Novartis begins shipment of Fluvirin®

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.

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.