Smallpox vaccination of Regional Response Groups
Patient informationleaflet
Dried smallpox vaccine
Patient Information Leaflet The information contained within this Patient Information Leaflet was written to apply during a smallpox outbreak.
There are a few instances where the information does not match fully with the rest of the pack.
These are marked * for easy reference. |
Read all of this leaflet carefully before you receive this vaccine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask the doctor or nurse who gives you the vaccine.
In this leaflet:
1. What smallpox vaccine is and what it is used for
2. Before smallpox vaccine is given to you
3. Having smallpox vaccine
4. Possible side effects of smallpox vaccine
5. Storing smallpox vaccine
The active ingredient in smallpox vaccine is a live virus called vaccinia. When the dried virus is mixed with a fluid immediately before use, there are approximately one hundred million viruses in every millilitre of the liquid.
Smallpox vaccine that is ready to use also contains some inactive ingredients. These are sodium phosphate, peptone, citric acid, glycerol and phenol.
Marketing authorisation holder
Until 1992, the marketing authorisation (licence) holder for smallpox vaccine was the Secretary of State for Health. Since that time, the licence was discontinued but the stocks of vaccine were stored in case of future need.
Manufacturer
Dried smallpox vaccine was made either by the Lister Institute, Elstree, Hertfordshire or by the Swiss Serum and Vaccine Institute in Berne, Switzerland.
The Lister Institute material is provided as a multidose ampoule and is stored at - 20-C. The Swiss Serum and Vaccine Institute material is presented as a single-dose ampoule and is stored at +2-C to +8-C.
All the vaccine that is available at the moment was made when smallpox vaccine was still licensed for use in the United Kingdom.
Regular checks on the numbers of live viruses in both vaccines have been made since that time.
Each vaccine has been carefully stored under appropriate conditions.
Each vaccine type is immediately distinguishable by its carton container.
Each vial of dried vaccine must be mixed with the reconstitution fluid just before injection. There is enough virus in each vial to vaccinate several people.
1. What smallpox vaccine is and what it is used for
Smallpox vaccine is intended to protect you against getting smallpox. The vaccinia virus in the vaccine causes your immune system to develop antibodies to the virus. The antibodies that you make to vaccinia virus also protect you against infection with the smallpox virus. Smallpox vaccine does not contain smallpox virus (smallpox virus is called variola virus) and the vaccine cannot cause smallpox. The vaccine contains vaccinia virus which is a type of virus called a poxvirus. Naturally occurring vaccinia virus can cause an infectious disease in people and in some animals. It is now very rare that people come into contact with vaccinia virus so the infection is almost never seen. Infected persons may develop a blistering skin rash and a feeling of being generally unwell. The illness is usually mild in previously healthy people. The vaccinia virus that is in the vaccine is extremely unlikely to cause an illness in people who have normal skin and who have a normal immune system.
Smallpox is an infectious disease caused by variola virus that is usually caught from another person who already has the symptoms of the disease. Smallpox can be caught by breathing in virus that is shed into the air by a person who is already ill with the disease. It can also be caught by direct contact with the person's skin or with things that the person has touched. After catching the smallpox virus, symptoms can appear after about one week, but sometimes there are no symptoms for up to 17 days. During the time when there are no symptoms, other people cannot catch the virus from the infected person. The infected person then begins to feel very unwell, gets a fever, headache, backache, and sore throat, and soon after develops a blistering rash that spreads over much of the body. In people who have not been vaccinated and have never had the disease, about one-third of previously healthy adults die. Death is even more likely in people who have other illnesses before they get smallpox and in very young children. In those who recover from the disease, scarring of the skin is common.
There are no medicines that are known to effectively treat smallpox.
A doctor may advise you to receive smallpox vaccine if *:
or
or
You have to travel to an area where there are, or have recently been, some cases of smallpox, and there is a considerable risk that you may come into contact with an infectious person.
Smallpox vaccine cannot completely protect you against smallpox. If you are already infected with the smallpox virus when you are given smallpox vaccine, you may still get the illness. However, vaccination can provide protection if given up to 3 days after exposure.
However, when smallpox was still common, infections in people who had been vaccinated in the past, especially within three years, were usually much less severe and far fewer of these people died. After having the vaccine, protection does not last for life. Section 3 of this leaflet explains when further doses may be given.
2. Before smallpox vaccine is given to you
Smallpox vaccine would not usually be given to you (or to your child, if you are the legal guardian of the person who is to be vaccinated) if the answer to any of the following questions is 'YES'.
However, if it is thought that you are at very high risk of getting smallpox, * you may be advised by a doctor to have the vaccine even if the answer to any of the following questions is 'YES'. This is because your risk of getting smallpox may be much greater than your risk of having any problems after vaccination.
Smallpox vaccine would not usually be given to you if the answer to any of the following questions is 'YES':
Have you ever had an allergic reaction to any of the ingredients contained in smallpox vaccine? The inactive ingredients contained in smallpox vaccine are sodium phosphate, peptone, citric acid, glycerol and phenol.
Have you ever had any serious illness following a previous vaccination against smallpox that was thought to be caused by the vaccine?
Do you have eczema (a skin condition) or a history of eczema?
Ask your doctor if you are not sure. The live vaccinia virus in the vaccine can sometimes cause a rash that may be very severe and a serious generalised illness if it is given to people with eczema.
Do you have any infection of the skin?
Have you been told that your immunity to infections may be poor at the moment? For example, do you have a cancer or other major illness, are you having or have you recently had radiotherapy or chemotherapy, or are you having steroid treatment? Do you have HIV infection or AIDS? If you are concerned that you may be infected with HIV you should speak to your doctor. The live vaccinia virus in the vaccine can sometimes cause a severe rash and a serious illness if the vaccine is given to people with poor immune systems.
Are you pregnant, do you think you may be pregnant or are you trying to become pregnant? The live vaccinia virus in the vaccine can sometimes cause an infection in the growing unborn baby that can be fatal to the child.
Do you have an infection with a high temperature at the moment?
Have you recently been exposed to any other infectious disease?
Vaccination may have to be delayed in these cases. If there is anything you do not understand, or if you have more questions about whether smallpox vaccine is right for you, you should ask the doctor or nurse to explain before you agree to have the vaccine.
Take care with smallpox vaccine
There is a possibility that the vaccinia virus in smallpox vaccine can be spread from your arm to people who come into contact with you during the first three weeks after vaccination. The vaccinia virus is extremely unlikely to cause an infectious illness in healthy people with normal immune systems and normal skin who may come into contact with you. For both vaccinees and contacts, thorough washing with soap and water or disinfectant is advisable if direct contact with the vaccination site or its covering materials has occurred.
However, people who come into close contact with you (for example, people who live in the same house) who have eczema or who have poor immune systems may catch the virus from you and may get a general rash and illness that may be severe. If you think that you may be a cause of risk to any of your contacts, you should ask your doctor or nurse for advice before you have the vaccine.
Pregnancy and breast-feeding
Smallpox vaccine is not usually given to pregnant women. Tell the doctor or nurse if you are pregnant, think you may be pregnant, are trying to become pregnant, or are breast-feeding a child. The doctor or nurse will discuss this with you and advise you if you should be vaccinated now or wait.
Driving and using machines
It is not thought likely that smallpox vaccine would interfere with your ability to drive or use machines. If however you experience any side effects, seek medical advice.
Taking other medicines or having other vaccines
Smallpox vaccine is not usually given at the same time as other vaccines that contain live viruses.
In an emergency, * you may be advised to have smallpox vaccine at the same time as other vaccines that contain live viruses. In this case, the vaccines will be given at different injection sites. Any medicines that you usually take should be taken as normal after the vaccination.
3. Having the smallpox vaccine
Smallpox vaccine should be given to you by a doctor or nurse who has been trained to give vaccines, including smallpox vaccine. The place where you have the vaccine should be equipped to deal with any uncommon severe allergic reaction.
Smallpox vaccine is given by placing a very small amount of the liquid vaccine on a needle on to your skin and then scratching the skin lightly. A little blood may sometimes appear.
Your skin will not be cleaned with antiseptic before vaccination because this may kill the vaccinia virus. Sometimes the skin may need to be cleaned with soap and water before the vaccination. The doctor or nurse will decide this. The usual site for vaccination is the upper part of your arm, towards the back.
Covering the site of vaccination
After vaccination, a dry dressing will be placed over the site and held in place with tape or a bandage. *
You should keep the vaccination site covered with similar dry dressings (do not use adhesive plasters on the site*) until the blister that usually forms at the site has dried up and the dried scab has fallen off. You should avoid getting the vaccination site wet until the scab has fallen off and you should not apply any cream or ointments of any type to the site.
Any used dressings and the scab as well if possible, should be burnt or should be wrapped up and disposed of carefully, if possible in a sealed plastic bag. After changing and disposing of the dressing, you should wash your hands thoroughly. If you are not sure about anything, ask your doctor or nurse for instructions about changing the dressing and the type of dressing you should use.
Checking the site of vaccination
The doctor or nurse will ask you to return 6-10 days * after vaccination, so that the injection site can be checked. Usually, a small red and raised spot appears by the fourth day and then a blister forms by 10 days. This becomes crusted over and the scab that forms usually drops off by three weeks.
If you do not show the usual skin changes, the doctor or nurse may advise that the vaccination needs to be repeated.
If the site of vaccination becomes red, painful or swollen, or if you notice extra spots or blisters away from the vaccination site, or a high temperature of more than 38-C on more than one occasion in a 24- hour period you should contact the doctor * or nurse immediately for advice (see also section 4 of this leaflet). Some tenderness and a raised temperature are not uncommon especially in younger vaccinees.
Duration of protection
It is thought that smallpox vaccine provides very good protection against smallpox for 3 years after the vaccination. It is thought to be very likely that vaccination provides at least some protection against infection for more than three years and may at least prevent very severe smallpox if you do catch the virus.
However, if after 3 years, you carry on being at risk from catching smallpox, you should contact the doctor or nurse for advice on being re-vaccinated.
4. Possible side effects of smallpox vaccine
Like all medicines and vaccines, smallpox vaccine can have side effects.
Serious allergic reactions are always a very rare possibility after receiving a vaccine. These reactions may include difficulty in breathing, blue discolouration of the tongue or lips, low blood pressure (including dizziness) and collapse. When these signs or
symptoms occur they usually develop very quickly after the vaccine is given and while the person affected is still in the clinic or doctor's surgery, where urgent treatment can be given. If any of these symptoms occur after leaving the place where your vaccine was given, you must consult a doctor * immediately for emergency medical help.
If you notice any of the following possible side effects or notice any other unusual symptoms during the three weeks after vaccination, you should contact the doctor or nurse for advice immediately:
Extremely rarely, the vaccinia virus in smallpox vaccine may cause an infection of the brain and nervous system called encephalitis. Affected people usually develop fever and headache one or two weeks after vaccination and then symptoms that are caused by a disturbance of the working of the brain and nerves.
In some cases, these disturbances become permanent and occasionally this side effect can be fatal.
A generalised rash and illness due to vaccinia is a very rare side effect of vaccination. It is extremely unlikely to occur in people who are generally healthy and have normal skin before vaccination. However, even some healthy people may sometimes get a small number of spots away from the vaccination site that may blister. If you see any spots or blisters that are not at the actual vaccination site, you should contact the doctor or nurse immediately for advice.
A severe reaction at and around the site of vaccination is rarely seen. This may begin as redness and soreness spreading away from the vaccination site, with or without swelling, and may be due to a local allergic reaction, to local spread of the vaccinia virus or to a bacterial infection of the vaccination site.
If you touch the vaccination site and then another part of your body, particularly your eyes or mouth, a rash due to the vaccinia virus may develop. As advised in section 3, you should keep your vaccination site covered and avoid touching or scratching it.
A mild feeling of being generally unwell is possible shortly after vaccination. However, if you have been vaccinated because you have been in contact with a case, * these symptoms could also be the first sign that you may be developing smallpox despite having the vaccine.
Therefore, you should stay at home but report these symptoms to the doctor or nurse immediately.
Overdose
Overdose is extremely unlikely because only a very small amount of vaccine is scratched into the skin and this is done by a trained doctor or nurse.
5. Storing smallpox vaccine
The vaccines will have been stored at -20-C in the dark (Lister Institute material) or at +2-C to +8-C in the dark (Swiss Serum and Vaccine Institute material) until just before they are diluted for use so that they keep their effectiveness.
The 'Expiry' date that appears on the box will be the one that was approved when the vaccines were made. Therefore, this will now show that the vaccines have expired.
However, repeated checks on the vaccines since that time have shown that they still contain enough live virus to be useful for vaccination.