by Nigel Gray

Summary:
Medsafe has now formally confirmed — in writing — that it never used, defined, or relied on the terms “safe”, “effective”, or “safe and effective” in any of its regulatory work or public communications.
This directly contradicts years of government‑wide messaging that claimed vaccines were “safe and effective because Medsafe approved them.”

What Medsafe told me (OIA H2026082448)

In response to my Official Information Act request asking for:

  • definitions of “safe”, “effective”, and “safe and effective”
  • internal guidance on using those terms
  • risk‑communication frameworks
  • cross‑agency alignment
  • Medsafe’s interpretation of “safe and effective”

Medsafe refused the entire request under section 18(g)(i) — information not held.

And then they added this extraordinary statement:

“Medsafe does not use the terms ‘safe’, ‘effective’ or ‘safe and effective’. Medsafe uses the terms ‘acceptably safe’ or ‘benefits outweigh the risks’.”

This is now an official, documented position.

Why this matters

For years, New Zealanders were told:

  • “The vaccines are safe and effective.”
  • “Medsafe has confirmed they are safe and effective.”
  • “Medsafe approval means they are safe and effective.”

But Medsafe now confirms:

  • It never used those terms
  • It never defined those terms
  • It never issued guidance on those terms
  • It never aligned those terms with other agencies
  • It never assessed medicines using those terms

Instead, Medsafe uses the statutory language:

  • “Acceptably safe”
  • “Benefits outweigh the risks”

These are not the same as “safe and effective”.

The core contradiction

If Medsafe never used or defined “safe and effective”, then:

  • Who authorised the phrase?
  • Who decided it should be used in public messaging?
  • Who assessed whether it was accurate?
  • Who checked whether it was misleading?
  • Why did every agency use the same phrase if none of them held definitions or guidance?

This is a cross‑agency communications failure, and the public deserves clarity.

What happens next

I will be taking this to the Ombudsman, because:

  • Medsafe’s refusal suggests no agency holds definitions or risk‑communication analysis for the most widely used public‑health phrase of the pandemic
  • The public was repeatedly told the phrase was grounded in Medsafe’s regulatory assessment
  • Medsafe now confirms it was not
  • This raises serious issues of accuracy, transparency, and public accountability

The Ombudsman is the appropriate authority to investigate how this happened and why no agency appears to hold the underlying information.

In fact that phrase was used by Chris James Group Manager at Medsafe — @ 7.25 mins in this video — on the day provisional approval for Pfizer’s substance was announced: