Search This Blog

Saturday, June 27, 2020

Promising results mean coronavirus vaccine trial could start by August


Animal studies of a potential COVID-19 vaccine have been so encouraging that researchers plan to speed up testing of the vaccine in humans.
Initially, the next phase of the trial was expected to begin in September, but that start date has now been moved to August.
Developed by researchers at the Duke-NUS Medical School in Singapore, the uses called messenger RNA to trigger an in the body. Once injected, the vaccine prompts the body to make proteins like those of the actual virus. The body will then know what coronavirus-infected cells look like and can learn to fight them off.
Most vaccines are purely preventive, but this vaccine may also be able to treat an active case of coronavirus, the scientists added.
The vaccine activates “two arms of the immune system,” explained study author Dr. Eng Eong Ooi, deputy director of the Emerging Infectious Diseases Program at Duke-NUS Medical School in Singapore.
One “arm,” Ooi explained, prevents a coronavirus infection by teaching the body to recognize the virus. The other kills off infected cells, preventing the illness from spreading within the body.
“In preclinical studies, that’s come true—that we can develop both arms of the immune response against coronavirus,” Ooi said during a Wednesday media briefing on the vaccine.
Ooi was joined by Thomas Denny, chief operating officer of the Duke Human Vaccine Institute, and David Ridley, faculty director of the health sector management program at Duke’s Fuqua School of Business, to discuss the challenges ahead in the race to produce a safe and effective coronavirus vaccine.
Researchers around the world are developing more than 140 vaccines against the coronavirus, according to The New York Times’ vaccine tracker. There are currently 18 potential vaccines being tested for safety and correct dosing in Phase 1 or 2 , and three vaccines are in Phase 3 trials, where they are undergoing large-scale testing.
The Duke team emphasized that any expectation for a vaccine by the end of this year is overly optimistic.
“I think it’s entirely possible that a vaccine will be approved this year, but not at scale,” Ridley explained. “We might have some people vaccinated this year, but the average person won’t be vaccinated.”
Denny added, “We may have some good science by the end of the year and think we have some leading candidates. But manufacturing them to have it all administered, that’s a tall order to be ready by the beginning of 2021.”
There are currently no RNA vaccines on the market for any disease, the researchers said, but many are being tested in clinical trials, both for coronavirus and other diseases.
Most coronavirus vaccines being studied require two doses—including Moderna’s RNA vaccine—but Ooi said the vaccine being developed by Duke-NUS and the pharmaceutical company Arcturus Therapeutics is different. So far, it appears this vaccine requires only one dose because it has a replicating effect that makes the vaccine “expand in the body,” Ooi explained.
The vaccine will likely be the first of its kind to get this far in clinical trials if the trials proceed as expected.
Although there is some level of uncertainty with a unique vaccine like this one, the research thus far has demonstrated that the vaccine is safe.
“We are quite confident that given the kind of safety profile we observe with using RNA to deliver drugs, we should be able to get a fairly decent safety profile,” Ooi said. “I would think this vaccine will be tolerable and acceptable to the public.”
There are several steps and many months of testing ahead for this vaccine.
If the next phase of the trial begins in August, the vaccine will initially be tested on a small group of healthy adults. If it is shown to be safe, it may be tested on more , such as the elderly. This phase is “quite standard,” according to Ooi.
The following step, though, is less certain. In the next phase, a large population would be given either the vaccine or a placebo, and then studied to see if they are infected with the virus naturally. But the speed and efficacy of that stage depend on how common infections are at that time, Ooi explained.
“We can vaccinate the individuals and then see whether that would protect them from COVID, compared to a group where they got the placebo instead,” Ooi said. “But, if for whatever reason the disease incidence or prevalence of disease goes down, then it’ll take us a much longer time to assess efficacy.”
Even if the go according to plan, it is difficult to say when the vaccine could become available for general use. Ooi predicted this time next year “at the soonest.”
The research and development of the vaccine is being funded, in part, by the government of Singapore.
Posted by at No comments:

Replacing lockdowns with weekly test of all residents to curb coronavirus spread

A team of researchers affiliated with several institutions in the U.K. and one in the U.S. has suggested a novel way to control the spread of COVID-19—lift all restrictions in a test city and replace them with weekly testing of all residents. Those who test positive would be quarantined. In their paper published in the journal Royal Society Open Science, the group outlines their idea and suggests it as a way to slow or even stop the pandemic.
As the world continues to grapple with the ongoing pandemic, researchers propose various ideas to slow or stop its spread. In this new effort, the researchers are proposing that a mid-size city (population approximately 250,000) be used as a case for a novel way to slow or stop the spread of the virus—lift all of the restrictions that are in place in the city, and instead institute a policy of weekly testing for everyone who lives or works there. If someone tests positive, they and their family would then quarantined.
The researchers insist their math shows the merits of such a strategy. They note that current research suggests that it takes approximately 6.5 days for an infected person to pass on the virus to someone else. If that person were tested and found to be infected, they could be prevented from infecting others, thus halting the spread of the disease. They also note that if one person in 2000 were infected at any one time, the city would only need to quarantine 1000 households, which they suggest could very easily be done in the . They further suggest such an approach could slow or even stop the spread of the disease in the test city within a matter of weeks. And if it worked as proposed in the test city, the approach could be used for a whole country.
The researchers also suggest that it should be possible to test everyone in a on a weekly basis by using saliva-based tests (RT-Lamp) because they are not only cheaper than those in use now, but are less uncomfortable to the people being tested.
More information: Julian Peto et al. Weekly COVID-19 testing with household quarantine and contact tracing is feasible and would probably end the epidemic, Royal Society Open Science (2020). DOI: 10.1098/rsos.200915


Posted by at No comments:

Roche not yet meeting demand for molecular COVID-19 tests – chairman

Swiss drugmaker Roche is unable to meet demand for molecular tests to identify active COVID-19 infections, its chairman told Swiss daily Tagesanzeiger.
“The demand exceeds our production,” Christoph Franz was quoted as saying in Saturday’s paper. The decision on where tests were shipped to depended, among other things, on infection rates and the availability of diagnostic equipment.

Demand for its antibody tests, which determine whether people have ever been infected with the coronavirus, can be met as Roche has been boosting production, he said.
The drugmaker has said that it aims to more than double production of antibody tests to well over 100 million a month by the end of the year.
Franz said that Roche had started research on a potential drug to treat COVID-19 but added that these efforts were at a very early stage.

Posted by at No comments:

Brazil agrees to produce AstraZeneca’s experimental COVID-19 vaccine

Brazil announced on Saturday that it had signed a $127 million agreement to start producing locally an experimental vaccine developed by AstraZeneca that has shown promise to fight the COVID-19 pandemic.
The AstraZeneca vaccine is considered the world’s leading candidate and most advanced in terms of development to obtain licensure and become an official vaccine against the disease, according to the World Health Organization.
The British drugmaker is already carrying out large-scale, mid-stage human trials of the vaccine, which was developed by researchers at Oxford University.
Elcio Franco, Brazil’s No.2 public health official, said in a press conference that the country will initially produce some 30 million doses of the vaccine, half by December and half by January of next year.
Franco said Brazil is paying for the vaccine but is aware of the risk, in case the vaccine does not pass all necessary licensure requirements or another vaccine obtains approval faster.
The vaccine will be produced by Brazil’s Fundação Osvaldo Cruz, also known as Fiocruz, the country’s leading public health organization, Franco said.
Brazil is the world’s second most affected country by the coronavirus pandemic, with more than 1.2 million confirmed cases as of Friday and more than 55,000 deaths.
Right-wing President Jair Bolsonaro has been widely criticized for this response to the pandemic. He has dismissed the severity of the disease and has shown indifference to the rising death toll while also pushing treatment using an unproven anti-malaria drug.

Posted by at No comments:

1/3 of parents in 3 states may not send children to school because of COVID-19

Kindergartners in face masks. Closed playground structures. Random COVID-19 testing.
They are among the long list of hypothetical scenarios for school in the pandemic era.
And as lawmakers and educators reimagine the K-12 model for fall, a new survey assessed parents’ plans for in-person school and support for 15 potential measures to reduce the risk of COVID-19 in schools in Illinois, Michigan, and Ohio.
The majority of parents surveyed (two-thirds) said they will likely send all of their children to school in fall. Most also support certain safety measures, including decreasing the number of children on buses, daily temperature screens for students, alternating between in-person and online classes, regular testing of school staff, and requiring school staff and older children to wear masks.
The report, published by the Susan B. Meister Child Health Evaluation and Research Center (CHEAR) at the University of Michigan, included 1,193 parents of school-aged children in the three states who were surveyed from June 12-22.
“Families are facing a challenging decision regarding whether to send their children to school for in-person classes in the middle of the COVID-19 pandemic,” says lead author Kao-Ping Chua, M.D., Ph.D., a pediatrician and researcher at Michigan Medicine C.S. Mott Children’s Hospital, CHEAR and the U-M Institute for Healthcare Policy and Innovation, which funded the report.
“On the one hand, sending children to school could increase the risk of COVID-19 among children and family members. On the other hand, children who don’t return to in-person school may experience disruptions in their education. Some families simply don’t have a choice because they need to go to work.”
Parents’ plans on sending their children to school were similar between each state but varied by demographic factors. Respondents who were Black, Hispanic, or Asian were less likely to report that they will send all of their children to school compared with respondents who were white/non-Hispanic.
Parents from low-income households were the least likely to report that they will send all of their children to school, with 40 % reporting that they are unsure of their plans or are not planning on sending at least one of their children.
“The disparity by household income raises the possibility of potential educational disruption among less advantaged students,” Chua says. “Efforts should especially be made to understand and address barriers to school attendance for these students, and to ensure high-quality education for students who do not attend school in-person.”
Views on masks and other safety measures
The survey revealed strong support for a number of measures to reduce COVID-19 exposure risk at school. Three-quarters of parents supported daily temperature screens of students and requiring testing of children if a classmate tests positive for COVID-19.
More than 60 % of parents supported decreasing the number of children on buses, alternating groups of children between in-person and virtual classes, staggering arrival and pick-up times, and random weekly COVID-19 testing for staff. Half supported random weekly COVID-19 testing of children and requiring children to eat meals in classrooms rather than cafeterias.
Most parents supported requiring face masks for school staff and middle and high school students, but were less likely to support requiring face masks for younger children, especially kindergarten through second grade.
Support was low for closing playground structures and stopping all extracurricular programs.
Overall, the average parent supported or strongly supported eight of the 15 measures assessed in the survey. While this number was lower in some demographic groups, three-quarters of parents supported four or more measures.
“Preferences for the number and types of measures vary among parents,” Chua says. “But they broadly agree with the notion that schools should take steps to keep children as safe as possible.”
Factors impacting a return to school
Twelve percent of parents surveyed indicated they will likely not send at least one of their children to school in fall, with health concerns being the biggest factor. Respondents were less likely to say their children would attend in-person school if they believe someone in their home has a condition that increases the risk of severe COVID-19 illness.
But many feel that the in-person school experience is best for their kids.
“I feel like (my child) gets a better education in person. I want her to be able to go to school where she can directly interact with teachers,” one Michigan parent said.
Twenty-one percent of parents said they weren’t sure yet about school attendance plans. Many are waiting to see how the COVID-19 pandemic evolves, while others are waiting to hear more about their schools’ plans.
“If the schools here decide to open, then that will mean we are trending in a favorable direction as far as the virus is concerned. I trust the local school districts to make the best decision based on their staff/cleaning/knowledge of the situation,” a parent from Illinois wrote.
Many respondents also indicated they had little choice to send children to school due to jobs and financial constraints.
“We have no family to babysit and do not have the funds to hire a babysitter if the kids stay home. If one of us has to stay home to watch them we will likely lose our house,” one Ohio respondent said.
Many families indicated that a surge in COVID-19 cases would cause them to reconsider plans for sending children to school. Others would likely reconsider based on the safety strategies implemented in schools or the type of educational experience their children might have.
Governors across the country are working with educators to develop plans to safely open school. Michigan Gov. Gretchen Whitmer is expected to announce her “Return to School Roadmap” on June 30, which will provide an outline for schools across the state to reopen for in-person learning in fall.
As these plans are announced, Chua believes it will be important to continue to survey parents regarding their plans and support for COVID-19 risk mitigation measures.
“In our survey, parents expressed a lot of uncertainty regarding their plans for school attendance,” he says. “Many are waiting to see how schools address safety and how the pandemic evolves. It’s very likely that parents’ views and plans will change as new information becomes available.”
###
Other authors of the report included Melissa DeJonckheere, Ph.D., Sarah Reeves, Ph.D., Alison Tribble, M.D., M.S.C.E., and Lisa Prosser, Ph.D., all from the Department of Pediatrics at Mott or Department of Family Medicine at Michigan Medicine.

Posted by at No comments:

Covid-19 could spark a mental health crisis – or post-traumatic growth

Some experts are warning of a looming mental health crisis in the wake of the Covid-19 pandemic that we are apparently ill-prepared for, and journalists are amplifying this message.
Everyone, it seems, is depressed and there is a new health curve to flatten.
We believe these warnings are being overdone, and definitely overlook the potential for post-traumatic growth (more on that in a minute).
There’s no question that the Covid-19 pandemic, the largest global disruption since World War II, is devastating millions of people with unexpected illness, disability, or death; financial insecurity; postponed weddings or virtual graduations; and more. A recent census study of Americans estimated the rates of anxiety and depression to be as high as 35%. We are being warned that the pandemic may increase rates of post-traumatic stress disorder, since being exposed to actual or potential death is the very definition of trauma.
While it is valuable to report on people’s mental states, emphasizing the potential for anxiety and depression too much can devolve into fearmongering and backfire.
People respond to trauma in various ways. Most show resilience and don’t develop long-standing mental health problems after experiencing a traumatic event. This response makes our work as psychologists feasible, as we see patients who show resilience even when facing the unimaginable terror or trauma.
Post-traumatic growth is a concept similar to resilience, but distinct from it. It’s a term coined by psychologists Richard Tedeschi and Lawrence Calhoun in the mid-1990s. In essence, post-traumatic growth is positive change that occurs in the aftermath of struggling with a major life crisis or traumatic event. According to Tedeschi and Calhoun, perhaps 50% of people experience post-traumatic growth after enduring a trauma.
It looks different for each person. Post-traumatic growth is a process, not an outcome, and typically involves developing positive responses in these areas: appreciation of life, enhanced relationships with others, new possibilities in life, newly identified personal strength, and spiritual or existential change.
Viktor Frankl, an Austrian psychiatrist, wrote in his book “Man’s Search for Meaning” that people are able to thrive after trauma by finding or imposing meaning on the experience. As a survivor of the Nazi concentration camps, Frankl knew what he was talking about. If he could see growth in his experiences, then Americans should be able to see it in an epidemic that has altered daily life.
Post-traumatic growth often arises after a situation has ended. None of us has an idea when the pandemic and its effects will be over, so that uncertainty may keep us from moving forward. It’s all the more reason to get things back to what we defined as normal at the beginning of the year.
We aren’t recommending trauma or adverse experiences as a growth journey, or suggesting that Covid-19 is a good thing. It isn’t. It has overwhelmed millions of people around the globe. But filling the uncertainty with dire prophecies about declining mental health adds to the anxiety people feel and becomes self-fulfilling. People need to be comforted and the research on post-traumatic growth can help with that. Negative attitudes such as stigma and shame can prevent seeking help, which could prevent this type of recovery, whereas optimism, altruism, social support, and self-confidence may foster post-traumatic growth.
The paradox of this process is that experiencing loss, although devastating, may help some individuals focus on what they have, and be grateful for the small things. Learning about the many aspects of life that are out of our control allows us to focus on what is within our control and make meaning out of the situation and the decisions we make.
Vulnerability can often become the glue that binds together people and communities, building strength that was otherwise unimagined. A crisis like this pandemic may provide unsought opportunities to grow and find new ways to appreciate life. We may someday look back on this and see the first half of 2020 in a far different light than we do now.
Jay Behel is an associate dean of student affairs and associate professor in the Division of Behavioral Sciences at Rush Medical College in Chicago. Jennifer A. Coleman is a clinical psychologist and assistant professor with the Road Home Program for veterans and their families at Rush University Medical Center.

Posted by at No comments:

Pandion Therapeutics files for IPO

Pandion Therapeutics (PAND) has filed a preliminary prospectus for a $75M IPO.
The Watertown, MA-based biopharmaceutical firm develops therapies for autoimmune disorders leveraging its TALON protein engineering platform that, it says, enables it to employ a modular approach to create candidates using immunomodulatory effector molecules that act at known control nodes within the immune system.
Lead candidate is PT101, a subcutaneously administered IL-2 mutein Fc fusion protein designed to selectively expand regulatory T cells for the treatment of autoimmune disease. Final data from a Phase 1a study in healthy volunteers should be available in H1 2021.
2019 Financials: Operating Expenses: $23.2M (+111%); Net Loss: ($21.9M) (-101%); Cash Burn: ($13.4M) (-26%).

Posted by at No comments:
Subscribe to: Comments (Atom)