Novartis confident in safety and efficacy of its seasonal influenza vaccines produced in Italy
As precaution, Italian ministry of health temporarily halts distribution of two seasonal influenza vaccines Agrippal and Fluad, produced at Novartis site in Italy
Recent clinical trials of these influenza vaccines and administration during seasonal vaccination campaigns have shown no unexpected adverse events to date
Novartis is proactively engaging with health authorities to address the situation
Patient safety is highest priority at Novartis
Basel, October 25, 2012 - Novartis confirms its confidence in the safety and efficacy of its seasonal influenza vaccines Agrippal® and Fluad® manufactured in Italy. Patient safety is of the highest priority to Novartis. Novartis internal assessments and the clinical data gathered during the 2012-2013 seasonal influenza studies required for European licensure of Agrippal and Fluad demonstrate a safety and immunogenicity profile similar to that of prior years. To date, data from the ongoing seasonal vaccination campaign have revealed no safety signals.
The Italian ministry of health took this precautionary measure following a report by Novartis of small particles in the vaccines. Recently, Novartis voluntarily provided the Italian health authorities with its assessments supporting the quality, efficacy and safety of the specific vaccines in question. Novartis confirms that these particles can occur in the vaccine manufacturing process and is confident that there is no impact on the safety or efficacy of the vaccine.
The company will continue to work with the Italian Ministry of Health and AIFA to understand the reasons for their decision and to clarify any questions. The company is fully committed to providing high quality vaccines to patients and will continue to work with the authorities to make vaccines available.
Novartis will provide further updates when more information is available. For more information visit www.novartisvaccines.com/fluinfo.
Agrippal and Fluad are not available in the United States of America and marketed in Germany under the tradename Begrippal® and in Italy additionally under the tradenames Influpozzi sub unità and Influpozzi adiuvato.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 126,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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