SWIFTWATER, Pa., July 14, 2015 /PRNewswire/ -- Sanofi
Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE:
SNY), announced today that its first doses of Fluzone®
(Influenza Vaccine) for the 2015-2016 influenza ("flu") season have
been released by the U.S. Food and Drug Administration (FDA) for
shipment. This represents the first of more than 65 million total
doses of seasonal influenza vaccine manufactured by Sanofi Pasteur
that will be delivered to U.S. health care providers and pharmacies
beginning in July and continuing throughout the 2015-2016 flu
season.
According to the U.S. Centers for Disease Control and Prevention
(CDC), the single best way to prevent influenza is to get an annual
vaccination, which is recommended for everyone six months of age
and older, with rare exception.i,ii In fact, during the
2013-2014 season, the CDC estimated influenza vaccination prevented
7.2 million influenza-associated illnesses, 3.1 million medically
attended illnesses, and 90,000 hospitalizations.iii
"Influenza is a serious respiratory illness that is easily
spread and can lead to severe complications involving the heart,
lung, endocrine and other organ systems, potentially leading to
death," said David P. Greenberg,
M.D., Vice President, Scientific & Medical Affairs, and Chief
Medical Officer, Sanofi Pasteur U.S. "Vaccination is important
for high-risk age groups, including children and older adults. For
older adults, vaccination is particularly important given their
susceptibility to influenza and its complications due to an
age-related weakening of the immune system."
Sanofi Pasteur will supply a wide portfolio of Fluzone influenza
vaccine options this season to meet the immunization needs of
multiple age groups, from children as young as six months of
age through adults 65 years of age and older:
- Fluzone High-Dose vaccine is specially formulated for
adults 65 years of age and older. As people age, the immune system
weakens, which can put older adults at risk for influenza-related
complications.iv Clinical data demonstrated that Fluzone
High-Dose vaccine was 24.2 percent more effective than Fluzone
vaccine in preventing laboratory-confirmed influenza caused by any
influenza viral type or subtype in association with influenza-like
illness, in adults 65 years of age and older.v
- Fluzone Intradermal Quadrivalent vaccine, licensed by
the FDA in 2014 for adults 18 through 64 years of age, will be
available for the first time this influenza season. Fluzone
Intradermal Quadrivalent vaccine offers four-strain protection in a
microinjection system that is convenient, efficient, and easy to
use, allowing for streamlined administration by health care
providers. The vaccine is administered directly into the skin
through a 90 percent smaller, 1.5 mm microneedle. As the skin
has a high concentration of immune cells, an intradermal vaccine is
able to use the skin's natural defenses to induce a robust immune
response. In addition, the microinjection system is ideal for
vaccine administrators, since it has a pre-affixed needle and an
integrated needle shield.
- Fluzone Quadrivalent vaccine helps protect against four
influenza strains (two A strains and two B strains), in contrast to
trivalent influenza vaccines, which help protect against three
strains (two A strains and only one B strain). The influenza B
strain is associated with high hospitalization and mortality rates,
especially in children and young adults. In fact, on average, over
multiple recent seasons, 34 percent of influenza-related deaths in
children up to 18 years of age were due to influenza
B.vi Fluzone Quadrivalent vaccine is licensed for use in
people six months of age and older.
- Fluzone vaccine, a trivalent influenza vaccine that
protects against three influenza strains, is approved for use in
people six months of age and older.
"Sanofi Pasteur is committed to helping people fight
influenza by offering a broad range of vaccines for patients across
multiple age groups," added Dr. Greenberg. "Patients should
speak to their health care providers to determine which influenza
vaccine option is most appropriate."
Health care providers who placed reservations with Sanofi
Pasteur should expect to receive initial shipments by the end of
August to support fall immunization campaigns.
Health care providers wishing to reserve vaccine can do so by
visiting www.vaccineshoppe.com or by calling 1-800-VACCINE
(1-800-822-2463). Members of the public seeking a specific vaccine
option, such as Fluzone High-Dose vaccine, Fluzone Intradermal
Quadrivalent vaccine, or Fluzone Quadrivalent vaccine, can search
for local providers at www.Fluzone.com.
About Fluzone Vaccines
Indication
Fluzone, Fluzone Quadrivalent, Fluzone
Intradermal Quadrivalent, and Fluzone High-Dose vaccines are given
to help prevent influenza disease caused by influenza A and B
strains contained in each vaccine.
Fluzone and Fluzone Quadrivalent vaccines are given to people 6
months of age and older. Fluzone Intradermal Quadrivalent vaccine
is given to people 18 through 64 years of age. Fluzone High-Dose
vaccine is given to people 65 years of age and older.
Safety Information
Side effects to Fluzone, Fluzone
Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone
High-Dose vaccines include pain, redness, and swelling at the
injection site (also itching in adults receiving Fluzone
Intradermal Quadrivalent vaccine); muscle aches, fatigue, headache,
and fever (also irritability, abnormal crying, drowsiness, appetite
loss, and vomiting in young children receiving Fluzone or Fluzone
Quadrivalent vaccine). Itching, redness, swelling, and firmness at
the injection site occurred more frequently with Fluzone
Intradermal vaccine (containing 3 influenza strains) than with
Fluzone vaccine. Other side effects may occur.
Fluzone, Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent,
and Fluzone High-Dose vaccines should not be administered to anyone
with a severe allergic reaction (e.g., anaphylaxis) to any vaccine
component, including egg protein or thimerosal (the multidose vial
is the only presentation containing thimerosal), or to a previous
dose of any influenza vaccine.
Tell the doctor if you/your child has ever experienced
Guillain-Barré syndrome (severe muscle weakness) after a previous
dose of influenza vaccine. If you notice any other problems or
symptoms following vaccination, please contact your health care
professional immediately. Vaccination with Fluzone, Fluzone
Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone
High-Dose vaccine may not protect all individuals.
For more information about Fluzone, Fluzone Quadrivalent,
Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine,
talk to your health care professional and see complete Patient
Information.
About Influenza Vaccine Manufacturing
Direct
shipments to health care providers and distributors mark the start
of the influenza immunization season. While shipments will be
ongoing through the influenza season, running from July through
November 2015, Sanofi Pasteur began
its seasonal manufacturing of the more than 65 million doses at the
start of the year, following receipt of this year's influenza virus
strains from the CDC.
As new influenza strains emerge and strain activity fluctuates
throughout the year, each influenza season is unique. Global
influenza surveillance monitors influenza activity to identify
emerging and circulating strains, their respective levels of
prevalence and their virulence.vii Surveillance data are
studied months before the upcoming influenza season to determine
which circulating strains should be selected for the upcoming
season's influenza vaccine.viii Each February (for the
Northern Hemisphere) and September (for the Southern Hemisphere),
the World Health Organization (WHO) recommends strains for
inclusion in influenza vaccines.
Influenza vaccine production is a complex process which takes
months once the strain selection is made and received by
manufacturers. Not only is vaccine production complex, it is also a
highly regulated process that requires quality testing at each step
in the process.
As the world's largest producer of seasonal influenza vaccine
for both Northern and Southern Hemispheres, Sanofi Pasteur supplies
more than 200 million doses worldwide annually.
About Influenza
Influenza is a serious respiratory
illness that is easily spread and can lead to severe complications,
even death. Each year in the United
States, up to 20 percent of the population gets the flu and,
on average, more than 200,000 people are hospitalized from
influenza-related complications. Influenza seasons are
unpredictable and can be severe. Depending on virus severity during
the influenza season, annual deaths can range from a low of 3,000
to a high of about 49,000 people.ix Combined with
pneumonia, influenza is the nation's eighth leading cause of
death.x Vaccination is safe and effective and
the best way to help prevent influenza and its complications.
Children six months through eight years of age who have not
previously received two doses of influenza vaccine may require two
doses of vaccine for the 2015-2016 influenza season. Parents should
consult their health care provider about the number of doses of
influenza vaccine their child should receive. Individuals who are
not immunized early in the season still have time to do so prior to
the peak of influenza activity, which typically occurs in
February.
Influenza vaccination is beneficial throughout the season, and
even into the spring, as long as influenza viruses are still in
circulation.
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
Forward Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact
of cost containment policies and subsequent changes thereto, the
average number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk Factors" and "Cautionary
Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2014. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
i Centers for Disease Control and Prevention (CDC).
Preventing the Flu: Good Health Habits Can Help Stop Germs.
http://www.cdc.gov/flu/protect/habits.htm. Accessed May 27, 2015.
ii CDC. Who Should Get Vaccinated Against Influenza?
http://www.cdc.gov/flu/protect/whoshouldvax.htm. Accessed on
May 27, 2015.
iii CDC. Estimated Influenza Illnesses and
Hospitalizations Averted by Influenza Vaccination – United States, 2013-14 Influenza Season.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6349a2.htm. Accessed
May 27, 2015.
iv CDC. What You Should Know and Do this Flu Season If
You Are 65 Years and Older
http://www.cdc.gov/flu/about/disease/65over.htm. Accessed on
May 27, 2015.
v 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.
vi Ambrose CS, Levin MJ. The rationale for quadrivalent
influenza vaccine. Hum Vaccin Immunother. 2012; 8:81-88
vii World Health Organization (WHO). Influenza:
Surveillance and Monitoring.
http://www.who.int/influenza/surveillance_monitoring/en/.
Accessed March 27, 2015.
viii CDC. Selecting Viruses for the Seasonal Influenza
Vaccine.
http://www.cdc.gov/flu/professionals/vaccination/virusqa.htm. Accessed
March 27, 2015.
ix CDC. Key Facts about Influenza (Flu) & Flu
Vaccine. http://www.cdc.gov/flu/keyfacts.htm. Accessed July 7, 2015.
x CDC. National Center for Health Statistics.
VitalStats. http://www.cdc.gov/nchs/vitalstats.htm. Accessed
July 7, 2015.
Logo -
http://photos.prnewswire.com/prnh/20140721/128925
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/sanofi-pasteur-ships-first-2015-2016-seasonal-influenza-vaccine-doses-in-united-states-300112104.html
SOURCE Sanofi Pasteur