SWIFTWATER,
Pa., Aug. 3, 2015 /PRNewswire/
-- Sanofi Pasteur, the vaccines division of Sanofi,
announced that Vaccine published positive results from a new
analysis of data from a large-scale, multi-center efficacy trial.
In this new analysis, researchers observed significantly fewer
serious cardio-respiratory events possibly related to influenza
("the flu") in study participants 65 years of age and older who
received a higher-dose split-virus inactivated influenza vaccine
(IIV-HD) compared to a standard-dose split-virus inactivated
influenza vaccine (IIV-SD).
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 (Fluzone® High-Dose vaccine,
Sanofi Pasteur, Swiftwater, PA) or
IIV-SD (Fluzone vaccine, Sanofi Pasteur) and followed for six to
eight months post-vaccination for the occurrence of influenza and
serious events, including events leading to death or
hospitalization (or its prolongation), or events considered
life-threatening or medically important, or resulting in
disability. For the supplementary analysis reported in
Vaccine, cardio-respiratory events were grouped into seven
categories: pneumonia, asthma, chronic obstructive pulmonary
disease (COPD) or bronchial events, influenza (laboratory-confirmed
influenza diagnosed outside of normal study procedures), other
respiratory events, coronary artery events, congestive heart
failure, and cerebrovascular events.
The primary results from the efficacy trial were
published in The New England Journal of Medicine,
which reported that IIV-HD was 24.2 percent (95% confidence
interval [CI], 9.7 to 36.5) more effective in preventing
laboratory-confirmed influenza-like illness compared to
IIV-SD.i In the current supplementary analysis of the
trial, investigators reported that the rate of serious
cardio-pulmonary events possibly related to influenza was 17.7%
lower in the IIV-HD group (26.7 cases per 1000 person-seasons)
compared to the IIV-SD group (32.5 cases per 1000 person-seasons).
In addition, serious pneumonia was observed at a 39.8% lower rate
among IIV-HD recipients (4.4 cases per 1000 person-seasons)
compared to IIV-SD recipients (7.4 cases per 1000 person-seasons).
The rate of hospitalization (any cause) was 6.9% lower in the
IIV-HD group (95.7 cases per 1000 person-seasons) compared to the
IIV-SD group (102.7 cases per 1000 person-seasons).
"Influenza and pneumonia combined is the seventh leading
cause of death in older adults in this country," ii
said David P. Greenberg, MD, Vice
President, Scientific & Medical Affairs, and Chief Medical
Officer, Sanofi Pasteur US. "The results of this analysis
focused on serious cardio-respiratory events and hospitalizations,
and support the previously reported findings of the large efficacy
study, in which lower rates of laboratory-confirmed influenza were
observed following use of the higher-dose vaccine compared to the
standard-dose vaccine among the seniors who
participated."
The findings of this supplementary analysis were published in
Vaccine as "Prevention of serious events in adults 65 years
of age or older: a comparison between high-dose and standard-dose
inactivated influenza vaccines"
(DOI: http://dx.doi.org/10.1016/j.vaccine.2015.07.006) by
Carlos A. DiazGranados, MD,
Corwin A. Robertson, MD,
H. Keipp Talbot, MD, MPH,
Victoria Landolfi, MSc, Andrew J. Dunning, PhD, David P. Greenberg, MD, appears in
Vaccine, Volume 33, Issue 32 (2015), published by
Elsevier.
Copies of this paper are available to credentialed journalists
upon request; please contact Elsevier's Newsroom at
newsroom@elsevier.com or +31 20 4853564.
About Fluzone High-Dose (Influenza Vaccine)
Indication
Fluzone High-Dose vaccine is indicated for
active immunization for the prevention of influenza disease caused
by influenza A subtype viruses and type B virus contained in the
vaccine.
Fluzone High-Dose vaccine is approved for use in persons 65
years of age and older.
Safety Information
The most common local and systemic
adverse reactions to Fluzone High-Dose vaccine include pain,
erythema, and swelling at the injection site; myalgia, malaise,
headache, and fever. Other adverse reactions may occur. Fluzone
High-Dose vaccine should not be administered to anyone with a known
hypersensitivity (eg, anaphylaxis) to any vaccine component,
including egg protein, or to a previous dose of any influenza
vaccine.
If Guillain-Barre syndrome has occurred within 6 weeks following
previous influenza vaccination, the decision to give Fluzone
High-Dose vaccine should be based on careful consideration of the
potential benefits and risks. Vaccination with Fluzone
High-Dose vaccine may not protect all individuals.
Before administering Fluzone High-Dose vaccine, please see
accompanying full Prescribing Information.
About Vaccine
Vaccine is the pre-eminent
journal for those interested in vaccines and vaccination. It is the
official journal of The Edward Jenner Society, The International
Society for Vaccines and The Japanese Society for Vaccinology and
is published by Elsevier. www.elsevier.com/locate/vaccine
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in diabetes
solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed in
Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more
than 1 billion doses of vaccine each year, making it possible to
immunize more than 500 million people across the globe. A world
leader in the vaccine industry, Sanofi Pasteur offers a broad range
of vaccines protecting against 20 infectious diseases. The
company's heritage, to create vaccines that protect life, dates
back more than a century. Sanofi Pasteur is the largest company
entirely dedicated to vaccines. Every day, the company invests more
than EUR 1 million in research and
development. For more information, please visit:
www.sanofipasteur.com or www.sanofipasteur.us
_______________________________
i DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy
of high-dose versus standard-dose influenza vaccine in older
adults. N Engl J Med 2014; 371:635-645.
ii Heron M. Deaths: Leading Causes for 2010. Natl
Vital Stat Rep. 2013 Dec 20;62(6):1-96.
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