Decision to change the tetanus vaccine and immunisation schedule

19 November 2020

Dear [name and contact details withheld]

REQUEST FOR INFORMATION

Thank you for your request dated 21 October 2020, transferred to us by Ministry of Health under the Official Information Act 1982 (OIA), for information relating to the decision to change the immunisation schedule for tetanus.

You noted “the Tetanus Immunisation schedule and Vaccine have changed this year” and specifically requested

“A copy of the relevant documentation pertaining to this decision”.

Please see our response to your request, detailing the decision process for the change in tetanus vaccine and immunisation schedule, below. Additionally, please see Appendix 1, attached with this response, for copies of documents relevant to this decision.

Appendix 1. [PDF, 5.7 MB]

Please note that PHARMAC approaches its assessment of requests for information under the OIA on the basis that, once released, the information becomes publicly available - in other words once we release the information to you it becomes available to any other party in that exact form (whether by you distributing it to others or by virtue of us receiving the same request from a different third party).

Some of the information contained in the papers we are releasing is not related to the tetanus vaccine and is therefore ‘out of scope’ of your request. Where this is the case, we have redacted the irrelevant material or, if an entire page was irrelevant, excluded the page. We have also redacted some information, under remit of the OIA, where we consider this is necessary to:

• protect information where the making available of the information would be likely to unreasonably prejudice the commercial position of the person who supplied or who is the subject of the information (section 9(2)(b)(ii)); and/or
• protect information which is subject to an obligation of confidence or which any person has been or could be compelled to provide under the authority of any enactment, where the making available of the information would be likely to prejudice the supply of similar information, or information from the same source, and it is in the public interest that such information should continue to be supplied (section 9(2)(ba)(i)); and/or
• enable PHARMAC to carry on, without prejudice or disadvantage, negotiations, including commercial negotiations (section 9(2)(j)).

Appendix 1 does not contain meeting records/minutes that were ‘in scope’ of your request, in reliance of section 18(d) of the OIA, as these are publicly available and we have instead provided direct links to/directions for accessing these documents.

As required under the OIA, we also considered whether, in the circumstances, the withholding of this information was outweighed by other considerations which render it desirable, in the public interest, to make this information available.  In this case we did not consider that the public interest outweighed the reasons for withholding the information.

Please note you have the right, by way of complaint under section 28(3) of the OIA to an Ombudsman, to seek an investigation and review of our decision.

Decision process

In November 2017, the Ministry of Health convened a meeting to review the National Immunisation Schedule. At this meeting, attendees reviewed the World Health Organization (WHO) recommendations to ensure lifelong protection from tetanus/diphtheria, and the New Zealand Immunisation Schedule at the time. A copy of the 2017 National Immunisation Schedule Review meeting minutes, as previously released by the Ministry of Health in response to an OIA request (and with ‘out of scope’ information withheld by PHARMAC for ease of reference), is provided within Appendix 1.

In September 2018, the Immunisation Subcommittee of the Pharmacology and Therapeutics Advisory Committee (“Subcommittee”) reviewed a clinical data update from Seqirus (NZ) Ltd for the diphtheria tetanus and acellular pertussis (TdaP-Booster) vaccine. Record of the Immunisation Subcommittee meeting held 18 September 2018(external link), and all other past meetings, can be found on our website: www.pharmac.govt.nz(external link) > About > How we get expert advice > PTAC subcommittees > Immunisation Subcommittee > Immunisation Subcommittee minutes.

In November 2018, PHARMAC issued a request for proposals (RFP) for the supply of various vaccines and influenza vaccines.(external link) The RFP requested proposals for the adult diphtheria and tetanus vaccine (ADT Booster), in addition to a range of other vaccines. ADT Booster was the funded brand of tetanus vaccine at the time of the RFP opening.

Following the RFP closing, PHARMAC evaluated the submissions provided in response to the RFP then prepared a memorandum titled ‘Vaccine RFP 2019: Possible RFP brand or dose schedule changes’ (Appendix 1) for consideration by the Immunisation Subcommittee of the Pharmacology and Therapeutics Advisory Committee (“Subcommittee”). This memorandum was reviewed by the Subcommittee at the March 2019 meeting. The record of the Immunisation Subcommittee meeting held 8 March 2019(external link) can be found on our website.

In May 2019, PHARMAC issued a consultation for a proposal for changes to funded vaccines in the National Immunisation Schedule(external link). Following review of the consultation feedback for the proposal, PHARMAC prepared a memorandum titled ‘Proposal for the supply of various vaccines with proposed changes to the funded brand or eligibility criteria and to decline bids for various other vaccines’ (Appendix 1) for the PHARMAC Board of Directors (“Board”). This memorandum was reviewed by the Board at the June 2019 meeting. Minutes of the June 2019 PHARMAC Board meeting(external link) can be found on our website: www.pharmac.govt.nz(external link) > About > Who we are > Our Board > Minutes of PHARMAC Board Meetings.

In July 2019, PHARMAC issued a decision notification for changes to funded vaccines in the National Immunisation Schedule(external link) which would take effect in 2020. This decision notification also noted “eligibility criteria will be amended to restrict the tetanus booster at age 45 to individuals who have not received 4 tetanus vaccinations in their lifetime.”

We trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this. 

Yours sincerely

Rachel Read
Manager, Policy and Government Services