Study Suggests Tamiflu Does Not Increase Risk of Suicide

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 

Dr. Antoon

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.

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Short-Range Human Travel Helps Trigger and Spread Flu Infections Each Year

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

Dr. Chattopadhyay

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. Continue reading

Cochrane Reviews Efficacy of Vaccination To Prevent Flu In Healthy Adults

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. Continue reading

Potential Universal Influenza Vaccine Uses Nanoparticle Technology

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.  Continue reading

Defective Viral Genomes May Indicate Greater Flu Virus Severity

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.

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Pandemic Flu May Increase Risk of Type 1 Diabetes In Genetically Predisposed Patients

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.

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Nasal Spray Flu Vaccine Ineffective and Not Recommended

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

Dr. Jackson

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.

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Dissolvable Microneedle Patches Can Be Vaccination Game Changer

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.

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Efficacy of Recombinant Flu Vaccine in Adults 50 Years of Age or Older 

MedicalResearch.com Interview with:

Lisa M. Dunkle, M.D. Chief Medical Officer Protein Sciences Corporation 1000 Research Parkway Meriden, CT 

Dr. Dunkle

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

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Salt-Impregnated Surgical Masks Make Viruses Harmless

MedicalResearch.com Interview with:

Hyo-Jick Choi, PhD Assistant Professor, Department of Chemical and Materials Engineering University of Alberta Edmonton, AB, Canada T6G 1H9

Dr. Hyo-Jick Choi

Hyo-Jick Choi, PhD
Assistant Professor,
Department of Chemical and Materials Engineering
University of Alberta
Edmonton, AB, Canada T6G 1H9

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Respiratory diseases such as influenza transmitted either through breathing aerosols exhaled/coughed out by an infected person or through direct contact. Despite controversy over its efficacy, surgical mask has been widely used by general public during the past respiratory disease outbreaks because of low cost, easy wearability, and widespread use in normal day-to-day situation. Critical issue is that virus captured on the filter of the mask still maintains infectivity for long time, raising concerns of secondary infections and transmissions.

This led us to develop a strain-nonspecific and reusable airborne virus deactivation system based on salt recrystallization principle. Salt recrystallization is hypothesized to cause deactivation of viruses transmitted through aerosols via two successive processes:

1) salt on filter fiber dissolves upon exposure to the pathogenic aerosols and
2) salt crystallizes as aerosols evaporate.

To demonstrate the concept, we coated the fiber of the surgical mask filter with sodium chloride (NaCl) salt crystal and tested its performance using three different types of influenza viruses. Salt-treated filter provided higher filtration efficiency compared to non-treated regular filter and successfully destroyed multiple subtypes of influenza viruses trapped on the filter within few minutes, leading to significant infectivity loss.

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First Childhood Exposure Determines How Sick You Get From Flu As Adult

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.

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When Not Mandatory, Many Resident Physicians Did Not Get Flu Vaccine

Mubdiul Ali Imtiaz, MD Department of Internal Medicine Rutgers University, New Jersey Medical School Newark, NJ 07103.

Dr.  Mubdiul Ali Imtiaz

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%).

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No Evidence That Tylenol Beneficial in Flu Infections

MedicalResearch.com Interview with:
Dr. Irene Braithwaite
Deputy Director
Medical Research Institute of New Zealand
Wellington NZ

Medical Research: What is the background for this study? What are the main findings?

Dr. Braithwaite: We know from animal models that the reduction of fever is associated with an increased risk of dying from influenza. We also know that some influenza viruses cannot replicate well in the human febrile range (38 to 40 Celsius). Yet, guidelines on the management of community acquired influenza infection in humans is to rest, maintain hydration and to take antipyretics such as paracetamol on the basis that this may help and is unlikely to cause harm. We undertook this study to see whether using regular paracetamol during influenza infection might be harmful, as it may allow the influenza virus to replicate more readily, and increase and/or prolong symptoms.

To the best of our knowledge, this is the first randomised controlled trial comparing the effects of regular paracetamol (1gram four times daily for five days) versus placebo in human adults infected with influenza. We found that there was no difference in influenza viral loads, temperature or influenza symptoms between the regular paracetamol group and placebo group.

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Flu Vaccines Prevent Over Half of Hospitalizations For Influenza Pneumonia

Carlos G. Grijalva, MD MPH Associate Professor Department of Health Policy Vanderbilt University Medical Center Nashville, TN 37212MedicalResearch.com Interview with:
Carlos G. Grijalva, MD MPH
Associate Professor
Department of Health Policy
Vanderbilt University Medical Center
Nashville, TN 37212 

Medical Research: What is the background for this study?

Dr. Grijalva: Influenza is an important cause of disease. Every year influenza causes more than 200,000 hospitalizations in the US. The most effective strategy to prevent influenza infections is vaccination. Several studies have shown that influenza vaccines can prevent fever or respiratory symptoms caused by influenza. However, whether influenza vaccines can prevent more serious complications of influenza such as pneumonia, remains unclear

This was a multicenter collaboration between academic institutions and the centers for disease control and prevention. We used data from the Etiology of Pneumonia in the community or EPIC study, a large prospective study of hospitalizations for pneumonia conducted between 2010 and 2012. The EPIC study enrolled patients from Chicago, IL, Salt Lake City, UT, and Memphis and Nashville, TN. The main goal of the EPIC study was to determine the causes of pneumonia in children and adults hospitalized with pneumonia.

Medical Research:? What are the main findings?

Dr. Grijalva: We conducted a case-control study using data from EPIC. Our study included more than 2700 patients hospitalized for pneumonia, including both children and adults. Approximately 6% of these patients had influenza pneumonia and were identified as cases. Other patients hospitalized for pneumonia that was not caused by influenza were the controls. We compared the history of influenza vaccination between cases and controls. We found that influenza vaccination was associated with a reduced risk of influenza pneumonia that required hospitalization. The estimated vaccine effectiveness was 57%. This means that about 57% of hospitalizations due to influenza-associated pneumonia could be prevented through influenza vaccination.

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Elders Also Benefit When Young Adults Get Flu Vaccine

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.

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Researchers Aim To Make Influenza Vaccine More Effective For High Risk Patients

Adrian Egli, MD PhD Research Group leader Infection Biology Laboratory Department of Biomedicine University of Basel and University Hospital Basel Basel, SwitzerlandMedicalResearch.com Interview with:
Adrian Egli, MD PhD Research Group leader
Infection Biology Laboratory
Department of Biomedicine
University of Basel and University Hospital Basel
Basel, Switzerland

Medical Research: What is the background for this study? What are the main findings?

Dr. Egli: Infections with influenza viruses are associated with a high morbidity and mortality. In particular, people with a weak immune system are at danger for more severe complications. This includes elderly people, pregnant women, patients after transplantation, patients with HIV infection, chronic diseases such as diabetes and many more. In these high-risk groups, annual vaccination is clearly recommended.

However, due to the immunsuppressive condition the immune response to the influenza vaccine is often reduced. The seroconversion rate – a 4-fold antibody titer increase upon vaccination – is one of the key markers for a successful vaccination. In young adults the seroconversion rate is normally >85%; however, in patients with immunosuppression, this can be lower than 40%. Improving vaccine efficacy is one of the key focuses of my research group. We try to understand, how to improve vaccines and better protect the people at the highest risks for influenza-associated complications.

In this study, we could show that an important cytokine, called Interferon lambda, is clearly associated with the vaccine induced antibody response upon influenza vaccination. We could show that genetic polymorphisms, in one of the Interferon lambda gene family (IFNL3), are modulating the expression of this gene. This strongly affects the cross talk between the innate and adaptive immune response in the context of vaccination. We observed that, the more Interferon lambda is present, the lower the antibody response is. People with a lower expression of Interferon lambda had a significant higher response to the vaccine. Therefore, we developed substances to block the effect of Interferon lambda. We could show in vitro, that due to the Interferon lambda blockade, the antibody production was improved.

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Mandatory Flu Shots For Health Care Workers Boosts Vaccination Rates

Allison Weinmann  MBBS, FRACP Senior Staff, Division Infectious Diseases Director HFHS Immunization Team Medical Director Infection Control and Prevention, West Bloomfield Hospital Henry Ford Health System Clinical Assistant Professor, Wayne State University Detroit, Mi 48202MedicalResearch.com Interview with:
Allison Weinmann  MBBS, FRACP
Senior Staff, Division Infectious Diseases
Director HFHS Immunization Team
Medical Director Infection Control and Prevention, West Bloomfield Hospital
Henry Ford Health System
Clinical Assistant Professor, Wayne State University
Detroit, Mi 48202

Medical Research: What are the main findings of this study?

Dr. Weinmann: The main findings included:

  • Mandatory influenza immunization for health care workers without allowing optional opt-out (and only allowing for documented medical or religious exemption) successfully raised our immunization uptake among all our employees to over 99% sustainable for the last 2 years which we consider a very important patient safety initiative.
  • Less than 2% of workers met a medical or religious exemption.
  • A prior optional opt out with mask wearing was problematic for staff and patients and did not reach our goal of close to 100% immunization uptake.

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Fluzone High-Dose Vaccine Found More Effective Than Standard-Dose Vaccine

David P. Greenberg, M.D. Vice President, Scientific & Medical Affairs, and Chief Medical Officer Sanofi Pasteur US.MedicalResearch.com Interview with:
David P. Greenberg, M.D.
Vice President, Scientific & Medical Affairs, and Chief Medical Officer
Sanofi Pasteur US.

 

Medical Research: What are the main findings of the study?

Dr. Greenberg: The New England Journal of Medicine published positive results from a randomized, double-blind, large-scale, multi-center efficacy trial, which found that Fluzone® High-Dose (Influenza Vaccine) was more efficacious in preventing influenza illness (“the flu”) in adults 65 years of age and older compared to standard-dose Fluzone vaccine. Fluzone High-Dose vaccine was found to be 24.2 percent (95% CI, 9.7 to 36.5) more effective in preventing influenza relative to standard-dose Fluzone vaccine for the primary endpoint (laboratory-confirmed influenza associated with typical clinical symptoms occurring at least 14 days post-vaccination caused by any viral type or subtype). In other words, investigators determined that participants in the Fluzone High-Dose vaccine group were less likely to get the flu than those in the standard-dose Fluzone vaccine group. The study safety data were consistent with previous Fluzone High-Dose vaccine studies.

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