The FINANCIAL — 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. "Patients are at the center of everything we do and their safety is our highest priority. We are pleased that the precautionary holds in Canada and Switzerland have been lifted," said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. "We have remained confident in the safety and efficacy of our vaccines; now we are focused on resuming distribution as soon as possible to protect against seasonal influenza."
The safety and efficacy of these seasonal influenza vaccines are supported by the clinical data gathered during the 2012-2013 seasonal influenza studies required for licensure. As Novartis reported, for the current season, more than one million doses have been administered and no unexpected adverse events have been reported.
Novartis is working diligently with other local health authorities who implemented similar precautionary measures to address their questions and plan to restore distribution as soon as possible.