Tuesday, October 30, 2012
Ministry of Health and Long-Term Care
Questions and Answers from MOHLTC Regarding Novartis Vaccine Suspension
For the Public
Q: Why is Health Canada advising Provinces and Territories to suspend use and distribution of two Novartis seasonal flu vaccines at this time?
A: Health Canada has suspended use and distribution of two Novartis vaccines - Agriflu and Fluad.
This is being done as a precautionary measure because white floating material discovered clumping in the vaccines was found in a limited number of lots of the vaccine produced in Italy.
It is important to note that Health Canada reviewed Agriflu and Fluad for safety and effectiveness before they were approved for use in Canada. Clumping of the kind noted in Europe is common in vaccines; Health Canada has previously seen such particles in other vaccines and has not observed an impact on the safety or effectiveness of the vaccines in which this occurred.
Q: What is the government of Ontario doing to respond to this situation?
A: The Ministry of Health and Long-Term Care (MOHLTC) is monitoring this situation closely. We are working closely with the Ontario Government Pharmaceutical and Medical Supply Service (OGPMSS) as well as Public Health Units and health care providers to ensure that:
- Ontario complies with the advice to suspend use and distribution of Agriflu and Fluad;
- Health care providers understand that they should not be administering these vaccines if they have them in their stock; and should store them appropriately until further notice.
- Public health units and health care providers receive replacement vaccine to ensure that the seasonal influenza immunization campaign can continue.
MOHLTC has other seasonal flu vaccines available including Vaxigrip and Fluviral. These will be distributed, where needed, to ensure that Ontarians can be immunized against seasonal influenza.
Q: If I received the Agriflu or Fluad influenza vaccines, are there any health risks that I should be aware of?
A: There is no evidence that there is any risk associated with these Novartis vaccines. Health Canada has indicated that should a safety concern be identified, immediate and appropriate action will be taken. Health Canada, as well as Public Health Ontario, have also indicated that to date, they have received no reports of serious or unexpected adverse events related to the administration of these vaccines. The action taken by Health Canada to temporarily suspend the distribution and use of these vaccines is a precautionary measure and is not related to any health risks having been directly observed.
Q: If I have already received the flu shot, should I get immunized again?
A: Currently there is no recommendation that Ontarians who have already been immunized should be “re-immunized”.
Q: Should I still go to get my flu shot if I haven’t gotten one yet?
A: Yes. The Chief Medical Officer of Health strongly recommends that Ontarians get their seasonal flu shot. The Ministry of Health and Long Term Care is working with OGPMSS, Public Health Units, and health care providers to ensure that other seasonal flu vaccines are distributed so that Ontarians can be immunized and that this year’s seasonal influenza campaign can continue successfully.
Q: Have any adverse events from Agriflu or Fluad been reported?
A: No serious or unexpected adverse effects have been reported.
The Public Health Agency of Canada and Public Health Ontario monitor for adverse events following immunization. To date no reports of serious or unexpected adverse events related to the administration of these vaccines have been received.
Q: What is happening with the seasonal influenza campaign in Ontario?
A: Ontario currently has a sufficient supply of vaccines from other manufacturers to provide influenza vaccine to everyone who wishes to receive it.
Getting your influenza vaccine is important to protect yourself and your family.
Q: Where can I go to get information?
A: MOHLTC will make additional information available as it is received. The public can also check Health Canada’s website for additional information and updates.
For Public Health Units and Health Care Providers
Q: Is it known when Health Canada will complete its review of this situation?
A: Health Canada has indicated that they are intending to have the review completed as soon as possible, likely within a few days. MOHLTC will remain in contact with Health Canada and will share any further information that we receive.
Q: What about immunization of Long-Term Care Home (LTCH) residents? What should Public Health Units be telling Long-Term Care Homes?
A: Public Health Units are asked to advise LTCHs that they should not immunize residents with Fluad or Agriflu. MOHLTC will work with PHUs to provide replacement vaccine that can be distributed to LTCHs. Either Fluviral or Vaxigrip can be used, pending completion of Health Canada's review. There is no indication at this time that LTCH residents who have already been immunized using the Novartis vaccines should be re-immunized.
Q: What should PHUs do, if they are running short of vaccine for clinics that are already scheduled?
A: PHUs are asked to call the Health Care Provider Hotline at 1-866-212-2272 to request additional vaccine. MOHLTC is working with OGMPSS to expedite delivery of vaccines.
Q: What should PHUs tell health care providers about storing or disposal of Fluad and Agriflu?
A: Health care providers are asked to keep Fluad and Agriflu stored appropriately and to maintain the cold chain of these vaccines. PHUs are asked to work with health care providers to determine if they will need to send vaccine back to PHUs and/or OGPMSS. It is acknowledged that some health care providers may have issues with storage space – MOHLTC will work with PHUs to address this issue.
Q: If PHUs receive questions from members of the public who have received the Agriflu or Fluad influenza vaccines, what message should be conveyed regarding any health risks?
A: There is no evidence that there is any health risk associated with the Novartis vaccines. Health Canada has indicated that should a safety concern be identified, immediate and appropriate action will be taken. Health Canada, as well as Public Health Ontario, have also indicated that to date, they have received no reports of serious or unexpected adverse events related to administration of these vaccines. This action is being taken as a precautionary measure and is not related to any health risks having been directly observed.
Q: Have any adverse events following immunization (AEFIs) from Agriflu or Fluad been reported?
A: No serious or unexpected adverse effects have been reported.
As noted, the Public Health Agency of Canada and Public Health Ontario monitor for adverse events following immunization. To date no reports of serious or unexpected adverse events related to these vaccines have been received.
As of October 26, 2012, there has been only one minor AEFI report in the province following immunization with a Novartis influenza vaccine (Agriflu). In addition, provincial reports of adverse events following influenza vaccine of all types used in Ontario are in keeping with previous years. Ontario has not seen any safety signal in relation to the Novartis influenza vaccines and to date there has been no safety signal reported in Europe related to Novartis influenza vaccines.
Q: What is the Ministry’s messaging about continuation of this year’s Seasonal Influenza Campaign?
A: Ontario currently has sufficient vaccine available to continue this year’s campaign. MOHLTC will work with PHUs and health care providers to distribute the other influenza vaccines; Fluviral and Vaxigrip, to ensure that this year’s campaign can continue and that vaccine is available to all Ontarians who wish to be immunized.