Information for patients
Some health organizations have requested precautionary measures for the Agrippal and Fluad vaccines. This section covers the available information for patients on the current situation.
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Should patients who have recently been vaccinated with Agrippal or Fluad be concerned?
Anyone who has been vaccinated with these vaccines should not be concerned. Patient safety is our highest priority at Novartis and we are confident in the safety and efficacy of our seasonal influenza vaccines. This confidence is supported by clinical data gathered during the 2012-2013 seasonal influenza studies, which are required for licensure.
For the current season more than one million doses have been administered and no unexpected adverse events have been reported.
The one batch in question was not released for distribution. Protein aggregates can naturally occur in vaccines in very small quantities, typically dissolve when shaken, and are not uncommon.
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Should patients who have been vaccinated contact their doctors?
Novartis is not advising people to see their doctors because we are confident in the data demonstrating the safety and efficacy of our vaccines.
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Do patients already vaccinated with Agrippal or Fluad need to be revaccinated?
No. Individuals already vaccinated with Agrippal and Fluad have no reason for concern. For the current season more than one million doses of these vaccines have been administered and no unexpected adverse events have been reported.
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Press coverage has mentioned that particles were found in the vaccine. Do these particles pose a safety concern?
No. There is no reason to believe that the protein aggregates are in any way harmful; in fact all data points to the opposite. These aggregates can naturally occur in vaccines in very small quantities – they are formed by proteins essential to the vaccine manufacturing process. The safety and efficacy of these vaccines are not impacted by the presence of protein aggregates.
