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The post Trump volunteers to take coronavirus vaccine ‘first’ or ‘last,’ defends Birx in interview with Dr. Marc Siegel appeared first on Virus Reports.
]]>President Trump told Fox News medical contributor Marc Siegel on Wednesday that he’s in an impossible situation regarding whether he should be the first to take a coronavirus vaccine.
“Well, you know the way it works. If I’m the first one they’ll say ‘he’s so selfish. He wanted to get the vaccine first,” Trump told Siegel. “Then other people would say ‘hey, that’s a very brave thing to do’.”
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“I would absolutely, if they wanted me to and thought it was right, I’d take it first or I’d take it last.”
Trump’s dilemma comes the same day that pharmaceutical company Pfizer and biotech firm BioNTech said that the U.S. government has placed a $1.95 billion order for 100 million cases of their COVID-19 vaccine. An additional 500 million cases can be acquired by the Department of Health and Human Services should the vaccine prove safe and effective.
The two companies are jointly developing four potential vaccines, one of which will begin the first of three phases of trial testing later this month on 30,000 participants.
“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” Health and Human Services Secretary Alex Azar said Wednesday.
“Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”
Trump is apparently feeling pressure to show his support for vaccination.
“You do know that if I take it first, either way I lose on that one. If I don’t take it they’ll say ‘he doesn’t believe in the program’,” Trump told Siegel Wednesday.
Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and a leading member of the National Coronavirus Task Force, said Wedensday that the U.S. is moving as quickly as possible on finding a vaccine that’s safe and effective.
PRESIDENT TRUMP PRAISES DR. DEBORAH BIRX
“If you want to do it correctly, with safety, and real attention to safety and efficacy, I think we are going as fast as we possibly can,” Fauci said during a TB Alliance forum Wednesday.
Fauci and Trump have at times been at odds during the coronavirus pandemic, and he along with Dr. Deborah Birx, the task force’s coordinator, were absent from Trump’s first coronavirus briefing in months Tuesday.
Trump told reporters that Birx, who has an office in the West Wing, was right outside the door, though he did not mention where Fauci was.
Fauci, the nation’s leading infectious disease specialist, told CBS he was never informed of the briefing.
“Dr. Birx is a big advisor of yours that isn’t getting enough attention,” Siegel said to Trump Wednesday.
Trump was quick to defend the doctor who received a beating from The New York Times earlier this week who called her the “chief evangelist” and said she has repeatedly curtailed Fauci’s realistic efforts by “ostensibly” offering reassurance to the president.
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“She is responsible for all the incredible work that has taken place on AIDS in Africa,” Trump told Siegel. “Millions of people are alive right now because of her. She’s an unbelievable woman.”
The post Trump volunteers to take coronavirus vaccine ‘first’ or ‘last,’ defends Birx in interview with Dr. Marc Siegel appeared first on Virus Reports.
]]>The post Scientists call for volunteers to be infected with the coronavirus to test vaccines appeared first on Virus Reports.
]]>A woman holds a small bottle labeled with a “Vaccine COVID-19” sticker and a medical syringe in this illustration taken April 10, 2020.
Dado Ruvic | Reuters
Over 100 prominent scientists, including 15 Nobel laureates, are calling for healthy volunteers to be exposed to the coronavirus to see whether vaccines against Covid-19 actually work.
The scientists signed an open letter to Dr. Francis Collins, the head of the National Institutes of Health (NIH) in the U.S., on Wednesday calling for human “challenge trials” that they say could “greatly accelerate” the development of a Covid-19 vaccine.
Challenge trials see healthy volunteers deliberately exposed to a virus, after being given a vaccine, to test whether the vaccine works to prevent infection.
Such trials are not without controversy, but organization ‘1 Day Sooner’ and other prominent experts insist the benefit of fast-tracking challenge trials outweigh the risks, and are calling on the U.S. government to authorize them.
“If challenge trials can safely and effectively speed the vaccine development process then there is a formidable presumption in favor of their use, which would require a very compelling ethical justification to overcome,” the letter published by 1 Day Sooner, an organization that advocates for challenge trials, states.
Scientists that signed the letter, including the director of the University of Oxford’s Covid-19 vaccine program, said “human challenge trials can provide information much faster than conventional efficacy trials, which take months longer.”
“In such trials, volunteers still receive the vaccine candidate or a control. Instead of resuming life as usual and waiting to ‘catch’ a virus, volunteers are deliberately exposed to the pathogen under controlled conditions. Beyond being faster than conventional trials, a challenge test is likelier to conclude with interpretable results, e.g. should the presence of virus around the study site begin to fade over time,” they added.
The signatories of the letter come from a range of disciplines including epidemiology, medicine, economics and philosophy. They argue that “the Covid-19 pandemic must be fought urgently on many fronts, but it is hard to picture robust economic and social recoveries in the absence of a vaccine. We are writing to underscore the vast importance of human challenge trials as a method to help develop vaccines.”
The letter notes that U.S. lawmakers are already supporting the move. In April, 35 members of the House of Representatives called on U.S. regulators to consider allowing volunteers to be infected with the coronavirus to speed up vaccine testing.
Over a hundred vaccine candidates are already under development around the world and there are 23 candidate vaccines in the clinical evaluation stage, according to the World Health Organization.
There appears to be a cautious acceptance that challenge trials could play a part in fast-tracking the development of a coronavirus vaccine. For his part, the NIH’s Director Dr Francis Collins has said challenge trials are “on the table for discussion — not on the table to start designing a plan.”
The letter was also signed by more than 2,000 challenge volunteers organized by 1 Day Sooner. Laying out the principles for an “effective” human challenge trial, the experts said “crucial protections must be extended to protect the health and autonomy rights of volunteers.“
Guidance from the World Health Organization (WHO) says that human challenge trials are ethical when they meet certain criteria. Protections that should clearly be in place, experts said, including that trial participants are relatively young and in good health and provided with the highest quality medical care with frequent monitoring.
The WHO notes that it is essential challenge trials are “conducted within an ethical framework in which truly informed consent is given” and that they should be undertaken with “abundant forethought, caution, and oversight.” Consideration must be given to both potential individual risks and benefits, WHO says, as well as to potential societal benefits and risks, such as the release into the environment of a pathogen that might not otherwise be present.
The experts on Thursday said ethical and scientific review of any challenge trials must be of the highest quality and finally, but most importantly, “the autonomy of the volunteers is of paramount concern … This means that the informed consent process must be robust.”
The post Scientists call for volunteers to be infected with the coronavirus to test vaccines appeared first on Virus Reports.
]]>The post Volunteers can now sign up for large coronavirus vaccine studies appeared first on Virus Reports.
]]>A network of more than 100 clinical trial sites at hospitals and medical clinics across the United States will take on the unprecedented challenge of testing covid-19 vaccines and other preventive treatments, federal officials announced Wednesday.
The Covid-19 Prevention Trials Network, which knits together the existing federal clinical trial infrastructure developed largely to test HIV vaccines and treatments, launched with a website for volunteers to join the roster of people to be considered when the first trials begin later this month.
The scientific effort to develop a covid-19 vaccine will depend crucially on tens of thousands of volunteers, in a gargantuan scientific, medical and logistical undertaking, with the aim of providing “substantial quantities of a safe, effective vaccine by January 2021,” Health and Human Services Secretary Alex Azar said in a statement.
Testing a vaccine is a conceptually simple idea, but it is a careful and methodical process that unfolds through a phased system of trials that grow progressively larger. Early clinical trials, some of which have reported encouraging results, assess the right dose of the vaccine and monitor for any safety concerns in dozens or a few hundred patients. But the ultimate test of these vaccines will be large trials designed to test whether they are effective at preventing or reducing the severity of the disease.
The first late-stage vaccine trial, in which 30,000 people will be randomly assigned to receive either an experimental vaccine made by the biotechnology company Moderna or a placebo, is expected to begin in the second half of July. There are expected to be at least five such large vaccine trials conducted through the network over the coming months — as well as trials of other preventive measures, such as monoclonal antibody drugs.
“This is what we do for a living and have done for a living,” said Larry Corey, a virologist and past president of the Fred Hutchinson Cancer Center, who is co-leading the trial network. “We have a considerable infrastructure, probably the country’s biggest infrastructure in vaccines.”
Launching trials of this scale in such a short time requires the coordination of a long list of details, to ensure that the data is consistent across many different locations.
In the Moderna trial, 30,000 volunteers will be followed for two years, and will be asked to keep a diary of symptoms and be available for weekly check-in phone calls, according to Richard Novak, chief of the Division of Infectious Diseases at the University of Illinois at Chicago College of Medicine, who said he will be recruiting 1,000 volunteers for that study.
“It really is an intense effort,” Novak said. The infrastructure needed ranges from equipment that is regularly audited to show that freezers never fail, staff to screen potential participants, setting up a call center to facilitate thousands of check-ins, to building the bridges to the community to ensure that a diverse array of people — and particularly those at greatest risk of covid-19 — sign up.
“Getting this up and running is a 24/7 job,” Novak said.
The post Volunteers can now sign up for large coronavirus vaccine studies appeared first on Virus Reports.
]]>The post Coronavirus: Volunteers wanted for antibody test trials appeared first on Virus Reports.
]]> 
Image copyright
AFP
Volunteers are being sought from NHS staff and other public service workers for a study into the effectiveness of Covid-19 antibody home testing kits.
A number of the rapid response kits are to be studied, including one from a consortium including Oxford University.
The test to see if someone has already had coronavirus has been described by the prime minister as a game changer to get people back to work.
Public Health England has begun looking for 2,500 volunteers for the study.
Experts have questioned the usefulness of the tests because little has been known about whether antibodies protect people from the virus but the government said the study would help its understanding of Covid-19.
A Department of Health spokesman said: “No reliable home test has yet been found, and we do not know whether antibodies indicate immunity from reinfection or transmission.
“This research is part of our ongoing surveillance work to increase our understanding of how to tackle this virus.”
Image copyright
Reuters
Commercial tests, which ask the user to send a blood sample off to a lab, have been suspended in the UK and people have been warned not to buy unapproved tests.
In March, the government bought 3.5 million antibody home tests but scientists at Oxford University found they were unreliable.
Public Health England (PHE) has since launched a separate study of 10,000 healthcare workers which involves antibody blood tests to learn more about immunity to the virus.
The Rapid Test Consortium, involving Oxford University and four UK manufacturers – BBI Solutions, Abingdon Health, CIGA Healthcare and Omega Diagnostics – has claimed its device, which uses a finger prick of blood to produce results in 10 minutes, is highly accurate.
Sir John Bell, Regius Professor of Medicine at Oxford University, who has been overseeing the government’s antibody testing validation and strategy, said: “We’ve really set the gold standard in what you need to expect from these tests and I suspect a lot of people will be really interested in what we have produced in the last couple of months.”
PHE has been planning to recruit 2,500 volunteers to see how effective and easy tests would be to use, with initial results expected in late summer.
The post Coronavirus: Volunteers wanted for antibody test trials appeared first on Virus Reports.
]]>The post In Oregon Town, Volunteers Are Going Door-To-Door To Pin Down Coronavirus Infections appeared first on Virus Reports.
]]>While authorities across the U.S. struggle to make policy without any hard numbers for how many people are actually infected with the coronavirus, Oregon State University has launched a project to change that — at least for one small city.
The project is known as TRACE, Team-based Rapid Assessment of Community-Level Coronavirus Epidemics, and its leader, Ben Dalziel, says it has a straightforward goal: “To understand the prevalence of the virus in a community. In this case, Corvallis, Oregon.”
Prevalence means how many people have the virus at any given moment.
The project officially kicked off on the weekend of April 25-26, and is expected to last four weekends. Maintaining social distancing, two-person teams from the university community go door-to-door in different neighborhoods, asking residents to participate.
If they agree, people take their own nasal swab, and the teams take the swabs back to the lab for analysis.
Participants can go online to get their results, which are also sent by mail.
The researchers chose the neighborhoods to provide a representative sample of the 58,640 people who live in Corvallis.
Because of a shortage of tests, the Centers for Disease Control and Prevention had originally recommended that priority for testing go to people who are sick and might be infected with the virus. Now, that list has expanded somewhat to include people such as healthcare workers or nursing home residents, who are at high risk of infection.
That misses people who may be infected but have no symptoms — at least not at the time they took the test. It’s now pretty clear that such people can transmit the virus to others.
TRACE tests people whether they are sick or not.
The original proposal was to conduct 960 tests for four successive weekends. But Dalziel says that number was scaled back, because they’ve realized that it was more important to reach more neighborhoods, even if that meant fewer people per neighborhood.
So far, the team has only been able to look at the data from the first 455 people tested, but that allowed a preliminary assessment of prevalence.
Dalziel says the estimate is that two per thousand, or 0.2% of the town’s residents, are infected.
“The prevalence of infections is often very low, even when there are a very large number of cases,” says Marm Kilpatrick, who studies disease dynamics at the University of California, Santa Cruz. That’s because prevalence only captures a snapshot of the illness, it doesn’t include all the people who have gotten sick since the beginning of the epidemic.
Still, he says prevalence screening can be particularly helpful in identifying flare-ups of infection in a community.
“A study like this that actually screens people for infection, and doesn’t require people going to a hospital, could detect that much earlier,” he says.
Dalziel says that although 0.2% might not sound like much, it’s still worrying.
“Two in a thousand is a level of prevalence that if we were to reopen too quickly, we would risk entering another epidemic exponential growth phase,” he says.
The post In Oregon Town, Volunteers Are Going Door-To-Door To Pin Down Coronavirus Infections appeared first on Virus Reports.
]]>The post Infecting volunteers with Covid-19 may speed up vaccine appeared first on Virus Reports.
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The post Infecting volunteers with Covid-19 may speed up vaccine appeared first on Virus Reports.
]]>The post 3300 volunteers given antibody tests get their results | WNT appeared first on Virus Reports.
]]>A Stanford doctor said official records showed 1,000 COVID-19 cases in a California county, but antibodies showed the number could be up to 80,000.
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