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Pfizer Says Early Data Signals COVID-19 Vaccine Is Effective

AHA Publisher — Tue, 10 Nov 2020 08:00:02 +0000

Associated Press via CBN News – Pfizer says an early peek at its vaccine data suggests the shots maybe 90% effective at preventing COVID-19, indicating the company is on track later this month to file an emergency use application with U.S. regulators. Monday’s announcement doesn’t mean a vaccine is imminent: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries. Pfizer Inc. did not provide any more details about those cases and cautioned the initial protection rate might change by the time the study ends. Even revealing such early data is highly unusual. “We’re in a position potentially to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice president of clinical development, told The Associated Press. “We’re very encouraged.” Authorities have stressed it’s unlikely any vaccine will arrive much before the end of the year, and limited initial supplies will be rationed. The shots made by Pfizer and its German partner BioNTech are among 10 possible vaccine candidates in late-stage testing around the world – four of them so far in huge studies in the U.S. Another U.S. company, Moderna Inc., also has said it hopes to be able to file an application with the Food and Drug Administration later this month. Volunteers in the final-stage studies, and the researchers, don’t know who received the real vaccine or a dummy shot. But a week after their second required dose, Pfizer’s study began counting the number who developed COVID-19 symptoms and were confirmed to have the coronavirus. Because the study hasn’t ended, Gruber couldn’t say how many in each group had infections. Doing the math, that would mean almost all the infections counted so far had to have occurred in people who got the dummy shots. Pfizer doesn’t plan to stop its study until it records 164 infections among all the volunteers, a number that the FDA has agreed is enough to tell how well the vaccine is working. The agency has made clear that any vaccine must be at least 50% effective. No participant so far has become severely ill, Gruber said. Nor could he provide a breakdown of how many of the infections had occurred in older people, who are at the highest risk from COVID-19. Participants were tested only if they developed symptoms, leaving unanswered whether vaccinated people could get infected but show no symptoms and unknowingly spread the virus. FDA has required that U.S. vaccine candidates be studied in at least 30,000 people. In addition to adequate numbers of older adults, those studies must also include other groups at high risk, including minorities and people with chronic health problems. And it told companies they must track half their participants for side effects for at least two months, the time period when problems typically crop up. Pfizer expects to reach that milestone later this month but said Monday no serious safety concerns have been reported. Because the pandemic is still raging, manufacturers hope to seek permission from governments around the world for emergency use of their vaccines while additional testing continues – allowing them to get to market faster than normal but raising concerns about how much scientists will know about the shots. The FDA’s scientific advisers last month said they worry that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work. Those advisers said it’s critical these massive studies are allowed to run to completion. Copyright 2020 The Associated Press. All rights reserved. To read the original article click here. For more articles from CBN News click here.

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Albany, Wisconsin Teams Search for Molecular Clues to Defeat COVID-19

AHA Publisher — Wed, 29 Apr 2020 07:00:26 +0000

Morgridge Institute for Research via Newswise – Newswise — In the center of the COVID-19 pandemic, hospitals are racing to maintain quality care for patients with severe disease while facing a shortage of resources and limited understanding of the novel coronavirus. One physician on the front lines—Dr. Ariel Jaitovich, a pulmonary and critical care physician at Albany Medical Center in New York—sought out a collaboration with investigators at the Morgridge Institute for Research and the Department of Biomolecular Chemistry at the University of Wisconsin School of Medicine and Public Health (SMPH) to better understand the molecular profile of COVID-19 and provide insights that may improve treatment. “It’s a new disease. Two months ago, we knew nothing about it,” says Jaitovich. “What we are trying to do now is develop a systematic way to better understand what this disease is about.” By analyzing approximately 150 patient COVID-19 samples from Albany Medical Center, the collaborative research team is hoping to better understand what factors influence whether a patient will suffer from complications such as acute respiratory distress syndrome (ARDS). One example is the immunological concept of a cytokine storm—where the inflammatory response of the immune system goes into over-drive—as a possible trigger for ARDS. “There’s no clear understanding of whether these people who do really bad are the ones who have a toxic level of inflammation…if this cytokine storm is necessarily associated with worse outcomes in COVID patients,” Jaitovich says. Jaitovich reached out to Morgridge investigator, SMPH professor, and mass spectrometry expert Josh Coon to help because, he says, “Josh runs one of the most sophisticated and advanced labs to investigate proteins.” Coon leads the Laboratory for Biomolecular Mass Spectrometry at UW-Madison and he had been looking for a way to leverage his lab’s technology to help with the pandemic. The lab’s efforts will be managed by LBMS associate director Katie Overmyer and assistant staff scientist Evgenia Shishkova. “It’s what we do. We take a problem, we apply our technologies. We help our collaborators solve this problem,” says Overmyer. The research team is using an approach called mass spectrometry to measure lipids, proteins and other small molecules called metabolites in samples from patients hospitalized with COVID-19. They will be compared to control samples from hospitalized patients who tested negative for COVID-19. The technology allows scientists to identify different compounds and better understand their properties. Coon says it may help them identify molecular signals that might distinguish a mild case from a severe case. Much of the previous research on coronaviruses and influenza has typically focused on proteomics (proteins), lipidomics (lipids), and metabolomics (metabolites) separately, Overmyer notes. “This multi-omic approach is fairly new and not well adopted yet,” she says. “I think that’s going to be the really powerful tool here, to be able to link those and maybe make better inferences about what’s going on than a single [approach] would allow.” In addition to the cytokine storm process, Coon says there are other potential indicators of disease severity that involve blood clotting factors in the vessels of the lung. The research team hopes that studying the different proteins, metabolites, and lipids involved in these unique disease mechanisms can reveal more about what is happening in patients with COVID-19. “Can we stratify those patients based on those molecular measurements and help predict what an outcome might be? I think those are the overall goals: to really try to understand what’s happening at a molecular level,” Coon says. While the Coon laboratory works on characterizing the molecular signatures, Jaitovich’s team will also work to identify the genetic influences on the disease. To analyze this data, which involves RNA sequencing, Jaitovich is collaborating with Morgridge bioinformatics experts Ron Stewart and Scott Swanson. “We should be able to get an idea about what genes or gene sets are involved in things like inflammation, and how that might differ between COVID-19 and other ARDS cases,” says Stewart, principal investigator and associate director of bioinformatics at Morgridge. Swanson will lead the analysis to determine if there are unique gene expression profiles that might differ between the mild and severe cases. “I can look at those genes, and we have all kinds of databases available to us that tell us about which genes are related to different physiological characteristics,” he says. “We’re following the footsteps of established techniques that have produced results in this specific domain of ARDS, if not necessarily for coronaviruses. So, I’m optimistic that something intelligible and meaningful will come out of even just that first pass of analysis.” By combining the mass spectrometry data with the RNA sequencing data, Jaitovich says that the ultimate outcome of this project is to identify potential targets to help treat the disease. “This is extremely important for many reasons, because you can, for example, intervene early with people who are more likely to do worse over time based on these early identified markers,” he says. “You can better allocate resources in a moment in which there is a shortage of resources to deal with this pandemic.” The team is working to analyze patient samples as soon as they arrive. “Certainly, as long as we’ve been in business…there’s never been a pandemic like this with such urgency to really come up with a scientific solution,” says Coon. “It is difficult, because we deal with real-world problems of patients who are suffering from it or losing loved ones. You know, a lot of anxiety,” says Jaitovich. “On the other hand, there is a lot of support, including healthcare workers, patients and families. There is massive support by the institution’s leadership…they are all committed to working together toward the common goal: alleviating people’s suffering.” To read the original article click here.

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New COVID-19 Test Gives Results in Four Hours

AHA Publisher — Wed, 01 Apr 2020 07:00:43 +0000

Tulane University via Newswise – The tests detect the virus in saliva and mucus swab samples from patients who meet the clinical and epidemiological criteria for testing. Newswise — A laboratory based at Tulane Medical Center and in partnership with UMC-LCMC is conducting a new test for COVID-19 that can yield results within four hours. The test was made possible through the joint efforts of the Tulane University School of Medicine, the LSU School of Medicine, Tulane Medical Center, LCMC Health and Roche Diagnostics. Researchers at the Tulane Medical Center Laboratory ran its first set of tests using the Cobas 6800 analyzer, as the test is known, over the weekend and is now capable of running nearly 200 tests a day on patients at both Tulane Medical Center and University Medical Center. Roche Diagnostics is the Switzerland-based manufacturer of the Cobas 6800 analyzer. The FDA this month issued emergency use authorization to Roche to test patients who show signs and symptoms of COVID-19 infection. The tests detect the virus in saliva and mucus swab samples from patients who meet the clinical and epidemiological criteria for testing. Because of its rapid turnaround, doctors can quickly release patients who test negative and quarantine and treat those who test positive. It also means that tests no longer need to be shipped to the state lab in Baton Rouge. The Louisiana Department of Health recommends testing for any patient with fever, respiratory symptoms and negative flu test. Any provider can order testing based on their clinical judgment. Those with mild symptoms such as fever and a cough should self-isolate and call ahead to their physician’s office so they can limit exposure to others. Anyone with severe symptoms such as difficulty breathing or shortness of breath, persistent pain or chest pressure, new confusion, bluish lips or face should call 911 and go to a hospital emergency room. “Hospitals need in-house testing to manage patients admitted with presumptive symptoms of COVID-19,” said Dr. Byron Crawford, medical director of the Tulane Medical Center Laboratory and a professor of pathology at Tulane School of Medicine. This new rapid testing solution will improve hospitals’ ability to quickly diagnose COVID patients and help conserve precious resources and space in COVID-specific units. “You want to know as soon as possible whether a patient has COVID or not. You want to get those who test negative out as soon as possible, otherwise it ties up physicians, health care workers and PPEs (personal protective equipment),” Crawford said. Crawford credited the multi-talented individuals from the Tulane University School of Medicine, LSU School of Medicine, Tulane Medical Center, UMC-LCMC and Roche Diagnostics “for working as a team to improve patient care at both UMC and TMC while also helping our overall community in this pandemic.” Dr. Gordon Love, professor and chair of pathology at LSU Medical School and Medical Director of Laboratories at University Medical Center, agreed. “I knew that Tulane Medical Center Laboratory had the instrument to detect COVID-19 virus but could not obtain the chemicals to run the tests,” Love said. “LCMC Health’s leadership was able to obtain these chemicals from Roche Diagnostics and I was able to work with Dr. Crawford to bring the testing up at TMC. This is a great example of LSU Medical School, University Medical Center and Tulane Medical Center working together for the benefit of the people of New Orleans to fight the COVID-19 virus.” Dr. Lee Hamm, dean of Tulane Medical School, said the lack of rapid testing had been “one of the critical issues in dealing with this pandemic. By working together between Tulane, LSU, and LCMC/UMC we have been able to achieve rapid testing now – this is a huge achievement for our patients.” To read the original article click here.

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