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Some Questions and Answers for BCG Vaccine SSI
1. Is there any bovine content in BCG
Vaccine SSI or its diluent?
The response from the manufacturer reads: 'The BCG vaccine and
diluent do not contain bovine material. The substrates used in the
production of the vaccine and in the diluent are purely synthetic'.
2. Various questions describing scenarios
where the vaccine has been out of cold chain conditions.
The response from the manufacturer reads: ' Even at room
temperature (ie approx 23C) the BCG vaccine will only lose less than
2% of its activity, so it should be safe to use if it is returned to
the fridge after 7 hours. BCG vaccine is to be stored at cool
conditions but stability studies have shown that the loss of
activity is less than 2% if the vaccine is left at room temperature
for up to 48 hours. The long term stability following such storage
has not been studied by the manufacturer.
The diluent can be kept at room temperature for the entire
duration of the shelf life'.
3. Can BCG vaccine SSI be given to a baby
within 3 weeks of it receiving a dose of OPV as part of its primary
immunisations?
Answer - Yes. BCG and oral polio vaccines do not need to be
separated by a time interval of three weeks. Polio immunity is
essentially within the intestine, so should not interfere with the
response to BCG and vice versa.
4. An 8 week old baby has been given OPV
just 24 hours after BCG vaccine. Any problems anticipated re. immune
response/ADRs to be flagged up?
Answer - the advice set out in the Green Book should apply ie
when BCG is given to infants there is no need to delay the primary
immunisations which include OPV because the latter viruses replicate
in the intestine to induce local immunity and serum antibodies and
three doses are given.
In any event an interval of 24 hours could be considered almost
concurrent and there should not be any problems re. ADRs.
5. Confirmation of the volume of diluent
Diluted Sauton SSI to be added to the vial?
The information table from DH states 'transfer to the vial the
volume of Diluted Sauton SSI given on the label'. The label on the
vaccine states that 1 ml should be added and the vials of the
diluent state that the content is 1ml.
Yet the nurses have noticed that vials of diluent actually
contain more than 1ml. Should they be measuring out 1ml from the
vial of diluent rather than using the total content of the vial?
Answer - there is an overage in the vial of diluent and 1.0 ml of
diluent must always be measured out .
6. DH information sheet states that in
practice a maximum of 6 to 7 doses may be administered from each
vial. A nurse is concerned that she is only getting 5 doses from
each vial.
Answer- it is probably down to the individual's technique in the
preparation of the vaccine.
7. Concerns raised because there is an
apparent lack of powder in the vials containing BCG vaccine SSI.
The response from the manufacturer reads: 'BCG vaccine SSI is a
lyophilised powder for reconstitution. The amount of lyophilised
material in each vial is 0.75mg. Consequently the content is not
immediately visible to the human eye and the vial may appear empty.
Close examination of the vial for reconstitution will allow the
contents of the vial to be seen. A portion of the contents may stick
to the stopper.'
8. What is the material used for the
stoppers in BCG vaccine SSI and the diluent?
The response from the manufacturer reads: 'Both vials (BCG
vaccine for reconstitution and Sauton diluent) are fitted with
rubber stoppers, not latex stoppers'.
9. Are there any colourants/additives in the
BCG vaccine SSI?
The manufacturer has advised that neither the BCG vaccine nor the
diluent contains any other additives other than the ones listed in
the SPC and contains no colourants at all.
10. Can BCG vaccine SSI be stored for up to
half an hour in a plastic syringe after reconstitution prior to
administration?
According to the manufacturer, there is documentation that the
vaccine will be viable for up to 4 hours after reconstitution at
room temperature.
Regarding the matter of viability in a plastic syringe, there is
no documentation available. It is a well known fact that bacteria
adhere to plastic surfaces. Since the vaccine constitutes live
bacteria, we cannot be sure that the vaccine recipient gets a
sufficient dose of vaccine unless each dose is drawn from the vial
just before use.
11. Does BCG vaccine SSI contain any dairy
products, any eggs or any nuts?
The manufacturer has advised that the BCG vaccine produced by SSI
does not contain any dairy products, any egg or any nuts. All
chemicals used in the production of BCG vaccine SSI are either
synthetic or of vegetable origin.
12. Can BCG vaccine be given to a patient
who has a penicillin allergy?
The manufacturer has advised that neither penicillin nor any
other antimicrobial agent are used during the production of BCG
vaccine.
Thus, BCG vaccine may safely be used in a patient who is allergic to
penicillin.
13. Is BCG vaccine SSI listed as a Black
Triangle product?
BCG Vaccine SSI is listed as a Black Triangle on the MCA
published list. All suspected adverse reactions should be reported
through the Yellow Card scheme.
14. Are there any blood products in BCG
vaccine SSI or are there any blood products used in the
manufacturing process for the vaccine?
The manufacturer has advised that there are no blood products in
BCG vaccine SSI nor are any blood products used in the manufacturing
process for the vaccine.
15. Are there any materials of animal origin
used in the manufacture of BCG vaccine SSI?
The manufacturer has advised that all raw materials used in the
manufacture of BCG vaccine SSI are of non-animal origin.
L Gershon
Dept of Health PH6.3
21/05/03
These questions and
answers are also available in Portable Document Format (10kb)
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