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Big... New FOI Response Shows MHRA Failed To Test Mass Manufactured 'Process 2' Batch Of Pfizer Vaccine
UK's medicines regulator comes clean
On December 8th, 2020, June Raine, the Head of the Medicines and Healthcare products Regulatory Agency (MHRA), publicly declared that "no corners have been cut" during the temporary authorisation of the Pfizer Covid vaccine. However, thanks to the persistence of former Ministry of Defence employee, Nick Hunt, recent findings prove Raine’s statement was not true.
For context, it's common in development trials across various sectors to first use products made in small-scale facilities or laboratories. Investing in mass production usually comes later, once there's sufficient confidence in the product's design. Scaling up, naturally, introduces new risks.
With pharmaceuticals, regulations are in place to manage this process. This is to ensure the final product remains consistent and effective.
Concerns first arose in 2022 regarding the Pfizer Covid vaccine. There were suspicions that the vaccine MHRA approved in December 2020, manufactured using "Process 2", differs from the version tested in Pfizer's clinical trials, manufactured using "Process 1". Josh Guetzkow, an Israeli academic, brought the difference to light, referencing Freedom of Information requests from various countries and Pfizer documents released by U.S. courts.
In May 2023, he published this rapid response in the British Medical Journal alongside Professor Retsef Levi, airing his concerns.
Guetzkow highlighted two things. First, there is a lack of publicly available reports comparing vaccines produced by both processes. Second, there is significant variability in the rate of serious adverse events across different vaccine lots, underscoring the need to better understand variability in the production process.
In October 2020, Pfizer had committed to comparing safety and immunogenicity results between vaccines produced by both processes. Yet, when Hunt submitted his initial FOI request concerning the latter to MHRA in July, their initial response directed him to the European Medicine Agency's archive without specific guidance.
Here’s the bombshell.
Nick then requested an internal review. In their response, MHRA admit their replies “were not compliant with the (FOI) Act and did not provide or address the specific information (Nick) asked for”.
They then confess they do not possess the "Process 2" report.
The document goes on to state the “Process 2 drug... was shown to be comparable through side-by-side comparability studies and heightened characterisation testing”. In short, trust us, we’ve seen the data but we can’t show it to you and we don’t have it.
Worse yet, MHRA also revealed they failed to chase Pfizer on the promised report that the company should have published comparing the products. This was because of the “extensive usage of vaccines manufactured via Process 2”.
Something tells me they won’t cover this in the Covid Inquiry...
This is simplified summary of Nick’s article with added context and links. The article was published just hours ago on The Daily Sceptic - you can read the original report here.