Zostavax delisted from, Shingrix listed to National Immunisation Schedule

OIA response

Thank you for your request dated 30 June 2023 under the Official Information Act 1982 (OIA) for information relating to the change of brand of shingles vaccine from Zostavax to Shingrix. You wrote:

I would like to request, under the official information act, any communications, emails, minutes of meetings, including those from the Immunisation sub committee, which discuss the removal of Zostavax from the NZ immunisation schedule. I would like to know the medical rationale behind its removal.

I know that Merck, the makers of Zostavax, are involved in lawsuits in the USA over its usage. Has this factored in the decision?

Zostavax shingles vaccine discontinued by supplier

In response to your request, I can advise that there is no specific medical rationale for the removal of Zostavax from the Pharmaceutical Schedule (the National Immunisation Schedule(external link)). Zostavax was removed from the Schedule as it was discontinued by the pharmaceutical supplier. There was no consideration or discussion of any lawsuits in the decision to delist Zostavax. 

In August 2020, Merck Sharpe and Dohme (MSD) advised Pharmac that it would be discontinuing supply of its zoster vaccine (Zostavax) as it intended to convert its zoster manufacturing sites over to manufacture of its developmental COVID-19 vaccine. MSD subsequently advised in 2021 that it had stopped development of its COVID-19 vaccine but would still discontinue its zoster vaccine.

Pharmac sought clinical advice from its Immunisation Advisory Committee (formerly the Immunisation Subcommittee) about whether an alternative herpes zoster/shingles vaccine was required to replace Zostavax. Pharmac then secured the supply of Shingrix and listed it on the Schedule from 1 August 2022 for use once all funded stock of Zostavax had been used.

Zostavax documents already publicly available

In an OIA response of 31 January 2023 we released a copy of the clinical advice paper to the Immunisation Advisory Committee (May 2022) [PDF, 319 KB] regarding the proposal to fund Shingrix for the prevention of herpes zoster and post-herpetic neuralgia in adults 65 years of age or older. The clinical advice paper asks the Immunisation Advisory Committee questions about the discontinuation of Zostavax and the proposal to fund Shingrix. For a summary of the discussion, see the record of the meeting of May 2022 for the Immunisation Advisory Committee [PDF, 245 KB] published on our website. 

Additional documents released in response to your request

I believe the above information addresses your request for information, on the basis that it confirms there was no “medical rationale” behind the removal of Zostavax from the Schedule. 

However, to provide a comprehensive response to your request, I have released two additional documents (combined in a single PDF) with this letter. The additional documents released with this response are:

  1. Memorandum for consideration by the Director of Operations under delegated authority (July 2022) – Shingrix (recombinant zoster vaccine) listing and purchase; and,
  2. The minute of the Director of Operations decision under delegated authority (July 2022).

Please note that we approach our assessment of requests for information under the OIA on the basis that 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).

We have redacted a small amount of information from the documents as we consider this is necessary to:

  • protect the privacy of natural persons (section 9(2)(a));
  • 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));
  • maintain the effective conduct of public affairs through the free and frank expression of opinions by or between officers and employees of an organisation in the course of their duty (section 9(2)(g)(i); and,
  • enable Pharmac to carry on, without prejudice or disadvantage, negotiations, including commercial negotiations (section 9(2)(j)).

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.

Closing

We trust that this information answers your queries. Please note, you have the right to make a complaint to the Ombudsman about our response to your OIA, under section 28(3) of the OIA. Details of how to make a complaint(external link) are on the Ombudsman’s website.

To make information more freely available, we publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.