Last updated on April 18, 2014 at 21:21 EDT

Novartis Canada Resumes Seasonal Influenza Vaccine Distribution as Health Canada Lifts Suspension

October 31, 2012

Canadians urged to protect themselves for the coming flu season.

Video: B-Roll – October 31, 2012: John Dorsey Head, Vaccines and
Diagnostics at Novartis Pharmaceuticals Canada Inc. receiving Agriflu(®) influenza vaccine. Video available here.

DORVAL, QC, Oct. 31, 2012 /CNW/ – 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

About Agriflu(®)
Agriflu(®) is an inactivated influenza subunit virus vaccine for immunization
against influenza, indicated for everyone aged 6 months and older.
Agriflu(®) is available in convenient, ready-to-use pre-filled syringes. It has
been sold throughout Europe as Aggripal(®) since 1998.

About Fluad(®)
Fluad(® )is an adjuvanted inactivated influenza subunit virus vaccine,
specifically indicated in adults 65 years of age and older. Fluad(®) contains the adjuvant MF59(TM), which helps increase antibody production and improve immune response
in the elderly. Fluad(®) is available in convenient, ready-to-use pre-filled syringes. It has
more than 12 years of clinical experience and more than 60 million
doses have been distributed worldwide.

About Novartis Pharmaceuticals Canada Inc. 
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians.  In 2011, the
company invested close to $100 million in research and development in
Canada.  Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada.  It was named for the seventh time as one of the “50
Best Employers in Canada” for 2011. For further information, please
consult www.novartis.ca.

SOURCE Novartis Pharmaceuticals Canada Inc.

Image with caption: “John Dorsey Head, Vaccines and Diagnostics at Novartis Pharmaceuticals Canada Inc. receives Agriflu® influenza vaccine. (CNW Group/Novartis Pharmaceuticals Canada Inc.)”. Image available at: http://photos.newswire.ca/images/download/20121031_C3872_PHOTO_EN_19973.jpg

Source: PR Newswire