was the first to enter human trials in the United States has been shown to elicit neutralizing antibodies and a helpful T-cell response with the aid of a carefully engineered spike protein that mimics the infection-spreading part of the virus.
The latest paper about a Moderna-NIH vaccine that recently entered phase 3 human trials was published today in the journal Nature; its leading authors are Barney Graham and Kizzmekia Corbett at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center, part of the National Institutes of Health, and Andrea Carfi of biotech company Moderna. It describes both preclinical results and important protein engineering led by a team at The University of Texas at Austin.
The paper describes in part work to stabilize an otherwise-shifting part of the virus: the protein that fuses with and infects cells, called the spike protein. Earlier research into coronaviruses was critical for the fastest-ever progression from virus genome sequencing to vaccine testing in humans, which took only 66 days.
Several things were key for rapid vaccine development, including understanding the precise atomic-level structure of the spike protein and how to stabilize it, said UT Austin associate professor of molecular biosciences Jason McLellan, an author on the paper. As fast as this all happened, the development was possible because of years of earlier research.
The members of the NIAID team and McLellan laboratory at UT Austin announced earlier this year that they had mapped the molecular structure of a stabilized spike protein within weeks of receiving the genetic sequence, publishing the structure of the SARS-CoV-2 spike protein in the journalScience. NIAID and the biotechnology company Moderna, based in Cambridge, Massachusetts, worked to develop a messenger RNA (mRNA) vaccine, which, according to the NIH, directs the bodys cells to express the spike in its prefusion conformation to elicit an immune response.Todays paper describes findings that the vaccine keeps infection from spreading into the airways of mice, produces neutralizing antibodies and prompts a response in immune cells called memory T-cells.
The stabilized spike protein, known as the S-2P protein, also features in several other coronavirus vaccines currently in clinical trials.
The SARS-CoV-2 spike protein is a shape-shifter, changing its structure before and after fusing with cells. The immune system responds best when the spike protein is in its prefusion shape, so McLellans team reengineered the proteinin two key places to lock it into that shape.
McLellans postdoctoral researcher Nianshuang Wang had identified genetic mutations necessary to stabilize the shape-shifting spike protein for MERS-CoV back in 2017, and the team found the same tactic works with the new coronavirus. Using small genetic modifications to the gene sequence that encodes for the protein, the researchers essentially make part of the spring-loaded portion of the molecule more rigid, preventing it from rearranging.
Instead of a painful process of trial and error, the researchers designed the necessary mutations within about a day of receiving the SARS-CoV-2 virus genome. The McLellan lab completed the atomic-level structure, and graduate student Daniel Wrapp harvested and purified the spike protein. Soon after, Corbett and Graham at the NIAID verified that the S-2P protein generated potent antibodies in mice.
Scientists at UT Austin, NIAID, Moderna, the University of North Carolina at Chapel Hill and Vanderbilt University Medical Center in Nashville, Tennessee co-authored the Nature study.
Funding for the research came from by the National Institutes of Health and the Department of Health and Human Services.
The University of Texas at Austin is committed to transparency and disclosure of all potential conflicts of interest. The authors submitted required financial disclosure forms with the university and hold intellectual property rights that may yield revenue from discoveriesdescribed in this research.
News Release
Wednesday, August 5, 2020
Collaborative network to enlist medical imaging and clinical data sciences to reveal unique features of COVID-19.
The National Institutes of Health has launched the Medical Imaging and Data Resource Center (MIDRC), an ambitious effort that will harness the power of artificial intelligence and medical imaging to fight COVID-19. The multi-institutional collaboration, led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of NIH, will create new tools that physicians can use for early detection and personalized therapies for COVID-19 patients.
This program is particularly exciting because it will give us new ways to rapidly turn scientific findings into practical imaging tools that benefit COVID-19 patients, said Bruce J. Tromberg, Ph.D., NIBIB Director. It unites leaders in medical imaging and artificial intelligence from academia, professional societies, industry, and government to take on this important challenge.
The features of infected lungs and hearts seen on medical images can help assess disease severity, predict response to treatment, and improve patient outcomes. However, a major challenge is to rapidly and accurately identify these signatures and evaluate this information in combination with many other clinical symptoms and tests. The MIDRC goals are to lead the development and implementation of new diagnostics, including machine learning algorithms, that will allow rapid and accurate assessment of disease status and help physicians optimize patient treatment.
This effort will gather a large repository of COVID-19 chest images, explained Guoying Liu, Ph.D., the NIBIB scientific program lead on this effort, allowing researchers to evaluate both lung and cardiac tissue data, ask critical research questions, and develop predictive COVID-19 imaging signatures that can be delivered to healthcare providers.
Maryellen L. Giger, PhD, the A.N. Pritzker Professor of Radiology, Committee on Medical Physics at the University of Chicago, is leading the effort, which includes co-Investigators Etta Pisano, MD, and Michael Tilkin, MS, from the American College of Radiology (ACR), Curtis Langlotz, MD, PhD, and Adam Flanders, MD, representing the Radiological Society of North America (RSNA), and Paul Kinahan, PhD, from the American Association of Physicists in Medicine (AAPM).
This major initiative responds to the international imaging communitys expressed unmet need for a secure technological network to enable the development and ethical application of artificial intelligence to make the best medical decisions for COVID-19 patients, added Krishna Kandarpa, M.D., Ph.D., director of research sciences and strategic directions at NIBIB. Eventually, the approaches developed could benefit other conditions as well.
The MIDRC will facilitate rapid and flexible collection, analysis, and dissemination of imaging and associated clinical data. Collaboration among the ACR, RSNA, and AAPM is based on each organizations unique and complementary expertise within the medical imaging community, and each organizations dedication to imaging data quality, security, access, and sustainability.
About the National Institute of Biomedical Imaging and Bioengineering (NIBIB):NIBIBs mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating engineering and physical science with biology and medicine to advance our understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB supports emerging technology research and development within its internal laboratories and through grants, collaborations, and training. More information is available at the NIBIB websitehttps://www.nibib.nih.gov.
About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIHTurning Discovery Into Health
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MUSKEGON, MI A man whose long prison sentence on marijuana charges gained widespread attention after Michigan legalized the drug is hospitalized with COVID-19, one of more than 150 at the Muskegon Correctional Facility to have contracted the illness in the last week.
Flint native Michael Alonzo Thompson, now 69, was sentenced to 40 to 60 years on charges related to the sale of 3 pounds of marijuana to an undercover officer in 1996. He was brought to Duane L. Waters Hospital, inside the Michigan State Prison, in Jackson, last week, his attorney, his daughter, and a legal advocacy organization each confirmed to MLive.
I knew something was wrong the last time I talked to him. His voice didnt sound right, said his daughter, Rashawnda Littles.
Thompson contracted the virus months after advocates filed a clemency petition on his behalf, arguing that his punishment outweighed his crime, especially after Michigan legalized the substance that he was convicted of dealing.
They also argued that Thompson has maintained a near-perfect record throughout his 25 years of incarceration, indicating that he would not be a threat to society if released.
In an interview with MLive, Littles described a Navy veteran and family man who once received the key to the city of Flint for his efforts to disrupt gang violence.
I dont want my father to be a story, she said. I want him to be a man that we can remember as a success (that) he did his time with dignity, and got out to be with his family. Thats the story I want to hear.
The case has received national attention, as supporters, including some celebrities, calling for his release, including through the social media campaign, #FreeMichaelThompson.
And on Wednesday, Attorney General Dana Nessel sent a letter to Gov. Gretchen Whitmer in support of commuting Thompsons sentence.
While technically legal, the sentence imposed on Mr. Thompson is the product of a different time in Michigan legal history. And it is a time that has passed, reads the letter, in part.
That letter joins one submitted in April by David Leyon, the Genesee County prosecutor, who argued that the mounting threat posed by COVID-19 rendered a reconsideration of Thompsons case more urgent.
RELATED: Coronavirus outbreak at Muskegon prison increases to more than 150 inmates
But his advanced age and illness are not likely to speed up his release, said Chris Gautz, a spokesperson for the Michigan Department of Corrections (MDOC), because Thompsons conviction included weapons charges.
Thompsons case has received national attention in the last several months after he lost several prior attempts at clemency. Deedee Kirkwood, a Los Angeles-based cannabis activist who has been in daily contact with Thompson for about five years, helped to file one such petition before then-Governor Rick Snyder in 2018.
When that petition failed, Thompson had to wait two years to try again. The request was filed again in January, this time by attorneys at the Last Prisoner Project, a prison reform organization that works specifically with people serving long sentences for marijuana-related crimes.
The group filed a motion to expedite the petition in March, citing the health risk to Thompson, who has Type 2 diabetes and is classified as an older adult more at risk of experiencing the most adverse effects of COVID-19, said Sarah Gersten, that groups executive director.
Now, unfortunately, our worst fears have been realized, Gersten said, after Thompson informed his supporters on Friday, July 31, that he had been hospitalized with the illness.
Tens of thousands of people have written letters to Michigan lawmakers in support of that petition, Gersten said, and the social media campaign on Thompsons behalf has garnered some high-profile supporters, including comedian Sarah Silverman and television personality Montel Williams.
Thompson has also received support from Michigan officials, including Leyton, and Attorney General Nessel, who first expressed her support for Thompson via Twitter before submitting a letter to Gov. Whitmer, requesting that her office reconsider Mr. Thompsons application as expeditiously as possible and that he be released as soon as possible if your office will be granting his application.
A decades-long sentence like that imposed on Mr. Thompson is usually reserved for second-degree murder convictions or for particularly heinous rape cases involving multiple aggravated factors, Nessel wrote in her letter. Sentences of this length for selling marijuana are simply unheard of, even when accompanied by firearms offenses. Given that recreational and medicinal marijuana is now legal in Michigan, allowing Mr. Thompson to continue to serve this very draconian sentence is even more offensive and unreasonable.
Our hopes are that the Governors office and parole board hears these pleas from lawmakers and officials in their state that believe Michael should be free, Gersten said.
Many of Thompsons supporters argue that, because Michigan made recreational marijuana use and distribution legal in 2018, Thompson and other people incarcerated on marijuana-related charges should have their cases reconsidered.
This man is sitting here behind bars for the same thing you can go into a recreational store and buy, said Littles, Thompsons daughter.
But Gautz, the MDOC spokesperson, said that Thompsons earliest possible release date is 2038, and that only a commutation by Gov. Gretchen Whitmer could supersede that.
Even with that possibility, he added, Thompson would have to go through several months of hearings before his case reached Whitmers desk, and the governor could not override that process.
Thompson was convicted on five felony counts related to selling marijuana to an undercover law enforcement officer, according to news reports of the time. The charges included three drug charges possession with intent to sell; conspiracy to possess with intent to sell; and selling marijuana and two weapons charges.
Thompsons advocates say the weapons charges were unrelated to the drug dealing that guns were found in his home after he had been detained for dealing, that one was registered to his wife, and the others were antiques.
But because Thompson had a prior record three other felony drug charges he was not allowed to own a gun. That record also made Thompson subject to Michigans habitual offender statute, which lengthened his sentencing considerably.
In short, the extended sentence on the gun charges are what put Thompson behind bars for decades.
The judge in that case rejected a plea agreement negotiated with the prosecutors office, which would have seen Thompson plead guilty to just the two weapons counts, with the three drug counts dismissed and a sentence of probation.
In light of recent attempts at prison reform in the state, however, some in law enforcement such as Leyton, the prosecutor in the same county where Thompson was convicted have argued that Thompsons punishment no longer fits the crime.
I was not the elected prosecutor at the time but, what I can say based on my review of the case file almost 25 years later is that the sentence handed down by the judge certainly appears to be disproportionate to the crime committed, Leyton said in an April statement issued when he supported Thompsons petition for release.
Of about 39,000 people incarcerated throughout Michigan at the start of the pandemic, Gautz said that Michigan identified about 5,000 cases that could be reconsidered for parole, because those people had already served their minimum sentences.
About 3,500 people have been paroled since the start of the pandemic, Gautz said, but added that the move was not to open up space in crowded facilities.
Of those, Gautz said, the priority for parole included older inmates, and those with underlying health issues that could put them at greater risk for COVID-19.
While Thompson meets those two criteria, Gautz said, he would not have been included in that group of 5,000 because he has not served his minimum possible sentence.
Consequently, Gautz said, Thompsons case cannot be considered for a standard parole, but would have to receive a commutation from Gov. Gretchen Whitmer directly. Thompson would first have to go through several hearings before his case even reaches her desk, he added.
That timeline and the law are still in place, Gautz said. It would be months before the Governor would be able to act, because of the confines of state law.
That process is affirmed in a press release corresponding with Nessels letter, which describes a hearing process involving the parole board and assistant attorney general, before a recommendation can be brought to the Governors desk.
But, Nessels letter also states, sentencing guidelines today would not have seen such a harsh punishment imposed on Thompson. The weapons charges may have been different because he was not carrying them at the time of the drug sale, and Thompsons offense would be sentenced to a maximum of four years imprisonment, or a maximum of eight years if charged as a second drug offense, reads the release.
Gersten, the Last Prison Project director, also described the limits of the state parole process, saying that the Michigan prison system unlike federal prisons does not have a strong compassionate release statute for people like Thompson to attempt to leverage.
Thompson has so far served 25 of his minimum 40-year sentence. Gersten called this a de facto life sentence, made all the more serious now that he has been exposed to a deadly virus.
For months, the Muskegon Correctional Facility, where Thompson has been housed for several years, avoided an outbreak of COVID-19. But when news of the first confirmed coronavirus cases within those walls emerged last week, Thompsons supporters say they feared for his health.
Now 155 cases have been confirmed inside the prison, which houses just over 1200 people. Inmates confirmed to have contracted the virus have been sent to the Jackson hospital where Thompson is, or to the Carson City Correctional Facility, according to Gautz.
Thompsons supporters were concerned when they learned that his close friend inside the prison had contracted the virus. That man had recently helped Thompson to organize an event in honor of George Floyd, the Minnesota man whose death at the hands of police sparked an international movement against police brutality.
On Friday, July 31, Gerstens team received news from Thompson that he, too, was sick, and had been transferred to the Jackson hospital.
Thompson is now extremely weak, said Kirkwood, Thompsons friend and advocate. She said he lacks the nutrition he needs to address his Type II diabetes, which she said he developed while in prison, and that the man she once knew to do 500 pushups a day while incarcerated now has no energy.
Gersten argued that, even if Thompson recovers, this outbreak indicates a lack of safety inside the Muskegon prison.
The response from (MDOC) has been, Were doing everything in our power to ensure the safety and health of people in our care, but we know that has not, to date, been the case, Gersten said. If that were truly the case, Michael would have never contracted the virus.
Gautz previously told MLive that inmates have been given access to cleaning supplies, including bleach, a previously-banned substance, and PPE including masks. He also said that all Michigan facilities were tasked with developing plans for dealing with outbreaks, and that the Muskegon prison is currently implementing theirs, including creating isolation units for people who had close contact with infected inmates.
Mass testing took place last week of the two units where cases were first identified, and another 762 people were tested on Tuesday, Aug. 5, Gautz said.
According to MDOC numbers, 68 people incarcerated across the state and two prison guards have died of COVID-19.
As Thompsons case makes its way through legal channels, his advocates say they want people to know about who the man is, beyond the crime he committed.
He is an amazing human being, He is full of virtues, said Kirkwood. He does not lie. He is a maximum, honorable human being.
In her letter to the governor, Nessel touched upon Thompsons record in prison, calling him a model prisoner, and citing numerous positive reports from corrections officers for his work assignments
The fact of Thompsons COVID-19 diagnosis also played a role in exposing how Thompsons sentence has grown obsolete, Nessel goes on to argue.
If the trial court had sentenced him proportionately, Mr. Thompson would not have been anywhere near a prison as COVID-19 spread through our States prisons despite the best efforts of the MDOC to contain it, she wrote.
Read more on MLive:
Coronavirus outbreak at Muskegon prison increases to more than 150 inmates
Replacement for Muskegon-area Habitat for Humanity launches after embezzlement scandal
Some Michigan residents among first to receive trial coronavirus vaccine
Nearly $6 billion has been allocated. Clinical trials are entering a crucial third phase, and Operation Warp Speed is getting closer to the goal of delivering 300 million doses of a COVID-19 vaccine by January.
But when Americans line up for their immunizations, the vaccine they receive might not be what they expect. The popular notion of a vaccine a shot in the arm that prevents diseases such as measles, polio or shingles for years or a lifetime may not apply.
Under recently released federal guidelines, a COVID-19 vaccine can be authorized for use if it is safe and proves effective in as few as 50% of those who receive it. And effective doesnt necessarily mean stopping people from getting sick from COVID-19. It means minimizing its most serious symptoms, experts say.
We should anticipate the SARS-CoV-2 vaccine to be similar to the influenza vaccine, said Dr. Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland. That vaccine may or may not keep people from being infected with the virus, but it does keep people out of the hospital and the ICU.
Even with expectations scaled back, the development of a vaccine against a virus that no one knew about seven months ago is considered remarkable. One assessment calls it the compression of six years of work into six months.
Of the more than 150 vaccines in the works worldwide, Operation Warp Speed has identified 14 promising candidates. (A vaccine being developed by El Segundo-based ImmunityBio, headed by Times owner Dr. Patrick Soon-Shiong, is among the 14. It has not yet been tested in humans.)
Of those 14, seven have been designated as front-runners, including three whose early clinical trial results have undergone independent evaluation.
The vaccine being developed by Moderna and the National Institutes of Health was deemed promising in an editorial published in the New England Journal of Medicine, and two studies in the Lancet delivered a similar message for vaccines being developed at Oxford University and by the Chinese company CanSino.
These vaccines have induced an immune response in people participating in early tests, but inducing an immune response does not always mean success in fighting a disease. For instance, scientists recently developed a vaccine for another respiratory virus that increased antibodies but failed its Phase 3 clinical trial.
While there is no way to predict what lies ahead, experts say, the first round of COVID-19 vaccines will likely not eliminate the need for other public health measures, such as masks and social distancing.
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The minimum 50% efficacy recommendation spelled out in late June by the Food and Drug Administration would likely ease the burden on hospitals. And to whatever extent a COVID-19 vaccine prevents infection, it could reduce the spread of the virus and help to create pockets of immunity throughout the country, said Dr. Peter Hotez, dean of Baylor College of Medicines National School of Tropical Medicine.
Ideally, you want an antiviral vaccine to do two things, Hotez said. First, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.
In this case, he added, the bar does not seem that high.
Developing a vaccine capable of inducing sterilizing immunity that is, the ability to prevent the virus from causing an infection takes time and research, which might not be possible as death tolls continue to rise and the recession grows deeper. Yet with so many companies on the hunt for that vaccine, there is hope one of them might actually achieve it.
Dr. Mark Feinberg, CEO of the International AIDS Vaccine Initiative, cites the success of the Ebola vaccine. Not only did it speed through its clinical trials from starting Phase 1 to getting early Phase 3 results in 10 months but it also was nearly 100% effective within 10 days of a single dose being administered.
Thats not likely to be the case now. The challenge is that the novel coronavirus hasnt been around long enough, Feinberg said.
Scientists had studied other coronaviruses SARS and MERS and mapped the novel coronavirus genome not long after the first COVID-19 deaths were recorded. They identified the spike protein on the virus outer shell, which the virus uses to infiltrate the host cell and created a three-dimensional model of the virus to see how antibodies block infection by binding onto the spike protein.
Even so, scientists dont yet know what immunity against the virus looks like. That information typically comes from studying the bodys natural response to disease. The number of T-cells and neutralizing antibodies that fight off an infection can become a blueprint for a vaccine.
But the novel coronavirus is not easily giving up those secrets.
Physicians have noted a wide range of immune responses to COVID-19, Feinberg said. Some patients produce high levels of neutralizing antibodies, while others produce only low levels.
Whats interesting is that all have recovered, and we do not know how they did this, said Feinberg, a former chief public health and science officer with the pharmaceutical giant Merck.
Scientists are also uncertain how long immunity from a natural infection or a vaccine lasts and whether a decline in antibodies in two to three months is cause for concern.
The third phase of clinical trials might answer some of these questions. Moderna is enrolling 30,000 people for its Phase 3 trial, which started Monday.
If we get a vaccine that is 60% efficacious, we can use the information to identify what distinguishes people who are protected from those who are susceptible, Feinberg said. Then we will know what the minimum target is for an immune response.
But the absence of that information does not preclude the distribution of a vaccine. Many vaccines are effective even though scientists dont know the amount of antibodies needed to prevent infection. A vaccine can even be effective if it doesnt prevent infection.
The polio vaccine that Jonas Salk developed does not stop the poliovirus from infecting the gastro-intestinal tract, said Feinberg, but it stops the virus from traveling to the central nervous system where it causes the diseases worst symptom, paralysis.
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With so many questions still unanswered, the effectiveness of a COVID-19 vaccine may not be known until well after Americans have received their shots.
Among the recommendations in the FDA guidelines is a provision for emergency use authorization, allowing for the distribution of a vaccine if the known and potential benefits of a product outweigh the known and potential risks of the product.
I imagine that it is likely that the FDA will issue an emergency use authorization if any of the vaccines in development show significant and convincing evidence of efficacy and safety, said Feinberg, whose research organization is collaborating with Merck to develop a COVID-19 vaccine.
Under an emergency use authorization, the vaccine could be administered before the completion of the Phase 3 trials, potentially helping to flatten the curve but giving scientists little time to study side effects or understand how it interacts with other vaccines.
Dr. Paul Offit, a vaccine expert at Childrens Hospital of Philadelphia, has raised concerns that the FDA would greenlight manufacturing and distribution of vaccines before the necessary reviews have been completed.
Offit worries that a vaccine with limited efficacy delivered prematurely might give people a false sense of being protected and lead to serious outbreaks of the disease.
We should wait for the completion of Phase 3 trials, no matter how long they take, he said. With luck, they could be finished in six to nine months.
But postponing the delivery date for a vaccine would not align with the January goal of Operation Warp Speed.
The Trump administrations ambitious timeline has led to $5.7 billion being allocated to seven companies, and critics like Hotez and Offit wonder if speed is getting in the way of science.
Dr. Robert Gallo, director of the Institute Human Virology at the University of Maryland, argues that Operation Warp Speed, a private-public partnership, is science by committee, directed by a few individuals, when there needs to be robust debate and exchange of information.
If science problems need innovation, then there needs to be wide openings for original thinking and a means to argue or counter without the worry that you cannot get funded, he said.
Gallo, who cofounded the Global Virus Network, is concerned that the seven front-runners in Operation Warp Speed are each using the same strategy for their vaccine, one designed to neutralize the spike protein.
If that method proves ineffective, then the timeline for delivering a vaccine will be extended.
Im sure it is not wise to put all these eggs in one basket, he said.
"It spread like wildfire, wildfire. Very, very scary," Gov. MIke De Wine said Tuesday. "We know that our faith-based leaders want nothing more than to protect those who come to worship."
To illustrate how one infected person can spread the virus, state health officials released a color graphic showing how the cases radiated to some who weren't even at the service.
DeWine urged people attending religious services to wear masks. He had mandated wearing face coverings for people 10 and older on July 22. On Wednesday, he ordered children in schools to wear masks, with a few exceptions.
The governor said he was going to send letters to churches, mosques and synagogues to share important health information.
"It is vital that, any time people gather together, everyone wear masks, practice social distancing, wash hands, and while indoors, making sure there is good ventilation and airflow," he said.
In the case of community spread from the worshipper at the undisclosed church, a 56-year-old man went to the service. A total of 53 people got sick and 18 of those churchgoers spread it to at least one other person.
One instance of spread was a family in which a 34-year-old man became sick. His 31-year-old wife also became infected, as did four children who range in age from 1 to 11.
The wife and two children of the 56-year-old worshipper mentioned by the governor also got sick. The state didn't detail the seriousness of the 91 people's illnesses.
More than 96,000 people in Ohio have tested positive for the coronavirus.
CNN's Rebekah Riess constributed to this report.
President Donald Trump reiterated Wednesday that the coronavirus will "go away," and he continued to push for schools to reopen since the virus "doesn't have much of an impact" on children.
"It's going away. It'll go away. Things go away. No question in my mind that it will go away," Trump said during a White House press briefing.
Trump applauded the country's coronavirus vaccine and therapeutic development, saying it has had "tremendous success" and is "ready to deliver them literally as soon" as they're approved.
Earlier in the day, Johnson and Johnson announced the U.S. will buy 100 million doses of its potential vaccine, joining a handful of other companies that have struck similar deals with the federal government.
"We think we're going to have the vaccines before the end of the year, maybe long before the end of the year," Trump said.
The president also continued to push for schools to reopen this fall, saying that he believes most of them will. When it comes to the coronavirus, he said children are able to "throw it off very easily."
"They may get it, but they get it and it doesn't have much of an impact on them," he said. "For whatever reason the China virus, children handle it very well."
Trump's comments Wednesday evening come after he told Fox News earlier in the day that virus would "go away like things go away" and made claims that children are "virtually immune" to Covid-19.Facebook later removed a video post on the president's personal page of the Fox News segment, saying it violated its policies around Covid-19 misinformation, NBC News reported.
"This video includes false claims that a group of people is immune from COVID-19 which is a violation of our policies around harmful COVID misinformation," Andy Stone, a Facebook policy spokesperson, said.
White House coronavirus advisor Dr. Anthony Fauci said Friday the coronavirus is so contagious it won't likely ever completely go away.
"I do not believe it would disappear because it's such a highly transmissible virus,"Fauci, director of the National Institute of Allergy and Infectious Diseases,testified before the House Select Subcommittee.
World Health Organization officials also warned Monday there may never be a magical cure for thecoronaviruseven as scientists and drugmakers across the globe race to find a safe and effective vaccine.
While experts do agree that children are less likely to fall seriously ill from the coronavirus, studies have shown that childrenover 9 years old can spread thecoronavirusas well as adults.
White House coronavirus advisor Dr. Anthony Fauci has said that while school districts should try their best to return students to school in the fall, the main consideration should be the health and safety of the students, teachers and their families.
Infectious disease experts have warned against returning kids to school where the coronavirus is spreading uncontrollably. Many large school districts have already opted to begin the fall school year online.
Maybe you are an altruist looking for a way to help fight the coronavirus. Maybe you are hoping to be among the first to try an experimental vaccine. Or maybe you are just bored or could use a few hundred dollars.
Whatever your reasons, scientists, bioethicists and current volunteers say participating in a vaccine trial can be meaningful. And without hundreds of thousands of volunteers, there will be no vaccine for anyone.
But you may be surprised by the commitment and risks that a trial entails. Heres what you need to know.
A number of sites maintain lists of coronavirus vaccine trials. The Covid-19 Prevention Network site, created by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, helps connect volunteers to Phase 3 studies.Right now, for example, Moderna is looking to enroll around 30,000 volunteers.
ClinicalTrials.gov also lists Covid-19 vaccine studies at different phases and COVID Dash, a portal managed by a group of doctors, clinical trial professionals and students who want to encourage people to volunteer, features studies across the world.
There are three primary phases of a vaccine trial. A Phase 1 trial is focused on safety. If you participate, you are likely to be among the first human beings to try the vaccine. Researchers will want to track whether it affects you negatively, such as making you feverish or dizzy. Typically they will monitor you and a few dozen other subjects closely after each dose, and then check in periodically for about a year.
At the time you receive the vaccine, the developer wont know if it prevents Covid-19. And even if it does, theres little chance youll get the right amount. Still, Phase 1 trials are appealing to some volunteers because clinicians can sometimes assure all subjects that theyll get the experimental vaccine, not an inactive placebo.
Phase 2 is bigger and typically involves a few hundred people. At this point, researchers are still watching for side effects, but they are also examining whether their vaccine is generating an immune response, said Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and the leader of the Covid-19 Prevention Network.
If you think about a vaccine developers desired immune response like a bar that a pole-vaulter needs to clear to move to the next round, you want to see that you got over the bar, he said. To extend the metaphor, the pole-vaulter wont know if clearing that bar was enough to win, he said. Just because a vaccine has generated an immune response, doesnt mean it was sufficient to protect anyone, he said.
Only a Phase 3 trial allows researchers to study if their vaccine works. They do this by enrolling tens of thousands or hundreds of thousands of volunteers, giving one-half of the group to two-thirds of them the vaccine, and giving the rest a placebo or an alternative treatment. They do not expose anyone to the coronavirus, but they try to enroll a large enough group in locations with enough cases that they can bank on some people getting infected in the normal course of their lives. They then evaluate whether the vaccine reduced the frequency of acquiring the infection and lessened the severity of the disease in the test group, Dr. Corey said.
Theres no guarantee that youll actually be protected from the coronavirus at any phase of a vaccine trial, no matter how hyped the product has been. By a Phase 3 trial, of course, theres more to suggest that it works than a Phase 1 trial. But you might not get the vaccine at all. It might be an inactive placebo or an alternative intervention.
Researchers have to give these to some subjects to create a control group, said Nir Eyal, the director of the Center for Population-Level Bioethics at the Rutgers School of Public Health.
Otherwise what do you compare the results to? Dr. Eyal asked.
During the Ebola outbreak, there was a push to try to run efficacy trials without a control group, he said. But eventually most researchers came around to the idea that, without a control group, a study would tell them basically nothing because as with the coronavirus its spread is mercurial, and very different in different areas at different times.
It could be a few hundred or a few thousand dollars. It varies by the trial.
What you are doing is providing compensation for time and trouble, said Dr. Daniel Hoft, director of the Saint Louis University Center for Vaccine Development.
Organizers try to avoid creating a financial incentive. So even if they could pay much more, they dont.
Updated August 4, 2020
If the money seems extraordinarily attractive to you, think again, Arthur L. Caplan, a bioethicist, said. You dont want to let compensation blind you to the need to pay attention to the risks.
Lets say that you are adversely affected by an experimental vaccine. You might assume that the vaccine developer will cover your health care costs. But typically they only commit to reimbursing your insurance company, Dr. Caplan said.
Insurance companies will rarely pay anything if you are hurt in an experiment, he said. So ask a lot of questions first. If I get injured what happens? is among those he recommends. Dr. Corey added that in some cases, the institute running the trials or the U.S. governments pandemic relief fund, known as the Public Readiness and Preparedness Act, might cover those costs.
Across the world, a lively debate is underway about that.
This type of vaccine research is called a challenge trial, which entails giving volunteers a vaccine then deliberately exposing them to the virus to see if they end up infected.
The approach is controversial because Covid-19 has no cure and can be fatal. But it is also tantalizing because it promises to dramatically speed up research.
In mid-July, scientists at Oxford University announced that they would soon begin recruiting volunteers for such a trial. In the United States, a handful of vaccine developers have cautiously signaled they are open to a similar path eventually.
Dr. Eyal believes that the most ethical way to conduct these trials is to focus on young, healthy volunteers who meet criteria that suggest theyd be unlikely to develop a severe case of Covid-19. There are no guarantees, however, which is why some experts are adamantly opposed to challenge trials.
But if you are not deterred, and want to help advance the science, the site 1 Day Sooner invites people to sign up for future challenge trials. As of last week, the site ticker showed that more than 32,000 people from 140 countries were ready to volunteer.
Over the last seven days, a grim new COVID-19 calculus has emerged: one person died every 80 seconds from the coronavirus in America.
And the pace at which those 7,486 people died appears to be accelerating, a new NBC News tally revealed Wednesday.
In July, a total of 26,198 deaths were reported, meaning one every 102 seconds. As of Wednesday morning, more than 158,000 people in the U.S. had died of the virus since the start of the pandemic.
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The numbing new national snapshot of how COVID-19 is claiming more and more lives came as Johns Hopkins University reported another milestone: The world death toll from this plague had eclipsed 700,000.
The U.S. has logged over 4.8 million confirmed cases. And around 1.8 million of those have come since July 7, when the 3 millionth case was reported, NBC News figures show.
While most of the new cases and deaths have been in the South and Sun Belt, states in the northeast like New York, New Jersey and Massachusetts that were hit hardest at the start of the pandemic and were able to flatten the curve have also reported worrying upticks.
Under fire for being slow to respond to the COVID-19 crisis and presiding over the biggest economic disaster since the Great Depression, President Donald Trump once again downplayed the extent of the pandemic in a call-in interview Wednesday with "Fox & Friends."
This thing is going away, he said. It will go away like things go away.
Joe Biden, the Democrat hoping to oust Trump from the White House come November, fired back.
Donald Trump continues to live in a world of delusion, Biden said in a statement.
In other developments:
Joe Murphy is a data editor at NBC News Digital.
Corky Siemaszko is a senior writer for NBC News Digital.
Suzanne Ciechalski contributed.
He continued to say that the virus is "going away" and to suggest that children are immune. And in a series of confusing comments, he also falsely alleged that Arizona's and Nevada's voting systems do not verify signatures on mail-in ballots.
Trump retreated at least slightly, saying, "They don't really know what it is. Nobody knows yet." But then he said, "Somebody was, you know, left some terrible explosive type devices and things around, perhaps. Perhaps it was that. Perhaps it was an attack. I don't think anybody can say right now. We're looking into it very strongly. Right now, it's -- I mean, you have some people think it was an attack and you have some people that think it wasn't."
Arizona and Nevada vote-by-mail signature
"You look at Arizona, you don't even have to have, as you know, they have a provision where they don't have to check signatures," the President said. "You sign it and you could have a totally different signature, it's okay. It won't be approved."
"They have the right to go seven days after election for approval," Trump added. "We won't know who won the state of Nevada."
It's unclear exactly what Trump is saying and if he originally meant to say "Nevada" instead of Arizona, but here are the facts around Arizona and Nevada mail-in voting and signature verification.
Facts First: Both Arizona and Nevada do check signatures on mail-in ballots and verify them with the corresponding signature on file.
Arizona
According to Arizona's Citizens Clean Elections Commission, 80% of voters in the state receive their ballots by mail. Signatures on these ballots are verified before being tabulated.
"When you vote by mail, your signature on the early ballot affidavit is compared to the signature on file with your voter registration record," the commission says. Voters can also make sure their vote has been counted by going online.
Recently, Arizona Democrats filed a lawsuit in order to allow five days for voters to correct a missing signature. As the commission notes, "voters have until 5:00 p.m. on the 5th business day after the primary or general election to confirm/correct their signature." But the lawsuit maintains that this rule should also apply to ballots missing a signature.
Nevada
When Trump made these claims during the briefing, a reporter quickly fact-checked him on the spot.
"Oh you're talking about Nevada," the reporter said, noting that she called Nevada's Secretary of State's office where a spokeswoman told her that Trump's claim "simply isn't true and that Nevada will continue to check ballot signatures against voter registration cards, it's done at the county level."
Trump denied this, saying, "their machinery, which is old, doesn't allow them to" and moved on to criticizing how long mail-in ballots could take to count.
Nevada recently passed a law that will send all registered voters in the state mail-in ballots for the November election. As the law notes, "The clerk or employee shall check the signature used for the mail ballot against all signatures of the voter available in the records of the clerk."
Nevada counting delays
"I don't think it is appropriate," he added.
Absentee vs. mail-in voting
In a stream of consciousness about mail-in voting and alleged fraud, Trump once again claimed that absentee and mail-in ballots are "much different."
"Absentee ballots are different than mail-in ballots, what you call universal mail in ballots, much different," Trump said. "You have to apply for it, you have to do different things, and it's a much better system."
Rick Hasen, a University of California-Irvine professor and one of the nation's top experts in election law, told CNN, "The President seems to be trying to distinguish between mail-in voting where someone has to have an excuse and no excuse voting by mail."
While there can be some differences in the methods used to implement absentee and mail-in voting, experts say that they are both secure ways of voting.
"The bottom line is that absentee and mail balloting are secure in America," Wendy Weiser, the director of the Democracy Program at the Brennan Center, told CNN. "Election officials, Republicans and Democrats alike, pretty much universally are confident in the system."
Children and Covid-19
Facts First: This is still false. While children are far less likely on the whole to get seriously ill or die from coronavirus than adults, they are not "immune" from the possibility; some children do indeed get seriously ill or die. And children also transmit the virus to others.
"I'm starting to sense that maybe he doesn't know what the word 'immune' really means," Dr. Sanjay Gupta, CNN's chief medical correspondent, said on air after the briefing. "Kids clearly get infected. We were just looking up some of the more recent statistics. Between 250- and 350,000 young people, people under the age of 18, have become infected with this virus. The risk is lower for them getting sick or dying, but it's not zero by any means.
"And kids can still transmit the virus. Kids 10 and older transmit this virus just like adults do. Kids younger than that, frankly, I don't think we know enough. Because these kids have largely been at home since the middle of March. They have very few contacts. So I think we're going to learn a lot more about the transmissibility, but it's no question: fourth, fifth grade and above, kids can transmit just like adults do."
The virus 'going away'
He simply reiterated the claim on Wednesday evening, saying, "It's going away. It'll go away, things go away, absolutely -- no question in my mind it will go away. Hopefully sooner rather than later."
Although the delineations arent always clear-cut, the immune systems responses to pathogens can be roughly grouped into three categories: type 1, which is directed against viruses and certain bacteria that infiltrate our cells; type 2, which fights parasites like worms that dont invade cells; and type 3, which goes after fungi and bacteria that can survive outside of cells. Each branch uses different cytokines to rouse different subsets of molecular fighters.
Updated August 4, 2020
People with moderate cases of Covid-19 take what seems like the most sensible approach, concentrating on type 1 responses, Dr. Iwasakis team found. Patients struggling to recover, on the other hand, seem to be pouring an unusual number of resources into type 2 and type 3 responses, which is kind of wacky, Dr. Iwasaki said. As far as we know, there is no parasite involved.
Its almost as if the immune system is struggling to pick a lane, Dr. Wherry said.
This disorientation also seems to extend into the realm of B cells and T cells two types of immune fighters that usually need to stay in conversation to coordinate their attacks. Certain types of T cells, for instance, are crucial for coaxing B cells into manufacturing disease-fighting antibodies.
Last month, Dr. Wherry and his colleagues published a paper in Science finding that, in many patients with severe Covid-19, the virus had somehow driven a wedge between these two close-knit cellular communities. Its too soon to tell for sure, but perhaps something about the coronavirus is preventing B and T cells from talking to each other, he said.
These studies suggest that treating bad cases of Covid-19 might require an immunological reset drugs that could, in theory, restore the balance in the body and resurrect lines of communication between bamboozled cells. Such therapies could even be focused on specific subsets of patients whose bodies are responding bizarrely to the virus, Dr. Blish said: the ones who have deranged cytokines from the beginning.
But thats easier said than done. The challenge here is trying to blunt the response, without completely suppressing it, and getting the right types of responses, Dr. August said. Its hard to fine-tune that.
Timing is also crucial. Dose a patient too early with a drug that tempers immune signaling, and they may not respond strongly enough; give it too late, and the worst of the damage may have already been done. The same goes for treatments intended to shore up the initial immune response against the coronavirus, like interferon-based therapies, Dr. Blish said. These could stamp out the pathogen if given shortly after infection or run roughshod over the body if administered after too long of a delay.
