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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