A SYMBOLIC curtain fell at the beginning of this month. US Health and Human Services Secretary Robert F Kennedy Jr announced he was ending his predecessor Alex Azar’s Covid-19 emergency use authorisation (EUA) declarations, while giving manufacturers a further 12-month window to seek full Food and Drug Administration (FDA) approval for their products.
‘Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,’ said Kennedy. ‘By ending these Covid-19 emergency use authorization declarations, we’re reinforcing public confidence that emergency authorities are temporary and targeted.’
Ending the EUA declaration is an important gesture but it changes little of consequence. The principal objective of Azar’s EUAs was to push DARPA’s mRNA Pandemic Prevention platform into use with as minimal scrutiny as possible. Mission accomplished. The mRNA Pandora’s Box from which Moderna and BioNTech have profited handsomely was prised open. On its own, it fails to deliver what’s needed most – accountability.
At least the FDA was always transparent about what an EUA is. Guidance published in January 2017 makes clear that an EUA is a mechanism for allowing the use of an ‘unapproved investigational medicinal product (IMP)’. The PREP Act, which was used to create a mass market for DARPA’s mRNA platform while freeing the companies from any liability, openly and intentionally strips American recipients of EUA investigational medicines of the historical legal protections intended to prevent non-consensual medical experimentation. It does this by legally segregating emergency use of IMP from the clinical trial itself. PREP Act declarations have no extraterritorial validity – they are American law. The reality is that covid-era EUAs amounted to unregulated and involuntary experimentation on the public for private gain and public policy objectives.
Where the real reckoning is needed is in the UK. During the Covid era, the UK public had none of the three things – transparency, accountability, and [conduct] rooted in the rule of law – that Secretary Kennedy says Americans deserve, and it was our medicines regulator, the Medicines Healthcare products Regulatory Agency (MHRA), which bore the greatest responsibility for the deployment of the DARPA P3 mRNA platform.
The European regulatory framework under which the UK initiated the global rollout of mRNA ‘vaccines’ in 2020 is different from the US framework. The European framework has no similar legal segregation stripping recipients of legal protections attached to IMPs manufactured under the Medicines for Human Use (Clinical Trials) Regulations 2004. Arguably, by virtue of Regulation 174 being a provision of the separate and distinct Human Medicines Regulations (HMR) 2012, it is implied that any product being authorised by a national regulator for temporary supply has a marketing authorisation somewhere that can be relied upon, just not a valid European one issued centrally by the European Medicines Agency.
The MHRA cleaves to the line that its authorisation for temporary supply of the Pfizer/BioNTech vaccine BNT162b2 (the legal identifier of the Pfizer BioNTech’s clinical trial candidate) under Regulation 174 HMR 2012 was lawful. Yet closer scrutiny points to it having adopted the US EUA framework without telling the public and bending the laws reserving IMP use for clinical trials to do so.
The MHRA released to the UK Covid Inquiry its recommendation for the Regulation 174 Authorisation for Temporary supply of the Oxford/AstraZeneca SARS-CoV2 vaccine. The document contains a section about Pfizer/BioNTech BNT162b2, in which the MHRA says in paragraph 12: ‘It is our view, on the basis of these, that the R174 authorisation which relates to specific pre-commercial batches of the Pfizer vaccine currently allocated for emergency use in the UK, is distinguishable from the CMA, as that approval relates to vaccine batches produced through a fully commercial process. It is also marketed under a different name; partitioning the market in that way is a normal feature of regulatory and business practice.’
This is unadulterated bureaucratic double-speak. The pre-commercial batches were ‘unapproved investigational medicinal product’. The UK public deserved full transparency over that. They didn’t get it.
Describing himself as ‘delighted’, on December 2, 2020 the then Health Secretary Matt Hancock told the Commons, ‘Ever since this pandemic hit our shores, almost a year ago, we have known that a vaccine would be critical to set us free.’
In parts Hancock’s statement is shamelessly disingenuous. ‘We have said from the start that a vaccine must be safe and effective, before we would even consider deploying. Any vaccine must go through a rigorous process of clinical trials involving thousands of people, and extensive independent scrutiny from the MHRA, one of the world’s most respected medical regulators.’
When the public was told a vaccine was being authorised for use, neither its then interim Chief Executive Dr June Raine nor Hancock told the public the product to be used (BNT162b2, which is the legal name of BioNTech’s clinical trial candidate) was as the FDA puts it, an ‘unapproved investigational medicinal product’.
Nor when they said a vaccine was ‘safe and effective’ were they being candid. This claim was extrapolated; they couldn’t actually have known it to be true because the product they authorised was not the one the companies actually tested in the trials.
The Commission on Human Medicines (CHM) minutes from 2020 https://www.conservativewoman.co.uk/cws-top-ten-blogs-of-the-year-untested-the-mass-produced-covid-vaccines-that-skipped-clinical-trails/ show that the National Institute of Biological Standards and Controls (NIBSC) concern in November 2020 was ensuring the first batch of BNT162b2 selected for UK supply was sufficiently similar to the product being tested in the clinical trial to be a qualified clinical trial comparator.
The CHM minutes of November 27 and 28, 2020 show that Batch EJ0553, ultimately selected as the first UK batch, was a substitute batch put forward by Pfizer/BioNTech after NIBSC rejected the first two batches offered. These batches are given the aliases CTM12 and CTM in the minutes (CTM is short for Clinical Trials Material.) They were manufactured using an upscaled manufacturing process and found to be unqualified to be clinical trial comparators because they weren’t similar enough to the Process 1 product used in the clinical trials.
The Batch EJ0553 vial that contained the dose of Pfizer/BioNTech BNT162b2 used on the UK’s first recipient, 91-year-old Margaret Keenan, is on display at the Science Museum. It is labelled as an FDA EUA product. As Pfizer’s November 20, 2020 response to FDA queries shows, this was originally intended to be the first batch deployed in the USA – under FDA EUA authorisation for an ‘unapproved investigational medicinal product’ (IMP). The same document shows that CTM12 and CTM[13], the aliases used in the CHM minutes for the rejected batches, are Batches EE8492 and EE8493. Despite the initial rejection, both these batches were supplied to the UK public and EJ0553 and the non-qualified comparator batch EE8493 were used formally in Pfizer’s booster trial.
If the UK batches were pre-commercial emergency use product, they were by the FDA definition an ‘unapproved Investigational Medicinal Product’. In all 19million people were injected with BNT162b2 in a de facto clinical trial of an IMP authorised for use under Regulation 174 of the HMR 2012. Batch EJ0553 was not tested in humans before it was used in the UK covid vaccine rollout. This lack of candour means that recipients in the UK could not and did not give informed consent.
Ironically the date chosen for Hancock’s announcement that the UK government had officially approved the Pfizer/BioNTech Covid-19 vaccine – December 2, 2020 – was the 59th anniversary of the withdrawal of another notorious drug, thalidomide, the pharmaceutical poster-child epitomising regulatory failure.
A prudent communications team ought to have avoided such a date for the sensitive launch of a high profile first in class genetic pharmaceutical like mRNA, if only to avoid any future potential symbolic association between mRNA and the drug responsible for the hitherto highest profile drug disaster in modern medical history.
The timing of the announcement appears to have been driven by other considerations and fixed months earlier. The UK Vaccine Taskforce either inadvertently overlooked it or didn’t care when they issued a purchase order on October 16, 2020 stipulating delivery of the first batch of Pfizer BioNTech’s BNT162b2 on December 3, 2020.
One chapter of the Emergency Use era may be closing, but this disgraceful mechanism for experimenting on the unsuspecting public needs to be the last of its kind. And as for the MHRA, it is time for a proper reckoning. Americans aren’t the only people who deserve a medicines regulator that is transparent, accountable and rooted in the rule of law.
