Note: please see LINK BAG for answers to common questions on pandemic influenza (H1N1) 2009 and recommendations from the Federal Office of Public Health:
http://www.bag.admin.ch/influenza/06411/index.html?lang=de

1. What vaccines against pandemic influenza (H1N1) 2009 are licensed in Switzerland? Currently, Swissmedic has completed its review and has approved three pandemic influenza (H1N1) 2009 vaccines for Switzerland.

2. Are the vaccines against pandemic influenza (H1N1) 2009 similar to vaccines against seasonal influenza? 
Focetria® and Pandemrix® are similar to seasonal influenza vaccines with respect to the manufacturing process of the HA antigen component (based on fertilised chicken eggs). Celtura® is based on newer technology with respect to the  manufacturing process of the HA antigen component (based on canine cell lines). All three licensed pandemic influenza vaccines are different from seasonal influenza vaccines with respect to the adjuvant component, the monovalence (HA antigen of only one influenza virus), and the HA antigen dose.

Pandemrix® is a vaccine against the pandemic (H1N1) 2009 influenza A virus (containing 3.75 mcg HA antigen). Pandemrix® is an inactivated influenza vaccine made by using fertilised chicken eggs, and containing the adjuvant AS03 (HA antigen and adjuvant are in separate vials to be combined prior to administration).

Focetria® is a vaccine against the pandemic (H1N1) 2009 influenza A virus (containing 7.5 mcg HA antigen). Focetria® is an inactivated influenza vaccine made by using fertilised chicken eggs and contains the adjuvant MF59 (premixed).

Celtura® is a vaccine against the pandemic (H1N1) 2009 influenza A virus (containing 3.75 mcg HA antigen). Celtura® is an inactivated influenza vaccine made by using Madin Darby Canine Kidney (MDCK) cells and contains the adjuvant MF59 (premixed).

Seasonal influenza vaccines are vaccines against 3 types of non-pandemic influenza viruses (this year's seasonal vaccines for the northern hemisphere, according to WHO 2009 recommendations, are against a non-pandemic A(H1N1) virus, a A(H3N2) virus, and an influenza B virus). Licensed seasonal influenza vaccines used in Switzerland are inactivated and manufactured by using fertilised chicken eggs. Most seasonal influenza vaccines do not use an adjuvant except Fluad® produced by Novartis. Fluad® is an inactivated seasonal influenza vaccine that is adjuvanted with MF59 and licensed for use in adults aged 65 years or older. A non-adjuvanted MDCK-cell-based seasonal flu vaccine (Optaflu® produced by Novartis) has been licensed in Switzerland but is not yet commercialised.

3. What is an adjuvant? Which influenza vaccines contain an adjuvant in Switzerland?
An adjuvant is a substance added to a vaccine with the aim of improving the immune response to protect against the disease. By adding an oil-in-water adjuvant in influenza vaccines, the amount of HA antigen (influenzavirus proteins) in the vaccine may be reduced.

ASO3 is an oil-in-water adjuvant that consists of: squalene, vitamin E (α-tocopherol), and polysorbate 80. AS03 adjuvant has shown a substantial enhancement of the immune response together with different antigens.

MF59 is an oil-in-water adjuvant that consists of squalene, polysorbate 80 and sorbitan trioleate. MF59 adjuvant has shown a substantial enhancement of the immune response together with different antigens.

All three licensed pandemic influenza vaccines in Switzerland are adjuvanted and have a lower dose of HA antigen.

All licensed seasonal influenza vaccines in Switzerland contain a higher amount of inactivated HA antigen (usually 15 mcg for each selected virus strain) per dose against 3 non-pandemic influenza viruses and no adjuvant, with the exception of Fluad® which contains 15 mcg HA antigen and MF59 adjuvant and is licensed for use in adults aged 65 years or older. For Fluad®, the adjuvant MF59 was added for the purpose of countering the natural waning immunity of older adults called senescence,which leads to a weaker immune response to vaccinations in general.

4. Why do multidose vials contain thiomersal? Is thiomersal safe?
The pandemic influenza (H1N1) 2009 vaccines available in multidose vials will contain a small amount of thiomersal per dose. Thiomersal is a mercury-based compound that has been used as a preservative in vaccines since the 1930s. A preservative in multidose vials helps prevent contamination of the vial contents and non-sterile injections that could cause injection-site abscesses and blood-stream infections. The available literature has not supported a concern for adverse health outcomes with the use of thiomersal in vaccines.

The vaccines available in single-dose vials do not contain thiomersal.

6. How will Swissmedic monitor reports of adverse events following pandemic influenza (H1N1) 2009 vaccination?
Swissmedic has ongoing, timely access to review new international data on the use of pandemic influenza vaccines as the data become available. Any adjustments to the indications for the use of the vaccines or antiviral medications against pandemic influenza will be made and communicated immediately. Up-to-date information will be available from the Swissmedic website.

Swissmedic has prepared a dedicated online system called "Paniflow" to provide continuous monitoring of the safety of the pandemic influenza (H1N1) 2009 vaccines used in Switzerland. Healthcare providers are thus urged to report cases of serious or unexpected suspected adverse events following immunization using the Paniflow reporting tool.
http://www.swissmedic.ch/marktueberwachung/00091/01046/index.html?lang=en

Swissmedic also works in collaboration with international authorities to share information regarding any early signals concerning suspected adverse events following vaccination or medications used against pandemic influenza (H1N1) 2009.

7. Which adverse drug reactions from pandemic influenza (H1N1) 2009 may be expected?
Adverse reactions from pandemic influenza (H1N1) 2009 vaccines that may be expected will be similar to those of seasonal influenza vaccines. Studies on the pandemic influenza (H1N1) 2009 vaccines have shown an increased incidence of local or systemic inflammatory responses, compared with seasonal influenza vaccines. These include low-grade fever, body aches and fatigue a few days following vaccination, or pain at the injection site. As with any medication, rare serious drug reactions can occur.

More information on adverse reactions is in the Product Information

8. For which adverse drug reactions should a patient see a doctor?
Patients with suspected, severe or unexpected adverse drug reactions after receiving vaccination or medications against influenza should consult their doctor or pharmacist.

9. Which adverse drug reactions (ADRs) should Pharmacists and Doctors report?
Report all suspected serious or unexpected ADRs following vaccination and necessitating a medical consultation and not otherwise explained.

Report all serious or unusual ADRs, especially general hypersensitivity reactions, fever higher than 39⁰C, organ responses (eg, convulsions, neuritis, thrombocytopenia), and autoimmune diseases that are new or have appeared to worsen.

Report strong local reactions (such as arm swelling which exceeds 2 joints and lasts more than 6 days).

In addition, report any unexpected increase in known or unknown ADRs. This may be an early indication of a concern with a batch of vaccine that has not met production specifications.

10. How should Doctors and Pharmacists report adverse drug reactions?
Principles:
1. Only those suspected adverse drug reactions (ADR) that have been observed after vaccination with the H1N1 flu vaccine are collected in the PaniFlow system. The Paniflow System will be accessible through the Swissmedic Pandemie Portal http://www.swissmedic.ch/pandemieportal.asp.

2. All suspected adverse drug reactions (ADR) that have been observed with other medications - i.e. that are not connected to the pandemic influenza (H1N1) 2009 vaccine - should be reported as usual using the yellow ADR report form to the Regional Pharmacovigilance Centres.

3. Exception: Please send reports of suspected adverse drug reactions in pregnant women taking Tamiflu or Relenza directly to the STIS at the Regional Pharmacovigilance Centre in Lausanne, using the yellow ADR report form.

11.  What adverse drug reactions will Swissmedic be especially monitoring?
Swissmedic will place emphasis on the detection of serious adverse drug reactions (ADRs), and suspected causal links between ADRs and pandemic influenza (H1N1) 2009 vaccines or antiviral medications. The agency monitors not only pandemic influenza (H1N1) 2009 vaccines but also drugs for treatment and prevention of influenza.

Of particular importance is the detection of suspected ADRs in population groups that we currently have only limited experience with the use of vaccines and medications.

Of continued importance is receiving reports of lack of efficacy (vaccine failure, suspected resistance to antiviral drugs or interactions with other medications).