HL Deb 01 December 2003 vol 655 cc19-20WA
Lord Morris of Manchester

asked Her Majesty's Government:

Further to the Written Answer by the Lord Bach on 9 October (WA 67), whether the Department of Health will revise the Written Answer given by the Lord Hunt of Kings Heath on 20 January (WA 79) with regard to the administration of anthrax vaccine in conjunction with other vaccines. [HL36]

The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)

Lord Hunt's answer, in January 2003, in which he stated that the product licence summary of product characteristics (SPC) documentation for anthrax vaccine stated that "the vaccine should be used alone" was correct at that time. The Medicines and Healthcare Products Regulatory Agency later approved (in April 2003) an amendment to the product licence SPC documentation on the recommendation of the Committee on Safety of Medicines. This amendment, as referred to by Lord Bach in his response, deleted the words "the vaccine should be used alone" and substituted the words, "Anthrax vaccine must not be mixed with any other vaccine or other medicinal product in the same syringe. If necessary, Anthrax vaccine may be given at the same time as other vaccines. Other injectable vaccines should be administered by separate injections into different anatomical sites and ideally into different limbs". The SPC documentation and the patient information leaflet have now been amended accordingly. Patients are also advised in the leaflet: "Please tell your doctor or nurse about any medicines that you are taking, whether prescribed or bought from a pharmacy (chemist). If you are taking medicines that weaken your immune system, you can still have Anthrax vaccine but you may not be as well protected as other people."

Lord Morris of Manchester

asked Her Majesty's Government:

Further to the Written Answer by the Lord Bach on 9 October (WA 75), why the Ministry of Defence did not until after 22 January 2003 ask the Committee on Safety of Medicines to review the licensing information on the administration of anthrax vaccine. [HL37]

Lord Warner

The review of the information contained in the summary of product characteristics for the anthrax vaccine (undertaken in February and March 2003) relating to concomitant use with other vaccines or medicinal products was initiated by the Medicines Control Agency (now Medicines and Healthcare Products Regulatory Agency) and was not undertaken at the request of the Ministry of Defence.

This review followed the Parliamentary Question relating to the position of the anthrax vaccine in 1990–91, tabled by my noble friend Lord Morris of Manchester on 22 January 2003, and an interim Answer given by my noble friend the Parliamentary Under-Secretary of State, Ministry of Defence (Lord Bach) on 4 February 2003 at column WA 26.

On 9 October 2003 Lord Bach responded to this Question at cols. WA 67–79. It was in response to the issues raised in this Question that the MCA (now MHRA) asked the Committee on Safety of Medicines to review the information contained within the summary of product characteristics relating to the concomitant use of the anthrax vaccine with other vaccines and medicinal products to ensure that the information given was clear, up to date, took account of all the currently available scientific data, and consistent with the approach taken with other vaccines.