Scottish Government Health Directorate H1N1/Swine Flu Vaccine
Questions and Answers
About the swine flu vaccine
What is the swine flu vaccine?
The vaccine has been developed to protect against the H1N1 virus that causes swine flu. There are two different brands of the vaccine, Pandemrix, manufactured by GSK, and Celvapan, from Baxter. People will be given Pandemrix unless they have an anaphylactic allergic reaction to egg products, in which case they will be given Celvapan, which has been developed specifically for those with such an allergy.
How many doses of the vaccine are needed?
The vaccine will be given as follows:
Pandemrix (Manufactured by GSK)
For individuals aged from 10 years to less than 60 years of age:
· One dose (0.5ml) of Pandemrix
For all children aged from 6 months of age to less than 10 years of age:
· One half dose (0.25ml) of Pandemrix
For individuals aged 60 years and over:
· One dose (0.5ml) of Pandemrix
For immunocompromised individuals aged from six months to less than 10 years of age:
· Two half doses (0.25ml) of Pandemrix should be given with a minimum of three weeks between doses
For immunocompromised individuals aged 10 years and over:
· Two doses (0.5ml) of Pandemrix should be given with a minimum of three weeks between doses
Celvapan (Manufactured by Baxter)
For children from 6 months of age and adults:
· Two doses (0.5ml) of Celvapan should be given with a minimum of three weeks between doses.
The two vaccine products are not interchangeable and the same brand of vaccine must be used for both doses if two doses are needed.
Is the swine flu vaccine safe?
The vaccine has been licensed by the European authorities and is endorsed by the World Health Organization. While it is new, it is very similar to existing vaccines which have undergone extensive clinical trials involving thousands of people.
Experience with seasonal flu vaccines has shown that changing the strain of a virus in a vaccine does not substantially affect its safety profile. The scientific evidence suggests that the risk of a serious reaction is extremely small – and far outweighs the risk of becoming seriously ill from the swine flu virus itself.
How effective is the vaccine?
As the vaccine is an exact match to the swine flu strain currently circulating, it is anticipated that it will give at least the amount of protection, if not better, that seasonal flu vaccines offer against infection with flu virus strains – which currently protects 70-80 % of those vaccinated.
Does the vaccine contain mercury?
Pandemrix contains very small quantities of a preservative called thiomersal that contains ethylmercury, which is used to prevent bacterial contamination during the preparation, storage and use of the vaccine. This is different to the type of mercury that may be toxic in the diet or the environment (called methylmercury). Ethylmercury is excreted quickly and does not accumulate
World Health Organization and UK Commission on Human Medicine studies have found no evidence of health risks linked to the minute quantities of thiomersal in vaccines, including to children, pregnant women and their babies.
In 2003, the Committee on Safety of Medicines (CSM) concluded that the balance of benefits and risks of thiomersal-containing vaccines remains overwhelmingly positive. In 2004, the European Medicines Agency (EMEA) also concluded that studies show no association between vaccination with thiomersal-containing vaccines and specific neurodevelopmental disorders. And recent research shows no association between neuropsychological functioning at the age of seven to ten years and exposure to mercury during the prenatal period, the neonatal period and the first seven months of life.
Is the vaccine adjuvanted? What is in the adjuvant?
An adjuvant is added to vaccines so that a lower dose is needed to offer the same level of protection. The adjuvant enhances the immune response seen following vaccination.
The Pandemrix vaccine contains an adjuvant called squalene, which is extracted from fish oil and occurs naturally in plants, animals and humans. It also contains vitamin E (which we all have in our food and in our bodies) and polysorbate 80, a food additive that is in many medicines.
Is there anyone who can’t have the swine flu vaccine?
The vaccine should not be given to anyone who has had a severe allergic reaction to an initial dose of the vaccine or any of its components. People should consult their GP if they are worried that this may apply to them.
Is the vaccine safe for people with egg allergies?
Pandemrix is prepared in hens’ eggs and should not be given to people with a confirmed anaphylactic reaction after exposure to egg products. Celvapan is not (cultured cells are used), so is safe to use in people with a severe allergy to egg products.
Is the vaccine safe for people with an allergy to latex?
Yes, both brands are manufactured and packaged without the use of latex.
Does the vaccine contain any pork product?
Some porcine (pork) products are used in the manufacture of the Celvapan vaccine, however there are no detectable traces of these products in the vaccine itself. The Pandemrix vaccine does not contain porcine products.
Is there a link between Guillain-Barré syndrome and swine flu vaccines?
Guillain-Barré syndrome (GBS) is an autoimmune nervous system reaction that can occur after acute viral infections, but this is rare. It has also been reported very rarely after vaccination with influenza vaccine (one case per million people vaccinated in one US study). However, a recent study in the UK found that there is no association between GBS and seasonal flu vaccines, although there is a strong association with between GBS and influenza-like illness.
Over thirty years ago, GBS was associated with the swine flu vaccines used in the US, though the exact reason why the 1976 vaccine increased the risk of GBS remains unknown. The swine flu vaccines being used in the national vaccination programme are different from those used in the US in 1976.
Who will receive the vaccine first?
On the advice of independent scientific advice from the Joint Committee on Vaccination and Immunisation (JCVI) as to who is most at risk of developing complications from swine flu, the following groups have been given priority to receive the vaccination:
· people aged between six months and 65 years in the seasonal flu vaccine at-risk groups;
· pregnant women;
· people who live with someone whose immune system is compromised, for example, people with cancer or HIV/AIDS;
· people aged 65 and over in the seasonal flu vaccine at-risk groups.
In addition, frontline health and social care workers are being offered vaccination at the same time as these priority groups.
If you are in the above at risk groups (with the exception of health and social care workers) you will be offered the vaccination by your GP practice. GPs have been inviting those outlined above for vaccination, however if you have not yet heard from your GP, you should contact then to arrange an appointment.
In addition, young children aged from six months to five years old are being offered vaccination in the second phase of the programme. This is now taking place and parents should expect to be contacted by their local GP or Health Board in the coming weeks to bring their child forward for vaccination.
Who is in the seasonal flu at-risk group?
These are people with an underlying health problem making them more susceptible to complications from swine flu. They include:
· chronic lung disease – such as chronic bronchitis, emphysema and cystic fibrosis. This also includes severe asthma where the person requires continuous or repeated use of inhaled or systemic steroids or has been admitted to hospital because of their asthma. It is recommended that all children who have previously been admitted to hospital for lower respiratory tract disease should be immunised.
· chronic heart disease – such as chronic ischaemic heart disease, congenital heart disease and hypertensive heart disease that require regular medication/and or follow-up and chronic heart failure.
· chronic kidney disease – such as nephrotic syndrome, chronic kidney failure and kidney transplantation.
· chronic liver disease – such as cirrhosis, biliary atresia and chronic hepatitis
· chronic neurological disease – people who have had a stroke and those who have transient ischaemic attacks (TIAs). It may also include multiple sclerosis and related conditions, as well as hereditary and degenerative disease of the central nervous system.
· immunosuppression (whether caused by disease or treatment) – people who have no spleen and people who are on immunosuppressant treatment (for example, people undergoing chemotherapy leading to immunosuppression) or high doses of systemic steroids.
· diabetes mellitus – people requiring insulin or oral hypoglycaemic drugs, and diet controlled diabetes.
Does asthma fit into the at risk group ‘chronic respiratory disease’?
Individuals suffering from severe asthma (i.e. asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission) are considered to be an at-risk group for seasonal flu, and are covered in the swine flu vaccine at risk groups.
What should people do if they are in a priority group?
People in the initial priority groups will be contacted by their GP, inviting them to go to a vaccination clinic or make an appointment at their practice. If you have not yet heard from your practice, you may wish to get in touch to make an appointment.
Parents of young children over six months and under five years should expect to be contacted by their local GP or Health Board in the coming weeks to bring their child forward for vaccination.
Why aren’t all people aged 65 and over a priority group?
People aged 65 and over who are otherwise healthy are not a swine flu priority group as they appear to have some natural immunity to the swine flu virus. Surveillance has shown fewer swine flu cases in people aged 65 and over than in younger people.
This may be because they are less exposed to the virus due to how they socialise, or because they were exposed to a similar H1N1 virus in 1918 or 1957 and have developed some immunity as a result.
Can the vaccine give people swine flu?
No. The vaccine does not carry a live virus, so it cannot give swine flu to the person being vaccinated.
Does the vaccine have any side-effects?
All vaccinations can produce side-effects such as redness, soreness and swelling at the site of the injection. Some people may also experience symptoms like fever, headache and muscle aches, but they are much milder than the flu itself and usually disappear in one or two days without treatment.
How long does the vaccine provide protection for?
It is anticipated that the vaccine will provide protection against swine flu for the duration of the pandemic. The vaccine may also provide some protection should the virus change.
Will the H1N1 vaccine still provide people with protection if the swine flu virus mutates?
While it is impossible to predict if or how the virus will change, experience with the similar vaccine for the H5N1 (bird flu) strain suggests the swine flu vaccine would provide a high level of protection from closely related strains.
Do people who receive the seasonal flu vaccination need to get the swine flu vaccination also?
Yes, if they are in a priority group. The swine flu vaccine is different to the seasonal flu vaccination, which will not protect against swine flu.
If people are normally advised to have the seasonal flu vaccine each winter, they need to continue to receive this every year to ensure they are protected against most of the flu strains in circulation.
The swine flu vaccine can be given at the same time as other vaccines, including the seasonal flu vaccine. If two vaccinations are administered at the same time, they will be given at different places on the body (e.g. one in each arm).
Is the vaccine compulsory?
No. People in the priority groups are strongly advised to be vaccinated, but everyone has a right to choose whether to have it.
Where a child is too young to consent themselves to being vaccinated, the right to decide rests with the person with parental responsibility.
Do people who have already had swine flu still need the vaccination?
Yes. Unless a case of swine flu has been confirmed by a laboratory test, most people cannot be certain that they have had the disease. People in the priority groups should therefore still have the vaccine unless they have had a positive test for swine flu.
How soon after receiving the vaccination can people go back to work or school?
Those receiving the vaccination can return to their normal routine straight after the vaccination or in between doses, if two are required (your GP will advise you about this). As the vaccines do not contain a live virus they do not make a person infectious.
What other things can people do to protect themselves and others from catching swine flu?
The swine flu virus can be transmitted through the droplets that come out of an infected person’s nose and mouth when they cough or sneeze. The most effective way of reducing the risk of catching or spreading swine flu is for people to follow good respiratory and hand hygiene practices:
· cover their mouth and nose when coughing and sneezing, using a tissue;
· throw the tissue away quickly and carefully;
· wash their hands regularly with soap and water; and
· clean hard surfaces (like door handles and remote controls) frequently with a normal cleaning product.
There is a simple way to remember this: catch it, bin it, kill it.
Pregnant women and the swine flu vaccine
Why is it important for pregnant women to be vaccinated?
In pregnancy, the immune system is naturally suppressed, which means pregnant women are more likely to develop complications if they catch swine flu.
Generally most people will have only mild symptoms and recover within a week. However, evidence suggests pregnant women are considerably more likely to develop serious complications and be hospitalised with swine flu. Complications can include pneumonia, difficulty breathing and dehydration and are more likely to happen in the second and third trimester.
If a pregnant woman develops a complication of swine flu, such as pneumonia, there is a small chance this will lead to premature labour or miscarriage. There is not yet enough information to know precisely how likely these birth risks are, so it is therefore recommended for pregnant women to be vaccinated.
If a woman is about to give birth, having the swine flu vaccine could help avoid catching the disease and then passing it on to her baby.
Is the swine flu vaccine safe for pregnant women?
Both vaccines have been licensed for use in pregnant women. Licensed vaccines, including influenza vaccines, are held to a very high standard of safety and the vaccines would not be licensed if they were considered unsafe.
In licensing the current swine flu vaccines for use in pregnancy, the European regulators gave careful consideration to the severe burden of illness caused by swine flu in pregnant women. They also considered the safety record of seasonal influenza vaccines and the nature of the adjuvants that were incorporated in the pandemic vaccines. There is extensive safety experience from seasonal influenza vaccination in all trimesters of pregnancy, since such vaccination has been recommended for several years in many countries. In the UK, vaccination against seasonal influenza is also recommended for pregnant women who are in the clinical at-risk groups, regardless of the stage of pregnancy.
No safety concerns have been raised after vaccination of millions of pregnant women with seasonal flu vaccines. There is no indication from reproductive toxicity studies that inclusion of adjuvants is associated with any risks in pregnancy.
Women who are known to have become pregnant shortly after receiving the H5N1 vaccines have gone on to have normal pregnancies.
Which vaccine will pregnant women be given?
We can protect pregnant women straight away with the GSK vaccine (Pandemrix), which only requires one dose. This is important because pregnant women are at increased risk. Where Pandemrix is not appropriate if the patient has a severe allergy to eggs, the Celvapan vaccine will be offered.
Is there a risk to pregnant women, or their unborn babies, from the thiomersal in the Pandemrix vaccine?
World Health Organization and the UK Commission on Human Medicine studies have found no evidence of health risks linked to the very small quantities of thiomersal in vaccines, including to children, pregnant women and their unborn babies.
In 2003, the Committee on Safety of Medicines (CSM) concluded that the balance of benefits and risks of thiomersal-containing vaccines remains overwhelmingly positive. In 2004, the European Medicines Agency (EMEA) also concluded that studies show no association between vaccination with thiomersal-containing vaccines and specific neurodevelopmental disorders. And recent research shows no association between neuropsychological functioning at the age of seven to ten years and exposure to mercury during the prenatal period, the neonatal period and the first seven months of life.
Can pregnant women be offered the vaccine at any stage of pregnancy?
Yes. Both the vaccines are licensed for use at any stage of pregnancy.
Social care/ healthcare workers and the swine flu vaccine
Why is it important for frontline health and social care workers to be vaccinated?
Due to the nature of their work, frontline health and social care workers are potentially more exposed to swine flu, and in turn spreading the virus among their families or patients in their care.
By receiving the vaccination, it also reduces the need for them to have time off work, meaning services to those in their care continue to run smoothly.
How soon after receiving the vaccination can health and social care workers return to work?
Those receiving the vaccination can return to their normal duties straight after the vaccination or in between doses, if two are required. The vaccine does not carry a live virus, so it cannot give swine flu to the person being vaccinated, or put their families or those they work with at risk of infection.
What else can health and social care workers do to protect themselves and those they work with?
To further reduce the risk of catching or spreading swine flu, health and social care workers should continue with good respiratory hygiene hand and hand-washing practices.
About swine flu
What is swine flu?
Swine flu is a respiratory disease caused by a new strain of the influenza virus (H1N1), which has some elements of a virus found in pigs. Since the virus was first identified in Mexico in April 2009, it has become a pandemic, which means it has spread around the globe. Because it is a new type of flu virus, no one has immunity to it and everyone could be at risk of catching and spreading it.
What are the symptoms of swine flu?
Swine flu causes mild symptoms in most people, generally lasting for about a week. These include the sudden onset of fever, tiredness, cough and a sore throat, but the disease can also cause headache, aching muscles, chills, sneezing, a runny nose, loss of appetite, vomiting and diarrhoea.
How serious is it?
Some people are at greater risk of becoming seriously ill with swine flu than others, including those with long-term health conditions, pregnant women or those whose immune system is affected by a disease or treatment for a disease. In some cases, people may need to be treated in hospital, and in the very worst cases may die.
How does swine flu spread?
As with other cold and flu viruses, swine flu spreads when tiny particles of the disease come out as droplets when an infected person coughs or sneezes without covering their nose and mouth with a tissue, leaving others at risk of breathing them in.
If someone with swine flu coughs or sneezes into their hand, the droplets can be easily spread to any hard surfaces they touch and the germs can live there for some time. If other people touch these surfaces – such as door handles, phones and remote controls – and then touch their face, they can become infected.
Can swine flu be treated?
Antiviral drugs such as Tamiflu and Relenza will usually lessen the symptoms and length of infection of those who have caught the swine flu virus. This helps slow the spread of infection, because people who have milder symptoms for a shorter amount of time are less likely to infect others, and helps relieve pressure on the NHS because people taking antivirals are less likely to develop complications that require further treatment.
If a person is confirmed to have swine flu by a healthcare professional, they will be told where the nearest antiviral collection point is so that a 'flu friend' - a friend or relative who does not have swine flu - can pick up antiviral drugs for them.
How does the vaccine differ from antiviral drugs Tamiflu and Relenza?
The swine flu vaccine prevents people from catching the disease, whereas Tamiflu and Relenza are antiviral drugs for the treatment of swine flu once it has been caught. Taking antiviral drugs will not protect people who have not had swine flu from catching it.
What should someone do if they think they have swine flu?
People in Scotland who are worried about flu-like symptoms should stay at home and contact their GP or call NHS24 on 08454 24 24 24 or visit www.nhs24.com.
For more information about the vaccination, you can contact the Scottish Swine Flu Vaccination Helpline on 08000 28 28 16.
If you’ve had swine flu, can you get it again?
People who have had swine flu should not catch the same strain of the virus again as their body will have developed some level of immunity to it. However, unless a case of swine flu has been confirmed by a laboratory test, most people cannot be certain that they have had the disease, or that they will be protected if the strain mutates. People in the priority groups are therefore recommended to receive the vaccination to ensure they are fully protected against the virus.
