As with every vaccine, safety is a major priority. It is important that we offer as many people as possible the protection of a vaccine against Swine Flu, especially those people who are most at risk of complications of this virus. While rates of swineflu have dropped from the peak seen in late 2009, we are still seeing cases and want to be be prepared for a possible second or later wave of infection - as was experienced in previous pandemics.

Millions of doses of the new Swine Flu vaccines have now been given across Europe, and as we expected, the Swine Flu Vaccine has a similar safety profile to that of seasonal flu vaccines.  Over the years, hundreds of millions of people have received seasonal flu vaccines.

Common side effects being seen are again as expected - most are mild and may include soreness, redness or swelling where the injection was given. Headache, fever, aches and tiredness may also occur for a day or so. Life threatening allergic reactions to vaccines are very rare. Read more about vaccine safety below.

At the bottom of this page, we provide links to the Irish Medicines Board website, which has weekly updates and reports on vaccine safety and reactions being seen, from Ireland and Internationally, and where any adverse reactions, however mild, can be reported by people who have received the vaccine in Ireland. We also provide links to EU and international websites with related information on vaccine safety.

Who has approved the vaccines for use in Ireland?
Swine Flu vaccines have been put through a rigorous licensing process and are licensed by the European Medicines Agency and the Irish Medicines Board.  Clinical tests on the vaccines are being done on an ongoing basis, and millions of doses of these vaccines have been given to people across Europe this year.

If it’s a mostly mild illness, why vaccinate so many people?
First of all, it’s a mild illness for most people, but not for everyone.  Getting the vaccine protects a person from swine flu, but it also protects the people around them, as they won't get flu and pass it on to their children, elderly relatives, or people close to them who are pregnant or not in full health. So, the more people that get the vaccine, the less flu gets passed around.

Is it safe for pregnant women to be vaccinated?
Yes. Like seasonal flu vaccines, which have been used for more than 60 years, the Swine Flu vaccine is safe to use in pregnancy. The vaccines are fully licensed, serious side effects are expected to be very rare and the Swine Flu vaccine cannot give you Swine Flu.

Will vaccinating a mother during pregnancy protect her baby?
Vaccination during pregnancy may protect the baby and also helps prevent the mother getting flu and passing it on to her baby.

Is the vaccine safe if I'm breastfeeding?
Yes the vaccine is safe for breastfeeding mothers and their babies.

What is Thiomersal and is it safe?
Thiomersal in an ingredient in the Pandemrix Swine Flu vaccine and, yes, it is safe. It is used to stop vaccines becoming contaminated. It is a mercury based preservative which been used in medical products and vaccines for more than 60 years.

Thiomersal is broken down in the body and one of the products is ethyl mercury. It appears that ethyl mercury is being confused with methyl mercury and therefore is presumed to have the same toxicity as methyl mercury despite it being a different compound.

There is no evidence that ethyl mercury in vaccines has any adverse effects apart from the minor reactions such as swelling and redness at the site of injection. Everybody in the population (including pregnant women) is expected to be exposed to small amounts of methyl mercury via food, especially fish. Vaccination is not a significant source of mercury at an individual level, and the benefits of uncontaminated vaccine are very considerable.

What is Guillain-Barré Syndrome (GBS)?
Guillain-Barré Syndrome (GBS) is a nerve condition that can result in temporary paralysis and was seen in some people who received another type of Swine Flu vaccine in 1976. GBS can be a complication of getting the flu. Studies have shown since then that GBS may occur very rarely with flu vaccinations - about one case for every million people vaccinated. More recent studies have shown us that the risk of getting GBS as a result of having the flu itself is actually much greater. There is also evidence that the vaccine protects against GBS.

What are vaccine adjuvants?
Adjuvants are added to vaccines to reduce the amount of antigenic material (killed virus) needed to produce an immune response in people who get it. This means more doses of vaccine can be developed more quickly and in the case of a pandemic, more people can access the vaccine earlier.

What about the safety of adjuvants such as squalene?
Squalene is a naturally occurring substance found in plants, animals, and humans. It is manufactured in the liver of every human body and circulates in our bloodstream. Squalene is also found in a variety of foods, cosmetics, over the counter medications, and health supplements. Squalene is commercially extracted from fish oil, and in particular shark liver oil. Squalene used in pharmaceutical products and vaccines is purified from this source.

Is there anyone who cannot get Swine Flu vaccine?
Vaccine should not be given to children under 6 months of age, and should be postponed if you have a temperature over 38ºC. Everyone aged over 6 months can get the vaccine - unless they have a severe allergy to eggs or other substances in the vaccine or have previously had Guillain Barré Syndrome. If you have any of these allergies or concerns you can discuss them with your GP or at the vaccine clinic. If people have a life-threatening allergy to eggs, one of the vaccines available in Ireland (Celvapan) is not made using eggs so may be used in these cases.

How long does it take the vaccine to work?
The vaccine starts to work within two weeks.

The National Immunisation Advisory Committee has also confirmed that for the Pandemrix vaccine (manufactured by GSK), one dose of the vaccine will be sufficient to protect most people from Swine Flu.  People with immunosuppression will still require two doses of this vaccine, and this includes people who have cancer, are on cancer treatment or who are taking long-term steroid tablets.

For the Celvapan vaccine (manufactured by Baxter), 2 doses of vaccine are still required to give full protection from Swine Flu. 

Both vaccines are considered to be equally effective and have the same safety profile.

What can I expect after vaccination?
The most common side effects being seen are mild and may include soreness, redness or swelling where the injection was given. Headache, fever, aches and tiredness may occur. Some people may have mild sweating and shivering as their immune system responds to the vaccine, but this is not Swine Flu and will pass after a day or so. Severe or life threatening allergic reactions to vaccines are very rare.

What if I don't feel well after vaccination?
Take paracetamol or ibuprofen if you have a fever or any pain where the injection was given. If you are pregnant, take paracetamol for fever, not ibuprofen or aspirin. Avoid clothes rubbing against the injection area and drink plenty of fluids. Remember if you or a child is unwell after getting a vaccine, they could be sick for some other reason – don’t assume it’s the flu vaccine and take medical advice if needed.

As with any vaccines risks have to be balanced with the benefits ,and the authorities in Ireland are satisfied that the benefits from both vaccines outweigh any possible risks of side effects.

LINKS
Visit the Irish Medicines Board website, which has weekly updates and reports on vaccine safety and reactions being seen, from Ireland and Internationally, and where any adverse reactions, however mild, can be reported by people who have received the vaccine in Ireland.

Link to World Health Organisation Update on Pandemic Vaccine Safety (Nov 19)

EMEA - European Medicine Agency Influenza Site
Health Protection Surveillance Centre
Department of Health and Children
World Health Organisationl
USA Centers for Disease Control
European Centre for Disease Control