This Official Information Act (OIA) request (submitted October 5, 2025, ref: H2025073669) seeks reports mandated by Condition 54 of the Pfizer Comirnaty COVID-19 vaccine’s provisional approval, as outlined in the New Zealand Gazette notice 2021-go338 (February 3, 2021). Condition 54 requires Pfizer New Zealand Limited to submit, within five working days of production, “any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies.”

Submitted only one day ago, the request awaits a substantive response from the Ministry of Health (MoH), due by approximately November 7, 2025. However, this request echoes a consistent pattern of prior OIAs on FYI.org.nz, where identical or similar requests for Condition 54 reports have been met with MoH/Medsafe responses stating that such reports “do not exist” (OIA s18(e)) or are not held. Over four years since the vaccine’s provisional approval and with over 10 million doses administered in New Zealand, the absence of these mandated reports in the public domain raises critical questions about transparency and compliance with the gazette conditions, which have been reiterated in renewals through 2025 (e.g., 2023-go5134).

Corroborating Prior OIAs Highlighting Non-Disclosure:

The following requests, all publicly accessible on FYI.org.nz, sought similar Condition 54 reports but received no substantive documents, pointing to a systemic gap in public access to efficacy and failure data:

• Request #26209 (2024, Erika Whittome, ref: H2024038268): Identical to this request, seeking efficacy, vaccine failure, and subgroup reports. MoH stated it “did not have the information requested” and referenced prior responses. Follow-ups (refs: H2024040163, H2024040733) were redirected to unrelated systems (e.g., Te Whatu Ora’s E2B safety data), with no Condition 54 reports provided.

• Request #17184 (2021, T. Baker, ref: H202114374): Requested reports for Conditions 52 (duration of efficacy/boosters) and 54. MoH explicitly stated “no such reports exist” and refused release under OIA s18(e). Only commercially sensitive data was withheld; no efficacy reports were shared.

• Request #15967 (2021, T. Baker, ref: H202108049): Sought reports for Conditions 52, 54, 56 (Periodic Safety Update Reports), and 57 (safety reviews). No Condition 54 reports were released; responses were combined with another OIA, and follow-ups (ref: H202108894) yielded only procedural letters, not data.

• Request #17917 (2021, K. Smith, ref: H202114374 variant): Referenced Condition 54 in the context of efficacy inconsistencies and informed consent. MoH provided no reports, only general datasheets, with partial refusals.

• Request #19000 (2021, J. Doe, ref: H2022018490 variant): Focused on “negative vaccine effectiveness and vaccine failure.” Acknowledged by MoH, but no Condition 54-specific reports were released.

Broader Context for Public Awareness:
Medsafe’s public resources, such as the Comirnaty datasheets (e.g., JN.1 2024), note limited efficacy insights, such as lower protection in immunocompromised groups or reduced effectiveness against variants, but lack the detailed post-marketing reports mandated by Condition 54. Safety monitoring via the Centre for Adverse Reactions Monitoring (CARM) is robust, with summaries available (Medsafe Vaccine Reports), but these focus on adverse events (e.g., myocarditis) rather than efficacy, vaccine failure, or subgroup analyses. Observational data, such as one-dose effectiveness of 44–80% against infection (ref: H2023025722, MoH Response 2023), exists but does not fulfill Condition 54’s scope.

The provisional consent for Comirnaty, initially granted for nine months in 2021, has been renewed multiple times (e.g., October 2021, April 2022, November 2023) and transitioned to full approval for original formulations in November 2023, with variant-specific consents active until November 2025 (Medsafe Status). Despite this, no public evidence confirms that Condition 54 reports have been shared, even as global studies note variant-driven failures and immunogenicity variations.

Why This Matters:
The consistent non-disclosure across multiple OIAs suggests a gap between the gazette’s mandates and public access to critical data on vaccine performance, particularly for vulnerable subgroups or real-world effectiveness. This pattern, spanning 2021–2025, invites scrutiny of how regulatory conditions are enforced and whether efficacy data is being prioritized alongside safety. For those seeking to understand the vaccine’s real-world impact, these links provide primary sources to explore the issue independently and critically.

Sources: FYI.org.nz archives, New Zealand Gazette, Medsafe publications. This annotation is for public information to foster transparency and critical thinking, not as legal or medical advice.