Comirnaty in 2021: Two Countries, Two Different Regulatory Pathways

Comirnaty in 2021: NZ vs US Regulatory Approval

Let’s be clear about what we are actually dealing with. The claim that the Comirnaty vaccine was “experimental” – during the period, coincidentally, in which evidence of cabinet wrong-doing in August 2021 may have gone on – turns on a simple factual question: what was the actual regulatory status of the product in New Zealand and the United States, and were those statuses equivalent?

They were not. The Food and Drug Administration (FDA)’s full approval of Comirnaty on 23 August 2021 applied only to individuals aged 16 years and older. The 12–15 age group remained under Emergency Use Authorization (EUA) in the United States. In New Zealand, Medsafe’s extension of provisional consent to 12–15 year-olds occurred in June 2021, before the FDA’s adult approval, and was a separate domestic regulatory act under Section 23 of the Medicines Act 1981.

The inference by Dr Bloomfield in a carefully worded affidavit that Kiwis could take comfort from the FDA’s August 2021 approval, which somehow “sanctified” New Zealand’s approval of the vaccine for children, is therefore unsupported. The two jurisdictions were regulating different age groups under different legal frameworks at different times.

However, there are some important similarities between EUA in the US, and our own provisional consent. It is not widely known that neither require ANY safety or clinical effectiveness data, nor proof that the products were made in registered, audited labs. 

After Health Minister (at the time) Andrew Little oversaw a hurried reworking of section 23 of the Medicines Act when his Government was found to have acted unlawfully in rolling out a product with little to no safety data to the whole country, parliament did not change the fact that provisionally consented products need not prove they aren’t dangerous or useless. There is what amounts to a hopeful assumption that they may prove to have more benefits than harms but that’s about it. Little described creating this much heightened risk as an overdue modernisation of the Medicines Act.

The US Position: Full Approval for Adults Only

On 23 August 2021, the FDA granted full approval – a Biologics License Application (BLA) – to the Pfizer-BioNTech vaccine, marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older. The FDA’s own Chemistry, Manufacturing and Controls (CMC) Review Memorandum for the BLA states explicitly: “The vaccine is indicated for use in individuals 16 years of age or older.”

The 12–15 age group remained under Emergency Use Authorization. In New Zealand, the Royal Commission’s report confirms that Medsafe’s February 2021 provisional consent was “for use in people aged 16 and over also, as the vaccine’s safety and efficacy had not yet been established for younger age groups”. This is the critical point: the FDA itself had not granted full approval for the 12–15 age group at the time of the August 2021 BLA for the over 16s.

Under the EUA framework, the product is authorised on the basis that it “may be effective” and that the known and potential benefits outweigh the known and potential risks. This is a different legal standard from the BLA, which requires substantial evidence of effectiveness and a full review of manufacturing data. The NZ Royal Commission acknowledged that “there were obvious data limitations – more than would usually be expected due to the speed of the vaccine’s development”.

The NZ Position: A Separate Regulatory Pathway

On 3 February 2021, Medsafe granted provisional consent under Section 23 of the Medicines Act 1981 for Comirnaty for individuals 16 years of age and older. The Royal Commission records that Medsafe “did not recommend granting full consent for Comirnaty because some quality and clinical issues remained unresolved”. The consent was for nine months and with 58 conditions requiring Pfizer to produce more data on quality and safety within specific timeframes. The Commission also noted that “due to the speed of development and the expected modifications for large scale manufacture, substantially less quality data existed than in a standard application”.

On 21 June 2021, Medsafe extended the approved use of Comirnaty to include 12-15yr olds (although cabinet did not action this approval until later that year, on August 20th). This approval occurred two months before the FDA’s adult BLA. The NZ approval therefore could not have relied on a US approval that did not yet exist.

The Process 1 / Process 2 Problem

The BMJ has documented that the pivotal clinical trial used “clinical batches” manufactured via “Process 1” using PCR “cell-free” technology. In order to upscale production for large-scale distribution, a new method was used, “Process 2” which used DNA plasmids in E coli bacteria. The differences included “changes to the DNA template used to transcribe the RNA and the purification phase, as well as the manufacturing process of the lipid nanoparticles”.  (Note: These differences are seismic in importance, rendering the new product completely different in clinical and licensing terms. And just one of these differences, the use of plasmid DNA, has exposed the vaccinated planet to a substantial rise in cancer risk.)

The UK COVID-19 Inquiry recorded that Pfizer “commenced upscaling the manufacture of the vaccine at its facility at Puurs, Belgium, ‘at risk’, before authorisations were granted” and that “improvements were made to the manufacturing process to adjust the scalability, robustness, and productivity”.

The FDA’s CMC Review Memorandum for the BLA addressed the comparability question directly. It stated that “data obtained from the analytical comparability assessment for the ACMF (Andover clinical manufacturing facility) and Suite DS (drug substance) batches further support the DS manufacturing process for the consistent production of the BNT162b2 DS with acceptable quality”.  A regulatory document from the FDA review process further noted that “the Process 2 batches manufactured at the Andover and BioNTech sites were demonstrated to be comparable with respect to identity” and that “overall, the submitted data confirm consistent and comparable quality of Process 2 batches”. However, the same document noted a difference: “All process 2 batches were found comparable, while the Process 1 batches showed a somewhat different poly(A) tail pattern.”

However, unusually for a BLA licence, the original EUA document remained attached, covering for significant data gaps. This allowed for ‘pending’ information to remain outstanding, which was assumed would show closer equivalence of the trial drug to the mass-produced (Process 2) injection. This seems the best candidate for the slight of hand used to make the process 1/2 deception appear legal-ish. 

The BMJ rapid response by Guetzkow and Levi noted that the trial protocol amendment stated that “each lot of ‘Process 2’-manufactured BNT162b2 would be administered to approximately 250 participants 16 to 55 years of age” with comparative analyses. However, “to the best of our knowledge, there is no publicly available report on this comparison of ‘Process 1’ versus ‘Process 2’ doses”. The authors also noted that “a recent study found significant variability in the rate of serious adverse events (SAEs) across 52 different lots of Comirnaty marketed in Denmark”.

What This Means for New Zealand

The critical question for the NZ context is not whether the FDA reviewed the comparability data. It is whether New Zealand authorities had the information necessary to determine which manufacturing process was used for the vials supplied to New Zealand, whether the Process 2 product had been adequately assessed for safety and efficacy, and whether the NZ provisional consent covered the product that was actually administered.

From an OIA response in July 2024, Health NZ (HNZ) did not hold a record of what batches had what label, and HNZ held no record of manufacturing sites of mRNA drug substance. If New Zealand authorities did not hold records of which manufacturing process was used for NZ-supplied vials, then the regulatory decision was made without the information necessary to determine whether the product was the one assessed in the clinical trials or the one manufactured under the scaled-up process.

The “Sanctification” Suggestion Fails

Any inference that the FDA’s August 2021 approval may have “sanctified” New Zealand’s approval of the vaccine for children fails on multiple grounds. The age groups were different. The FDA BLA covered ages16+. The NZ decision that is relevant covered 12–15 yr olds. A foreign approval for a different age group cannot serve as the legal or scientific basis for a domestic approval of a younger population. The timing was different. The NZ provisional approval for 12–15 was granted in June 2021. The FDA BLA for 16+ was granted in August 2021. The NZ decision preceded the US decision. The legal frameworks were different. The NZ provisional consent was a domestic mechanism under Section 23 of the Medicines Act 1981. The US BLA was a foreign regulatory action. The product for children remained under EUA in the US. Even after the August 2021 BLA, the 12–15 age group in the United States continued to receive the vaccine under an EUA, until full approval for them was granted in October 2022. The manufacturing process question remains unresolved for NZ. The FDA’s review of Process 2 comparability data does not answer the question of whether NZ authorities had that data or knew which process was used for NZ vials.

Implications for the “Experimental” Question

The question of whether the vaccine was “experimental” in New Zealand law is a matter of statutory interpretation of the Medicines Act 1981 and engages the Bill of Rights Act 1990, as well as the international declarations from Nuremburg, Helsinki, Geneva etc. It is not resolved by reference to the FDA’s regulatory actions.

The factual record supports the following observations. The NZ product was supplied under a provisional consent framework. The Royal Commission confirms that Medsafe “did not recommend granting full consent” because “some quality and clinical issues remained unresolved”. This is the nature of provisional consent: it is a mechanism for early access while data is still being generated. The NZ authorities did not have a full approval from any comparable jurisdiction for the 12–15 age group at the time of their decision. The FDA’s full approval for 16+ came later and did not cover the paediatric population. The manufacturing process changed between the clinical trials and the commercial supply. The BMJ has documented that the trial used Process 1, while commercial supply used Process 2. The FDA reviewed comparability data, but it is not established that NZ authorities had access to that data or knew which process was used for NZ vials.

Conclusion

The regulatory statuses of Comirnaty in New Zealand and the United States in 2021 were not equivalent. The FDA’s full approval applied only to adults aged 16 and older. The 12–15 age group remained under EUA in the United States. New Zealand’s provisional approval for 12–15 year-olds was a separate domestic regulatory act, granted in June 2021 under Section 23 of the Medicines Act 1981, with extensive conditions requiring post-approval data submission. These conditions may have fallen by the wayside, at least as far as public disclosure is concerned. 

Any defence that the FDA’s August 2021 approval “sanctified” New Zealand’s approval of the vaccine for children is unsupported by the documentary record. The two jurisdictions were regulating Pfizer’s vaccine for different demographics under different legal frameworks at different times.

The Process 1 / Process 2 manufacturing change adds a further layer of complexity. The FDA reviewed comparability data for the BLA, but the question of whether NZ authorities had the information necessary to determine which process was used for NZ-supplied vials, and whether that process had been adequately assessed under NZ law, remains unresolved in the public record.

All of this is said with the kabuki theatre of regulatory antics in mind. As Sasha Latypova has pointed out repeatedly, in the US the legal mechanisms allow for a defensive countermeasure against a perceived bioweapon to be injected into a population without ANY information, or even consent. She is testifying on exactly this as an expert in the Netherlands right now, in the court action against top players in the mass rollout of the genetic injections. 

References

U.S. Food and Drug Administration. “FDA Approves First COVID-19 Vaccine.” FDA News Release, 23 August 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

New Zealand Royal Commission of Inquiry into COVID-19 Lessons Learned. “Phase Two Main Report.” https://www.covid19lessons.royalcommission.nz/assets/Uploads/Royal-Commission-Covid-19-Lessons-Learned-Ph2-Main-Report.pdf

UK COVID-19 Inquiry. Witness Statement. https://www.covid19.public-inquiry.uk/wp-content/uploads/2025/01/23184326/INQ000485977.pdf

British Medical Journal. “Effect of mRNA Vaccine Manufacturing Processes on Efficacy and Safety Still an Open Question.” Rapid Response, 11 October 2026. https://www.bmj.com/content/378/bmj.o1731/rr-2

U.S. Food and Drug Administration. “CMC Review Memorandum: COMIRNATY (BLA 125742/0).” 21 August 2021. https://phmpt.org/wp-content/uploads/2023/11/109_Courtesy-Copy_2_BLA-125742-0_CMC-Review-Memo-August-21-2021-COMIRNATY.pdf

U.S. Food and Drug Administration. “Process 1 and Process 2 Comparability Assessment.” https://downloads.regulations.gov/FDA-2021-P-0786-0008/content.pdf

New Zealand Gazette. “Provisional Consent to the Distribution of a New Medicine.” Notice No. 2021-go338, 20 June 2021. https://gazette.govt.nz/notice/id/2021-go338

Medsafe. “New Zealand Data Sheet: Comirnaty.”
https://www.medsafe.govt.nz/Profs/Datasheet/c/comirnaty0.3mlGreyCapinj.pdf