Novartis resumes distribution of two seasonal influenza vaccines in Canada

Novartis Pharmaceuticals Canada Inc. has announced it is resuming distribution of two seasonal influenza vaccines in Canada, Fluad^® and Agriflu^®, following the announcement by Health Canada earlier today that it has completed its review of safety information for Agriflu^® and Fluad^® and is releasing the two vaccines for immediate use. As a precautionary step, Health Canada had asked Novartis to suspend distribution of Agriflu^® and Fluad^® on October 26, 2012.

Health Canada indicated it looked at the results of its own testing, conducted a health risk assessment, and reviewed information from its European partners as well as data submitted by Novartis in making its decision. None of the information reviewed by Health Canada indicated a safety issue.

"This is good news for Canadians who can go with confidence to get their flu vaccination," said Dr. Allison McGeer, Microbiologist and Infectious Disease Consultant at Toronto's Mount Sinai Hospital. "Our job now as health care professionals is to make sure that any vaccination programs that were interrupted get back on track as quickly as possible, so that Canadians are protected from influenza this season."

Novartis anticipates no further interruption for those customers relying on Novartis vaccines.

"We have remained confident in the safety and efficacy of our vaccines. We are pleased that Health Canada's assessment confirms this today and we can resume shipments to customers," said John Dorsey, Head, Vaccines and Diagnostics at Novartis Pharmaceuticals Canada Inc.  "This resumption of supply will enable healthcare professionals to keep immunizing people against seasonal influenza."

The Public Health Agency of Canada is now advising health care professionals in possession of these vaccines that they can start using them once again. The Public Health Agency of Canada closely monitors vaccination-related adverse events and, to date, it has received no reports of serious or unexpected adverse events related to these vaccines. The Public Health Agency of Canada and Health Canada will continue to work with Novartis to monitor the safety and effectiveness of the vaccines used here in Canada. Should a safety concern be identified immediate and appropriate action will be taken.

"Patients' health and safety is our primary priority at Novartis which is why we took precautionary steps, although we were confident in the safety and efficacy of the Agriflu^® and Fluad^® vaccines," said Dr. Riad Sherif B., President of Novartis Pharmaceuticals Canada Inc. "We would like to thank Health Canada for its professionalism, expertise and assessment  of our vaccines. We are pleased to have a rapid resolution of the situation in order that all Canadians can protect themselves and their families. We believe it is critical that everyone gets their seasonal influenza vaccine this year."