Author Interviews, Infections, Respiratory / 25.03.2021

MedicalResearch.com Interview with: Pranay Sinha, MD Section of Infectious Diseases Boston University School of Medicine MedicalResearch.com: What is the background for this study? Response: We hypothesized that mitigation measures such as physical distancing and mask wearing instituted in Boston would reduce transmission of common respiratory viruses such as influenza, Rhinovirus, and Parainfluenzavirus. We compared the rate of detection of such viruses at Boston Medical Center on comprehensive respiratory panels in the ambulatory, emergency room, and hospital settings in 2020 to rates in the previous five years. (more…)
Author Interviews, CDC, COVID -19 Coronavirus, Heart Disease / 25.08.2020

MedicalResearch.com Interview with: Eric J. Chow, MD, MS, MPH Epidemic Intelligence Service Officer (completed in 2020); Influenza Division. Centers for Disease Control and Prevention  MedicalResearch.com: What is the background for this study? What are the main findings?
  • Both heart disease and influenza epidemics cause substantial morbidity and mortality every year. In some seasons, influenza virus infections alone contribute up to 810,000 hospitalizations and 61,000 deaths. There is increasing evidence that there is overlap between infections, specifically influenza, and heart disease. In our study, we sought to describe the frequency and risk factors for acute cardiac events in patients who are hospitalized with influenza.
  • In over 80,000 adults hospitalized with influenza over 8 seasons (2010-2018), almost 12% were diagnosed with acute cardiac events, with acute heart failure and acute ischemic heart disease being the most common.
  • Among patients hospitalized with influenza who experienced acute cardiac events, almost one-third were admitted to the intensive care unit and 7% died while hospitalized.
  • Our study also reaffirmed that people who are older, smoke tobacco or have underlying cardiovascular disease, diabetes and kidney disease are at increased risk for the most common acute cardiac events, acute heart failure and acute ischemic heart disease.
  • Although vaccinated persons had a lower risk of acute ischemic heart disease and acute heart failure, this study was not designed to specifically assess vaccine effectiveness.  However, this and other studies support the importance of influenza vaccines for people with underlying heart conditions. 
(more…)
Author Interviews, COVID -19 Coronavirus, Flu - Influenza, JAMA / 19.08.2020

MedicalResearch.com Interview with: Jeremy Samuel Faust, M.D., M.S., M.A., FACEP Brigham & Women's Hospital Department of Emergency Medicine Division of Health Policy and Public Health Instructor, Harvard Medical School President, Roomful of Teeth Vocal Arts Project (www.roomfulofteeth.org)  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We sought to compare the initial covid-19 outbreak in NYC to the peak of the 1918 H1N1 pandemic in that same city. We found that the covid-19 pandemic was associated with more than 70% as many deaths per capita (monthly) as 1918 H1N1 was. But because baseline mortality rates are about 1/2 of what they were a century ago, death rates were over 400% of usual rates in March and April of this year compared to recent years, while 1918 was "merely" over 280% of usual death rates from prior years leading up to it. (more…)
Author Interviews, Flu - Influenza, Infections, NEJM, Vaccine Studies / 15.07.2020

MedicalResearch.com Interview with: Frederick Hayden MD Stuart S Richardson Professor Emeritus of Clinical Virology Professor Emeritus of Medicine Division of Infectious Diseases and International Health University of Virginia  MedicalResearch.com: What is the background for this study? Response: Although primary prevention approach for influenza infections is vaccination, vaccine efficacy is incomplete and uptake rates are variable in the population. Preventing people who have been exposed to someone with influenza from developing the disease is an important way to prevent its rapid spread, reduce the disruption to peoples' lives and, in some cases, reducing the risk of serious illness or even death.  Prior studies have shown that antivirals like oseltamivir and inhaled zanamivir can reduce the risk influenza illness in those exposed. The BLOCKSTONE study was designed to assess the efficacy of postexposure prophylaxis with a single oral dose of baloxavir for the preventing influenza in household contacts. This antiviral drug was approved first in 2018 for treatment of adults with uncomplicated influenza.  (more…)
Author Interviews, COVID -19 Coronavirus, Infections, Pediatrics / 07.04.2020

genentech MedicalResearch.com: What are the applicable pediatric and post-exposure indications? Response: We recently announced that the U.S. FDA has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted an NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours. The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation. (more…)
Author Interviews, Cost of Health Care, Infections / 07.03.2020

MedicalResearch.com Interview with: Dr. Steve Miller MD MBA Chief Clinical Officer Cigna MedicalResearch.com: What is the background for this study? Response: With diagnoses of coronavirus increasing, Cigna is committed to helping contain the virus, removing barriers to testing and treatment, and giving peace of mind to its clients and customers. (more…)
Author Interviews, Flu - Influenza, Genetic Research, PNAS / 10.09.2019

MedicalResearch.com Interview with: Jacob S. Yount, PhD Associate Professor Department of Microbial Infection and Immunity The Ohio State University, College of Medicine Co-Director, Viruses and Emerging Pathogens Program OSU Infectious Diseases Institute MedicalResearch.com: What is the background for this study? Response: Genetic defects in a human protein known as IFITM3 are linked to hospitalization and death upon influenza virus infections.  IFITM3 is an immune system protein that can inhibit virus entry into cells and it is produced as an early response to virus infections.  In order to better study the role of IFITM3 during infections, we engineered a mouse model that lacks this protein.   (more…)
Author Interviews, Flu - Influenza, Pulmonary Disease, Stem Cells, University of Pennsylvania / 22.08.2019

MedicalResearch.com Interview with: Andrew E. Vaughan, PhD Assistant Professor, Biomedical Sciences School of Veterinary Medicine University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Severe respiratory infections, including influenza, can progress to acute respiratory distress syndrome (ARDS), wherein barrier function and gas exchange are compromised.  It’s a very life threatening scenario.  This is due in part to loss of alveolar type 2 (surfactant producing) and type 1 cells (gas exchanging).  Interestingly alveolar type 2 cells are also stem cells in the lung.  We wondered whether transplant of these cells might aid in recovery from severe influenza infection, and sure enough, it did! (more…)
Author Interviews, CDC, Flu - Influenza, Vaccine Studies / 29.05.2019

MedicalResearch.com Interview with: Megan C. Lindley, MPH Deputy Associate Director for Science Immunization Services Division CDC MedicalResearch.com: What is the background for this study? Response: Despite longstanding recommendations from the Advisory Committee on Immunization Practices, healthcare personnel influenza vaccination coverage remains below the Healthy People 2020 target of 90%. Healthcare employers use a variety of strategies to promote influenza vaccination among healthcare personnel, including facility-level mandates for vaccination. Several U.S. states have also enacted laws related to healthcare personnel influenza vaccination, but the effect of these laws on vaccination uptake is unclear. Our study used influenza vaccination coverage data reported by over 4,000 U.S. hospitals to examine three kinds of laws: (1) Assessment laws, which require hospitals to assess healthcare personnel influenza vaccination status; (2) Offer laws, which require hospitals to offer the influenza vaccine to healthcare personnel; and (3) Ensure laws, which require hospitals to require healthcare personnel to demonstrate proof of influenza vaccination. (more…)
Author Interviews, Brigham & Women's - Harvard, Flu - Influenza, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: Sonja Kytomaa MA Research Associate Brigham and Women’s Hospital Scott D. Solomon, MD The Edward D. Frohlich Distinguished Chair Professor of Medicine Harvard Medical School Senior Physician Brigham and Women’s Hospital International Associate Editor, European Heart Journal   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Influenza is associated with an increased risk of cardiovascular events, yet few studies have explored the temporal association between influenza activity and hospitalizations, especially due to heart failure (HF). Our aim with this study was to explore the temporal association between influenza activity and hospitalizations for HF and myocardial infarction (MI) in the general population. We related the number of MI and HF hospitalizations by month, which were sampled from 4 US communities and adjudicated in the surveillance component of the Atherosclerosis Risk in Communities (ARIC) study, to monthly influenza-like illness activity, as reported by the Centers for Disease Control and Prevention. We found that a 5% increase in influenza activity was associated with a 24% increase in HF hospitalizations rates, while overall influenza was not significantly associated with MI hospitalizations. Influenza activity in the months before hospitalization was not associated with either outcome. (more…)
Author Interviews, CDC, Flu - Influenza, OBGYNE, Pediatrics / 07.02.2019

MedicalResearch.com Interview with: Kim Newsome, MPH National Center on Birth Defects and Developmental Disabilities CDC  MedicalResearch.com: What is the background for this study? Response: This study supports data from previous studies that have shown increased risks for infants born to pregnant women who are severely ill with flu. MedicalResearch.com: What are the main findings? Response: Our study found that severely ill women with 2009 H1N1 influenza during pregnancy were more likely to have adverse birth outcomes (such as their baby being born preterm or of low birth weight) than women without influenza.  (more…)
Author Interviews, Flu - Influenza, Infections, PLoS, University of Michigan / 25.01.2019

MedicalResearch.com Interview with: Betsy Foxman PhD Hunein F. and Hilda Maassab Endowed Professor of Epidemiology Director, Center for Molecular and Clinical Epidemiology of Infectious Diseases Ann Arbor, Michigan 48109-2029 MedicalResearch.com: What is the background for this study? Response: Influenza is a major cause of human illness and death worldwide. Vaccines are the best available means of prevention. However, vaccine effectiveness has been low to moderate in recent years and coverage remains low in many countries. There is increasing evidence suggesting the microbiome plays an important role in shaping host immunity and may be a potential target for reducing disease. In our study, we used a household transmission study to explore whether the respiratory microbiome was associated with influenza susceptibility.  (more…)
Author Interviews, Flu - Influenza, Genentech / 30.10.2018

MedicalResearch.com Interview with: Mark D. Eisner, MD, MPH Vice PresidentProduct Development Immunology, Infectious Disease and Ophthalmology Genentech Dr. Eisner discusses the announcement that the FDA has approved XOFLUZA™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza. MedicalResearch.com: What is the background for this announcement? Response: Each year, an estimated 3-11 percent of the U.S. population gets the flu, and it can be very serious, resulting in hospitalization or even death. Since 2010, the Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths. The severity of last year’s flu season underscores the need for new medical options beyond currently available antivirals. XOFLUZA was granted Priority Review in June 2018 based on results from the Phase III CAPSTONE-1 study of a single dose of XOFLUZA compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled Phase II study in otherwise healthy people with the flu. (more…)
Author Interviews, Flu - Influenza, Roche / 11.10.2018

MedicalResearch.com Interview with: Mark D. Eisner, MD, MPH Vice President, Product Development Immunology Infectious Disease and Ophthalmology Genentech  MedicalResearch.com: What is the background for this study? Response: CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated the efficacy and safety of a single dose of baloxavir marboxil compared with placebo and oseltamivir in people 12 years and older who are at a high risk of complications from the flu. The Centers for Disease Control and Prevention (CDC) defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity or heart disease. A total of 2,184 participants enrolled in the study and were randomly assigned to receive a single, oral dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice daily for five days. The primary objective of the study evaluated the efficacy of a single dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms. Key secondary endpoints compared outcomes in baloxavir marboxil versus placebo or oseltamivir – these included time to resolution of fever, time to cessation of viral shedding, infectious virus detection in swabs of the nose and throat, prescription of antibiotics and influenza-related complications. Genentech announced initial results from the study on July 16, 2018 but the full data was presented for the first time during a late-breaking oral presentation at the annual IDWeek meeting in San Francisco, CA on October 6, 2018. Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza A and B viruses, including oseltamivir-resistant strains and avian strains (e.g. H7N9, H5N1). Baloxavir marboxil is the first potential influenza treatment to demonstrate a clinically meaningful benefit for people highly vulnerable to serious influenza complications in clinical trials. The FDA accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The NDA was based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Results from a placebo-controlled Phase II study in otherwise healthy people with the flu were included as supporting data in the NDA. The FDA is expected to make a decision on approval by December 24, 2018. (more…)
Abbott, Author Interviews, Flu - Influenza / 08.10.2018

MedicalResearch.com Interview with: Dr. Norman Moore PhD Abbott’s Director of Scientific Affairs for Infectious Diseases  MedicalResearch.com: What is the background for this test? How does ID NOW differ from other tests for influenza? Response: This test was developed to give providers – and their patients – lab-accurate results more quickly than ever, right at the point of care. It was designed for ease of use, as well as to be portable and small enough that it can be used in a broad range of healthcare settings, including walk-in clinics, urgent care centers, doctors’ offices and emergency rooms. Prior to ID NOW, traditional molecular tests offered great performance, but took too long to impact treatment decisions. ID NOW is able to deliver the performance and accuracy of lab-based tests in a timeframe that offers the best chance of improving treatment decisions.  (more…)
Author Interviews, Flu - Influenza, Genentech / 26.07.2018

MedicalResearch.com Interview with: Mark Eisner MD MPH Mark D. Eisner, MD, MPH Vice President, Product Development Immunology, Infectious Disease, and Ophthalmology Genentech   MedicalResearch.com: What is the background for this study? Would you briefly explain how baloxavir marboxil differs from other flu treatments?  Response: CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated a single dose of baloxavir marboxil compared with placebo and oseltamivir in people 12 years and older who are at a high risk of complications from the flu. The high risk inclusion criteria in CAPSTONE-2 were aligned with the Centers for Disease Control and Prevention (CDC), which defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes or heart disease. For these people, flu can lead to hospitalization or even death. Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for five days. The FDA recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The NDA was based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Results from a placebo-controlled Phase II study in otherwise healthy people with the flu were included as supporting data in the NDA. The FDA is expected to make a decision on approval by December 24, 2018. Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication. By inhibiting this protein, baloxavir marboxil prevents viral replication earlier in the flu virus life cycle. (more…)
Author Interviews, Flu - Influenza, Infections, Mental Health Research, Primary Care, Roche / 14.03.2018

MedicalResearch.com Interview with: James W. Antoon, MD, PhD, FAAP Assistant Professor of Clinical Pediatrics University of Illinois at Chicago Associate Medical Director, Pediatric Inpatient Unit Children's Hospital, University of Illinois Hospital & Health Sciences System Chicago, IL 60612  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Oseltamivir, commonly known as Tamiflu, is the only commercially available medication FDA approved to treat the flu.  Since the 2009 H1N1 flu epidemic pediatric prescriptions for Tamiflu have soared.  In the United States, about 40% of Tamiflu prescriptions are given to children less than 16 years of age.  Following reports of abnormal behavior, such as hallucinations, self-injury and suicide attempts in adolescents on Tamiflu, the FDA placed a new warning about these neuropsychiatric symptoms on the drug label.  Whenever the FDA puts out label warning about a drug, doctors and the public take notice. Whether Tamiflu truly causes these side effects is unclear.  For this study we chose to focus on the most consequential of those reports: suicide. The potential link between a drug and suicide is a particularly difficult topic to study for a number of reasons. There are things that happen together or at the same time that can influence someone to attempt suicide and it is very difficult to know which thing is actually having an affect. In our study, other things that can influence suicide are socioeconomic status, mental health, trauma, abuse, among others.  Separating the effects of these confounders can be difficult. It is also possible that the disease itself, which in this case is the flu, causes the effect of suicide. Finally, and luckily, suicide is rare. Our database had 12 million children per year and over five year 21,000 attempted suicide. Of those, only 251 were taking Tamiflu. To get past these issues, we took advantage of a growing drug safety research collaboration between the Departments of Pediatrics and Pharmacy at our institution.  Previous studies have compared those on Tamiflu to those not on Tamiflu to see if there are more side effects in the Tamiflu group.  Our team utilized a novel study method called a case-crossover design. What’s different about this study is that we used each patient as their own comparison.  In other words, we compared each patient to themselves rather than a different group of people.  We essentially studied how patients behaved when the Tamiflu was in their system compared to other l periods where they were not on Tamiflu.  This allowed use to account for the personal differences noted above like mental health and socioeconomic status.   We also compared those children with flu who got Tamiflu and those with flu who did not get Tamiflu to see if the infection itself could be associated with increased suicide. After accounting for all these variables, we did not find any an association between Tamiflu exposure and suicide. Our findings suggest that Tamiflu does NOT increase the risk of suicide in children or teenagers. (more…)
Author Interviews, Flu - Influenza / 02.03.2018

MedicalResearch.com Interview with: Ishanu Chattopadhyay, PhD Assistant Professor, Department of Medicine Section of Hospital Medicine Institute for Genomics and Systems Biology University of Chicago MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is estimated that flu kills thousands every year in US, some estimates put the yearly death toll to around 30,000 -- that is just in US, and that is irrespective of whether a new virus emerges. But why do waves of the disease sweep the globe every year, as if on a schedule? It had been suggested before that the trigger is a specific change in weather conditions, specifically, when normally humid air turns dry. In this new study, we explore this question in much greater detail than was possible before, bringing to bear massive amounts data, such as 150 million individual medical histories recorded over the last decade, along with massive climate datasets. What we found was both fascinating, and consequential -- no single factor is responsible wholly, and it requires a complex, yet precise, mix of weather conditions, demographic makeup, socio-economic variables, vaccination coverage, antigenic drift states of the virus, and human traveling habits, among others, to trigger the seasonal epidemic waves. Quite surprisingly, long range air-travel is far less important compared to short range ground travel. This work attempts to finally settle the lack of consensus in the scientific community on which factors are responsible, as well as each factor’s relative importance. (more…)
Author Interviews, Flu - Influenza, Vaccine Studies / 12.02.2018

MedicalResearch.com Interview with: “#influenza” by J.S. Zolliker is licensed under CC BY 2.0Dr. Vittorio Demicheli Servizio Regionale di Riferimento per l'Epidemiologia SSEpi-SeREMI, Azienda Sanitaria Locale ASL AL Alessandria, Piemonte, Italy MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The consequences of influenza in adults are mainly time off work. Only vaccination of pregnant women is recommended internationally, while mass vaccination of healthy adults is still matter of debate. The aim of this Cochrane Review is to assist informed decision making summarizing research that looks at the effects of immunizing healthy adults with influenza vaccines during influenza seasons. The review process found 52 clinical trials of over 80,000 adults. Only around 15% of the included studies were well designed and conducted. We focused on reporting of results from 25 studies that looked at inactivated vaccines. Injected influenza vaccines probably have a small protective effect against influenza and influenza-like illness (ILI_ (moderate-certainty evidence), as 71 people would need to be vaccinated to avoid one influenza case, and 29 would need to be vaccinated to avoid one case of ILI. Vaccination may have little or no appreciable effect on hospitalizations (low-certainty evidence) or number of working days lost. (more…)
Author Interviews, Flu - Influenza, Nature, Vaccine Studies / 26.01.2018

MedicalResearch.com Interview with: “Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Dr. Lei Deng PhD Postdoctoral researcher Institute for Biomedical Sciences at Georgia State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Influenza A viruses evade human herd immunity by genetic hypervariation. Annual influenza epidemics are estimated to cause about 3 to 5 million cases of severe illness, and about 290,000 to 650,000 deaths. Vaccination is still the most effective way to prevent diseases, but current influenza vaccines provide limited protections against mismatched circulating virus strains. This drives scientists to develop universal influenza vaccines that can induce broad immune responses against all influenza A virus infections. We used biochemistry and nanotechnology to generate a double-layered protein nanoparticle universal influenza vaccine. The layered nanoparticle contains genetically modified influenza virus components without irrelevant carry/structural proteins and chemicals and confers strong and long-lasting immunity in laboratory mice against H1N1, H3N2, H5N1 and H7N9 infections. We also explain the protection mechanism of antibody dependent cell-mediated cytotoxicity (ADCC) and antibody dependent cell-mediated phagocytosis (ADCP) play the main role in the immune protection.  (more…)
Author Interviews, Biomarkers, Flu - Influenza, Infections / 01.11.2017

MedicalResearch.com Interview with: Ana Falcón Department of Molecular and Cellular Biology National Center for Biotechnology Spanish National Research Council (CNB-CSIC) Madrid, Spain MedicalResearch.com: What is the background for this study? Response: Influenza A virus (IAV) infection can be severe or even lethal in toddlers, the elderly and patients with certain medical conditions. Infection of apparently healthy individuals nonetheless accounts for many severe disease cases and deaths, suggesting that viruses with increased pathogenicity co-circulate with pandemic or epidemic viruses. IAV virulence and pathogenesis are dependent on complex, multigenic mechanisms involving the viral genetic characteristics, the host conditions, the virus-host interactions, and the host response to the infection. Influenza virus pathogenicity has been studied in depth for many years, and several amino acid changes have been identified as virulence determinants, however, a general pathogenicity determinant has not been characterized. A proportion of influenza virus particles have defective genome RNAs (Defective Viral Genomes-DVGs) due to internal deletions of viral segments. The DVGs have the 3’ and 5’ ends of the parental RNA segments, and most have a single, large central deletion that generates viral RNAs of 180–1000 nucleotides. The presence of DVGs potentiates the host response in cultured cells and in animal models and leads to attenuated infection, possibly through recognition of double-stranded RNA by receptors that activate antiviral signaling cascades. (more…)
Author Interviews, Diabetes, Flu - Influenza, Genetic Research / 19.09.2017

MedicalResearch.com Interview with: Paz Lopez-Doriga Ruiz MD, PhD candidate Norwegian Institute of Public Health Department of Non Communicable Diseases OsloPaz Lopez-Doriga Ruiz MD, PhD candidate Norwegian Institute of Public Health Department of Non Communicable Diseases Oslo  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Some case reports have linked pandemic influenza to the development of type 1 diabetes. Other studies have suggested that also respiratory infections may contribute to type 1 diabetes risk.  Our findings supports a suggested role of respiratory infections in the etiology of type 1 diabetes and influenza virus could be a contributing factor to the development of clinical diabetes, due to stress and inflammation in predisposed individuals. (more…)
Author Interviews, Flu - Influenza, Kaiser Permanente, Merck, NEJM, Vaccine Studies / 10.08.2017

MedicalResearch.com Interview with: Michael Jackson  PhD, MPH Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network  MedicalResearch.com: What is the background for this study?
  • Response: Each year, Kaiser Permanente Washington is one of five sites across the country that participate in the United States Influenza Vaccine Effectiveness Network. The Network reports its early interim results in the MMWRand presents additional interim results to the Advisory Committee on Immunization Practices (ACIP)This New England Journal of Medicine publication is an update of those interim results.
  • The findings in this New England Journal of Medicine are special because prior randomized controlled trials indicated that the nasal spray vaccine (FluMist)—also called live attenuated influenza vaccine (LAIV)—would work well to protect children and teens from the flu, whereas in actual practice we found that the flu shot worked much better, particularly against the predominant strain, A(H1N1)pdm09.
  • The nasal spray vaccine was first seen to be less effective for young children than the flu shot in 2013-2014 for the A(H1N1)pdm09 virus strain. In response, the A(H1N1)pdm09 virus strain used in the nasal spray vaccine was changed for the 2015-2016 influenza season. The 2016/17 season was the first since 2015-2016 to be dominated by the A(H1N1)pdm09 virus, making this our first opportunity to evaluate the updated nasal spray vaccine.
  • The Influenza Vaccine Effectiveness Network evaluated the impact of this change as part of our estimates of influenza vaccine effectiveness in 2015-2016. Preliminary findings from this study were presented to the ACIP in June 2016, which led to the nasal spray vaccine not being recommended in 2016-2017 in the US, although the nasal spray vaccine remains licensed in the US. In 2016-2017, the LAIV A(H1N1)pdm09 vaccine strain was unchanged from 2015-2016.
(more…)
Author Interviews, Emory, Flu - Influenza, Lancet, Technology, Vaccine Studies / 28.06.2017

MedicalResearch.com Interview with: Dr Nadine G Rouphael MD Associate Professor of Medicine, Emory University Director of the VTEU and HIPC networks at the Hope Clinic of the Emory Vaccine Center Decatur GA 30030, USA MedicalResearch.com: What is the background for this new technology and study? What are the main findings? Response: Different groups including a group of researchers at Georgia Tech have been working on the microneedle technology for more than 20 years. The dissolvable microneedle patches are already used in several cosmetic products and drugs. However, vaccination with microneedle patches has been studied mostly in animals. Our phase 1 trial published this week in The Lancet showed that vaccination with the microneedle patches was safe, with no related serious adverse events reported. Local skin reactions to the patches were mostly mild itching and faint redness that lasted two to three days. No new chronic medical illnesses or influenza-like illnesses were reported with either the patch or the injection groups. Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. When asked after immunization, more than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations. (more…)
Author Interviews, Flu - Influenza, NEJM, Vaccine Studies / 22.06.2017

MedicalResearch.com Interview with: Lisa M. Dunkle, M.D. Chief Medical Officer Protein Sciences Corporation 1000 Research Parkway Meriden, CT MedicalResearch.com: What is the background for this study? What are the main findings? Response: The first and only recombinant protein influenza vaccine (RIV, Flublok) was approved in 2013 as a trivalent formulation for use in adults 18 years of age and older. This approval was based on demonstration of clinical efficacy (full approval) in adults 18-49 years of age and accelerated approval was granted for adults 50 years of age and older. Two clinical trials were conducted in 2014-2015 with RIV4 (Flublok Quadrivalent), of which the trial reported in the current NEJM is one. These studies supported full approval of Flublok in adults 50 years of age and older and approval of Flublok Quadrivalent in all adults 18 years of age and older. The second trial of immunogenicity of Flublok Quadrivalent in adults 18-49 years of age will be the subject of another publication in the near future. The main findings of the current trial are well summarized in the Conclusion of the Abstract: “RIV4 provided better protection than standard-dose IIV4 against confirmed influenza-like illness in older adults.” Additionally, the recombinant vaccine (RIV4, Flublok Quadrivalent) demonstrated significantly less injection site pain and tenderness following vaccination. Based on the characteristics of the study participants, one can conclude that RIV4 is safe and effective in most individuals with underlying chronic diseases (more…)
Author Interviews, CDC, Flu - Influenza, OBGYNE, Vaccine Studies / 31.05.2017

MedicalResearch.com Interview with: Dr. Elyse Olshen Kharbanda, MD MPH HealthPartners Institute Minneapolis, MN MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pregnant women who get the flu are at an increased risk for severe illness. To protect pregnant women, the Advisory Committee on Immunization Practices recommends women receive inactivated influenza vaccine (IIV) during any trimester of their pregnancy. This study used data from the Vaccine Safety Datalink to evaluate if there was an increased risk for selected major structural birth defects for infants whose mothers received IIV in the first trimester of pregnancy versus infants who were unexposed to IIV. Among over 425,000 live births, including 52,856 whose mothers received IIV during first trimester, we evaluated risks for major structural birth defects.  In this large observational study, we did not observe increased risks for major structural birth defects in offspring following first trimester maternal inactivated influenza vaccine exposure. (more…)
Author Interviews, BMJ, Flu - Influenza, Karolinski Institute, OBGYNE, Pediatrics, Pharmacology / 01.03.2017

MedicalResearch.com Interview with: Dr. Sophie Graner Department of Women's and Childrens Health Karolinska Institute, Stockholm, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pregnant women are at increased risks of severe disease and death due to influensa infection, as well as hospitalization. Also influenza and fever increase the risk of adverse pregnancy outcomes for their infants such as intrauterine death and preterm birth. Due to this, the regulatory agencies in Europe and the US recommended post exposure prophylaxis and treatment for pregnant women with neuraminidase inhibitors during the last influenza pandemic 2009-10. Despite the recommendations, the knowledge on the effect of neuraminidase inhibitors on the infant has been limited. Previously published studies have not shown any increased risk, but they have had limited power to assess specific neonatal outcomes such as stillbirth, neonatal mortality, preterm birth, low Agar score, neonatal morbidity and congenital malformations. (more…)
Author Interviews, Flu - Influenza, Pediatrics, Science, UCLA / 28.11.2016

MedicalResearch.com Interview with: Katelyn M. Gostic and Monique Ambrose Department of Ecology and Evolutionary Biology University of California Los Angeles MedicalResearch.com: What is the background for this study? What are the main findings? Monique Ambrose: Influenza pandemics pose a serious, recurrent threat to human public health. One of the most probable sources of future pandemic influenza viruses is the pool of influenza A virus (IAV) subtypes that currently circulate in non-human animals. It has traditionally been thought that the human population is immunologically naïve and unprotected against these unfamiliar subtypes. However, our work suggests that an individual ‘imprints’ to the influenza A virus (IAV) encountered in early childhood in such a way that they retain protection against severe disease if they later encounter a novel IAV subtype that belongs to the same genetic group as their first exposure. Our research looked at human cases of H5N1 and H7N9, two avian IAV subtypes of global concern, to investigate what factors most strongly predicted risk of severe disease. The most striking explanatory factor was childhood IAV imprinting: our results suggest that individuals who had childhood imprinting on an IAV in the same genetic group as the avian IAV they encountered later in life experienced 75% protection against severe disease and 80% protection against death. (more…)
Allergies, Asthma, Author Interviews, Flu - Influenza, Pediatrics, Vaccine Studies / 14.11.2016

MedicalResearch.com Interview with: Deepa Patadia, MD Wexner Medical Center The Ohio State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Influenza vaccination is recommended every autumn for all children 6 months of age and older. It is particularly important for children with asthma, who are at high risk of hospitalization or severe illness if they contract influenza infection. The rates of influenza vaccination in children with asthma have not previously been well studied, but Healthy People 2020 has set a target goal to vaccinate 70% of all children for influenza. We found that rates of vaccination in our large primary care population was much lower than the target rate, with less than 50% of all children receiving the vaccine each year over a 5 year period; however rates were higher in children with asthma, albeit still only at 55%. (more…)
Annals Internal Medicine, Author Interviews, Flu - Influenza, Pediatrics, Vaccine Studies / 16.08.2016

MedicalResearch.com Interview with: Dr. Mark Loeb BSc (McGill), MD (McGill), MSc (McMaster), FRCPC Professor, Department of Pathology and Molecular Medicine Joint Member, Dept of Clinical Epidemiology & Biostatistics Division Director, Infectious Diseases, McMaster University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is that in the U.S, the Advisory Committee on Immunization Practices (ACIP), the committee that advises the CDC on vaccination policy, decided this June not to recommend LAIV (nasal live vaccine) for children. This is because of non-randomized studies conducted in the U.S suggesting that the vaccine was ineffective. This was an unprecedented decision in influenza vaccine policy making for children. Our study, a randomized, blinded, controlled trial, which is the most rigorous type of study design, conducted over 3 years (2012-13, 2013-2014, 2014-2015 influenza seasons), showed in fact very similar protection for children and their communities for the live and inactivated vaccines. We conducted the study in the Hutterite community of Western Canada which allowed us to compare the effect of the vaccines in entire communities. That is, we were able to study the direct effect and the indirect effect of these vaccines. (more…)