Information for doctors
Some health organizations have requested precautionary measures for the Agrippal and Fluad vaccines. This section covers the available information for doctors on the current situation.
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Which products are impacted and in which countries?
The two products in question are Agrippal and Fluad.
Novartis welcomes the decisions by Health Canada and Swiss Agency for Therapeutic Products (Swissmedic) to lift the precautionary holds on the distribution of Novartis seasonal influenza vaccines Agrippal and Fluad. This follows additional analysis to reaffirm the safety and efficacy of the vaccines.
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.
In Italy, the Italian Medicine Agency (AIFA) announced on November 9 , 2012 that the temporary halt on the use of the Agrippal and Fluad vaccines has been lifted. This follows additional information provided by the company and AIFA's independant assessment, which reaffirm the vaccines' safety and efficacy. Distribution will resume immediately in Italy to support vaccination campaign.
In Germany, after consultation with the Paul Ehrlich Institut (PEI), Novartis has recalled certain batches of Aggripal and Fluad. The four affected batches of Aggripal are 126201, 126102A, 126101 and 126202A. One batch of Fluad is also affected – 128902. Begripal is the trade name of Agrippal in Germany. Optaflu is not affected by this precautionary measure.
In Austria, France, Korea and Spain health care authorities have requested cautionary holds be placed on Agrippal and Fluad until the situation is clarified.
In the United States, the Novartis influenza vaccine Fluvirin is not impacted by this issue and is available for the 2012-2013 influenza season. This is because Fluvirin is manufactured at a different Novartis site.
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If patients have already been vaccinated with Agrippal or Fluad, do doctors need to take any action?
No. Individuals who have already been vaccinated should not be concerned. For the current season more than one million doses of these vaccines have been administered and no unexpected adverse effects have been reported.
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When are the impacted countries likely to get more vaccine?
Novartis is committed to restoring distribution of Agrippal and Fluad as soon as possible. The exact timings for restoring supply are being determined on a country by country basis.
Novartis is actively engaging with the health authorities in the countries where Agrippal and Fluad are commercialized this season (Europe, Asia and Canada).
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Are other Novartis vaccines impacted?
No. Only Agrippal and Fluad are impacted.
