Influenza A (H1N1) 2009 Pandemic Vaccine (Without Adjuvant)

1. What is the Influenza A (H1N1) 2009 Pandemic Vaccine (without adjuvant)?
2. How is this vaccine different from ArepanrixTM H1N1?
3. Who is the vaccine for?
4. How is the vaccine administered?
5. How many doses are needed?
6. What evidence was used to support the authorization for sale of the vaccine?
7. Were studies conducted in pregnant women?
8. What are the benefits and potential risks associated with the vaccine?
9. What are the vaccine ingredients?
10. How was the vaccine authorized?
11. Does the company have to submit additional data on the vaccine?
12. What measures are in place to monitor vaccine safety?
13. Where can I find more information?

1. What is the Influenza A (H1N1) 2009 Pandemic Vaccine (without adjuvant)?

The Influenza A (H1N1) 2009 Pandemic Vaccine (without adjuvant), commonly referred to as the non-adjuvanted H1N1 pandemic vaccine, is a vaccine that was developed to protect against the Influenza A (H1N1) pandemic virus.

2. How is this vaccine different from Arepanrix™ H1N1?

Both of the pandemic vaccines contain an inactivated (non-live) version of the H1N1 virus strain that is recommended by the World Health Organization for the manufacture of vaccines during this influenza pandemic. This vaccine differs from ArepanrixTM H1N1 as it does not contain an adjuvant, which is a substance added to a vaccine to boost the immune response.

Without an adjuvant, more antigen (the active ingredient in the vaccine) is required in order to provide protection against the virus. The non-adjuvanted vaccine is made with a concentration of 15 ug of H1N1 antigen per 0.5 ml dose whereas, the adjuvanted vaccine is made with a concentration of 3.75 ug of H1N1 antigen per 0.5 ml dose.

3. Who is the vaccine for?

The Government of Canada purchased a small quantity of the non-adjuvanted H1N1 vaccine from GlaxoSmithKline (GSK) as a precautionary measure for use in pregnant women as no clinical data on the safety of the adjuvanted Arepanrix™ H1N1 vaccine for pregnant women is currently available. However other groups may benefit from immunization with the non-adjuvanted vaccine. Please consult the website of the Public Health Agency of Canada for recommendations on use.

Please refer to the Public Health Agency of Canada website for more information on recommendations for H1N1 vaccination during pregnancy.

4. How is the vaccine administered?

The vaccine is given intramuscularly by injection into the shoulder muscle (deltoid) by health professionals. Please refer to the product information leaflet for further instructions.

5. How many doses are needed?

Preliminary data suggest that only one dose of the vaccine is needed to produce an adequate immune response in adults. Dosing recommendations may be updated as new information becomes available.

6. What evidence was used to support the authorization for sale of the vaccine?

The following data was used to support the authorization for sale of the non-adjuvanted H1N1 pandemic vaccine:

• Quality (chemistry and manufacturing) data on the vaccine manufacturing process,
• Information from non-clinical (animal studies) and clinical studies in humans conducted with the vaccine and with a similar non-adjuvanted H1N1 pandemic vaccine manufactured by GSK in Germany, and
• Past experience with Fluviral®, a seasonal flu vaccine that is also manufactured by GSK and authorized for sale in Canada.

Data from global clinical trials that became available during the authorization process using similar or related pandemic vaccines were also considered. Further clinical studies and surveillance will continue post-authorization.

7. Were studies conducted in pregnant women?

Clinical trials are rarely conducted in pregnant women. However, there is extensive experience regarding the safety of non-adjuvanted seasonal influenza vaccines in pregnant women. Based on available data and the substantially elevated risk for a severe outcome in pregnant women infected with the H1N1 virus, the World Health Organization and the Public Health Agency of Canada recommend that pregnant women be immunized.

Similar non-adjuvanted H1N1 vaccines have been safely used in immunization programmes in other countries, such as Australia. Canada, in collaboration with its international partners will continue to monitor the safety and effectiveness of the vaccine used in pregnant women.

8. What are the benefits and potential risks associated with the vaccine?

Internationally accepted criteria have been established to assess the immunogenicity of influenza vaccines. Clinical trial results indicate that the vaccine meets all of these criteria, which suggests that the vaccine produces an adequate level of protection against the H1N1 pandemic virus.

As with all medicinal products, there may be side effects or adverse events associated with the use of the product. Some of the very common adverse events that may be observed include redness or swelling at the injection site, fever, or swelling of the lymph glands. Please refer to the product information leaflet for additional information on adverse events.

Individuals should not be given the vaccine if they have a history of a severe allergic reaction to any of the ingredients that are in the vaccine.

9. What are the vaccine ingredients?

The vaccine contains the virus strain recommended by the World Health Organization. In addition, it contains thimerosal, as a preservative, and very small amounts of egg proteins, trace amounts of formaldehyde, sodium deoxycholate and sucrose. Please refer to the product information leaflet for a full list of vaccine ingredients.

10. How was the vaccine authorized?

The non-adjuvanted H1N1 pandemic vaccine was authorized because scientific evidence indicated that the benefits of immunization with the vaccine outweighed any risks. The time frame between vaccine manufacturing and the need to use the vaccine in time to provide the public with protection against the virus is very short. As a result, it has not been possible for the manufacturer, GSK, to collect the usual full information necessary for a Notice of Compliance to be issued under the Food and Drug Regulations. For this reason, an Interim Order was used to provide an alternate pathway to allow for the authorization for sale of the vaccine. Under the Interim Order, the manufacturer is required to continue submitting data on the safety and effectiveness of the vaccine post authorization. Health Canada and the Public Health Agency of Canada will review this information as it becomes available.

11. Does the company have to submit additional data on the vaccine?

Yes, the manufacturer will continue to submit data on the safety and effectiveness of the vaccine as it becomes available. This data will include results from ongoing clinical trials.

12. What measures are in place to monitor vaccine safety?

Various mechanisms are in place to monitor the safety and effectiveness of the vaccine. Once authorized, all lots of the pandemic vaccine will be tested in Health Canada laboratories before they are released on the Canadian market.

The manufacturer is responsible for collecting information on the safety of the vaccine. This includes information on any adverse events that are reported following immunization. The Public Health Agency of Canada as well as other research organizations will also be actively monitoring the safety and effectiveness of the vaccine. The purpose of vaccine safety monitoring is timely identification of clinically significant adverse events following immunization that may be of public health concern.

Health Canada and the Public Health Agency of Canada have been working in close collaboration with other national regulatory and public health authorities to respond to the pandemic virus. There is a global commitment amongst regulatory authorities to share clinical and safety data on H1N1 vaccines in real-time and to rapidly share information on any potential adverse events following immunization.

13. Where can I find more information?

The product information leaflet and other regulatory documents can be found on the Health Canada website.

Recommendations for the use of H1N1 pandemic vaccines can be found on the Public Health Agency of Canada website. These websites will be updated as new information becomes available.