Influenza vaccines information center

The importance of vaccination

Patients are at the center of everything we do at Novartis and their health and safety are our primary concerns. Vaccinations are crucial for the prevention of many devastating diseases and contain the spread of seasonal influenza. According to the World Health Organization (WHO), influenza causes 3 to 5 million cases of severe illness and 250,000 to 500,000 deaths worldwide each year. As such, we believe seasonal influenza vaccines are a critical contributor to public health.

Novartis welcomes the announcement made today, on November 9, 2012, by the Italian Medicines Agency (AIFA) to lift the temporary halt on the use and distribution of Agrippal and Fluad seasonal influenza vaccines. This follows additional information provided by the company and AIFA’s independent assessment, which reaffirm the vaccines’ safety and efficacy. Within the European Union (EU), Italy is the regulatory reference country for Agrippal and Fluad. Novartis will continue to work with countries to lift remaining precautionary measures and resume supply as soon as possible. Distribution already resumed in Canada and Switzerland on October 31, 2012, as well as Singapore on November 2, 2012.

Novartis remains confident in the safety and efficacy of its seasonal influenza vaccines Agrippal and Fluad, which are supported by clinical data gathered during 2012-2013 studies required for licensure, as well as safety surveillance data collected to date. For the current season, more than one million people have been vaccinated and no unexpected adverse events have been reported to date.

The World Health Organization (WHO) recommends annual seasonal influenza vaccination for the elderly, people with chronic medical conditions and other vulnerable groups, such as pregnant women, health care workers and those with essential functions in society, as well as children from ages 6 months to 2 years.

According to its public statement, “Health Canada looked at the results of its own testing, conducted a health risk assessment, and reviewed information from its European partners and data submitted by Novartis in making its decision. None of the information reviewed indicated a safety issue.”

Swissmedic indicated that it came to a similar determination following additional analyses and clarification provided by Novartis, together with analyses of samples in its own laboratory that confirmed the quality of the vaccines.

Related documents:

Related links:

• Read the latest media release “Safety and efficacy of Novartis seasonal influenza vaccines reaffirmed with lifting of precautionary measure in Italy”

• Read the media release "Health Canada and Swissmedic lift precautionary holds on Novartis seasonal influenza vaccines" (October 31, 2012)

• Read the media release "Novartis confident in safety and efficacy of its seasonal influenza vaccines produced in Italy" (October 25, 2012)

• Download vaccine images

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