In a new two-part report, Paula Jardine investigates apparent collusion between Pfizer and members of the expert advisory board to the UK Vaccine Taskforce. In July 2020, months before the December 2020 MHRA temporary use authorisation (TUA) for Pfizer’s vaccine was issued, discussions mooting this ‘sleight of hand’ means of opening the door to fast-tracking the FDA regulatory approval (required in Pfizer’s multi-billion dollar Operation Warp Speed contract with the US government) were taking place.
IN July 2020, while Pfizer was negotiating Covid vaccine contracts with both the UK and US governments it was also, apparently, discussing with representatives of the UK government’s Vaccine Taskforce a temporary authorisation for the supply of the unlicensed medicine under Regulation 174 of the UK Human Medicines Regulations (HMR) 2012.
The two government contracts were being negotiated in tandem. The UK announced on July 20, 2020 that it had secured a supply agreement for 30million doses of the Pfizer/BioNTech vaccine BNT162. The companies, in their own announcement, stated optimistically that they expected to be ready to apply for regulatory approval in October. One day later Pfizer secured a $195billion Operation Warp Speed (OWS) contract with the US Department of Defense (DOD) for a demonstration project to ‘manufacture and distribute 100million doses of an ‘FDA [US Food and Drug Administration] authorised or approved’ novel mRNA-based vaccine based on demonstration of efficacy’. The contract stipulated that the doses were to be manufactured on American soil and contains what is described as an aspirational authorisation date of October 31, 2020.
The question is, did the companies agree to this unrealistically aggressive OWS timeline well before trials for efficacy and safety were complete, in the expectation of achieving it with some assistance from the UK government and its regulator, the Medicines and Healthcare products
Regulatory Enabling Agency, in the form of a TUA? It seems so and the evidence for this is set out below.
The UK’s July 20, 2020 announcement from Business Secretary Alok Sharma and Health Secretary Matt Hancock came prior to the start of the phase 3 clinical trial and months before any efficacy data was available. It stated that the UK government had entered into a ‘binding agreement’ with Pfizer/BioNTech for the supply of its vaccine. ‘A safe and effective vaccine is our best hope of defeating coronavirus and returning to life as normal,’ said Hancock.
This supply deal was brokered by the Vaccine Taskforce whose chair, Kate Bingham (now Dame Kate) said: ‘We are investing in a diverse portfolio of vaccine candidates to maximise the chances of finding a vaccine quickly that meets the UK’s rigorous regulatory and safety standards.’ Getting her excuses in early, she warned against over-optimism, saying: ‘The fact remains we may never get a vaccine and if we do get one, we have to be prepared that it may not be a vaccine which prevents getting the virus, but rather one that reduces symptoms.’
Despite this the MHRA told the British public in December 2020 the vaccine it was authorising was for ‘active immunisation to prevent Covid-19 disease’.
Pfizer/BioNTech issued their own press release on the UK vaccine supply deal and it is this which gives away the backroom agreements apparently entered into, or understood. The binding supply agreement was, the release stated, ‘subject to clinical success and regulatory approval’. But it went on to say: ‘Pfizer and BioNTech expect to be ready to seek Conditional Marketing Authorisation (CMA) or some form of regulatory approval as early as October 2020 (my italics). The companies currently expect to manufacture, globally, up to 100million doses by the end of 2020 and potentially more than 1.3billion doses by the end of 2021, subject to final dose selection from the clinical trial.’
Was it a done deal?
Conditional Marketing Authorisations are the European equivalents of FDA Emergency Use Authorisations (EUA). The ‘some form of regulatory approval’ referred to can only be a temporary use authorisation (TUA). This was precisely the mechanism used by the MHRA in December 2020 to authorise a single batch, EJ0553, of the Pfizer/BioNTech product (which was not identical to the one used in the phase 3 trials). Remember, the UK was fully under EU law until the end of the Brexit transition period on December 31, 2020 and while it was, the European Medicines Agency (EMA) had sole legal authority to grant BioNTech’s mRNA-Covid ‘vaccine’ the Conditional Marketing Authorisation referred to in the company press release. The only means available to the MHRA to authorise anything prior to December 31 was to bypass the EMA by authorising the temporary supply of the unlicensed product under Regulation 174. This they did, and on that day MHRA’s chief executive Dr June Raine said with brazen assurance, ‘The public’s safety has always been at the forefront of our minds – safety is our watchword.’
Since the BioNTech vaccine was not being evaluated in Europe as an advance medicine, an existing authorisation from the EU or the UK was needed to provide cover to accelerate the process allowing the FDA, who class mRNA as a gene therapy, to rubber-stamp it with its own EUA. The efficacy requirements for this require only a subjective judgement by the US Secretary of Health and Human Services that the countermeasure ‘might’ be effective. It is noteworthy therefore that the companies made the bold claim in November 2020 that their vaccine was 95 per cent effective, a statistic that was later revealed to be grossly misleading.
When the MHRA issued a TUA on December 2, 2020, some two weeks after Matt Hancock’s DHSC requested it to and following the 95 per cent effective claim, the companies said confidently that they were anticipating further regulatory approvals across the globe in the coming days and weeks: ‘This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK.’ So said Albert Bourla, chairman and chief executive officer, Pfizer, whose gratitude is not to be wondered at. It has benefited him personally to the tune of many, many millions.
Other regulators followed the MHRA like falling dominoes. Hard on its heels on December 11, 2020 the FDA issued the EUA Pfizer needed to meet its Warp Speed contract, five weeks behind the original aspirational target. The US government then granted Pfizer a further windfall, topping up the initial $1.95billion contract with an additional $4billion in Covid vaccine supply contracts.
The ‘laggard’ EMA finally squared the circle for the MHRA on December 21, 2020, when they issued a Conditional Marketing Authorisation that superseded the TUA, while the UK was still under EU law. The MHRA later admitted ‘this [TUA] was always intended to be a temporary arrangement’.
There are further ‘anomalies’, starting with the UK’s binding supply agreement. On July 22, 2020 BioNTech announced the price of its stock for a $500million supplemental share offer (by this juncture, its share price had risen from $18 when it made its US stock market debut in September 2019, to $93) and issued a prospectus. The Operation Warp Speed contract is not mentioned, but the UK supply agreement is – in tortured language – for the purpose, it appears, of over-selling the reality of this ‘binding agreement’. Yet as no money had changed hands, there was no actual contract, just a promise to enter into one at a later date on pre-agreed terms.
The OWS contract announcement was made by the US Department of Health and Human Services (HHS) on the same day (July 22, 2020) as BioNTech’s stock offer. It looks to have been timed to inflate investor interest to help BioNTech maximise the funds raised. It also points to the reason why the companies, at the time, were discussing ‘some form of regulatory approval’ with the UK taskforce – the US contract depended on the vaccine being authorised in the US: ‘The federal government will own the 100million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if (my emphasis)the product receives Emergency Use Authorization (EUA) or licensure from the US Food and Drug Administration (FDA), as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial.’
(The vaccine batch supplied by Pfizer to the UK in December 2020 was manufactured under the OWS contract, which means the UK government received US government property.)
There’s a final oddity. A document found via Pfizer’s website shows that Pfizer began drafting the clinical trial protocol on December 5, 2019, four months before it announced its collaboration agreement with BioNTech to develop their Covid vaccine and well before China alerted the World Health Organization (WHO) about the Wuhan pneumonias of ‘unknown cause’.
The drafting began a day after Dr Robert Kadlec, the then Assistant Secretary of Preparedness and Response (ASPR) at HHS, testified to a House of Representatives panel on pandemic influenza preparedness saying, ‘On the issue of vaccines alone, I think the key thing is – I can’t give you the particulars, but we’re going to have an announcement here shortly that will indicate some investments domestically to expand some of our new technologies – newer technologies for vaccine manufacturing. And I think the key thing there is, we are actively pursuing this in accordance with the executive order.’
BioNTech’s rival Moderna also began developing its Covid vaccine programme in December 2019, before China reported the Wuhan outbreak to the WHO.
Part 2 will focus on the UK government advisers and officials who oversaw the Vaccine Taskforce while it was brokering deals with vaccine companies including Pfizer.