Department of Health

Website of the Department of Health

Please note that this website has a UK government access keys system.

JCVI/CSM (Committee on the Safety of Medicines/Joint Committee Vaccination and Immunisation) Sub-Committee on Adverse Reactions to Vaccines

  • Last modified date:
    9 March 2007

Responses to questions about the work of the JCVI/CSM (Committee on the Safety of Medicines/Joint Committee on Vaccination and Immunisation) Sub-Committee on Adverse Reactions to Vaccines.

Questions

1. The Scottish Home and Health Department report on the deaths of Scottish Twins "temporally associated with DPT Immunisation"

 2. The DHSS paper calculating the likelihood of a chance association between DTP and SIDS (1985)

 3. Minutes of the June 1984 ARVI meeting (ARVI 84/20)

 4. Minutes of the June 1986 meeting of the Joint BPA/JCVI Liaison group and all Minutes of that group.

 5. Minutes of meetings of the Sub-Group of the Pertussis Sub Committee of the MRC, CDVIP.

 6. Reports on PHLS surveillance of adverse reactions to two measles vaccines (Rimevax and Attenuvax)

 7. Report to the CSM, June 1983 to September 1985 re "Suspected adverse reactions to measles vaccine."

8.   Adverse reactions associated with vaccines reported on Yellow Cards during the period 19th September 1985 to 15th January 1986. The reactions included at least 6 deaths, 6 convulstions, anaphylaxis (one resulting in death), allergies, apnea, petit mal etc.

Responses to questions 1-3

1.  We have gone through our paper work and the only document that mentions the Scottish twins is ' Vaccination and cot deaths in perspective, S C Roberts, 1987'. 

This paper by S C Roberts appeared in Archives of Disease in Childhood 1987 vol 62 pages 754-759 and cannot be reproduced here for copyright reasons. Copies can be obtained via your local library. Abstract available on  Archives of Disease in Childhood website

2.  We provide the information requested.(DHSS paper calculating the likelihood of a chance association between DTP and SIDS (1985)

3.  We provide the information requested but some has been redacted and is being withheld under section 40 and 43 of the Act.  You will see that the list of attendees is disclosed in each set of minutes but that all members names have been redacted in the body of the text in order that the comments made are unattributable under section 40 of the Act.  In addition, as some references are made to pharmaceutical companies which include commercial interests this has been excluded from the table under section 43 of the Act.

The ARVI 2nd Meeting 1984 referred to a preliminary draft version of a paper by Harrison C Stetler,  Kenneth J Bart, W alter A Orenstein , Edward W Brink, John P Brennan and Alan R Hinman "Should a personal or family history of convulsions be a contraindication to receipt of pertussis vaccine" (Centers for Disease Control, Technical Information Services Atlanta, Georgia) which cannot be reproduced for copyright reasons. Subsequently published Journal of Pediatrics 1985 August 107(2) p175-9

Section 43 is a qualified exemption and requires a public interest test. There is a general public interest in the disclosure of commercial information to help ensure that there is proper scrutiny of government actions, for example, in carrying out licensing functions in accordance with published policy. It is also in the public interest to show that public money is being used effectively and that Departments are getting value for money when purchasing goods and services. However, factors weighing in favour of withholding such information include where disclosure would make it less likely that companies or individuals would provide the Department with commercially sensitive information in the future, consequently undermining its ability to fulfil its role. Information to which s.43(2) applies has consequently been redacted from the versions of the JCVI AVRI minutes.

Responses to question 4

4.  We have gone through our papers and found 3 sets of minutes of the Joint BPA/JCVI for 1986, but some has been redacted under section 40 and 43 of the Act.  You will see that the list of attendees is disclosed in each set of minutes but that all members names have been redacted in the body of the text in order that the comments made are unattributable.  In addition, as some references are made to pharmaceutical companies which include commercial interests this has been excluded from the table under section 43 of the Act.  We could not find any other minutes for other dates.

The minutes of  the Joint Sub Committee on Adverse Reactions to Vaccines and Immunological Products (ARVI 86/1st Meeting ARVI 86/9) refer to a paper  translated from Norwegian which cannot be reproduced here for copyright reasons.

Solberg LK. 1985. DPT vaccination, visit to child health center and sudden infant death syndrome (SIDS): evaluation of DPT vaccination. Report to the Oslo Health Council 1985. (Available as NIH Library translation 85-152, Food and Drug Administration, Bethesda, MD.)

Section 43 is a qualified exemption and requires a public interest test. There is a general public interest in the disclosure of commercial information to help ensure that there is proper scrutiny of government actions, for example, in carrying out licensing functions in accordance with published policy. It is also in the public interest to show that public money is being used effectively and that Departments are getting value for money when purchasing goods and services. However, factors weighing in favour of withholding such information include where disclosure would make it less likely that companies or individuals would provide the Department with commercially sensitive information in the future, consequently undermining its ability to fulfil its role. Information to which s.43(2) applies has consequently been redacted from the versions of the JCVI Joint BPA/JCVI minutes.

Responses to questions 5-8

5.  We have gone through our papers and not found the minutes of the subgroup of the Pertusis sub committee of the MRC, CDVIP.

6.  We have provided the information requested in liaison with the Medicines and Healthcare Products Regulatory Agency (MHRA). Please note that we have removed personal information that could identify individuals under Section 40 of the FOI Act (details such as patient sex/age, ADR reference number etc).  In addition, following the 2004 Independent Review of Access to the Yellow Card Scheme we do not release any adverse drug reaction data subset in which there are five or fewer cases per cell. This is necessary to prevent potential identification of patients and/or reporters.

7.  We have provided the information requested in liaison with the MHRA. Please note that we have removed personal information that could identify individuals under Section 40 of the FOI Act (details such as patient sex/age, ADR reference number etc).  In addition, following the 2004 Independent Review of Access to the Yellow Card Scheme we do not release any adverse drug reaction data subset in which there are five or fewer cases per cell. This is necessary to prevent potential identification of patients and/or reporters.

8.  We have provided the in information requested in liaison with the MHRA. Please note that we have removed personal information that could identify individuals under Section 40 of the FOI Act (details such as patient sex/age, ADR reference number etc).  In addition, following the 2004 Independent Review of Access to the Yellow Card Scheme we do not release any adverse drug reaction data subset in which there are five or fewer cases per cell. This is necessary to prevent potential identification of patients and/or reporters.

Further information on Freedom of Information exemptions 40 and 43

Access keys