Novartis begins shipment of Fluvirin® seasonal influenza vaccine to US customers for 2011-2012 influenza season
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Novartis International AG /
Novartis begins shipment of Fluvirin® seasonal influenza vaccine to US customers
for 2011-2012 influenza season
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The issuer is solely responsible for the content of this announcement.
* Novartis plans to ship over 30 million doses of Fluvirin vaccine to US
customers for 2011-2012 season with sufficient supply to meet customer
demand
* Early delivery allows for early vaccination of priority individuals,
including seniors, pregnant women and those with chronic illnesses[1]
Basel, July 15, 2011 - Novartis announced today that the Company has started
shipping seasonal influenza vaccine to its US customers for the 2011-2012
influenza season. Early delivery of seasonal influenza vaccine will ensure
healthcare professionals have the ability to provide the earliest possible
protection against influenza. Novartis plans to ship over 30 million doses of
Fluvirin(®) influenza virus vaccine, which has been approved by the US Food and
Drug Administration (FDA) for adults and children 4 years of age and older[2].
In any given season, influenza may cause thousands of influenza-associated
deaths and hospitalizations[3], [4]. Federal health officials advise that the
single best way to protect against influenza is to get vaccinated each year even
if the target viruses in the 2011-2012 vaccine are the same as the year before.
Immunity to influenza viruses declines over time and may be too low to provide
protection after a year[5].
"We are very pleased that Novartis is again delivering Fluvirin to the US well
ahead of schedule and with sufficient supply to meet customer demand, " said Vas
Narasimhan, MD, President, US Vaccines, Head, North America Vaccines. "The early
arrival of the influenza vaccine will allow public health professionals to
administer vaccinations weeks ahead of their normal schedule, meeting an
important public health need to help protect as many individuals as possible."
The Centers for Disease Control and Prevention (CDC) recommends routine seasonal
influenza vaccination for all individuals 6 months of age and older. In
addition, the CDC advises that it is especially important for certain high-risk
groups - seniors, pregnant women, people with chronic illnesses such as asthma,
diabetes or heart disease and healthcare workers - as well as people who care
for those at high-risk, to receive an influenza vaccine each influenza
season[1].()
About Seasonal Influenza
Seasonal influenza is a highly communicable, acute viral infection that
predominantly attacks the respiratory tract and sometimes the lungs. It can
cause mild to severe illness and can also lead to death[3].
The number of people in the US who die every year from influenza and its
complications is comparable to the more than 41,500 people in the US who die
each year from breast cancer, and to about half of the estimated 71,000 people
who die annually of diabetes and its complications each year in the US[6], [7].
Influenza vaccination is one of the most effective public health interventions
ever implemented, sparing millions of people from complications, including
death, from this infectious disease. Use of currently available seasonal
influenza vaccines has been calculated to save more than 8 million lives
annually worldwide, translating to one person saved every five seconds[8].
About Fluvirin
Fluvirin vaccine is an inactivated influenza virus vaccine indicated for active
immunization of persons 4 years of age and older against influenza disease
caused by influenza virus subtypes A and type B contained in the vaccine[2].
For the 2011-2012 season, Fluvirin contains antigens that target three influenza
virus strains identified by World Health Organization (WHO) experts as likely to
dominate circulation. These include:
* A/California/7/2009 (H1N1)-like virus
* A/Perth/16/2009 (H3N2)-like virus
* B/Brisbane/60/2008-like virus[5]
Important Safety Information
Serious allergic reactions, including anaphylactic shock, have been observed in
people receiving Fluvirin Influenza Virus Vaccine. Fluvirin vaccine should not
be administered to individuals with a history of systemic hypersensitivity
reaction to eggs or egg proteins or other components of Fluvirin vaccine,
including thimerosal, or to anyone who has had a life-threatening reaction to
previous influenza vaccination. In clinical trials, the most common adverse
events in adults were headache, fatigue, injection site reactions (pain, mass,
redness, and induration), and malaise. These adverse events were generally
mild/moderate and transient. Vaccination with Fluvirin vaccine may not protect
all individuals who are susceptible to influenza. Immunocompromised persons,
including individuals receiving immunosuppressive therapy, may have a reduced
immune response to Fluvirin vaccine. If Guillain-Barré syndrome has occurred
within 6 weeks of receipt of prior influenza vaccine, the decision to use
Fluvirin vaccine should be based on careful consideration of the potential
benefits and risks. All people, including those who are pregnant, nursing,
and/or taking other medications, should consult their healthcare providers
before receiving Fluvirin vaccine.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "plans, " "will, " "may, " "can, " "likely, " or similar
expressions, or by express or implied discussions regarding potential future
revenues from Fluvirin. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views of
management regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Fluvirin to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Fluvirin
will achieve any particular levels of revenue in the future. In particular,
management´s expectations regarding Fluvirin could be affected by, among other
things, competition in general; government, industry and general public pricing
pressures; unexpected regulatory actions or delays or government regulation
generally; unexpected clinical trial results, including unexpected new clinical
data and unexpected additional analysis of existing clinical data; the company´s
ability to obtain or maintain patent or other proprietary intellectual property
protection; the impact that the foregoing factors could have on the values
attributed to the Novartis Group´s assets and liabilities as recorded in the
Group´s consolidated balance sheet, and other risks and factors referred to in
Novartis AG´s current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or otherwise.
About Novartis
Novartis Vaccines and Diagnostics is a division of Novartis, focused on the
development of preventive treatments. The division has two businesses: Novartis
Vaccines and Novartis Diagnostics. Novartis Vaccines is the world´s fifth-
largest vaccines manufacturer and second-largest supplier of flu vaccines in the
US. The division´s products also include meningococcal, pediatric and travel
vaccines. Novartis Diagnostics, the blood testing business, is dedicated to
preventing the spread of infectious diseases through the development of novel
blood-screening tools that protect the world´s blood supply.
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only company with leading
positions in these areas. In 2010, the Group´s continuing operations achieved
net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 119,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis.
References
[1] Centers for Disease Control and Prevention. Seasonal Flu Vaccine. April
5, 2011. Available at:http://www.cdc.gov/flu/about/qa/fluvaccine.htm. Accessed
on June 28, 2011.
[2] United States Food and Drug Administration. Influenza Virus Vaccine
Fluvirin® 2011-2012 Formula. Available
at:http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/
ApprovedProducts/UCM123694.pdf. Accessed on July 5, 2011.
[3] Centers for Disease Control and Prevention. Key facts about influenza (flu)
& flu vaccine. September 15, 2010. Available
at:http://www.cdc.gov/flu/keyfacts.htm. Accessed on June 28, 2011.
[4] Centers for Disease Control and Prevention. Seasonal influenza-associated
hospitalizations in the United States: Questions & Answers. February 8, 2011.
Available at:http://www.cdc.gov/flu/about/qa/hospital.htm. Accessed on June
28, 2011.
[5] Centers for Disease Control and Prevention. Vaccine Selection for the
2011-2012 Influenza Season. May 3, 2011. Available
at:http://www.cdc.gov/flu/about/qa/vaccine-selection.htm. Accessed on June
28, 2011.
[6] The Centers for Disease Control and Prevention. Breast Cancer Statistics.
Available at:www.cdc.gov/cancer/breast/statistics. Accessed on June 28, 2011.
[7] The Centers for Disease Control and Prevention. National Diabetes Fact
Sheet, United States 2005. Available
at:http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. Accessed on June
28, 2011.
[8] Lattanzi M, Rappuoli R. The grand challenge for the future. Vaccines for
poverty-related diseases from bench to field. In: Kaufmann SHE, Lambert P, eds.
Basel: Birkhauser; 2005:77.
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