Author Interviews, Cancer Research, CDC, HPV, Vaccine Studies / 09.07.2016

MedicalResearch.com Interview with: Laura J. Viens, MD Division of cancer prevention and control CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: We analyzed the most recent available data from 2008–2012 from CDC’s National Program of Cancer Registries (NPCR) and the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program for HPV-associated cancers.
  • These data cover 99% of the US population.
  • These data represent the official federal statistics on cancer incidence (new cases).
  • Every year between 2008 and 2012, about 39,000 men and women were diagnosed with cancers associated with HPV, an overall increase when compared with the 33,000 cancers associated with HPV between 2004 and 2008.
  • 23,000 (13.5 per 100,000 population) among females and 15,793 (9.7 per 100,000 population) among males.
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Author Interviews, Flu - Influenza, JAMA, Pediatrics, Vaccine Studies / 07.07.2016

MedicalResearch.com Interview with: Marta C. Nunes, PhD DST/NRF:Vaccine Preventable Diseases Respiratory and Meningeal Pathogens Research Unit University of Witwatersrand Chris Hani Baragwanath Academic Hospital Soweto, South Africa MedicalResearch.com: What is the background for this study? Response: Young infants are at increased risk for influenza infection and hospitalizations associated with influenza infection. While active annual influenza vaccination is the most efficient mode for the prevention of influenza infection, current vaccines are poorly immunogenic and not licensed for use in infants (more…)
Author Interviews, Infections, NEJM, Vaccine Studies / 29.06.2016

MedicalResearch.com Interview with: Philip Bejon, Ph.D. Professor of Tropical Medicine, Director of the Wellcome-KEMRI-Oxford Collaborative Research Programme, Group Head / PI, Consultant Physician and Unit Director Kilifi, Kenya MedicalResearch.com: What is the background for this study? Response: According to the latest World Health Organisation (WHO) estimates more than 400,000 people died from malaria in 2015, with over 90% of these deaths occurring in sub-Saharan Africa. The vast majority who die are children under 5, and almost all cases are caused by the P. falciparum strain of malaria transmitted by female Anopheles mosquitoes. RTS,S, which protects only against P. falciparum, was developed by GlaxoSmithKline with support from the PATH Malaria Vaccine Initiative (MVI) and with grant funds from the Bill & Melinda Gates Foundation to MVI. In July 2015, it received a positive opinion from the European Medicines Agency. Earlier this year, the WHO recommended further evaluation of the four-dose regimen of RTS,S in a pilot implementation programme in sub-Saharan Africa, to address several knowledge gaps before the vaccine might be rolled out more widely. (more…)
Author Interviews, Beth Israel Deaconess, Nature, Vaccine Studies, Zika / 28.06.2016

MedicalResearch.com Interview with: Dan Barouch, M.D., Ph.D. Professor of Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard Director, Center for Virology and Vaccine Research Beth Israel Deaconess Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: We showed that two vaccines, a DNA vaccine and a purified inactivated virus vaccine, both provided complete protection against Zika virus challenge in mice. To the best of our knowledge, this is the first demonstration of Zika vaccine protection in any animal model. (more…)
Author Interviews, OBGYNE, Pediatrics, Vaccine Studies / 05.06.2016

MedicalResearch.com Interview with: Dr Paul T Heath MB BS, FRACP, FRCPCH Reader / Honorary Consultant Paediatric Infectious Diseases St George’s, University of London and Vaccine Institute London, United KingdomDr Paul T Heath MB BS, FRACP, FRCPCH Reader / Honorary Consultant Paediatric Infectious Diseases St George’s, University of London and Vaccine Institute London, United Kingdom MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Heath: Vaccinating pregnant women is an important and proven strategy for protecting young infants against tetanus, influenza and pertussis. Among the infants at highest risk for complications of these infections are infants born prematurely but it is generally believed that because antibody transfer from mother to baby is maximal in the 3rd trimester, babies born prematurely may miss out on the benefits of maternal vaccination. (more…)
Author Interviews, Flu - Influenza, OBGYNE, Pediatrics, Vaccine Studies / 09.05.2016

MedicalResearch.com Interview with: Julie H. Shakib, DO, MS, MPH Assistant Professor of Pediatrics | University of Utah Medical Director | Well Baby and Intermediate Nursery Salt Lake City  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Shakib: Immunization against influenza in the first six months of life is ineffective  due to an immature immune response. Passive protection via maternal immunization offers an alternative but only a few studies have evaluated the efficacy of this immunization strategy. We found that in infants born to women immunized against influenza during pregnancy, the risk of laboratory-confirmed influenza and influenza-related hospitalization were reduced by 70% and 81% in their first 6 months of life, respectively.This large study provides more evidence that when women are immunized against influenza during pregnancy, their infants are much less likely to be diagnosed with influenza in their first 6 months. (more…)
Author Interviews, Columbia, Pediatrics, Vaccine Studies / 06.05.2016

MedicalResearch.com Interview with: Melissa Stockwell, MD, MPH, FAAP Florence Irving Associate Professor of Pediatrics and Population and Family Health Columbia University - College of Physicians & Surgeons and Mailman School of Public Health Medical Director, New York-Presbyterian Hospital Immunization Registry (EzVac) Co-Director, Primary Care Clinician Research Fellowship in Community Health New York, NY 10032  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Stockwell: Fragmentation of immunization records place children at risk for underimmunization and overimmunization. Nearly all 50 states, 5 cities, and the District of Columbia operate an immunization information system, which is a system that collects and centralizes immunization data for children and adolescents from immunization providers at a regional or state level. More than 75% of US office-based physicians have adopted an electronic health record (EHR), but until recently, clinicians wanting to access patient immunization information in an IIS generally had to manually look up the patient data on a state or local IIS website, that data was not available to them within their own EHR. In this study, we demonstrated that exchange of immunization information between an immunization information system (IIS) and an EHR at point of care had a significant impact on up-to-date rates, overimmunization, and immunization record completeness for low-income, urban children and adolescents. (more…)
Author Interviews, Flu - Influenza, Vaccine Studies / 27.04.2016

MedicalResearch.com Interview with: Dr Anna C. Phillips PhD CPsychol AFBPsS Reader in Behavioural Medicine School of Sport, Exercise & Rehabilitation Sciences University of Birmingham Edgbaston Birmingham MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Phillips: We know that various factors can affect the response to vaccination and that older adults have a poorer response than younger people, i.e. they produce fewer antibodies.  We also know that many immune messengers and important hormones have daily rhythms in their levels and wanted to test whether the antibody response to vaccination might also be affected by time of day.  We randomised surgeries to giving morning or afternoon vaccinations and tested before and one month after the vaccination for levels of antibodies. Two of the three flu strains (viruses) contained in the vaccine showed a higher antibody response in the morning than in the afternoon, up to 4 x higher to one of the strains (A/California) and 1.5 x higher to the B strain. None of the potential mechanisms we measured (immune messengers, hormones) seemed to be driving this effect. (more…)
Author Interviews, HPV, Kidney Disease, Transplantation, Vaccine Studies / 15.04.2016

MedicalResearch.com Interview with: Dr. Delphine Robotham MD Division of Pediatric Nephrology Johns Hopkins University School of Medicine Baltimore, Maryland Medical Research: What is the background for this study? What are the main findings? Response: Cervical cancer is the second most common cancer in women worldwide and is almost entirely caused by high risk HPV genotypes.  Vaccines to high risk HPV genotypes have shown great success in protecting healthy women from the sequelae of infection, including cervical cancer and genital warts. Young women with a kidney transplant as well as those with chronic kidney disease have abnormal immune systems and as a result have a significantly increased burden of HPV-related disease making the potential health benefits of the HPV vaccine substantial in this particularly vulnerable population.  This study examined the immune response to the HPV vaccine among girls and young women with kidney disease. The goal of this research was to determine if girls and young women with chronic kidney disease (abnormal kidney function, on dialysis, or post kidney transplant) showed evidence of immune response to the quadrivalent HPV vaccine.  Immune response was determined by measuring the amount of antibody made by the patients against each of the 4 HPV genotypes included in the vaccine.  There are established thresholds of antibody above which patients are believed to have protection from infection.  We found that study participants with chronic kidney disease and those on dialysis had antibody levels above the threshold, indicating the vaccine should be effective in protecting them from HPV related disease.  A significant proportion of patients with kidney transplants showed evidence of inadequate antibody response.  This is important information as it means patients with a kidney transplant, whom we know are at increased risk of developing cervical cancer from HPV infection, may not be protected from HPV infections from the HPV genotypes included in the vaccine. (more…)
Author Interviews, Hepatitis - Liver Disease, HIV, JAMA, Vaccine Studies / 13.04.2016

MedicalResearch.com Interview with: Odile Launay MD, PhD Paris Descartes University Assistance Publique Hôpitaux de Paris, Cochin Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Launay: In patients with HIV infection, responses to standard HBV vaccination regimens remain suboptimal compared with responses in HIV seonegative individuals. We previously reported that alternative regimens (a 4 injection IMdouble dose regimen and a 4 injection intradermal low dose regimen) improve antibody response compared with the standard HBV vaccination regimen (ANRS HB03 VIHVAC-B study). Further precision on the duration of response achieved with alternative HBV vaccination regimes was needed. We report in this paper the results from the follow-up of the study. The results of this study show that the 4 dose IM regimen induces higher seroconversion rate but also higher long term seroprotection in HIV infected patients (more…)
Author Interviews, CDC, HPV, Pediatrics, Vaccine Studies / 07.04.2016

MedicalResearch.com Interview with: Natalie L. McCarthy, MPH Centers for Disease Control and Prevention Atlanta, Georgia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recently, deaths immediately following 4vHPV vaccination have garnered intense media attention.  Often, these media stories do not take into account the background rates of death in older children and young adults or disclose the potential for non-vaccine related causes of death.  The publicity surrounding deaths temporally associated with HPV and the paucity of studies examining deaths in adolescents following vaccination, was the basis for our evaluation of deaths following vaccines administered to individuals 9 through 26 years of age in the Vaccine Safety Datalink (VSD). The VSD is a collaborative project between the Centers for Disease Control and Prevention and several integrated healthcare systems, which monitors the safety of vaccines in the U.S. This study assessed the risk of death in the first 30 days following vaccination, described the causes of death, and included an evaluation of the potential association of vaccination and death among older children and young adults. The risk of death was not increased during the 30 days following vaccination, and no deaths were found to be causally associated with vaccination. The causes of death were consistent with what would be expected for this age group. (more…)
Author Interviews, Pediatrics, Respiratory, Vaccine Studies / 28.03.2016

MedicalResearch.com Interview with: Tasnee Chonmaitree, M.D. Professor, Pediatrics and Pathology Division of Pediatric Infectious Diseases Department of Pediatrics University of Texas Medical Branch Galveston, TX 77555-0371 MedicalResearch.com: What is the background for this study? Dr. Chonmaitree: Respiratory infections are common in infants and young children; they are caused by viruses and/or bacteria. Viral upper respiratory tract infection or the common cold is exceedingly common and leads to bacterial complications such as ear infection, which the leading cause of antibiotic prescription in the US and the most common reason children undergo surgery (ear tube placement). In the past few decades, some bacterial and viral vaccines have become available aiming to reduce respiratory infections in children. MedicalResearch.com: What are the main findings? Dr. Chonmaitree: Our study looked to update information on how often infants in the first year of life acquired the common cold, and ear infection in the new vaccine era. The study was performed between 2009 and 2014 and included 367 infants followed closely from near birth up to one year of age. We found that on average, an infant had about 3 colds in the first year of life, and almost half of infants had ear infection by age 1 year. This was less than what happened in the past few decades. The reduction of ear infection may have been the result of many factors from bacterial and viral vaccine use, to increased breastfeeding rate and reduction in household smoking. Risk factors for ear infection included carriage of bacteria in the nose, frequencies of common cold and lack of breastfeeding. (more…)
Author Interviews, Herpes Viruses, Vaccine Studies / 28.03.2016

MedicalResearch.com Interview with: Zeena Y. Nawas, MD Clinical Research Fellow Center for Clinical Studies Houston, TX, 77004 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Nawas: T cell immunity is believed to be particularly critical to the control of genital herpes, an incurable, lifelong sexually transmitted disease that affects roughly 500 million people worldwide. Genital herpes is characterized by recurrent, painful genital lesions and can be transmitted to sexual partners, even when there is no visible sign of the infection. Current genital herpes therapies only partially control the infection in some patients. These individuals continue to experience clinical symptoms and viral shedding, which drives disease transmission. Incomplete control of genital lesions and transmission risk, and the inconvenience of taking a daily medication are hurdles for effective long-term disease management. GEN-003, is a first-in-class immunotherapy developed by Genocea Biosciences and is intended to treat genital herpes by inducing both a T cell and B cell (antibody) immune response. GEN-003 has demonstrated promising results to date by showing statistically significant reductions in the clinical signs of genital herpes and viral shedding, as well as safety and tolerability in its Phase 1/2 and Phase 2 clinical studies. (more…)
Annals Internal Medicine, Author Interviews, Flu - Influenza, Kaiser Permanente, Surgical Research, Vaccine Studies / 16.03.2016

MedicalResearch.com Interview with: Sara Y. Tartof, PhD, MPH Kaiser Permanente Southern California Department of Research & Evaluation MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Tartof: The flu is a highly contagious respiratory infection that can cause serious complications, hospitalizations and, in some cases, even death. Some people, such as older adults, young children and people with certain health conditions, are at high risk for serious complications. In addition to recommending annual flu vaccination for people 6 months of age and older, the Centers for Disease Control and Prevention recommends that hospitalized patients who are eligible receive the flu vaccine before discharge. Historically, inpatient rates of vaccination have been low. There has been concern among surgeons that vaccinating patients while they are in the hospital can contribute to increased risk of vaccine-related fever or muscle pain, which might be incorrectly attributed to surgical complications. However, there have been no data to support that concern. The objective of this study was to provide clinical evidence that would either substantiate or refute concerns about the safety of perioperative vaccination. (more…)
Author Interviews, CDC, Flu - Influenza, OBGYNE, Vaccine Studies / 04.02.2016

MedicalResearch.com Interview with: Ikwo Oboho, MD, ScMLCDR United States Public Health Service Medical Epidemiologist, Centers for Disease Control and PreventionPriority Populations Treatment Team| HIV Care & Treatment Branch | Division of Global HIV/TB Atlanta, GA 30333 MedicalResearch.com: What is the background for this study? Dr. Oboho: ·Pregnant women with flu are at high risk of serious illness and complications, including death. The study is based on data gathered from a nationwide flu surveillance network that includes 14 states. The analysis focused on pregnant women hospitalized with laboratory-confirmed flu over four recent flu seasons, from 2010 to 2014. MedicalResearch.com: What are the main findings?  Dr. Oboho: ·       During the study period, 865 pregnant women were hospitalized with flu. Sixty-three of these patients, or about 7 percent, had severe illness.
  • After adjusting for underlying medical conditions, vaccination status, and pregnancy trimester, we found that early treatment with the antiviral drug oseltamivir was associated with a shorter hospital stay.
  • Among pregnant women with severe flu illness who were treated early with oseltamivir — within two days of the start of symptoms — the median length of stay was about five days shorter compared to hospitalized pregnant women with severe flu illness who were treated later
  • Pregnant women who were hospitalized with severe cases of flu illness were half as likely to have been vaccinated as women with non-severe illness.
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Author Interviews, Herpes Viruses, Ophthalmology, Vaccine Studies / 30.01.2016

MedicalResearch.com Interview with: Frederick W. Fraunfelder, MD MBA Chairman and Roy E. Mason and Elizabeth Patee Mason Distinguished ProfessorDepartment of Ophthalmology Missouri University School of Medicine Director of the Missouri University Health Care’s Mason Eye Institute Medical Research: What is the background for this study? What are the main findings? Dr. Fraunfelder: The background starts with a paper by Hwang et al (Cornea. 2013 Apr;32(4):508-9.Reactivation of herpes zoster keratitis in an adult after varicella zoster vaccination. Hwang CW Jr1Steigleman WASaucedo-Sanchez ETuli SS.) After reading this paper, I started keeping track of keratitis cases that were reported to my registry (www.eyedrugregistry.com) and also to the FDA and WHO spontaneous reporting databases. We found case reports in adults and children of keratitis occurring soon after vaccination, and we presented this at the American Academy of Ophthalmology’s annual meeting that we just held in Las Vegas in November 2015. The main findings are that in rare instances, relatively speaking, herpes infection can occur in the cornea of the eye within days to weeks after vaccination. This may especially be true in adults who have had shingles in the past which caused a keratitis in the past. This keratitis may reoccur after the vaccination, and primary care providers should inquire about this past medical/ocular history and advise of the risk of recurrent keratitis after the vaccination for shingles. (more…)
Author Interviews, Education, Flu - Influenza, Vaccine Studies / 30.12.2015

MedicalResearch.com Interview with: Mubdiul Ali Imtiaz, MD Department of Internal Medicine Rutgers University, New Jersey Medical School Newark, NJ 07103 Medical Research: What is the background for this study? Response: Resident physicians (RPs) were defined to be all individuals enrolled in a graduate medical education training program in a healthcare setting. There were 611 resident physicians enrolled in 47 post-graduate residency and fellowship programs at RU-NJMS during the 2013-2014 academic year. Influenza immunization was strongly recommended, but not mandatory for Resident physicians during 2013-2014. A link to the online survey using a standardized, anonymous, self-administered questionnaire was emailed by the program-chiefs to their respective RPs to collect demographic characteristics, influenza immunization status during the 2013-2014 and the previous season, and reasons for non-vaccination. Medical Research: What are the main findings? Response: The overall self-reported immunization rate of  Resident physicians in 2013-2014 was 76.7%. The immunization rate did not differ by the location of medical school attended (P= 0.55) or sex (P= 0.69). Among the respondents, 95.8% had influenza vaccination in the past and 83.1% received influenza vaccine during 2012-2013 flu season. History of influenza vaccination ever and in 2012-2013 were both significantly associated with receiving the vaccine during the 2013-2014 season (P<0.01 for both). The most common reason for not being vaccinated (38.6%) was “lack of time to get immunized” (see Figure 1). The most common cited motivating factors to be vaccinated during the next influenza season among the NVRPs were “making vaccinations in the workplace at convenient locations and times” (43.2%), “availability of mobile flu vaccination carts in hospital floors” (40.9%), and “establishing mandatory flu vaccination for employment” (36.4%). (more…)
Author Interviews, Emory, Flu - Influenza, Vaccine Studies / 02.11.2015

MedicalResearch.com Interview with: Saad Omer MBBS MPH PhD Associate Professor Emory Vaccine Center Associate Professor Global Health and Epidemiology Rollins School of Public Health Emory University MedicalResearch: Can you give us a little background on this study? Dr. Omer: My background is in global health, epidemiology and pediatrics and I have been fortunate to conduct field and clinical vaccine trials in a number of countries and with multiple infectious diseases including influenza, polio, measles and pneumococcal vaccines. We were familiar with the data on investigating the potential effects of statins on other infections i.e. sepsis and community acquire pneumonia including Dr. Vandermeer’s study in 2012 suggesting that “statin use may be associated with reduced mortality in patients hospitalized with influenza”. Statins have lipid-lowering effects but they also exhibit anti-inflammatory and immunomodulatory properties. For lack of a better image, I think of statins as acting like a ‘big hammer made of Jell-O’: they have a broad, small dampening effect on immune response (as opposed to a narrow or deep effect). (more…)
Author Interviews, CDC, Cost of Health Care, HPV, Vaccine Studies / 30.10.2015

MedicalResearch.com Interview with: Shannon Stokley, MPH Epidemiologist in the CDC Immunization Services Division Medical Research: What is the background for this study? What are the main findings? Response: To determine whether the recommended HPV vaccination series is currently being administered to adolescents with health insurance, CDC and the National Committee for Quality Assurance (NCQA) assessed 2013 data from the Healthcare Effectiveness Data and Information Set (HEDIS). The HEDIS HPV Vaccine for Female Adolescents performance measure evaluates the proportion of female adolescent members in commercial and Medicaid health plans who complete the recommended HPV vaccination series by age 13 years. In 2013, in the United States, the median HPV vaccination coverage level for female adolescents among commercial and Medicaid plans was 12% and 19%, respectively (ranges = 0%–34% for commercial plans, 5%–52% for Medicaid plans). The results of this study indicate that there are significant opportunities for improvement as HPV vaccination coverage among female adolescents was low for both commercial and Medicaid plans. (more…)
Author Interviews, CDC, JAMA, OBGYNE, Vaccine Studies / 21.10.2015

MedicalResearch.com Interview with: Dr.Lakshmi Sukumaran MD, MPH Immunization Safety Office, Centers for Disease Control and Prevention Department of Pediatrics, Emory University School of Medicine Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Sukumaran: Pertussis (whooping cough) is a vaccine-preventable disease that has been increasing in incidence over the past decade in the United States. Newborns and infants are at increased risk of pertussis-related hospitalization and death compared with older children and adults. The Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women receive a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) during each pregnancy to protect her infant from pertussis disease, regardless of prior immunization status. However, there is limited data on the safety of repeated Tdap vaccines in pregnant women. Our study evaluated medically attended (associated with doctor visit or hospitalization) adverse events in mothers, such as fever, allergy and local reactions, and adverse birth outcomes, such as prematurity and low birth weight in newborns, in women receiving Tdap in pregnancy who had received a prior tetanus-containing vaccine. We found no significant differences in rates of these adverse outcomes in women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before. (more…)
Author Interviews, Infections, Respiratory, Vaccine Studies, Vanderbilt / 11.10.2015

Annabelle de St. Maurice MD, MPH Pediatric Infectious Disease Fellow Vanderbilt Children's HospitaMedicalResearch.com Interview with: Annabelle de St. Maurice MD, MPH Pediatric Infectious Disease Fellow Vanderbilt Children's Hospital  Medical Research: What is the background for this study? What are the main findings? Dr. de St. Maurice: Susceptibility to certain infectious diseases appears to vary by gender. For example, males may be at increased risk of certain infections in childhood, including lower respiratory tract infections such as RSV, however females may have more severe infections, such as influenza, during pregnancy. Some early studies have suggested that males may be at increased risk of pneumococcal infections but this has not been confirmed. Furthermore, whether those potential gender differences remain after introduction of pneumococcal conjugate vaccines is unknown. Invasive pneumococcal disease, which includes meningitis, bacteremic pneumonia and bacteremia/septicemia, is a significant cause of morbidity and mortality in the United States in children and adults. The 7-valent pneumococcal conjugate vaccine (PCV7) and the 13-valent pneumococcal conjugate vaccine (PCV13) led to declines in invasive pneumococcal disease rates as well as eliminated racial disparities in regards to invasive pneumococcal disease rates. Our study sought to identify potential gender differences in the incidence of invasive pneumococcal disease, and to determine the impact of vaccines on gender differences in the susceptibility to these diseases. We conducted a large study that used data from a population-based surveillance system of invasive pneumococcal diseases in Tennessee. This is part of a large CDC funded network of surveillance sites for these diseases. For our study, we identified patients with laboratory-confirmed invasive pneumococcal disease, and calculated the incidence of invasive pneumococcal diseases from 1998-2013 by gender. We also stratified the calculations by age groups and race, both well-known factors that affect the occurrence of invasive pneumococcal disease. Our study found that males had generally higher rates of invasive pneumococcal disease than females across age groups, regardless of race. Although introduction of the pneumococcal conjugate vaccines led to a significant decrease in invasive pneumococcal disease rates, males continued to have higher rates than females in several age groups. (more…)
Allergies, Author Interviews, CDC, Pharmacology, Vaccine Studies / 07.10.2015

MedicalResearch.com Interview with: Michael M. McNeil, MD, MPH Centers for Disease Control and Prevention Atlanta, GA Medical Research: What is the background for this study? What are the main findings? Dr. McNeil : Anaphylaxis is an uncommon potentially life-threatening allergic reaction which can occur immediately (usually within minutes) after exposures to food, drugs, venom and vaccines. More than 100 million people in the U.S. receive vaccinations each year. Most vaccines have the potential to trigger anaphylaxis, but the rates at which it occurs after vaccination are not well known. The CDC study examined data from the Vaccine Safety Datalink (VSD), a collaborative project between CDC and 9 integrated healthcare organizations, which contains vaccination records on more than 9 million patients. The study sought to determine the rates of anaphylaxis after all vaccines combined and some individual vaccines including seasonal influenza vaccines given to children and adults.  Patients studied received vaccinations between January 1, 2009 – December 31, 2011.  Electronic medical record data was screened for patients with specific diagnostic codes for anaphylaxis or who had received epinephrine prescriptions as a treatment for potential anaphylaxis. Researchers were able to look at data from 25,173,965 vaccinations during 17,606,500 visits to healthcare providers. The researchers identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after more than 25 million vaccine doses. The rate of anaphylaxis was calculated at 1.31 per million doses for all vaccines, and 1.35 per million for seasonal inactivated influenza vaccines. Patients ranged in age from 4 to 65 with a median age of 17. None of the patients with anaphylaxis were below the age of 4 years old. Only one of the 33 patients was hospitalized, and none died as a result of anaphylaxis. A majority (85%) of the case-patients had pre-existing atopic disease including previous anaphylaxis, asthma, and allergies. (more…)
Author Interviews, CDC, Flu - Influenza, Vaccine Studies / 25.09.2015

MedicalResearch.com Interview with: Carla L. Black PhD Immunization Services Division National Center for Immunization and Respiratory Diseases CDC Carla L. Black PhD Immunization Services Division National Center for Immunization and Respiratory Diseases CDC  Medical Research: What is the background for this study? What are the main findings? Dr. Black: The Advisory Committee on Immunization Practices (ACIP) recommends that all health-care personnel (HCP) be vaccinated annually against influenza. Vaccination of health-care personnel can reduce influenza-related morbidity and mortality among HCP and their patients. Overall, 77.3% of HCP reported receiving an influenza vaccination in the 2014-15 season, similar to the 75.2% coverage among HCP reported in the 2013-14 season. Coverage was highest among  health-care personnel working in hospitals (90.4%) and lowest among HCP working in long-term care (LTC) settings (63.9%). Flu vaccination coverage was highest in settings with employer flu vaccination requirements and promotion of flu vaccination. Vaccination coverage was 96% among HCP with an employer requirement for vaccination. Among HCP without an employer requirement for vaccination, vaccination coverage was higher for HCP working in settings where vaccination was offered on-site at no cost for one day (73.6%) or multiple days (83.9%) compared with  health-care personnel  working in settings where vaccination was promoted but not offered on-site (59.5%) or not promoted in any manner (44.0%). (more…)
Author Interviews, Cleveland Clinic, Cost of Health Care, Herpes Viruses, Vaccine Studies / 24.09.2015

Phuc Le, Ph.D., M.P.H. Center for Value-Based Care Research, Medicine Institute Cleveland, OHMedicalResearch.com Interview with: Phuc Le, Ph.D., M.P.H. Center for Value-Based Care Research, Medicine Institute Cleveland, OH  Medical Research: What is the background for this study? What are the main findings? Dr. Phuc Le: The live attenuated herpes zoster vaccine is approved by the FDA for persons aged 50 years and above. However, the Advisory Committee on Immunization Practices recommends it for only persons aged 60 years and older. Therefore, we aimed to analyze the vaccine’s cost-effectiveness among persons aged 50-59 years to see if ACIP’s recommendation is reasonable. We found that the vaccine is not cost-effective among people at aged 50 years, having an incremental costs of $323,000 per QALY gained, which is 3 times more than a commonly accepted threshold ($100,000/QALY). (more…)
Author Interviews, Cost of Health Care, Flu - Influenza, Geriatrics, Lancet, Vaccine Studies / 20.09.2015

Dr Ayman Chit PhD Sanofi Pasteur Swiftwater, PA 18370MedicalResearch.com Interview with: Dr Ayman Chit PhD Sanofi Pasteur Swiftwater, PA 18370 Medical Research: What is the background for this study? What are the main findings? Dr. Chit: Our analysis used data from a large-scale, multi-center efficacy trial, in which a higher-dose split-virus inactivated influenza vaccine (IIV-HD, Fluzone® High-Dose vaccine, Sanofi Pasteur) was compared to a standard-dose split-virus inactivated influenza vaccine (IIV-SD, Fluzone vaccine, Sanofi Pasteur) in persons 65 years of age and older.  These data were supplemented with US healthcare cost data. In the efficacy trial, a total of 31,989 adults 65 years of age and older were randomly assigned in a 1:1 ratio to receive either IIV-HD or IIV-SD and followed for six to eight months post-vaccination for the occurrence of influenza, serious adverse events, and medical encounters. Healthcare utilization (HCU) data were captured for all participants through a surveillance program that covered each influenza season, including the following events occurring within 30 days after any respiratory illness: use of prescription and non-prescription medications (limited to antipyretics/analgesics/non-steroidal anti-inflammatory drugs, antivirals and antibiotics), emergency room visits, non-routine or urgent care visits, and hospitalizations. In addition, all hospitalizations were captured for participants for the entire duration of the study. The primary results from the efficacy trial were published in The New England Journal of Medicine, which reported that IIV-HD was 24.2% (95% confidence interval [CI], 9.7% to 36.5%) more effective in preventing laboratory-confirmed influenza-like illness compared to IIV-SD.1 In the current supplemental analysis of the trial, we used US healthcare cost data to evaluate economic impacts of using IIV-HD compared to IIV-SD within the efficacy trial participants. In this analysis, total healthcare payer costs (the combined costs of study vaccine, prescription drugs, emergency room visits, non-routine and urgent-care visits, and hospital admissions) were about $116 less per person.
  1. DiazGranados et al, NEJM, 2014;14;371(7):635-45 
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Author Interviews, Cleveland Clinic, Flu - Influenza, Vaccine Studies / 11.09.2015

Dr. Glen Taksler, PhD Medicine Institute Cleveland Clinic Main CampusMedicalResearch.com Interview with: Dr. Glen Taksler, PhD Medicine Institute Cleveland Clinic Main Campus Medical Research: What is the background for this study? What are the main findings? Dr. Taksler: Although young, healthy adults who develop influenza are usually able to recover, they may spread the flu to other people in the community who have a higher risk of hospitalization or other serious complications. These higher-risk people have a limited ability to protect themselves from influenza, because flu vaccines are less effective in the elderly and in people with weakened immune systems. To better understand whether young, healthy adults could help the community-at-large by getting a flu vaccine, we looked at data on more than 3 million Medicare beneficiaries across 8 influenza seasons. We found that the elderly had 21% lower odds of developing influenza if they lived in areas where more nonelderly adults (people aged 18-64 years old) got a flu vaccine. Importantly, we found these benefits even in elderly adults who obtained an influenza vaccine, perhaps because flu vaccines are less effective in the elderly.  This means that elderly adults who were proactive to try to prevent influenza still benefited from communitywide vaccination. (more…)
Author Interviews, CDC, Vaccine Studies / 04.09.2015

MedicalResearch.com Interview with: Holly A. Hill, MD, PhD Immunization Services Division National Center for Immunization and Respiratory Diseases CDC Medical Research: What is the background for this study? What are the main findings? Response: The National Immunization Survey involves random digit-dialing – both landlines and cell phones – to generate a large national sample we use to assess vaccination coverage.  The phone survey is followed by a mail survey sent to the children’s vaccination providers to obtain vaccination histories. This 2014 NIS report is based on 14,893 children 19-35 months of age with provider- reported vaccination records. According to the 2014 NIS, the majority of parents are vaccinating their children against potentially serious diseases. Nationally, there were no significant decreases in vaccination coverage among children 19-35 months for routinely recommended childhood vaccines in 2014. As in past years, lower coverage for vaccines recommended during the second year of life were observed.  We still have opportunities for improvement. While national coverage was high for most vaccines routinely recommended for young children, vaccination coverage does vary by state and poverty status. High coverage rates for childhood vaccines explain why most vaccine-preventable diseases are at record low levels. However, it is crucial to maintain these rates in order to keep outbreaks from happening. (more…)
Author Interviews, PLoS, Vaccine Studies / 28.08.2015

Dr Javier Martin PhD Principal Scientist Division of Virology National Institute for Biological Standards and Control (NIBSC) Medicines and Healthcare products Regulatory Agency (MHRA) Blanche Lane, South Mimms, Potters Bar United KingdomMedicalResearch.com Interview with: Dr Javier Martin PhD Principal Scientist Division of Virology National Institute for Biological Standards and Control (NIBSC) Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom Medical Research: What is the background for this study? Dr. Martin: The global eradication of polio appears to be within reach.  There has been no case of poliomyelitis caused by circulating wild type 2 poliovirus since 1999, no case of type 3 since November 2012 and the last case of type 1 in Africa was in August 2014, leaving some areas of Pakistan and Afghanistan as the main remaining reservoirs of circulating wild type 1 poliovirus. Poliovirus strains in the live-attenuated oral polio vaccine (OPV) are known to quickly revert to neurovirulent phenotype following replication in humans after immunisation. These vaccine-derived poliovirus (VDPV) strains can transmit from person to person in populations with low immunity potentially leading to poliomyelitis outbreaks. (more…)
Author Interviews, Infections, University of Pennsylvania, Vaccine Studies / 22.08.2015

David B. Weiner, Ph.D. Professor, Department of Pathology and Laboratory Medicine Chair, Gene Therapy and Vaccine Program, CAMB Co-Leader Tumor Virology Program, Abramson Cancer Program University of Pennsylvania, Perelman School of MedicineMedicalResearch.com Interview with: David B. Weiner, Ph.D. Professor, Department of Pathology and Laboratory Medicine Chair, Gene Therapy and Vaccine Program, CAMB Co-Leader Tumor Virology Program, Abramson Cancer Program University of Pennsylvania, Perelman School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Weiner: MERS, like the Severe Acute Respiratory Syndrome (SARS), is characterized by high fever and severe cough from pneumonia. MERS is caused by an emerging human coronavirus, which is distinct from the SARS coronavirus. Since its identification in 2012, MERS has been linked to over 1,300 infections and close to 400 deaths. It has occurred in the Arabian Peninsula, Europe, and in the US and in Asia. It can be spread in a hospital setting. Scientists now report that a novel synthetic DNA vaccine can, for the first time, induce protective immunity against the Middle EastRespiratory Syndrome (MERS) coronavirus in animal species.   Researchers from the Perelman School of Medicine at the University of Pennsylvania. The NIH, the Public Health agency of Canada, and from a leading company in the development of synthetic DNA vaccine technology, Inovio described the results in a paper  published their work in Science Translational Medicine (STM) this week.  The experimental, preventive vaccine, given six weeks before exposure to the MERS virus, fully protects rhesus macaques from disease. The vaccine also generated potentially protective antibodies in blood drawn from camels, the purported source of MERS transmission in the Middle East. (more…)