MERIDEN, Conn.,
June 22, 2017 /PRNewswire/ -- Protein
Sciences Corporation announced the publication of clinical trial
results comparing Flublok® Quadrivalent – the quadrivalent version
of Flublok® influenza vaccine – to a traditional egg-based
quadrivalent inactivated vaccine. The data published in the June
22nd issue of the New England Journal of Medicine showed that
Flublok Quadrivalent provided significantly improved protection
against laboratory confirmed influenza illness in older
adults.
The publication notes that approximately 9,000 people aged 50
and older were enrolled and randomized in an efficacy study
designed to compare Flublok Quadrivalent to a traditional
quadrivalent vaccine. People who were given Flublok Quadrivalent
were over 40% less likely to develop culture-confirmed
influenza. This data satisfies both pre-specified criteria
for non-inferiority and superiority of Flublok over the traditional
egg-based quadrivalent inactivated vaccine. Flublok
Quadrivalent was approved by the FDA in October 2016 and will be available nationwide in
prefilled syringes for the upcoming flu season.
"This study shows that Flublok® Quadrivalent, produced
with modern recombinant technology can provide better protection
against confirmed influenza-like illness among older adults than
standard-dose quadrivalent influenza vaccine produced with
traditional technology," said
Lisa Dunkle MD, Chief Medical
Officer of Protein Sciences. "We demonstrated statistically
significantly better protection by Flublok based on considerably
fewer people contracting the flu after vaccination with Flublok
Quadrivalent. Today, we announce that these peer-reviewed results
have been published in the highly respected New England Journal of
Medicine. Furthermore, physicians are eligible for up to 1 hour
AMA PRA category 1 CME credit for
reading the article. Clearly, Flublok represents a major step
forward in combating influenza on a global scale."
Flublok is the only flu vaccine made without the use of
eggs and therefore is not subject to the mutations that are
sometimes introduced into the vaccine during the process of egg
adaptation that can cause the traditional vaccines to be
ineffective (see Skowronski et al. (2014) PLOS ONE
9(3), e92153). Flublok contains three times more
active ingredients than traditional vaccines and produced
significantly higher immune responses to the A strains of influenza
(especially H3N2) in the Flublok Quadrivalent study. Furthermore,
Flublok Quadrivalent is the first and only high antigen-content
quadrivalent flu vaccine that with its high efficacy makes it ideal
for older adults and those with a compromised immune system.
Flublok is highly purified and does not contain influenza virus,
antibiotics, formaldehyde, preservatives, egg protein, latex,
gluten or gelatin unlike other flu vaccines. Flublok
Quadrivalent is FDA approved for adults 18 and older.
For more information about Flublok, please visit
www.flublok.com.
About Protein Sciences
Protein
Sciences is a world leader in vaccine development and protein
production. Our mission is our inspiration: to save lives and
improve health through the creation of innovative vaccines and
biopharmaceuticals.
About Flublok®
Flublok, the
world's first recombinant protein-based vaccine for the prevention
of seasonal influenza disease, is approved for all adults over 18
years. FDA approved the quadrivalent formulation ("Flublok
Quadrivalent") in October 2016 that
will be commercially available for everyone over 18 years for the
2017/18 influenza season. Flublok is the only flu vaccine
made in a 100% egg-free system using modern cell culture
technology, making it unnecessary to use an infectious influenza
virus, antibiotics or harsh chemicals (e.g., formaldehyde) in
manufacturing. Flublok is highly purified and does not
contain any preservatives (e.g., thimerosal - a form of mercury),
egg proteins, gelatin or latex. In addition,
Flublok contains three times more antigen than
traditional flu vaccines (3x45mcg hemagglutinin protein versus
3x15mcg hemagglutinin protein). In a 2014/15 post-marketing
study of 9,000 adults 50 years and older, people who received
Flublok were over 40% less likely to develop cell culture confirmed
influenza than people who received a traditional flu vaccine.
Flublok is an exact copy of the influenza virus coat protein
and is not subject to the egg-adapted mutations associated with low
vaccine effectiveness (see Skowronski et al. (2014)
PLOS ONE 9(3), e92153).
Healthcare professionals in the U.S. wishing to order
Flublok should contact one of the following
distributors:
- Protein Sciences Corporation: 203-686-0800
www.flublok.com
- FFF Enterprises: 800-843-7477
www.myfluvaccine.com
- Cardinal Health: 866-677-4844
http://www.cardinal.com/flu
- McKesson: 877-MCK-4FLU
mms.mckesson.com
- Moore Medical: 800-234-1464
www.mooremedical.com/flu
- Henry
Schein: 1-800-772-4346
www.henryschein.com
Learn more at www.proteinsciences.com
and www.flublok.com.
Flublok Safety Information
Flublok
is approved for people 18 and older to prevent influenza
disease. The most common side effect from Flublok is pain at
the site of injection. Headache, fatigue or muscle ache may occur.
Tell the doctor if you have ever experienced Guillain-Barré
syndrome (severe muscle weakness) or have had a severe allergic
reaction to any component of Flublok vaccine. Vaccination with
Flublok may not protect all individuals. Please
see the complete Package Insert available at
www.flublok.com or call 203-686-0800 for more
information.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/superior-protection-by-flublok-influenza-vaccine-in-seniors-documented-in-new-england-journal-of-medicine-300478298.html
SOURCE Protein Sciences Corporation