Smallpox vaccination of Regional Response Groups
Volunteering for the smallpox vaccine
This information pack has been developed specifically for the non-emergency vaccination of a cohort of health care workers. It is intended for both vaccinees and vaccinators. It contains different guidance from that which would be required in an emergency vaccination programme in the event of a deliberate release.
Volunteers are being sought to be members of the cohort of health care workers to be vaccinated against smallpox. This document contains information that you should consider carefully before agreeing to participate. If you do not wish to volunteer you will not be asked to give a reason.
For further information, please refer to the Patient information leaflet.
As part of the Scottish smallpox plan 1 a small number of specialist health care and laboratory workers are being asked, as volunteers, to be part of Scottish response teams to deal with a potential smallpox outbreak. Members of these teams must be pre-vaccinated against smallpox. There will be Scottish response teams to cover Scotland as a whole. The organisation of these teams will be determined by the Smallpox Implementation Planning Group. Each team will have four to five members, each with four back-up staff on a rota system. The teams are likely to consist of an infectious disease physician, a public health doctor/epidemiologist, a paediatrician, an acute care nurse and a communicable disease/infection control nurse. In addition laboratory staff from the Designated Laboratory for Scotland RVL at Gartnavel General Hospital, Glasgow will be vaccinated.
In Scotland the Smallpox Implementation Planning Group will be responsible for ensuring the vaccination programme is completed. Comprehensive information about the vaccine and vaccination risks are provided in this information pack.
Smallpox has been eradicated - this means that volunteers will be vaccinated against a disease that no longer exists naturally. The vaccine is not as safe as many other modern vaccines and while adverse events are rare, the safety of vaccinees is paramount.
Exclusion criteria, consent, follow-up and guidelines for the management of adverse events are more stringent than would be applied to an emergency vaccination programme, should this ever be needed.
Vaccination and membership of Scottish response teams is voluntary and informed consent must be obtained.
Individuals who have been vaccinated against smallpox in the past are at present the preferred choice for vaccination, as re-vaccination is associated with less frequent side effects.
Smallpox vaccine does not contain smallpox virus and cannot give you smallpox. The vaccine however does contain live vaccinia virus. The antibodies that develop in response to vaccinia also protect against smallpox.
The UK Departments of Health are making available either 'old' or 'new' vaccine. Both are unlicensed. Expert subgroups of the Joint Committee on Vaccination and immunisation (JCVI) and Committee on Safety of Medicines (CSM) have recommended the use of the 'old' vaccine for non-emergency vaccination. Both DH and SEHD endorse this recommendation.
Pre-vaccination screening and exclusion criteria
In the absence of smallpox anywhere in the world, the following conditions are contra-indications to vaccination and will exclude you from vaccination;
History of eczema (past or present) or current skin exanthema, for example acne, burns, recent incisions, impetigo, contact dermatitis.
Pregnancy or planning pregnancy in the next month, or breast-feeding.
Immunosuppression including HIV, oral steroids or treatment for cancer, or for organ transplantation.
Household or sexual contact of an individual with skin eruptions (including eczema or history of eczema).
Household or sexual contact of a pregnant woman.
Household or sexual contact of immunosuppressed persons.
Household member under the age of 1 year.
Inflammatory eye conditions that may lead to rubbing of the eyes.
Previous allergic reaction to vaccinia vaccine.
Allergy to any vaccine ingredients.
Immunisation with a live vaccine within the last 4 weeks.
Currently ill with an infection with a high temperature (>38 °C).
Potential vaccines known to have the following underlying disease should also be excluded from the vaccination programme
Prior myocardial infarction, angina or suspected angina, cardiomyopathy or who has had coronary artery surgery
other heart conditions under the care of a doctor
vascular disease (stroke, peripheral vascular disease, transient ischaemic attacks (TIA))
In addition potential vaccines with 3 or more of the following risk factors should be excluded from vaccination:
Known diabetes mellitus and/or receiving anti-diabetic treatment
High blood pressure or anti-platelet therapy
Hypercholesterolaemia (defined as treatment with a statin)
First degree relative who had a heart condition before the age of 50
Current cigarette smoker
Safety, adverse events and post-vaccination restrictions
This section covers the risks related to the vaccination and activities that you should avoid during the post-vaccination period until the vaccination scab has dropped off (around 4 weeks).
Like all medicines and vaccines, smallpox vaccine can have side effects. See Complications of smallpox vaccination.
It is possible to spread the virus from the vaccination site to other parts of your body or to other people. This can be avoided by keeping the site covered at all times and not touching or scratching it.
Serious allergic reactions are always a possibility, but very rare, after receiving a vaccine. These include anaphylaxis.
A severe reaction at and around the site of vaccination is rarely seen. This may begin as redness and tenderness 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.
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 who have normal skin before vaccination. However, even some healthy people may sometimes get a small number of lesions, away from the vaccination site, that may blister.
Extremely rarely, the vaccinia virus in smallpox vaccine may cause encephalitis. Affected individuals develop fever and a headache 1 or 2 weeks after vaccination and then develop characteristic symptoms of agitation, drowsiness and fits. In some cases, the encephalitis may cause permanent brain damage and occasionally it may be fatal.
If the vaccine is successfully administered a characteristic skin reaction (called a 'take') start to appear in 6 or 7 days. In re-vaccinated individuals, the take may be quicker. In the first week, the lesion becomes a large blister, and starts to fill with pus. During the second week, the blister begins to dry up and a scab begins to form. The scab usually falls off 21-28 days after vaccination, leaving a small scar.
The rate of development and the appearance of the 'take' may vary among individuals. These variations are not considered to be adverse reactions.
The vaccinia virus will be present at the vaccination site until the scab falls off.
If the vaccination has not been successful by day 7, you will be offered a repeat vaccination.
Post vaccination restrictions
Following a meeting of a sub group of the Joint Committee on Vaccination and Immunisation (JCVI) the post vaccination guidance has been revised. The group reviewed the available data 2 from the US and UK civilian and military cohort who had been vaccinated. This showed a small or negligible risk of vaccinia transmission provided that appropriate precautions were taken.
They concluded that:
providing you remain well, you can continue to work and carry out normal duties, if the vaccination site is covered at all times with a suitable dressing and clothing.
there is no need for restriction of activity in relation to contact with people in the previously stated risk groups. These include neonates, pregnant women and the immunocompromised.
However, this is dependent on scrupulous attention to dressing care, appropriate education to minimise spread of the vaccinia virus in particular hand washing and the wearing of fitted elbow length sleeved clothing to further safeguard the dressings.
Dressing and site care
It is imperative that the vaccination site is kept covered at all times with an occlusive dressing, until the scab has fallen off.
The dressing provides a barrier to protect against spread of the vaccinia virus and should only be removed to change the dressing or to inspect the site and then a fresh dressing applied.
The dressing must be replaced at any sign of loss of adhesion.
Avoid getting the dressed vaccination site wet until the scab has fallen off. It is better to have a shower, but if you prefer to have a bath do not immerse the dressing.
Wear long sleeved clothing that fully covers the vaccination site (practically, clothing should be fitted at elbow length so as not to hinder effective hand hygiene). This is particularly important in situations of close physical contact, including in bed.
Dispose of the dressings (and the scab) by double bagging and disposing as clinical waste.
Use a separate laundry basket for items like clothing, towels or bedding that may have come into direct contact with the unvaccinated vaccination site and wash using a hot water cycle and detergent. Wash hands thoroughly after handling such materials.
Do not touch, rub or scratch the vaccination site even though it will be itchy.
Do not apply any cream or ointment of any type to the site.
Vaccinees should also not undertake any of the following activities until the scab at the vaccination site has dropped off (at around 4 - 6 weeks after vaccination)
Let other people touch the vaccination site
Share clothing or towels which have been in contact with the vaccination site
Get pregnant or breastfeed
Go swimming, including public bathing
Play contact sports such as wrestling, rugby, boxing or self defence, where there is a risk that the dressing may become dislodged
Travel abroad (pending individual risk assessment by the OH department). However, short business trips, particularly within Europe, are low risk.
It should be noted that vaccinees who feel unwell, febrile or develop satellite lesions should have no contact with patients.
After direct contact with the dressing and vaccination site, hands must be washed thoroughly with soap and warm water or if not available, alcohol-based hand rub.
This is vital in order to remove any virus from hands and to prevent contact spread to surrounding areas such as the mouth, eyes or surrounding skin or spreading the virus to others.
An effective hand washing technique involves three stages: preparation, washing and rinsing, and drying.
Preparation requires the removal of jewellery, watches and the pushing up of long sleeved clothing.
Wet hands under warm running water before applying soap or alcohol-based hand rub.
The soap or alcohol based hand rub must come into contact with all of the surfaces of the hand. The hands must be rubbed together vigorously for a minimum of 10-15 seconds, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers.
Hands should be rinsed thoroughly before drying with good quality paper towels.
An emollient hand cream should be applied to protect the skin from the drying effects if regularly washing hands.
Changing the dressing at home
You will be given non-sterile disposable gloves, dressings and clinical waste bags to take home.
If you need to change the dressing between occupational health department appointments, follow the strict infection control procedures above.
Put on the disposable gloves, and take off the used dressing. Place the contaminated dressing and gloves in the clinical waste bag.
Apply a new dressing.
Wash hands with soap and water.
Because of the recognised potential for cardiac complications, it is recommended that you have no prolonged strenuous exercise for 14 days post vaccination, in particular if you feel unwell.
OHD personnel will routinely follow you up at day 7 post vaccination and as necessary (the day of vaccination =0).
On the day 7 visit, the response to vaccination should be formally assessed according to WHO Criteria for checking vaccination site.
Reporting side effects
You should report all adverse events to your OHD or on-call ID Physician. The adverse events will be reported to CSM/MHRA via the Yellow Card reporting scheme.
Your Vaccination Certificate will contain the contact names and numbers of local experts who you should contact in an emergency.
Please carry your vaccination certificate with you at all times until your scab has fallen off.
Clinical Infectious Disease 2004:38:536-41 Talbot et al