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Smallpox vaccination of Regional Response Groups
Administering the vaccine
Key facts for occupational health departments and vaccinators
Designated occupational health departments in Scotland
Vaccination and follow-up of vaccinees will be undertaken at designated occupational health departments (OHDs) in Scotland.
The designated OHDs are centred on Edinburgh, Glasgow, Aberdeen and Dundee. If it is more convenient, vaccination at a local OHD can be arranged with the designated OHD.
OHDs will record clinical follow-up details, including: whether vaccination is successful (a 'take'), size of lesion, adverse events and any medication required.
OHD will need to retain a record of vaccinated staff. This information will also be held on a Scottish Database at the Scottish Centre for Infection and Environmental Health (SCIEH)/Health Protection Scotland (HPS), and via SCIEH/HPS to a UK National Database kept at the Health Protection Agency (HPA), Colindale.
Vaccinators
Occupational health staff will undertake vaccination after they have received suitable training. The OHD vaccinating teams should consist of two to three individuals per department and this should include an occupational health physician and an occupational health nurse.
It is recommended, though not a requirement, that vaccinators be vaccinated against smallpox, as the complications arising from accidental auto-inoculation are greatly reduced in vaccinated individuals. Vaccinators who wish to be vaccinated are subject to the same exclusion criteria and pre-vaccination screening as other non-emergency vaccinees. Please see
Volunteering for the smallpox vaccine.
Those who are immunocompromised should not handle the vaccine.
Use of the room and facilities normally used for immunisation together with appropriate personal protective equipment (face shield, mask, gloves and disposable apron) should reduce the vaccinator's risk of accidental exposure: these safety procedures will inform the vaccinator's decision whether or not to have the vaccination.
If vaccinators choose to be vaccinated, they should wait 7 days after their own vaccination before they vaccinate other individuals, even if they feel well and do not have any side effects resulting from vaccination.
The vaccine
The vaccine consists of a live virus (vaccinia virus) that multiplies in the superficial layers of the skin. It does not contain variola virus, the virus that causes smallpox (but it does provide immunity to smallpox).
The UK Health Departments are making available either 'old' or 'new' vaccine. Both are unlicensed. Expert subgroups of the JCVI and CSM have recommended the use of the 'old' vaccine for non-emergency vaccination as there is currently no clinical data available for the new vaccine. If vaccinees choose the 'new' vaccine, please contact the Scottish Executive Health Department (Telephone: 0131-244 2158) for details of how to proceed.
The old single dose Swiss Serum Institute (SSI) vaccine contains peptone, phenol, disodium phosphate, citric acid and glycerol. It was used routinely in the UK until the 1970s and for at-risk laboratory workers since then. It has recently passed potency and contamination testing.
Vaccine delivery, storage and documentation
Vaccine and bifurcated needle requests by occupational health departments should be made to the Scottish Executive Health Department (contact Dr Elizabeth Stewart on 0131-244 2158) by the lead occupational health physician in each designated OHD. See
Smallpox vaccine: Supply and distribution in Scotland for a list of the designated OHD's in Scotland.
The Scottish Executive Health Department will arrange delivery of the SSI vaccine in standard doses to the appropriate designated vaccine holding centre for onward transmission to the designated OHDs, in Scotland. The vaccine will be transported in appropriate packaging with a temperature sensitive strip or minimum/maximum thermometers.
The vaccine must be stored at each OHD in a secure temperature-controlled environment (between +2 °C and +8 °C). If vaccines are damaged or have been exposed to temperatures outside the permitted range, they should be discarded into a sharps bin and a replacement vial issued.
A record should be kept of the vaccine given, including the batch number in the volunteer's notes, in accordance with the guidance in the Health Departments'
Immunisation against infectious diseases 1996 (the 'Green Book'). It will also be necessary to follow this guidance on storage, distribution and disposal of vaccines.
As this vaccine is unlicensed, a record of prescribing must be maintained centrally in Scotland and also on a UK basis. The Scottish Executive Health Department should be notified of the number of doses prescribed, the name of the prescribing clinician and the number of doses that have been discarded (contact Dr Elizabeth Stewart on 0131-244 2158). This information will be forwarded to the Department of Health.
Infection control
Smallpox vaccine is a live virus, therefore it is recommended that single-use gloves (latex, vinyl or nitrile), a plastic apron and a disposable full facial visor or a fluid repellant face mask are worn for reconstituting the vaccine and vaccination to minimise the risk of accidental splashing.
Other standard infection control precautions should also be followed, for example hand hygiene, safe disposal of clinical waste and sharps. Further advice can be sought from the local Infection Control Team. Detailed guidance can be found at
www.doh.gov.uk/hai/index.htm and
http://www.show.scot.nhs.uk/scieh/
infectious/hai/infection-control/default.htm
Reconstitution of the Swiss Serum Institute vaccine
1. Wear protective clothing.
2. Cover any cuts or abrasions on the hands or forearms with a waterproof dressing.
3. Remove the vaccine ampoule, capillary tube of diluent, rubber bulb and instructions from the box.
4. Read the instructions carefully and be sure you understand them before making up the vaccine.
5. Remove the sealed capillary tube from its glass protective casing. Unwrap the rubber bulb and place it on a clean surface.
6. Gently tap the capillary tube until the diluent gathers at one end.
7. Hold the other (empty) end of the capillary tube with a sterile swab or gauze and snap off the end. Dispose of the swab/gauze and the capillary end in a sharps bin.
8. Slide the rubber bulb over the open tube end.
9. Hold the tube bulb-downwards and cover the hole in the bulb with a finger. Gently tap the capillary tube so that the fluid moves away from the unopened end.
10. Break off the sealed end of the capillary tube as in point 7 above.
11. Place the tube, bulb-downwards, in a rack.
12. Open the vaccine ampoule by holding the end in a sterile swab or gauze and snapping it off.
13. Introduce the capillary tube into the top of the open ampoule. Covering the hole in the bulb with a finger gently squeeze the diluent into the ampoule.
Allow 10 minutes for the plug of freeze-dried vaccine to dissolve in the fluid.
This vaccine is issued as a one-dose pack. However, if the reconstituted vaccine is administered carefully the content is sufficient to vaccinate up to four persons, but see 'Note' below.
NOTE
After reconstitution the vaccine should be used within 4 hours. Any excess vaccine is to be discarded as described below.
Recommended vaccination method
Multiple puncture vaccination applied to the deltoid area of the upper arm, using an individually wrapped, sterile, bifurcated needle.
Step-by-step instructions
1. Wear protective clothing.
2. Any cuts or abrasions on the hands or forearms must be covered with a waterproof dressing.
3. Skin preparation: the skin must be clean prior to vaccination. If necessary use soap and water to clean the vaccination area and ensure the skin is dry. No alcohol or other antiseptic is to be used, as the vaccine will be inactive.
4. Dip bifurcated needle into vaccine vial; a minute drop of vaccine adheres between the needle prongs: confirm the presence of the droplet between the prongs visually.
5. Ensure vaccinee is looking away from the site to minimise risk of accidental ocular contamination.
6. Holding the bifurcated needle perpendicular to the skin, make 15 punctures rapidly with strokes vigorous enough to allow a trace of blood to appear after 15 to 20 seconds.
NOTE: The bifurcated needle is for single usage only and should be discarded in an appropriate sharps bin immediately after vaccinating a patient. In order to avoid contamination of the vial, needles should never be dipped into the vaccine vial more than once.
7. Cover the vaccination with an absorbent, semi-permeable dressing (e.g. Mepore ultra or Tegaderm plus gauze).
8. Vaccinees should be observed for 15 minutes after vaccination for any immediate adverse reaction.
Vaccination certificate
A vaccination certificate should be issued to each vaccinee.
The contact details of the local OHD and Consultant in Infectious Diseases need to be added to the certificate. The vaccinee should be advised of the procedure in the event of an adverse reaction.
The vaccination certificate should be carried by the vaccinee until the vaccination site has healed over.
Dressing of the vaccination site
Dressing changes will be made on day 7, and as necessary.
Where practicable, vaccinees will return to the OHDs for dressing changes.
Additional gloves, dressings and dressing disposal bags will be supplied to the vaccinee, together with instructions for disposal should a visit to the OHD not be possible.
It is critical that the vaccination site is kept covered throughout the whole period until the scab falls off.
Disposal of vaccine
Unused vaccine, spent or partly spent vials should be disposed of safely by placing in a sharps bin labelled 'Hazardous Material', and sent for incineration.
The sharps bins must conform to UN3291 and BS7320 standards. They must not be filled above the line indicated.
All sharp materials used in the vaccination procedure, such as ampoules and needles, must be disposed of in the sharps bin.
Other contaminated materials should be disposed of in a clinical waste bag, and sent for incineration.
Spillages should be chemically disinfected using a sodium hypochlorite solution
(c. 10% available chlorine). Contaminated waste should be disposed of as above.
Recommended action following an accident with the vaccine1
1.
Surface contamination of the skin - wash the affected area thoroughly with soap and water; 70% alcohol may also be used if thought necessary.
2.
Contamination of the eye - irrigate thoroughly with running water or freshly opened eye-wash pack. Expert advice should be sought on prophylactic measures.
3.
Accidental subcutaneous inoculation or contamination of a wound - after an inoculation incident with a sharp, the wound should be allowed to bleed briefly and then be cleansed.
Vaccination packs for vaccinees
Further copies of this pack are available from SCIEH/HPS. Please call Mrs Ann Smith on
0141-300 1159.
This pack is also available to view on the Scottish Executive website at:
www.scotland.gov.uk/publications
1.Source: Advisory Committee on Dangerous Pathogens and Advisory Committee on Genetic Modification.
Vaccination of laboratory workers handling vaccinia and related poxviruses for humans. 1990. London:HMSO.ISBN 011885450
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