On December 8th, 2020, June Raine, the Head of MHRA, assured the public that there were no shortcuts taken when the Government granted Temporary Authorization for the Pfizer Covid vaccine. However, based on information obtained through the Daily Skeptic FOI request to MHRA, it seems that this statement may not have been entirely accurate.
Before delving further, let’s provide some context. In most development trials across various sectors, products are created using small-scale manufacturing facilities or labs. This cautious approach avoids investing in mass production (including new machinery, tooling, and potentially a new factory) until confidence in the design is established.
Conversely, scaling up production introduces new challenges. To simplify, imagine going from baking a dozen cupcakes in your kitchen to producing thousands for sale in stores. Acquiring, measuring, and mixing large quantities of ingredients becomes a substantial challenge. These ingredients may need to come from multiple sources, requiring assurance of their equivalence.
Achieving homogeneity in large vats is more complex than in a mixing bowl, and the baking process becomes more intricate. Alterations to the production process or the addition/substitution of ingredients may be necessary, raising the risk of ending up with cupcakes that are noticeably different.
Without comparing test results from the initial full-scale production batch to those from the cupcakes made in your kitchen, you’re essentially operating in the dark. Fortunately, there are stringent regulations overseeing this scaling-up process for medicines. One relevant document is available from the European Medicines Agency.
In 2022, I became aware of a potential ‘bait and switch’ scenario concerning the Pfizer Covid vaccine. There was suspicion that in December 2020, the MHRA approved a vaccine (manufactured by ‘Process 2’) different from the one tested in Pfizer’s clinical trials (manufactured by ‘Process 1’), and no comparative data was provided.
An example can be found in an article by Josh Guetzkow, an Israeli academic, which drew on FOI requests from other countries and the release of Pfizer documents mandated by U.S. courts.
One statement in Guetzkow’s article troubled me: “To the best of our knowledge, there is no publicly available report on this comparison of ‘Process 1’ versus ‘Process 2’ doses.” Just as correlation does not imply causation, the absence of evidence does not necessarily mean evidence of absence.
Guetzkow’s article led me to a disclosure by Pfizer in October 2020 (found at the bottom of page 46 here):
“The safety and immunogenicity results for individuals 16 to 55 years of age vaccinated with study intervention produced by manufacturing ‘Process 1’ and each lot of ‘Process 2’ will be summarized descriptively. A random sample of 250 participants from those vaccinated with study intervention produced by manufacturing ‘Process 1’ will be selected randomly for the analysis.”
Subsequently, I submitted an FOI request to MHRA for a copy of the pertinent Pfizer report. MHRA’s initial response directed me to the European Medicine Agency’s archive of reports, essentially asking me to find it myself. This did not seem particularly transparent.
Following this, I requested an Internal Review, and I have now received a response in which MHRA admits it does not possess such a report. This revelation is nothing short of a bombshell.
It has also come to light that the promised comparison between ‘Process 1’ and ‘Process 2’ products remained a condition of authorization until September 2022 when the EMA and MHRA ultimately conceded to Pfizer’s argument that the pledged comparison was unnecessary due to the “extensive usage of vaccines manufactured via Process 2.”
Inescapably, I conclude that June Raine was, to put it delicately, not entirely forthright with us in December 2020 when she asserted that no corners had been cut. Her agency failed to adhere to its own regulations for validating the production process. It was essentially operating without a clear path.
Nick, until his recent retirement, held a senior position in the Ministry of Defence overseeing the safety and effectiveness of ammunition used by the Armed Forces. He is also a co-author of the Perseus Group report on the U.K. medicines regulator, MHRA.
Until Nick Hunt retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.